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20 June 2014 EMA/373842/2014 Procedure Management and Business Support Annex I List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, marketing authorisation holders in the member states for ibuprofen-containing medicinal products and dexibuprofen-containing medicinal products (systemic formulations) Article 31 of Directive 2001/83/EC Procedure number: EMEA/H/A-31/1401 7 Westferry Circus Canary Wharf London E14 4HB United Kingdom An agency of the European Union Telephone +44 (0)20 7418 8400 Facsimile +44 (0)20 7418 8416 E-mail [email protected] Website www.ema.europa.eu © European Medicines Agency, 2014. Reproduction is authorised provided the source is acknowledged.

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20 June 2014 EMA/373842/2014 Procedure Management and Business Support

Annex I

List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, marketing authorisation holders in the member states for ibuprofen-containing medicinal products and dexibuprofen-containing medicinal products (systemic formulations)

Article 31 of Directive 2001/83/EC

Procedure number: EMEA/H/A-31/1401

7 Westferry Circus ● Canary Wharf ● London E14 4HB ● United Kingdom

An agency of the European Union Telephone +44 (0)20 7418 8400 Facsimile +44 (0)20 7418 8416 E-mail [email protected] Website www.ema.europa.eu

© European Medicines Agency, 2014. Reproduction is authorised provided the source is acknowledged.

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Austria Abbott GmbH Perfektastasse 84a 1230 Wien Austria

Brufen 400 mg - Filmtabletten

Ibuprofen 400 mg Film-coated tablet Oral use

Austria Abbott GmbH Perfektastasse 84a 1230 Wien Austria

Brufen 600 mg - Filmtabletten

Ibuprofen 600 mg Film-coated tablet Oral use

Austria Merz Consumer Care Austria GmbH Guglgasse 17 1110 Wien Austria

Dismenol forte Ibuprofen 400 mg Filmtabletten

Ibuprofen 400 mg Film-coated tablet Oral use

Austria Merz Consumer Care Austria GmbH Guglgasse 17 1110 Wien Austria

Dismenol Ibuprofen 200 mg Filmtabletten

Ibuprofen 200 mg Film-coated tablet Oral use

Austria Reckitt Benckiser Deutschland GmbH Theodor Heuss Anlage 68165 Mannheim Germany

Nurofen 400 mg überzogene Tabletten

Ibuprofen natrium 400 mg Coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 2/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Austria Reckitt Benckiser Deutschland GmbH Theodor Heuss Anlage 68165 Mannheim Germany

Nurofen Liquid 200 mg Kapseln

Ibuprofen 200 mg Capsule, soft Oral use

Austria Sanova Pharma GmbH Haidestraße 4 1110 Wien Austria

Dolgit 800 mg - Filmtabletten

Ibuprofen 800 mg Film-coated tablet Oral use

Austria Sanova Pharma GmbH Haidestraße 4 1110 Wien Austria

Dolgit 200 mg - Dragees

Ibuprofen 200 mg Dragee Oral use

Austria Sanova Pharma GmbH Haidestraße 4 1110 Wien Austria

Dolgit 600 mg - Dragees

Ibuprofen 600 mg Dragee Oral use

Austria Sanova Pharma GmbH Haidestraße 4 1110 Wien Austria

Dolgit 400 mg - Dragees

Ibuprofen 400 mg Dragee Oral use

Austria Sanova Pharma GmbH Haidestraße 4 1110 Wien Austria

Dolgit 400 mg - Kapseln

Ibuprofen 400 mg Capsule, soft Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 3/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Austria Bayer Austria GmbH Herbststraße 6-10 1160 Wien Austria

Aktren 400 mg - Kapseln

Ibuprofen 400 mg Capsule, soft Oral use

Austria Astellas Pharma GmbH Linzer Straße221 E02 1140 Wien Austria

Dolofort 400 mg - Filmtabletten

Ibuprofen 400 mg Film-coated tablet Oral use

Austria Reckitt Benckiser Deutschland GmbH Theodor Heuss Anlage 68165 Mannheim Germany

Nurofen Meltlets Mint 200 mg Schmelztabletten

Ibuprofen 200 mg Orodispersible tablet Oral use

Austria Reckitt Benckiser Deutschland GmbH Theodor Heuss Anlage 68165 Mannheim Germany

Nurofen Meltlets 200 mg Schmelztabletten

Ibuprofen 200 mg Orodispersible tablet Oral use

Austria Abbott GmbH Perfektastasse 84a 1230 Wien Austria

Brufen 400 mg Brausegranulat

Ibuprofen 400 mg Effervescent granules Oral use

Austria Boehringer Ingelheim International GmbH Binger Straße 173 55216 Ingelheim am Rhein Germany

BoxaGrippal 200 mg/30 mg - Filmtabletten

Ibuprofen 200 mg 30 mg

Film-coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 4/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Austria Sigmapharm Arzneimittel GmbH Leystraße 129 1200 Wien Austria

ib-u-ron 75 mg Zäpfchen

Ibuprofen 75 mg Suppository Rectal use

Austria Reckitt Benckiser Deutschland GmbH Theodor Heuss Anlage 68165 Mannheim Germany

Nurofen rapid 200 mg Weichkapseln

Ibuprofen 200 mg Capsule, soft Oral use

Austria Sigmapharm Arzneimittel GmbH Leystraße 129 1200 Wien Austria

ib-u-ron 150 mg Zäpfchen

Ibuprofen 150 mg Suppository Rectal use

Austria Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland

Ibunin 200 mg Filmtabletten

Ibuprofen 200 mg Film-coated tablet Oral use

Austria Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland

Ibunin 400 mg Filmtabletten

Ibuprofen 400 mg Film-coated tablet Oral use

Austria Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland

Ibuprofen Actavis 400 mg Filmtabletten

Ibuprofen 400 mg Film-coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 5/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Austria Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland

Ibuprofen Actavis 600 mg Filmtabletten

Ibuprofen 600 mg Film-coated tablet Oral use

Austria Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland

Ibuprofen Actavis 200 mg Filmtabletten

Ibuprofen 200 mg Film-coated tablet Oral use

Austria Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland

Ibuprofen Actavis 800 mg Filmtabletten

Ibuprofen 800 mg Film-coated tablet Oral use

Austria Abbott GmbH Perfektastasse 84a 1230 Wien Austria

Ibuprofen Rockspring 200 mg Brausegranulat

Ibuprofen 200 mg Effervescent granules Oral use

Austria Genericon Pharma GmbH Hafnerstraße 211 8054 Graz Austria

Ibuprofen Genericon 400 mg Filmtabletten

Ibuprofen 400 mg Film-coated tablet Oral use

Austria Gebro Pharma GmbH Bahnhofbichl 13 6391 Fieberbrunn Austria

Dexibuprofen Gebro 300 mg Pulver zur Herstellung einer Suspension zum Einnehmen

Ibuprofen 300 mg Powder for oral suspension

Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 6/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Austria Gebro Pharma GmbH Bahnhofbichl 13 6391 Fieberbrunn Austria

Dexibuprofen Gebro 400 mg Pulver zur Herstellung einer Suspension zum Einnehmen

Ibuprofen 400 mg Powder for oral suspension

Oral use

Austria Takeda Austria GmbH St. Peter Straße 25 4020 Linz Austria

Ibumetin 200 mg - Dragees

Ibuprofen 200 mg Dragee Oral use

Austria Takeda Austria GmbH St. Peter Straße 25 4020 Linz Austria

Ibumetin forte 400 mg - Filmtabletten

Ibuprofen 400 mg Film-coated tablet Oral use

Austria ratiopharm Arzneimittel Vertriebs-GmbH Albert Schweitzer Gasse 3 1140 Wien Austria

WICK DayMed Duo 200 mg/30 mg Filmtabletten

Ibuprofen 200 mg 30 mg

Film-coated tablet Oral use

Austria Reckitt Benckiser Deutschland GmbH Theodor Heuss Anlage 68165 Mannheim Germany

Nurofen 200 mg - Dragees

Ibuprofen 200 mg Dragee Oral use

Austria Kwizda Pharma GmbH Effingergasse 21 1160 Wien Austria

Adolorin Ibuforte 400 mg Dragees

Ibuprofen 400 mg Dragee Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 7/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Austria ratiopharm Arzneimittel Vertriebs-GmbH Albert Schweitzer Gasse 3 1140 Wien Austria

Ibuprofen ratiopharm 4 % Sirup für Kinder

Ibuprofen 40 mg/ml Syrup Oral use

Austria Genericon Pharma GmbH Hafnerstraße 211 8054 Graz Austria

Ibuprofen Genericon 600 mg Filmtabletten

Ibuprofen 600 mg Film-coated tablet Oral use

Austria Boehringer Ingelheim International GmbH Binger Straße 173 55216 Ingelheim am Rhein Germany

Thomaprodol 400 mg - Weichkapseln

Ibuprofen 400 mg Capsule, soft Oral use

Austria G.L. Pharma GmbH Schloßplatz 1 8502 Lannach Austria

Ibuprofen G.L. 400 mg - Filmtabletten

Ibuprofen 400 mg Film-coated tablet Oral use

Austria G.L. Pharma GmbH Schloßplatz 1 8502 Lannach Austria

Ibuprofen G.L. 600 mg - Filmtabletten

Ibuprofen 600 mg Film-coated tablet Oral use

Austria Reckitt Benckiser Deutschland GmbH Theodor Heuss Anlage 68165 Mannheim Germany

Nurofen rapid 400 mg Weichkapseln

Ibuprofen 400 mg Capsule, soft Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 8/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Austria Gebro Pharma GmbH Bahnhofbichl 13 6391 Fieberbrunn Austria

Seractil forte 400 mg - Filmtabletten

Dexibuprofen 400 mg Film-coated tablet Oral use

Austria Gebro Pharma GmbH Bahnhofbichl 13 6391 Fieberbrunn Austria

Seractil 200 mg - Filmtabletten

Dexibuprofen 200 mg Film-coated tablet Oral use

Austria Gebro Pharma GmbH Bahnhofbichl 13 6391 Fieberbrunn Austria

Seractil 300 mg - Filmtabletten

Dexibuprofen 300 mg Film-coated tablet Oral use

Austria Gebro Pharma GmbH Bahnhofbichl 13 6391 Fieberbrunn Austria

Eu-Med 200 mg Schmerztabletten

Dexibuprofen 200 mg Tablet Oral use

Austria Gebro Pharma GmbH Bahnhofbichl 13 6391 Fieberbrunn Austria

Monactil 200 mg - Filmtabletten

Dexibuprofen 200 mg Film-coated tablet Oral use

Austria Gebro Pharma GmbH Bahnhofbichl 13 6391 Fieberbrunn Austria

Atriscal 200 mg - Filmtabletten

Dexibuprofen 200 mg Film-coated tablet Oral use

Austria Gebro Pharma GmbH Bahnhofbichl 13 6391 Fieberbrunn Austria

Atriscal 300 mg - Filmtabletten

Dexibuprofen 300 mg Film-coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 9/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Austria Gebro Pharma GmbH Bahnhofbichl 13 6391 Fieberbrunn Austria

Atriscal 400 mg - Filmtabletten

Dexibuprofen 400 mg Film-coated tablet Oral use

Austria Gebro Pharma GmbH Bahnhofbichl 13 6391 Fieberbrunn Austria

Dexibuprofen "Gebro" 200 mg - Filmtabletten

Dexibuprofen 200 mg Film-coated tablet Oral use

Austria Gebro Pharma GmbH Bahnhofbichl 13 6391 Fieberbrunn Austria

Dexibuprofen "Gebro" 300 mg - Filmtabletten

Dexibuprofen 300 mg Film-coated tablet Oral use

Austria Gebro Pharma GmbH Bahnhofbichl 13 6391 Fieberbrunn Austria

Dexibuprofen "Gebro" 400 mg - Filmtabletten

Dexibuprofen 400 mg Film-coated tablet Oral use

Austria Gebro Pharma GmbH Bahnhofbichl 13 6391 Fieberbrunn Austria

Movone 200 mg - Filmtabletten

Dexibuprofen 200 mg Film-coated tablet Oral use

Austria Gebro Pharma GmbH Bahnhofbichl 13 6391 Fieberbrunn Austria

Movone 300 mg - Filmtabletten

Dexibuprofen 300 mg Film-coated tablet Oral use

Austria Gebro Pharma GmbH Bahnhofbichl 13 6391 Fieberbrunn Austria

Movone 400 mg - Filmtabletten

Dexibuprofen 400 mg Film-coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 10/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Belgium Pfizer bv Rivium Westlaan 142 2909 LD, Capelle a/d Ijssel The Netherlands

Advil 200 Ibuprofen 200 mg Effervescent tablet Oral use

Belgium Abbott S.A-N.V. Avenue Einstein 14 1300 Wavre Belgium

Brufen Ibuprofen 40 mg/ml Oral suspension Oral use

Belgium Abbott S.A-N.V. Avenue Einstein 14 1300 Wavre Belgium

Brufen 400 Ibuprofen 400 mg Coated tablet Oral use

Belgium Abbott S.A-N.V. Avenue Einstein 14 1300 Wavre Belgium

Brufen Forte 600 Ibuprofen 600 mg Film-coated tablet Oral use

Belgium Abbott S.A-N.V. Avenue Einstein 14 1300 Wavre Belgium

Brufen Granules 600 Ibuprofen 600 mg Granules for oral solution

Oral use

Belgium Abbott S.A-N.V. Avenue Einstein 14 1300 Wavre Belgium

Brufen Retard 800 Ibuprofen 800 mg Prolonged-release tablet

Oral use

Belgium Abbott S.A-N.V. Avenue Einstein 14 1300 Wavre Belgium

Brufen Granules Ibuprofen 400 mg Effervescent granules Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 11/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Belgium Teva Pharma Belgium N.V. Laarstraat 16 2610 Wilrijk Belgium

Buprophar Ibuprofen 200 mg Coated tablet Oral use

Belgium Teva Pharma Belgium N.V. Laarstraat 16 2610 Wilrijk Belgium

Buprophar Ibuprofen 400 mg Coated tablet Oral use

Belgium Socobom nv Louizalaan 149 bus 24 1050 Brussel Belgium

Dolofin Ibuprofen 400 mg Coated tablet Oral use

Belgium Laboratoria Qualiphar N.V./S.A. Rijksweg 9 2880 Bornem Belgique

Extrapan Ibruprofenum 200 mg

Ibuprofen 200 mg Coated tablet Oral use

Belgium Laboratoria Qualiphar N.V./S.A. Rijksweg 9 2880 Bornem Belgique

Extrapan Ibruprofenum 400 mg

Ibuprofen 400 mg Coated tablet Oral use

Belgium Laboratoires Belges Pharmacobel SA/NV Avenue de Scheut 46-50 1070 Bruxelles Belgique

Ibumed 200 mg Ibuprofen 200 mg Tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 12/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Belgium Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland

Ibuprofen Actavis 200 mg

Ibuprofen 200 mg Coated tablet Oral use

Belgium Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland

Ibuprofen Actavis 400 mg

Ibuprofen 400 mg Coated tablet Oral use

Belgium Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland

Ibuprofen Actavis 600 mg

Ibuprofen 600 mg Coated tablet Oral use

Belgium Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland

Ibuprofen Actavis 800 mg

Ibuprofen 800 mg Coated tablet Oral use

Belgium Boehringer Ingelheim International GmbH Binger Straße 173 55216 Ingelheim am Rhein Germany

Ibuprofen Boehringer Ingelheim 400 mg

Ibuprofen 400 mg Capsule Oral use

Belgium Eurogenerics Afgekort "E.G." Heizel Esplanade b22 1020 Laken Belgium

Ibuprofen EG 200 mg Ibuprofen 200 mg Coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 13/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Belgium Eurogenerics Afgekort "E.G." Heizel Esplanade b22 1020 Laken Belgium

Ibuprofen EG 40 mg/ml

Ibuprofen 40 mg/ml Oral suspension Oral use

Belgium Eurogenerics Afgekort "E.G." Heizel Esplanade b22 1020 Laken Belgium

Ibuprofen EG 400 mg Ibuprofen 400 mg Coated tablet Oral use

Belgium Eurogenerics Afgekort "E.G." Heizel Esplanade b22 1020 Laken Belgium

Ibuprofen EG 400 mg Ibuprofen sodium hydrate

512 mg Effervescent tablet Oral use

Belgium Eurogenerics Afgekort "E.G." Heizel Esplanade b22 1020 Laken Belgium

Ibuprofen EG 600 mg Ibuprofen 600 mg Coated tablet Oral use

Belgium Eurogenerics Afgekort "E.G." Heizel Esplanade b22 1020 Laken Belgium

Ibuprofen EG 800 mg Ibuprofen 800 mg Tablet Oral use

Belgium Mylan bvba/sprl Terhulpsesteenweg 6a 1560 Hoeilaart Belgium

Ibuprofen Lysine Mylan 200 mg

Ibuprofen lysine 342 mg Coated tablet Oral use

Belgium Mylan bvba/sprl Terhulpsesteenweg 6a 1560 Hoeilaart Belgium

Ibuprofen Lysine Mylan 400 mg

Ibuprofen lysine 684 mg Coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 14/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Belgium Mylan bvba/sprl Terhulpsesteenweg 6a 1560 Hoeilaart Belgium

Ibuprofen Lysine Mylan Pharma 200 mg

Ibuprofen lysine 342 mg Coated tablet Oral use

Belgium Mylan bvba/sprl Terhulpsesteenweg 6a 1560 Hoeilaart Belgium

Ibuprofen Lysine Mylan Pharma 400 mg

Ibuprofen lysine 684 mg Coated tablet Oral use

Belgium Boehringer Ingelheim International GmbH Binger Straße 173 55216 Ingelheim am Rhein Germany

Ibuprofen Pseudoéphedrine HCL Boehringer Ingelheim 200 mg -30 mg

Ibuprofen pseudoephedrine hydrochloride

200 mg 30 mg

Coated tablet Oral use

Belgium Sandoz nv/sa Telecom Gardens Medialaan 40 1800 Vilvoorde Belgium

Ibuprofen Sandoz 200 mg

Ibuprofen 200 mg Coated tablet Oral use

Belgium Sandoz nv/sa Telecom Gardens Medialaan 40 1800 Vilvoorde Belgium

Ibuprofen Sandoz 40 mg/ml

Ibuprofen 40 mg/ml Oral suspension Oral use

Belgium Sandoz nv/sa Telecom Gardens Medialaan 40 1800 Vilvoorde Belgium

Ibuprofen Sandoz 400 mg

Ibuprofen 400 mg Coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 15/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Belgium Sandoz nv/sa Telecom Gardens Medialaan 40 1800 Vilvoorde Belgium

Ibuprofen Sandoz 600 mg

Ibuprofen 600 mg Coated tablet Oral use

Belgium Sandoz nv/sa Telecom Gardens Medialaan 40 1800 Vilvoorde Belgium

Ibuprofen Sandoz 800 mg

Ibuprofen 800 mg Coated tablet Oral use

Belgium Teva Pharma Belgium N.V. Laarstraat 16 2610 Wilrijk Belgium

Ibuprofen Teva 200 mg

Ibuprofen 200 mg Coated tablet Oral use

Belgium Teva Pharma Belgium N.V. Laarstraat 16 2610 Wilrijk Belgium

Ibuprofen Teva 400 mg

Ibuprofen 400 mg Coated tablet Oral use

Belgium Teva Pharma Belgium N.V. Laarstraat 16 2610 Wilrijk Belgium

Ibuprofen Teva 600mg

Ibuprofen 600 mg Tablet Oral use

Belgium Rockspring Healthcare Limited 38/40 Chamberlayne Road London NW10 3JE United Kingdom

Ibuprofen/Codeine Phosphate Hemihydrate Rockspring 400mg/30mg

Ibuprofen codeine phosphate hemihydrate

400 mg 30 mg

Coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 16/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Belgium Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland

Ifenin 200mg Ibuprofen 200 mg Film-coated tablet Oral use

Belgium Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland

Ifenin 400mg Ibuprofen 400 mg Film-coated tablet Oral use

Belgium Abbott S.A-N.V. Avenue Einstein 14 1300 Wavre Belgium

Malafene 100mg/5ml Ibuprofen 20 mg/ml Syrup Oral use

Belgium Reckitt Benckiser (Healthcare) -SA/NV Researchdreef 20 1070 Brussels Belgium

Nurofen 200 Ibuprofen 200 mg Coated tablet Oral use

Belgium Reckitt Benckiser (Healthcare) -SA/NV Researchdreef 20 1070 Brussels Belgium

Nurofen 200 fastcaps Ibuprofen 200 mg Capsule, soft Oral use

Belgium Reckitt Benckiser (Healthcare) -SA/NV Researchdreef 20 1070 Brussels Belgium

Nurofen 200 fastsodium

Ibuprofen 200 mg Coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 17/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Belgium Reckitt Benckiser (Healthcare) -SA/NV Researchdreef 20 1070 Brussels Belgium

Nurofen 400 Ibuprofen 400 mg Coated tablet Oral use

Belgium Reckitt Benckiser (Healthcare) -SA/NV Researchdreef 20 1070 Brussels Belgium

Nurofen 400 fastcaps Ibuprofen 400 mg Capsule, soft Oral use

Belgium Reckitt Benckiser (Healthcare) -SA/NV Researchdreef 20 1070 Brussels Belgium

Nurofen 400 fastpowder

Ibuprofen 400 mg Powder for oral solution

Oral use

Belgium Reckitt Benckiser (Healthcare) -SA/NV Researchdreef 20 1070 Brussels Belgium

Nurofen 400 fastsodium

Ibuprofen 400 mg Coated tablet Oral use

Belgium Reckitt Benckiser (Healthcare) -SA/NV Researchdreef 20 1070 Brussels Belgium

Nurofen 400 fasttabs Ibuprofen lysine 684 mg Film-coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 18/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Belgium Reckitt Benckiser (Healthcare) -SA/NV Researchdreef 20 1070 Brussels Belgium

Nurofen fastsodium voor kinderen vanaf 12 jaar 200mg

Ibuprofen 200 mg Coated tablet Oral use

Belgium Reckitt Benckiser (Healthcare) -SA/NV Researchdreef 20 1070 Brussels Belgium

Nurofen Lysine 200 mg

Ibuprofen lysine 342 mg Film-coated tablet Oral use

Belgium Reckitt Benckiser (Healthcare) -SA/NV Researchdreef 20 1070 Brussels Belgium

Nurofen Lysine 400 mg

Ibuprofen lysine 684 mg Film-coated tablet Oral use

Belgium Reckitt Benckiser (Healthcare) -SA/NV Researchdreef 20 1070 Brussels Belgium

Nurofen Smelttabletten 200 mg

Ibuprofen 200 mg Orodispersible tablet Oral use

Belgium Reckitt Benckiser (Healthcare) -SA/NV Researchdreef 20 1070 Brussels Belgium

Nurofen voor kinderen vanaf 12 jaar 200 mg

Ibuprofen 200 mg Coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 19/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Belgium Omega Pharma Belgium Industriepark "De Prijkels" Venecoweg 26 9810 Nazareth Belgium

Optalidon 200 Nieuw formule

Ibuprofen 200 mg Coated tablet Oral use

Belgium Omega Pharma Belgium Industriepark "De Prijkels" Venecoweg 26 9810 Nazareth Belgium

Optalidon 400 Nieuw formule

Ibuprofen 400 mg Coated tablet Oral use

Belgium Johnson & Johnson Consumer SA/NV Antwerpseweg 15-17 2340 Beerse Belgium

Perdofemina 400mg Ibuprofen lysine 684 mg Film-coated tablet Oral use

Belgium Johnson & Johnson Consumer SA/NV Antwerpseweg 15-17 2340 Beerse Belgium

Perrdophen 400mg Ibuprofen lysine 684 mg Coated tablet Oral use

Belgium Johnson & Johnson Consumer SA/NV Antwerpseweg 15-17 2340 Beerse Belgium

Perdotensio 200mg Ibuprofen lysine 342 mg Film-coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 20/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Belgium Zambon SA/NV E.Demunterlaan 1/9 1090 Brussels Belgium

Spidifen 200 mg Ibuprofen 200 mg Granules for oral solution

Oral use

Belgium Zambon SA/NV E.Demunterlaan 1/9 1090 Brussels Belgium

Spidifen 200 mg Ibuprofen 200 mg Tablet Oral use

Belgium Zambon SA/NV E.Demunterlaan 1/9 1090 Brussels Belgium

Spidifen 200 mg Ibuprofen 200 mg Effervescent tablet Oral use

Belgium Zambon SA/NV E.Demunterlaan 1/9 1090 Brussels Belgium

Spidifen 400 mg Ibuprofen 400 mg Film-coated tablet Oral use

Belgium Zambon SA/NV E.Demunterlaan 1/9 1090 Brussels Belgium

Spidifen 400 mg Ibuprofen 400 mg Granules for oral solution

Oral use

Bulgaria Alvogen IPCo S.àr.l. Rue Heienhaff, 5 L-1736, Senningerberg Luxemburg

Alvofen Express Ibuprofen 200 mg Capsule, soft Oral use

Bulgaria Alvogen IPCo S.àr.l. Rue Heienhaff, 5 L-1736, Senningerberg Luxemburg

Alvofen Express Ibuprofen 400 mg Capsule, soft Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 21/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Bulgaria Ecopharm Group AD Cherni Vah blvd., bl. 3 1421 Sofia Bulgaria

Doloren Ibuprofen 200 mg Film-coated tablet Oral use

Bulgaria Ecopharm Group AD Cherni Vah blvd., bl. 3 1421 Sofia Bulgaria

Doloren Ibuprofen 400 mg Film-coated tablet Oral use

Bulgaria Zentiva, k.s. U kabelovny 130 102 37 Praha 10 Dolní Měcholupy Czech Republic

Extralgin Ibuprofen 200 mg Film-coated tablet Oral use

Bulgaria Zentiva, k.s. U kabelovny 130 102 37 Praha 10 Dolní Měcholupy Czech Republic

Extralgin Ibuprofen 400 mg Film-coated tablet Oral use

Bulgaria Zentiva, k.s. U kabelovny 130 102 37 Praha 10 Dolní Měcholupy Czech Republic

Extralgin Gold Ibuprofen 200 mg 30 mg

Film-coated tablet Oral use

Bulgaria STADA Arzneimittel AG Stadastr. 2-18 61118 Bad Vilbel Germany

Flexistad Ibuprofen 400 mg Film-coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 22/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Bulgaria STADA Arzneimittel AG Stadastr. 2-18 61118 Bad Vilbel Germany

Flexistad Ibuprofen 600 mg Film-coated tablet Oral use

Bulgaria STADA Arzneimittel AG Stadastr. 2-18 61118 Bad Vilbel Germany

Flexistad Ibuprofen 800 mg Film-coated tablet Oral use

Bulgaria Tchaikapharma Highquality Medicines 1 G. M. Dimitrov Blvd Sofia, 1172 Bulgaria

Ibufen Ibuprofen 200 mg Effervescent tablet Oral use

Bulgaria Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland

Ibudolor Ibuprofen 200 mg Film-coated tablet Oral use

Bulgaria Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland

Ibudolor Ibuprofen 400 mg Film-coated tablet Oral use

Bulgaria Actavis EAD Atanas Dukov str. 29 1407 Sofia Bulgaria

Ibudolor Ibuprofen 300 mg Prolonged-release capsule, hard

Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 23/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Bulgaria US Pharmacia Sp. z o.o. Ziebicka st. 40 50-507 Wroclaw Poalnd

Ibuprom Ibuprofen 200 mg Coated tablet Oral use

Bulgaria US Pharmacia Sp. z o.o. Ziebicka st. 40 50-507 Wroclaw Poalnd

Ibuprom Sprint MAX Ibuprofen 400 mg Capsule, soft Oral use

Bulgaria US Pharmacia Sp. z o.o. Ziebicka st. 40 50-507 Wroclaw Poalnd

Ibuprom Sprint Caps Ibuprofen 200 mg Capsule, soft Oral use

Bulgaria US Pharmacia Sp. z o.o. Ziebicka st. 40 50-507 Wroclaw Poalnd

Ibuprom Max Ibuprofen 400 mg Coated tablet Oral use

Bulgaria US Pharmacia Sp. z o.o. Ziebicka st. 40 50-507 Wroclaw Poalnd

Ibuprom Sinus Ibuprofen pseudoephedrine hydrochloride

200 mg 30 mg

Coated tablet Oral use

Bulgaria Abbott Products EOOD 48 Sitnyakovo blvd, Serdika offices 1505 Sofia Bulgaria

Brufen Ibuprofen 200 mg Effervescent tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 24/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Bulgaria Abbott Products EOOD 48 Sitnyakovo blvd, Serdika offices 1505 Sofia Bulgaria

Brufen Codeine Ibuprofen codeine phosphate hemihydrate

400 mg 30 mg

Film-coated tablet Oral use

Bulgaria Abbott Scandinavia AB P.O Box 1498 SE-171 29 Solna Sweden

Brufen Ibuprofen 20 mg/ml Oral suspension Oral use

Bulgaria Abbott Scandinavia AB P.O Box 1498 SE-171 29 Solna Sweden

Brufen Forte Ibuprofen 40 mg/ml Oral suspension Oral use

Bulgaria Abbott Scandinavia AB P.O Box 1498 SE-171 29 Solna Sweden

Brufen Ibuprofen 400 mg Effervescent granules Oral use

Bulgaria Abbott Scandinavia AB P.O Box 1498 SE-171 29 Solna Sweden

Brufen retard Ibuprofen 800 mg Prolonged-release tablet

Oral use

Bulgaria Pabianickie Zakłady Farmaceutyczne Polfa S.A. Marszalka Pilsudskiego st. 5 95-200 Pabianice Poland

Ibuprofen Polfa Ibuprofen 200 mg Coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 25/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Bulgaria Berlin-Chemie AG Glienicker Weg 125 12489 Berlin Germany

MIG-400 Ibuprofen 400 mg Film-coated tablet Oral use

Bulgaria Pharmaceutical plants Milve Ltd. 33 Nikola Mirchev 1113 Sofia Bulgaria

Milorofen Ibuprofen 200 mg Film-coated tablet Oral use

Bulgaria Reckitt Benckiser Healthcare International Limited Bath Road 103-105 Berkshire SL1 3UH Slough United Kingdom

Nurofen Express Forte

Ibuprofen 400 mg Capsule, soft Oral use

Bulgaria Reckitt Benckiser Healthcare International Limited Bath Road 103-105 Berkshire SL1 3UH Slough United Kingdom

Nurofen Forte Ibuprofen 400 mg Coated tablet Oral use

Bulgaria Reckitt Benckiser Healthcare International Limited Bath Road 103-105 Berkshire SL1 3UH Slough United Kingdom

Nurofen Active Ibuprofen 200 mg Orodispersible tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 26/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Bulgaria Reckitt Benckiser Healthcare International Limited Bath Road 103-105 Berkshire SL1 3UH Slough United Kingdom

Nurofen Ibuprofen 200 mg Coated tablet Oral use

Bulgaria Reckitt Benckiser Healthcare International Limited Bath Road 103-105 Berkshire SL1 3UH Slough United Kingdom

Nurofen Femina Forte Ibuprofen sodium dihydrate

512 mg Coated tablet Oral use

Bulgaria Reckitt Benckiser Healthcare International Limited Bath Road 103-105 Berkshire SL1 3UH Slough United Kingdom

Nurofen STOPCOLD Ibuprofen pseudoephedrine

200 mg 30 mg

Film-coated tablet Oral use

Bulgaria Reckitt Benckiser Healthcare International Limited Bath Road 103-105 Berkshire SL1 3UH Slough United Kingdom

Nurofen X2 Ibuprofen sodium dihydrate

256 mg Coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 27/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Bulgaria Reckitt Benckiser Healthcare International Limited Bath Road 103-105 Berkshire SL1 3UH Slough United Kingdom

Nurofen Migraine Pain

Ibuprofen lysine 342 mg Film-coated tablet Oral use

Bulgaria Reckitt Benckiser Healthcare International Limited Bath Road 103-105 Berkshire SL1 3UH Slough United Kingdom

Nurofen Express Ibuprofen 200 mg Capsule, soft Oral use

Bulgaria Boehringer Ingelheim International GmbH Binger Straße 173 55216 Ingelheim am Rhein Germany

Mucogrip Ibuprofen pseudoephedrine

200 mg 30 mg

Film-coated tablet Oral use

Bulgaria Zentiva, k.s. U kabelovny 130 102 37 Praha 10 Dolní Měcholupy Czech Republic

Ibalgin Fast Ibuprofen 400 mg Film-coated tablet Oral use

Croatia Berlin-Chemie Menarini Hrvatska d.o.o. Horvatova 80a, Zagreb 10000 Croatia

Berlistar forte 40 mg/ml oralna suspenzija

Ibuprofen 40 mg/ml Oral suspension Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 28/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Croatia Alkaloid d.o.o., Ulica grada Vukovara 226f Zagreb 10000 Croatia

BlokMax Lady 200 mg filmom obložene tablete

Ibuprofen 200 mg Film-coated tablet Oral use

Croatia Abbott Laboratories d.o.o. Koranska 2 Zagreb 10000 Croatia

Brufen 400 mg filmom obložene tablete

Ibuprofen 400 mg Film-coated tablet Oral use

Croatia Abbott Laboratories d.o.o. Koranska 2 Zagreb 10000 Croatia

Brufen 400 mg šumeće granule

Ibuprofen 400 mg Effervescent granules Oral use

Croatia Abbott Laboratories d.o.o. Koranska 2 Zagreb 10000 Croatia

Brufen 600 mg filmom obložene tablete

Ibuprofen 600 mg Film-coated tablet Oral use

Croatia Abbott Laboratories d.o.o. Koranska 2 Zagreb 10000 Croatia

Brufen 600 mg šumeće granule

Ibuprofen 600 mg Effervescent granules Oral use

Croatia Abbott Laboratories d.o.o. Koranska 2 Zagreb 10000 Croatia

Brufen Effect 200 mg šumeće granule

Ibuprofen 200 mg Effervescent granules Oral use

Croatia Abbott Laboratories d.o.o. Koranska 2 Zagreb 10000 Croatia

Brufen Effect 400 mg šumeće granule

Ibuprofen 400 mg Effervescent granules Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 29/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Croatia Abbott Laboratories d.o.o. Koranska 2 Zagreb 10000 Croatia

Brufen forte 40 mg/ml oralna suspenzija

Ibuprofen 40 mg/ml Oral suspension Oral use

Croatia Abbott Laboratories d.o.o. Koranska 2 Zagreb 10000 Croatia

Brufen SR 800 mg tablete s produljenim oslobađanjem

Ibuprofen 800 mg Film-coated prolonged-release tablet

Oral use

Croatia Abbott Laboratories d.o.o. Koranska 2 Zagreb 10000 Croatia

Dalsy forte 40 mg/ml oralna suspenzija

Ibuprofen 40 mg/ml Oral suspension Oral use

Croatia Abbott Laboratories d.o.o. Koranska 2 Zagreb 10000 Croatia

Dalsy sirup Ibuprofen 20 mg/ml Syrup Oral use

Croatia Abbott Laboratories d.o.o. Koranska 2 Zagreb 10000 Croatia

Ibuprofen Abbott 400 mg šumeće granule

Ibuprofen 400 mg Effervescent granules Oral use

Croatia Abbott Laboratories d.o.o. Koranska 2 Zagreb 10000 Croatia

Ibuprofen Abbott Effect 200 mg šumeće granule

Ibuprofen 200 mg Effervescent granules Oral use

Croatia Abbott Laboratories d.o.o. Koranska 2 Zagreb 10000 Croatia

Ibuprofen Abbott Effect 400 mg šumeće granule

Ibuprofen 400 mg Effervescent granules Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 30/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Croatia Fidifarm d.o.o. Obrtnička 37, Rakitje Brestovje 10437 Croatia

Fidiprofen 200 mg šumeće tablete

Ibuprofen 200 mg Effervescent tablet Oral use

Croatia Fidifarm d.o.o. Obrtnička 37, Rakitje Brestovje 10437 Croatia

Fidiprofen flu 200 mg + 30 mg tablete

Ibuprofen pseudoephedrine

200 mg 30 mg

Tablet Oral use

Croatia sanofi-aventis Croatia d.o.o., Heinzelova 70 Zagreb 10000 Croatia

Ibalgin 400 mg filmom obložene tablete

Ibuprofen 400 mg Film-coated tablet Oral use

Croatia sanofi-aventis Croatia d.o.o., Heinzelova 70 Zagreb 10000 Croatia

Ibalgin Rapid 400 mg filmom obložene tablete

Ibuprofen 400 mg Film-coated tablet Oral use

Croatia PharmaS d.o.o., Radnička cesta 47 Zagreb 10000 Croatia

IbuPhar 600 mg filmom obložene tablete

Ibuprofen 600 mg Film-coated tablet Oral use

Croatia PharmaS d.o.o., Radnička cesta 47 Zagreb 10000 Croatia

Ibuprofen PharmaS 200 mg filmom obložene tablete

Ibuprofen 200 mg Film-coated tablet Oral use

Croatia PharmaS d.o.o., Radnička cesta 47 Zagreb 10000 Croatia

Ibuprofen PharmaS 400 mg filmom obložene tablete

Ibuprofen 400 mg Film-coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 31/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Croatia Belupo, lijekovi i kozmetika d.d. Ulica Danica 5 Koprivnica 48000 Croatia

Ibuprofen 100 mg/5 ml oralna suspenzija

Ibuprofen 20 mg/ml Oral suspension Oral use

Croatia Belupo, lijekovi i kozmetika d.d. Ulica Danica 5 Koprivnica 48000 Croatia

Ibuprofen 400 mg filmom obložene tablete

Ibuprofen 400 mg Film-coated tablet Oral use

Croatia Belupo, lijekovi i kozmetika d.d. Ulica Danica 5 Koprivnica 48000 Croatia

Ibuprofen 600 mg filmom obložene tablete

Ibuprofen 600 mg Film-coated tablet Oral use

Croatia Belupo, lijekovi i kozmetika d.d. Ulica Danica 5 Koprivnica 48000 Croatia

Ibuprofen Belupo 800 mg filmom obložene tablete

Ibuprofen 800 mg Film-coated tablet Oral use

Croatia Belupo, lijekovi i kozmetika d.d. Ulica Danica 5 Koprivnica 48000 Croatia

Neofen 100 mg/5 ml sirup

Ibuprofen 20 mg/ml Syrup Oral use

Croatia Belupo, lijekovi i kozmetika d.d. Ulica Danica 5 Koprivnica 48000 Croatia

Neofen 200 mg filmom obložene tablete

Ibuprofen 200 mg Film-coated tablet Oral use

Croatia Belupo, lijekovi i kozmetika d.d. Ulica Danica 5 Koprivnica 48000 Croatia

Neofen Direkt 200 mg raspadljive tablete za usta

Ibuprofen 200 mg Orodispersible tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 32/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Croatia Belupo, lijekovi i kozmetika d.d. Ulica Danica 5 Koprivnica 48000 Croatia

Neofen Forte 400 mg filmom obložene tablete

Ibuprofen 400 mg Film-coated tablet Oral use

Croatia Farmal d.d. Branitelja domovinskog rata 8, Ludbreg 42230 Croatia

Ibuprofen Farmal 200 mg filmom obložene tablete

Ibuprofen 200 mg Film-coated tablet Oral use

Croatia Farmal d.d. Branitelja domovinskog rata 8, Ludbreg 42230 Croatia

Ibuprofen Farmal 400 mg filmom obložene tablete

Ibuprofen 400 mg Film-coated tablet Oral use

Croatia Farmal d.d. Branitelja domovinskog rata 8, Ludbreg 42230 Croatia

Ibuprofen Farmal 600 mg filmom obložene tablete

Ibuprofen 600 mg Film-coated tablet Oral use

Croatia Farmal d.d. Branitelja domovinskog rata 8, Ludbreg 42230 Croatia

Ibuprofen Farmal 800 mg tablete s produljenim oslobađanjem

Ibuprofen 800 mg Prolonged-release tablet

Oral use

Croatia Berlin-Chemie Menarini Hrvatska d.o.o. Horvatova 80a Zagreb 10000 Croatia

Ibustar 400 mg filmom obložene tablete

Ibuprofen 400 mg Film-coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 33/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Croatia Reckitt Benckiser d.o.o. Ulica grada Vukovara 269 D, Zagreb 10000 Croatia

Nurofen 200 mg obložene tablete

Ibuprofen 200 mg Coated tablet Oral use

Croatia Reckitt Benckiser d.o.o. Ulica grada Vukovara 269 D, Zagreb 10000 Croatia

Nurofen 400 mg obložene tablete

Ibuprofen 400 mg Coated tablet Oral use

Croatia Reckitt Benckiser d.o.o. Ulica grada Vukovara 269 D, Zagreb 10000 Croatia

Nurofen Cold and Flu 200 mg + 30 mg filmom obložene tablete

Ibuprofen pseudoephedrine

200 mg 40 mg

Film-coated tablet Oral use

Croatia Reckitt Benckiser d.o.o. Ulica grada Vukovara 269 D, Zagreb 10000 Croatia

Nurofen Express 200 mg meke kapsule

Ibuprofen 200 mg Capsule, soft Oral use

Croatia Reckitt Benckiser d.o.o. Ulica grada Vukovara 269 D, Zagreb 10000 Croatia

Nurofen Express 400 mg meke kapsule

Ibuprofen 400 mg Capsule, soft Oral use

Croatia PharmaSwiss d.o.o. Miramarska 23 Zagreb 10000 Croatia

Rapidol S 200 mg kapsula, meka

Ibuprofen 200 mg Capsule, soft Oral use

Croatia PharmaSwiss d.o.o. Miramarska 23 Zagreb 10000 Croatia

Rapidol S 400 mg kapsula, meka

Ibuprofen 400 mg Capsule, soft Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 34/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Croatia Jadran Galenski Laboratorij d.d. Svilno 20 Rijeka 10000 Croatia

Rhinorelief 200 mg + 30 mg tablete

Ibuprofen pseudoephedrine

200 mg 30 mg

Tablet Oral use

Cyprus Varnavas Hadjipanayis Ltd Yiannou Kranidioti Avenue 226 2234 Latsia Strovolos Cyprus

Brufen Ibuprofen 400 mg Film-coated tablet Oral use

Cyprus Remedica IP Ltd Aharnon Street , Limassol Industrial Estate, Limassol 3502 Cyprus

Bulfan Ibuprofen 200 mg Film-coated tablet Oral use

Cyprus Remedica IP Ltd Aharnon Street , Limassol Industrial Estate, Limassol 3502 Cyprus

Bulfan Ibuprofen 400 mg Film-coated tablet Oral use

Cyprus Reckitt Benckiser Hellas Chemical ABEE Taki Kavalieratou 7 Street 14564 Kato Kifissia Athens Greece

Nurofen liquid capsule

Ibuprofen 200 mg Capsule, soft Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 35/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Cyprus Reckitt Benckiser Hellas Chemical ABEE Taki Kavalieratou 7 Street 14564 Kato Kifissia Athens Greece

Nurofen cold & flu Ibuprofen 200 mg Film-coated tablet Oral use

Cyprus Reckitt Benckiser Hellas Chemical ABEE Taki Kavalieratou 7 Street 14564 Kato Kifissia Athens Greece

Nurofen Express Ibuprofen 400 mg Capsule, soft Oral use

Cyprus Lifepharma (Z.A.M) Ltd Agiou Nicolaou Street 8 1523 Lefkosia Cyprus

Nurofen Express Ibuprofen sodium dihydrate

256 mg Tablet Oral use

Cyprus Lifepharma (Z.A.M) Ltd Agiou Nicolaou Street 8 1523 Lefkosia Cyprus

Nurofen Express Ibuprofen sodium dihydrate

512 mg Tablet Oral use

Cyprus Reckitt Benckiser Hellas Chemical ABEE Taki Kavalieratou 7 Street 14564 Kato Kifissia Athens Greece

Nurofen Ibuprofen 200 mg Film-coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 36/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Cyprus Remedica Ltd Aharnon str, Limassol Industrial Estate, Limassol 3508 Cyprus

Perofen Ibuprofen 200 mg Coated tablet Oral use

Cyprus Remedica Ltd Aharnon str, Limassol Industrial Estate, Limassol 3508 Cyprus

Perofen Ibuprofen 400 mg Coated tablet Oral use

Cyprus Remedica Ltd Aharnon str, Limassol Industrial Estate, Limassol 3508 Cyprus

Perofen Ibuprofen 200 mg Film-coated tablet Oral use

Cyprus Remedica Ltd Aharnon str, Limassol Industrial Estate, Limassol 3508 Cyprus

Perofen Ibuprofen 400 mg Film-coated tablet Oral use

Cyprus Remedica Ltd Aharnon str, Limassol Industrial Estate, Limassol 3508 Cyprus

Perofen Ibuprofen 600 mg Film-coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 37/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Cyprus Medochemie Ltd 1-10 Constantinoupoleos str, Limassol 3505 Cyprus

Rufan Ibuprofen 200 mg Film-coated tablet Oral use

Cyprus Medochemie Ltd 1-10 Constantinoupoleos str, Limassol 3505 Cyprus

Rupan Femme Ibuprofen 400 mg Film-coated tablet Oral use

Cyprus Medochemie Ltd 1-10 Constantinoupoleos str, Limassol 3505 Cyprus

Rupan Max Ibuprofen 200 mg Film-coated tablet Oral use

Cyprus Boehringer Ingelheim International GmbH Binger Straße 173 55216 Ingelheim am Rhein Germany

Mucocold Ibuprofen 200 mg Film-coated tablet Oral use

Czech Republic

Pfizer Corporation Austria GmbH Floridsdorfer Hauptstraße 1 1210 Wien Austria

Advil Rapid Ibuprofen 400 mg Capsule, soft Oral use

Czech Republic

Apotex Europe B.V. Darwinweg 20 2333 CR Leiden The Netherlands

Apo-ibuprofen 400 mg

Ibuprofen 400 mg Film-coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 38/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Czech Republic

Banner Pharmacaps Europe B.V. De Posthoornstraat 7 5048 AS Tilburg The Netherlands

Apo-ibuprofen Rapid 400 mg soft capsules

Ibuprofen 400 mg Capsule, soft Oral use

Czech Republic

Abbott Laboratories, s.r.o. Evropská 2591/33d 160 00 Praha 6 Hadovka Office Park Czech Republic

Brufen 400 Ibuprofen 400 mg Film-coated tablet Oral use

Czech Republic

Abbott Laboratories, s.r.o. Evropská 2591/33d 160 00 Praha 6 Hadovka Office Park Czech Republic

Brufen 400 mg šumivé granule

Ibuprofen 400 mg Effervescent granules Oral use

Czech Republic

Abbott Laboratories, s.r.o. Evropská 2591/33d 160 00 Praha 6 Hadovka Office Park Czech Republic

Brufen 600 mg Ibuprofen 600 mg Effervescent granules Oral use

Czech Republic

Abbott Laboratories, s.r.o. Evropská 2591/33d 160 00 Praha 6 Hadovka Office Park Czech Republic

Brufen Retard 800 mg

Ibuprofen 800 mg Prolonged-release tablet

Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 39/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Czech Republic

Abbott Laboratories, s.r.o. Evropská 2591/33d 160 00 Praha 6 Hadovka Office Park Czech Republic

Brufen Sirup Ibuprofen 20 mg/ml Syrup Oral use

Czech Republic

Boehringer Ingelheim International GmbH Binger Straße 173 55216 Ingelheim am Rhein Germany

Buscofem 400 mg Ibuprofen 400 mg Capsule, soft Oral use

Czech Republic

Dolorgiet GmbH & Co. KG Otto-von-Guericke-Str. 1 53757 Sankt Augustin Germany

Dolgit 800 Ibuprofen 800 mg Film-coated tablet Oral use

Czech Republic

Zentiva, k.s. U kabelovny 130 102 37 Praha 10 Dolní Měcholupy Czech Republic

Ibalgin 200 Ibuprofen 200 mg Film-coated tablet Oral use

Czech Republic

Zentiva, k.s. U kabelovny 130 102 37 Praha 10 Dolní Měcholupy Czech Republic

Ibalgin 400 Ibuprofen 400 mg Film-coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 40/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Czech Republic

Zentiva, k.s. U kabelovny 130 102 37 Praha 10 Dolní Měcholupy Czech Republic

Ibalgin 600 Ibuprofen 600 mg Film-coated tablet Oral use

Czech Republic

Zentiva, k.s. U kabelovny 130 102 37 Praha 10 Dolní Měcholupy Czech Republic

Ibalgin Grip 200 mg/5 mg

Ibuprofen phenylephrine hydrochloride

40 mg Film-coated tablet Oral use

Czech Republic

Zentiva, k.s. U kabelovny 130 102 37 Praha 10 Dolní Měcholupy Czech Republic

Ibalgin Rapid Ibuprofen lysine 400 mg Film-coated tablet Oral use

Czech Republic

Berlin-Chemie AG Glienicker Weg 125 12489 Berlin Germany

Ibuberl 400 mg Ibuprofen 400 mg Film-coated tablet Oral use

Czech Republic

Vitabalans Oy Varastokatu 8 13500 Hämeenlinna Finland

Ibumax 200 mg Ibuprofen 200 mg Film-coated tablet Oral use

Czech Republic

Vitabalans Oy Varastokatu 8 13500 Hämeenlinna Finland

Ibumax 400 mg Ibuprofen 400 mg Film-coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 41/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Czech Republic

Vitabalans Oy Varastokatu 8 13500 Hämeenlinna Finland

Ibumax 600 mg Ibuprofen 600 mg Film-coated tablet Oral use

Czech Republic

Generics UK Albany Gate Darkes Lane Potters Bar Hertfordshire EN6 1AG United Kingdom

Ibumyl Rapid 400 mg Ibuprofen lysine 400 mg Film-coated tablet Oral use

Czech Republic

MEDREG s.r.o. Krčmářovská 223/33 196 00 Praha 9 Czech Republic

Ibunex 200 mg potahované tablety

Ibuprofen 200 mg Film-coated tablet Oral use

Czech Republic

MEDREG s.r.o. Krčmářovská 223/33 196 00 Praha 9 Czech Republic

Ibunex 400 mg potahované tablety

Ibuprofen 400 mg Film-coated tablet Oral use

Czech Republic

GALMED a.s. Těšínská 1349/296 716 00 Ostrava - Radvanice Czech Republic

Ibuprofen 400 mg Galmed

Ibuprofen 400 mg Film-coated tablet Oral use

Czech Republic

ALIUD PHARMA GmbH Gottlieb-Daimler-Str. 19 89150 Laichingen Germany

Ibuprofen AL 400 Ibuprofen 400 mg Film-coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 42/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Czech Republic

Dr. Max Pharma Ltd. First Floor Roxburge House, Regent Street 273-287 W1B 2HA London United Kingdom

Ibuprofen Dr. MAX 200 MG potahované tablety

Ibuprofen 200 mg Film-coated tablet Oral use

Czech Republic

Dr. Max Pharma Ltd. First Floor Roxburge House, Regent Street 273-287 W1B 2HA London United Kingdom

Ibuprofen Dr. MAX 400 mg potahované tablety

Ibuprofen 400 mg Film-coated tablet Oral use

Czech Republic

Galpharm Healthcare Limited Hugh House Upper Cliffe Road Barnsley, South Yorkshire S75 3SP Dodworth Dodworth Bussiness Park United Kingdom

Ibuprofen Galpharm 200 mg potahované tablety

Ibuprofen 200 mg Film-coated tablet Oral use

Czech Republic

Galpharm Healthcare Limited Hugh House Upper Cliffe Road Barnsley, South Yorkshire S75 3SP Dodworth Dodworth Bussiness Park United Kingdom

Ibuprofen Galpharm 400 mg potahované tablety

Ibuprofen 400 mg Film-coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 43/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Czech Republic

Wrafton Laboratories Limited Exeter Road Wrafton, Braunton Devon EX33 2DL United Kingdom

Ibuprofen Perrigo 200 mg potahované tablety

Ibuprofen lysine 342 mg Film-coated tablet Oral use

Czech Republic

Wrafton Laboratories Limited Exeter Road Wrafton, Braunton Devon EX33 2DL United Kingdom

Ibuprofen Perrigo 400 mg

Ibuprofen lysine 684 mg Film-coated tablet Oral use

Czech Republic

Abbott Laboratories, s.r.o. Evropská 2591/33d 160 00 Praha 6 Hadovka Office Park Czech Republic

Ibuprofen Rockspring 200 mg šumivé granule

Ibuprofen 200 mg Effervescent granules Oral use

Czech Republic

Zentiva, k.s. U kabelovny 130 102 37 Praha 10 Dolní Měcholupy Czech Republic

Modafen Ibuprofen pseudoephedrine hydrochloride

200 mg 30 mg

Film-coated tablet Oral use

Czech Republic

Boehringer Ingelheim International GmbH Binger Straße 173 55216 Ingelheim am Rhein Germany

Mucogrip 200 mg/30 mg

Ibuprofen pseudoephedrine hydrochloride

200 mg 30 mg

Film-coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 44/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Czech Republic

Reckitt Benckiser Healthcare International Limited Bath Road 103-105 Berkshire SL1 3UH Slough United Kingdom

Nurofen 200 mg Ibuprofen 200 mg Coated tablet Oral use

Czech Republic

Reckitt Benckiser Healthcare International Limited Bath Road 103-105 Berkshire SL1 3UH Slough United Kingdom

Nurofen 400 mg Ibuprofen 400 mg Coated tablet Oral use

Czech Republic

Reckitt Benckiser Healthcare International Limited Bath Road 103-105 Berkshire SL1 3UH Slough United Kingdom

Nurofen Instant 400 mg rozpustný prášek

Ibuprofen lysine 683,34 mg Powder for oral solution

Oral use

Czech Republic

Reckitt Benckiser Healthcare International Limited Bath Road 103-105 Berkshire SL1 3UH Slough United Kingdom

Nurofen Neo 200 mg obalené tablety

Ibuprofen sodium dihydrate

256 mg Coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 45/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Czech Republic

Reckitt Benckiser Healthcare International Limited Bath Road 103-105 Berkshire SL1 3UH Slough United Kingdom

Nurofen Neo Femina 400 mg obalené tablety

Ibuprofen sodium dihydrate

512 mg Coated tablet Oral use

Czech Republic

Reckitt Benckiser Healthcare International Limited Bath Road 103-105 Berkshire SL1 3UH Slough United Kingdom

Nurofen Rapid 200 mg capsules

Ibuprofen 200 mg Capsule, soft Oral use

Czech Republic

Reckitt Benckiser Healthcare International Limited Bath Road 103-105 Berkshire SL1 3UH Slough United Kingdom

Nurofen Rapid 400 mg capsules

Ibuprofen 400 mg Capsule, soft Oral use

Czech Republic

Reckitt Benckiser Healthcare International Limited Bath Road 103-105 Berkshire SL1 3UH Slough United Kingdom

Nurofen Stopgrip Ibuprofen pseudoephedrine hydrochloride

200 mg 30 mg

Film-coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 46/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Czech Republic

GlaxoSmithKline Consumer Healthcare, GlaxoSmithKline Export Ltd. Great West Road 980 Middlesex TW8 9GS Brentford United Kingdom

Panafen Ibuprofen 200 mg Film-coated tablet Oral use

Denmark Abbott Scandinavia AB Hemvärnsgatan 9 (Box 1498, 171 29 Solna) SE-171 54 Solna Sweden

Brufen Ibuprofen 400 mg Film-coated tablet Oral use

Denmark Nycomed Danmark ApS Langebjerg 1 DK-4000 Roskilde Denmark

Ibumetin Ibuprofen 200 mg Film-coated tablet Oral use

Denmark Takeda Pharma A/S Dybendal Alle 10 DK-2630 Taastrup Denmark

Ibumetin Ibuprofen 400 mg Film-coated tablet Oral use

Denmark Takeda Pharma A/S Dybendal Alle 10 DK-2630 Taastrup Denmark

Ibumetin Ibuprofen 600 mg Film-coated tablet Oral use

Denmark Actavis Nordic A/S Ørnegårdsvej 16 DK-2820 Gentofte Denmark

Ibuprofen "Actavis" Ibuprofen 400 mg Film-coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 47/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Denmark Abbott Scandinavia AB Hemvärnsgatan 9 (Box 1498, 171 29 Solna) SE-171 54 Solna Sweden

Brufen Ibuprofen 600 mg Film-coated tablet Oral use

Denmark Abbott Scandinavia AB Hemvärnsgatan 9 (Box 1498, 171 29 Solna) SE-171 54 Solna Sweden

Brufen Retard Ibuprofen 800 mg Prolonged-release tablet

Oral use

Denmark Infirst Healthcare Ltd. Strand 265 London WC2R 1BH United Kingdom

Flarin Ibuprofen 200 mg Capsule, soft Oral use

Denmark Infirst Healthcare Ltd. Strand 265 London WC2R 1BH United Kingdom

Flarin Ibuprofen 400 mg Capsule, soft Oral use

Denmark Vitabalans Oy Varastokatu 8 13500 Hämeenlinna Finland

Ibumax Ibuprofen 400 mg Film-coated tablet Oral use

Denmark Vitabalans Oy Varastokatu 8 13500 Hämeenlinna Finland

Ibumax Ibuprofen 600 mg Film-coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 48/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Denmark Vitabalans Oy Varastokatu 8 13500 Hämeenlinna Finland

Ibumax Ibuprofen 200 mg Film-coated tablet Oral use

Denmark Takeda Pharma A/S Dybendal Alle 10 DK-2630 Taastrup Denmark

Ibumetin Retard Ibuprofen 600 mg Prolonged-release tablet

Oral use

Denmark Alchemia Ltd., Jermyn Street 86 5th floor SW1 Y6AW London United Kingdom

Ibunin Ibuprofen 200 mg Film-coated tablet Oral use

Denmark Alchemia Ltd., Jermyn Street 86 5th floor SW1 Y6AW London United Kingdom

Ibunin Ibuprofen 400 mg Film-coated tablet Oral use

Denmark Alternova A/S Lodshusvej 11 DK-4230 Skælskør Denmark

Ibupama Ibuprofen 200 mg Film-coated tablet Oral use

Denmark Alternova A/S Lodshusvej 11 DK-4230 Skælskør Denmark

Ibupama Ibuprofen 400 mg Film-coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 49/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Denmark Alternova A/S Lodshusvej 11 DK-4230 Skælskør Denmark

Ibupama Ibuprofen 600 mg Film-coated tablet Oral use

Denmark Actavis Nordic A/S Ørnegårdsvej 16 DK-2820 Gentofte Denmark

Ibuprofen "Actavis" Ibuprofen 600 mg Film-coated tablet Oral use

Denmark Alternova A/S Lodshusvej 11 DK-4230 Skælskør Denmark

Ibuprofen "Alternova" Ibuprofen 400 mg Film-coated tablet Oral use

Denmark Alternova A/S Lodshusvej 11 DK-4230 Skælskør Denmark

Ibuprofen "Alternova" Ibuprofen 600 mg Film-coated tablet Oral use

Denmark Alternova A/S Lodshusvej 11 DK-4230 Skælskør Denmark

Ibuprofen "Alternova" Ibuprofen 200 mg Film-coated tablet Oral use

Denmark Farmalider S.A. C/ Aragoneses, 15 Alcobendas (Madrid), 28108 Spain

Ibuprofen "Farmalider"

Ibuprofen 20 mg/ml Oral suspension Oral use

Denmark Farmalider S.A. C/ Aragoneses, 15 Alcobendas (Madrid), 28108 Spain

Ibuprofen "Farmalider"

Ibuprofen 40 mg/ml Oral suspension Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 50/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Denmark Orifarm Generics A/S Energivej 15 POB 69 DK-5260 Odense S Denmark

Ibuprofen "Orifarm" Ibuprofen 200 mg Film-coated tablet Oral use

Denmark Orifarm Generics A/S Energivej 15 POB 69 DK-5260 Odense S Denmark

Ibuprofen "Orifarm" Ibuprofen 400 mg Film-coated tablet Oral use

Denmark Orifarm Generics A/S Energivej 15 POB 69 DK-5260 Odense S Denmark

Ibuprofen "Orifarm" Ibuprofen 600 mg Film-coated tablet Oral use

Denmark Teva Denmark A/S Parallelvej 10-12, DK-2800 Kongens Lyndby Denmark

Ibuprofen "Teva" Ibuprofen 200 mg Film-coated tablet Oral use

Denmark Teva Denmark A/S Parallelvej 10-12 DK-2800 Kongens Lyndby Denmark

Ibuprofen "Teva" Ibuprofen 400 mg Film-coated tablet Oral use

Denmark Berlin-Chemie AG Glienicker Weg 125 12489 Berlin Germany

Ibustar Ibuprofen 400 mg Film-coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 51/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Denmark Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland

Ifenin Ibuprofen 200 mg Film-coated tablet Oral use

Denmark Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland

Ifenin Ibuprofen 400 mg Film-coated tablet Oral use

Denmark Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland

Ifenin Ibuprofen 600 mg Film-coated tablet Oral use

Denmark Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland

Ifenin Ibuprofen 800 mg Film-coated tablet Oral use

Denmark Nycomed Danmark ApS Langebjerg 1 DK-4000 Roskilde Denmark

Ipren Ibuprofen 200 mg Film-coated tablet Oral use

Denmark Nordic Drugs AB Geijersgatan 2A Box 30035 200 61 limhamn Sweden

Seractiv Dexibuprofen 300 mg Film-coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 52/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Denmark Nordic Drugs AB Geijersgatan 2A Box 30035 200 61 limhamn Sweden

Seractiv Dexibuprofen 400 mg Film-coated tablet Oral use

Estonia AS Grindeks Krustpils 53 LV-1057 Riga Latvia

IBUFLUX 400 MG Ibuprofen 400 mg Film-coated tablet Oral use

Estonia Vitabalans Oy Varastokatu 8 13500 Hämeenlinna Finland

IBUMAX Ibuprofen 400 mg Film-coated tablet Oral use

Estonia Reckitt Benckiser (Poland) S.A. ul. Okunin 1 05-100 Nowy Dwor Mazowiecki Poland

NUROFEN Ibuprofen 200 mg Coated tablet Oral use

Estonia STADA Arzneimittel AG Stadastr. 2-18 61118 Bad Vilbel Germany

IBUDOLOR Ibuprofen 200 mg Film-coated tablet Oral use

Estonia Lannacher Heilmittel GmbH Schlossplatz 1 A-8502 Lannach Austria

IBUPROFEN LANNACHER

Ibuprofen 400 mg Film-coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 53/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Estonia Lannacher Heilmittel GmbH Schlossplatz 1 A-8502 Lannach Austria

IBUPROFEN LANNACHER

Ibuprofen 600 mg Film-coated tablet Oral use

Estonia Orion Corporation Orionintie 1 FIN-02200 Espoo Finland

BURANA Ibuprofen 400 mg Film-coated tablet Oral use

Estonia AS Grindeks Krustpils 53 LV-1057 Riga Latvia

IBUPROFEN-GRINDEKS

Ibuprofen 200 mg Film-coated tablet Oral use

Estonia Takeda Pharma AS Jaama 55B Polva 63308 Estonia

IBUMETIN Ibuprofen 200 mg Film-coated tablet Oral use

Estonia Takeda Pharma AS Jaama 55B Polva 63308 Estonia

IBUMETIN Ibuprofen 400 mg Film-coated tablet Oral use

Estonia Takeda Pharma AS Jaama 55B Polva 63308 Estonia

IBUMETIN Ibuprofen 600 mg Film-coated tablet Oral use

Estonia Vitabalans Oy Varastokatu 8 13500 Hämeenlinna Finland

IBUMAX Ibuprofen 600 mg Film-coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 54/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Estonia Reckitt Benckiser (Poland) S.A. ul. Okunin 1 05-100 Nowy Dwor Mazowiecki Poland

NUROFEN FORTE Ibuprofen 400 mg Coated tablet Oral use

Estonia Vitabalans Oy Varastokatu 8 13500 Hämeenlinna Finland

IBUMAX Ibuprofen 200 mg Film-coated tablet Oral use

Estonia Reckitt Benckiser (Poland) S.A. ul. Okunin 1 05-100 Nowy Dwor Mazowiecki Poland

NUROFEN EXPRESS Ibuprofen 200 mg Coated tablet Oral use

Estonia Reckitt Benckiser (Poland) S.A. ul. Okunin 1 05-100 Nowy Dwor Mazowiecki Poland

NUROFEN FORTE EXPRESS

Ibuprofen 400 mg Coated tablet Oral use

Estonia Berlin-Chemie AG Glienicker Weg 125 12489 Berlin Germany

IBUSTAR Ibuprofen 400 mg Film-coated tablet Oral use

Estonia Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland

IBUPROFEN ACTAVIS Ibuprofen 200 mg Film-coated tablet Oral use

Estonia Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland

IBUPROFEN ACTAVIS Ibuprofen 400 mg Film-coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 55/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Estonia Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland

IBUPROFEN ACTAVIS Ibuprofen 600 mg Film-coated tablet Oral use

Estonia Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland

IBUPROFEN ACTAVIS Ibuprofen 800 mg Film-coated tablet Oral use

Estonia Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland

IFENIN Ibuprofen 200 mg Film-coated tablet Oral use

Estonia Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland

IFENIN Ibuprofen 400 mg Film-coated tablet Oral use

Estonia Reckitt Benckiser (Poland) S.A. ul. Okunin 1 05-100 Nowy Dwor Mazowiecki Poland

NUROFEN ULTRA EXPRESS

Ibuprofen 200 mg Capsule, soft Oral use

Estonia ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany

IBUPROFEN-RATIOPHARM 200 MG

Ibuprofen 200 mg Film-coated tablet Oral use

Estonia ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany

IBUPROFEN-RATIOPHARM 400 MG

Ibuprofen 400 mg Film-coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 56/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Estonia Abbott Laboratories Baltics SIA Mukusalas 101 Riga LV 1004 Latvia

BRUFEN Ibuprofen 200 mg Film-coated tablet Oral use

Estonia Abbott Laboratories Baltics SIA Mukusalas 101 Riga LV 1004 Latvia

BRUFEN Ibuprofen 400 mg Film-coated tablet Oral use

Estonia ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany

BUTIFEN 400 MG Ibuprofen 400 mg Film-coated tablet Oral use

Estonia Mepha Lda. Lagoas Park, 2740-298 Porto Salvo Portugal

IBUPROFEN MEPHA 400MG

Ibuprofen 400 mg Film-coated tablet Oral use

Estonia Abbott Laboratories Baltics SIA Mukusalas 101 Riga LV 1004 Latvia

BRUFEN Ibuprofen 20 mg/ml Oral suspension Oral use

Estonia Abbott Laboratories Baltics SIA Mukusalas 101 Riga LV 1004 Latvia

BRUFEN Ibuprofen 800 mg Prolonged-release tablet

Oral use

Estonia Abbott Laboratories Baltics SIA Mukusalas 101 Riga LV 1004 Latvia

IBUPROFEN ROCKSPRING

Ibuprofen 200 mg Effervescent granules Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 57/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Estonia Abbott Laboratories Baltics SIA Mukusalas 101 Riga LV 1004 Latvia

BRUFEN Ibuprofen 400 mg Effervescent granules Oral use

Estonia Abbott Laboratories Baltics SIA Mukusalas 101 Riga LV 1004 Latvia

IBUPROFEN ROCKSPRING

Ibuprofen 600 mg Effervescent granules Oral use

Estonia Rockspring Healthcare Limited 38/40 Chamberlayne Road London NW10 3JE United Kingdom

CODEINE/IBUPROFEN ROCKSPRING

Ibuprofen codeine

400 mg 30 mg

Film-coated tablet Oral use

Estonia Abbott Laboratories Baltics SIA Mukusalas 101 Riga LV 1004 Latvia

BRUFEN Ibuprofen 40 mg/ml Oral suspension Oral use

Finland Orion Pharma Orionintie 1 PL 65 02101 ESPOO Finland

BURANA Ibuprofen 200 mg Film-coated tablet Oral use

Finland Orion Pharma Orionintie 1 PL 65 02101 ESPOO Finland

BURANA Ibuprofen 400 mg Film-coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 58/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Finland Orion Pharma Orionintie 1 PL 65 02101 ESPOO Finland

BURANA Ibuprofen 600 mg Film-coated tablet Oral use

Finland Orion Pharma Orionintie 1 PL 65 02101 ESPOO Finland

BURANA Ibuprofen 800 mg Film-coated tablet Oral use

Finland Orion Pharma Orionintie 1 PL 65 02101 ESPOO Finland

BURANA Ibuprofen 20 mg/ml Oral suspension Oral use

Finland Orion Pharma Orionintie 1 PL 65 02101 ESPOO Finland

BURANA Ibuprofen 40 mg/ml Oral suspension Oral use

Finland Orion Pharma Orionintie 1 PL 65 02101 ESPOO Finland

BURANA SLOW Ibuprofen 800 mg Prolonged-release tablet

Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 59/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Finland Orion Pharma Orionintie 1 PL 65 02101 ESPOO Finland

BURANA-CAPS Ibuprofen 400 mg Capsule, soft Oral use

Finland Orion Pharma Orionintie 1 PL 65 02101 ESPOO Finland

BURANA-PORE Ibuprofen 200 mg Effervescent tablet Oral use

Finland Orion Pharma Orionintie 1 PL 65 02101 ESPOO Finland

BURANA-PORE Ibuprofen 400 mg Effervescent tablet Oral use

Finland Vitabalans Oy Varastokatu 8 13500 Hämeenlinna Finland

IBUMAX Ibuprofen 200 mg Film-coated tablet Oral use

Finland Vitabalans Oy Varastokatu 8 13500 Hämeenlinna Finland

IBUMAX Ibuprofen 400 mg Film-coated tablet Oral use

Finland Vitabalans Oy Varastokatu 8 13500 Hämeenlinna Finland

IBUMAX Ibuprofen 600 mg Film-coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 60/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Finland Vitabalans Oy Varastokatu 8 13500 Hämeenlinna Finland

IBUMAX Ibuprofen 800 mg Film-coated tablet Oral use

Finland Oy Leiras Takeda Paciuksenkatu 21 PL 1406 00101 HELSINKI Finland

IBUMETIN Ibuprofen 400 mg Film-coated tablet Oral use

Finland Oy Leiras Takeda Paciuksenkatu 21 PL 1406 00101 HELSINKI Finland

IBUMETIN Ibuprofen 600 mg Film-coated tablet Oral use

Finland Laboratorios Farmalider S.A. Aragoneses, 15. Polígono Industrial de Alcobendas 28108 ALCOBENDAS Spain

IBUPROFEN FARMALIDER

Ibuprofen 20 mg/ml Oral suspension Oral use

Finland Laboratorios Farmalider S.A. Aragoneses, 15. Polígono Industrial de Alcobendas 28108 ALCOBENDAS Spain

IBUPROFEN FARMALIDER

Ibuprofen 40 mg/ml Oral suspension Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 61/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Finland Galpharm Healthcare Limited Hugh House Upper Cliffe Road Barnsley, South Yorkshire S75 3SP Dodworth Dodworth Bussiness Park United Kingdom

IBUPROFEN GALPHARM

Ibuprofen 200 mg Film-coated tablet Oral use

Finland Galpharm Healthcare Limited Hugh House Upper Cliffe Road Barnsley, South Yorkshire S75 3SP Dodworth Dodworth Bussiness Park United Kingdom

IBUPROFEN GALPHARM

Ibuprofen 400 mg Film-coated tablet Oral use

Finland Orion Pharma Orionintie 1 PL 65 02101 ESPOO Finland

IBUSAL Ibuprofen 200 mg Film-coated tablet Oral use

Finland Orion Pharma Orionintie 1 PL 65 02101 ESPOO Finland

IBUSAL Ibuprofen 400 mg Film-coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 62/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Finland Orion Pharma Orionintie 1 PL 65 02101 ESPOO Finland

IBUSAL Ibuprofen 600 mg Film-coated tablet Oral use

Finland Orion Pharma Orionintie 1 PL 65 02101 ESPOO Finland

IBUSAL Ibuprofen 800 mg Film-coated tablet Oral use

Finland Orion Pharma Orionintie 1 PL 65 02101 ESPOO Finland

IBUTABS Ibuprofen 400 mg Film-coated tablet Oral use

Finland ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany

IBUXIN Ibuprofen 200 mg Film-coated tablet Oral use

Finland ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany

IBUXIN Ibuprofen 400 mg Film-coated tablet Oral use

Finland ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany

IBUXIN Ibuprofen 600 mg Film-coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 63/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Finland ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany

IBUXIN Ibuprofen 800 mg Film-coated tablet Oral use

Finland ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany

IBUXIN RAPID Ibuprofen 400 mg Film-coated tablet Oral use

Finland Berlin-Chemie AG Glienicker Weg 125 12489 Berlin Germany

MIG-400 Ibuprofen 400 mg Film-coated tablet Oral use

Finland Reckitt Benckiser Healthcare International Limited Bath Road 103-105 Berkshire SL1 3UH Slough United Kingdom

NUROFEN APPELSIINI

Ibuprofen 40 mg/ml Oral suspension Oral use

Finland Reckitt Benckiser Healthcare International Limited Bath Road 103-105 Berkshire SL1 3UH Slough United Kingdom

NUROFEN MANSIKKA Ibuprofen 40 mg/ml Oral suspension Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 64/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Finland Orion Pharma Orionintie 1 PL 65 02101 ESPOO Finland

BURANA-C Ibuprofen ascorbic acid

400 mg 300 mg

Film-coated tablet Oral use

Finland Abbott Scandinavia AB P.O Box 1498 SE-171 29 Solna Sweden

ARDINEX Ibuprofen codeine

200 mg 30 mg

Film-coated tablet Oral use

Finland Orion Pharma Orionintie 1 PL 65 02101 ESPOO Finland

BURANA COMP Ibuprofen codeine

200 mg 30 mg

Film-coated tablet Oral use

Finland Orion Pharma Orionintie 1 PL 65 02101 ESPOO Finland

BURANA COMP Ibuprofen codeine

400 mg 60 mg

Film-coated tablet Oral use

Finland Abbott Oy Pihatörmä 1 B 02240 ESPOO Finland

IBUPROFEN/CODEINE PHOSPHATE ROCKSPRING

Ibuprofen codeine

400 mg 30 mg

Film-coated tablet Oral use

France PFIZER SANTE FAMILIALE 23-25, avenue du Docteur Lannelongue 75014 Paris France

ADVIL 200 mg, comprimé enrobé

Ibuprofen 200 mg Coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 65/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

France PFIZER SANTE FAMILIALE 23-25, avenue du Docteur Lannelongue 75014 Paris France

ADVIL 400 mg, comprimé effervescent

Ibuprofen 400 mg Effervescent tablet Oral use

France PFIZER SANTE FAMILIALE 23-25, avenue du Docteur Lannelongue 75014 Paris France

ADVIL 400 mg, comprimé enrobé

Ibuprofen 400 mg Coated tablet Oral use

France PFIZER SANTE FAMILIALE 23-25, avenue du Docteur Lannelongue 75014 Paris France

ADVILCAPS 200 mg, capsule molle

Ibuprofen 200 mg Capsule, soft Oral use

France PFIZER SANTE FAMILIALE 23-25, avenue du Docteur Lannelongue 75014 Paris France

ADVILCAPS 400 mg, capsule molle

Ibuprofen 400 mg Capsule, soft Oral use

France PFIZER SANTE FAMILIALE 23-25, avenue du Docteur Lannelongue 75014 Paris France

ADVILEFF 200 mg, comprimé effervescent

Ibuprofen 200 mg Effervescent tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 66/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

France PFIZER SANTE FAMILIALE 23-25, avenue du Docteur Lannelongue 75014 Paris France

ADVILMED 400 mg, comprimé enrobé

Ibuprofen 400 mg Coated tablet Oral use

France PFIZER SANTE FAMILIALE 23-25, avenue du Docteur Lannelongue 75014 Paris France

ADVILTAB 200 mg, comprimé enrobé

Ibuprofen 200 mg Coated tablet Oral use

France JOLLY JATEL 28, avenue Carnot 78951 Saint Germain en Laye Cedex France

ALGIFENE 200 mg, comprimé enrobé

Ibuprofen 200 mg Tablet Oral use

France ELERTE 181 - 183, rue André Karman BP 101 93303 Aubervilliers Cedex France

ANTARENE 200 mg, comprimé pelliculé

Ibuprofen 200 mg Tablet Oral use

France ELERTE 181 - 183, rue André Karman BP 101 93303 Aubervilliers Cedex France

ANTARENE 400 mg, comprimé pelliculé

Ibuprofen 400 mg Tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 67/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

France ELERTE 181 - 183, rue André Karman BP 101 93303 Aubervilliers Cedex France

ANTARENE CODEINE 200 mg/30 mg, comprimé pelliculé

Ibuprofen codeine

200 mg 30 mg

Tablet Oral use

France ELERTE 181 - 183, rue André Karman BP 101 93303 Aubervilliers Cedex France

ANTARENE CODEINE 400 mg/60 mg, comprimé pelliculé

Ibuprofen codeine

400 mg 60 mg

Tablet Oral use

France Bayer Sante Familiale 33, rue de l'Industrie 74240 Gaillard France

ASPROFEN 200 mg, gélule

Ibuprofen 200 mg Capsule, hard Oral use

France Abbott France 3 place Gustave Eiffel Bâtiment Florence 94518 Rungis Cedex France

BRUFEN 400 mg, comprimé pelliculé

Ibuprofen 400 mg Tablet Oral use

France Bayer Sante Familiale 33, rue de l'Industrie 74240 Gaillard France

CLARAFEN 400 mg, gélule

Ibuprofen 400 mg Capsule, hard Oral use

France CRISTERS 22 quai Gallieni 92150 Suresnes France

CRIFENE 400 mg, comprimé pelliculé

Ibuprofen 400 mg Tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 68/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

France MERCK MEDICATION FAMILIALE 37, rue Saint-Romain 69379 Lyon Cedex 08 France

ERGIX 200 mg DOULEUR ET FIEVRE, comprimé pelliculé

Ibuprofen 200 mg Tablet Oral use

France AJC INVEST Rue de la Rochefoucauld 6 16000 Angoulême France

EXPANFEN 200 mg, comprimé enrobé

Ibuprofen 200 mg Tablet Oral use

France COOPER Place Lucien-Auvert 77020 Melun Cedex France

GELUFENE 200 mg, gélule

Ibuprofen 200 mg Capsule, hard Oral use

France ELERTE 181 - 183, rue André Karman BP 101 93303 Aubervilliers Cedex France

HEMAGENE TAILLEUR 200 mg, comprimé pelliculé

Ibuprofen 200 mg Tablet Oral use

France Banner Pharmacaps (The Netherlands) PO Box 5037 5004 EA Tilburg The Netherlands

IBUCAPS 200 mg, capsule molle

Ibuprofen 200 mg Capsule, soft Oral use

France Pharmachemie B.V. Swensweg 5 - Haarlem PO Box 552 2003 RN Haarlem The Netherlands

IBUFEN 200 mg, comprimé enrobé

Ibuprofen 200 mg Tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 69/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

France Pharmachemie B.V. Swensweg 5 - Haarlem PO Box 552 2003 RN Haarlem The Netherlands

IBUFEN 400 mg, comprimé enrobé

Ibuprofen 400 mg Tablet Oral use

France Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland

IBUPROFENE ACTAVIS 400 mg, comprimé pelliculé

Ibuprofen 400 mg Film-coated tablet Oral use

France Biogaran Boulevard Charles de Gaulle 15 92700 Colombes France

IBUPROFENE ALMUS 200 mg, comprimé pelliculé

Ibuprofen 200 mg Film-coated tablet Oral use

France Biogaran Boulevard Charles de Gaulle 15 92700 Colombes France

IBUPROFENE ALMUS 400 mg, comprimé pelliculé

Ibuprofen 400 mg Film-coated tablet Oral use

France ARROW GENERIQUES 26, avenue Tony Garnier 69007 Lyon France

IBUPROFENE ARROW 200 mg, comprimé enrobé

Ibuprofen 200 mg Coated tablet Oral use

France ARROW GENERIQUES 26, avenue Tony Garnier 69007 Lyon France

IBUPROFENE ARROW 400 mg, comprimé pelliculé

Ibuprofen 400 mg Film-coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 70/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

France ARROW GENERIQUES 26, avenue Tony Garnier 69007 Lyon France

IBUPROFENE ARROW CONSEIL 400 mg, comprimé pelliculé

Ibuprofen 400 mg Film-coated tablet Oral use

France INTERNATIONAL DRUG DEVELOPMENT 5, rue Simonet 75013 Paris France

IBUPROFENE BIO VALYS 400 mg, comprimé effervescent

Ibuprofen 400 mg Effervescent tablet Oral use

France Biogaran Boulevard Charles de Gaulle 15 92700 Colombes France

IBUPROFENE BIOGARAN 200 mg, comprimé pelliculé

Ibuprofen 200 mg Film-coated tablet Oral use

France Biogaran Boulevard Charles de Gaulle 15 92700 Colombes France

IBUPROFENE BIOGARAN 400 mg, comprimé pelliculé

Ibuprofen 400 mg Film-coated tablet Oral use

France Biogaran Boulevard Charles de Gaulle 15 92700 Colombes France

IBUPROFENE BIOGARAN CONSEIL 200 mg, comprimé pelliculé

Ibuprofen 200 mg Film-coated tablet Oral use

France Biogaran Boulevard Charles de Gaulle 15 92700 Colombes France

IBUPROFENE BIOGARAN CONSEIL 400 mg, comprimé pelliculé

Ibuprofen 400 mg Film-coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 71/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

France CRISTERS 22 quai Gallieni 92150 Suresnes France

IBUPROFENE CRISTERS 200 mg, comprimé enrobé

Ibuprofen 200 mg Coated tablet Oral use

France CRISTERS 22 quai Gallieni 92150 Suresnes France

IBUPROFENE CRISTERS 200 mg, comprimé pelliculé

Ibuprofen 200 mg Film-coated tablet Oral use

France CRISTERS 22 quai Gallieni 92150 Suresnes France

IBUPROFENE CRISTERS 400 mg, comprimé pelliculé

Ibuprofen 400 mg Film-coated tablet Oral use

France EG LABO - LABORATOIRES EUROGENERICS "Le Quintet" - bâtiment A 12, rue Danjou 92517 Boulogne Billancourt Cedex France

IBUPROFENE EG 200 mg, comprimé pelliculé

Ibuprofen 200 mg Film-coated tablet Oral use

France EG LABO - LABORATOIRES EUROGENERICS "Le Quintet" - bâtiment A 12, rue Danjou 92517 Boulogne Billancourt Cedex France

IBUPROFENE EG 400 mg, comprimé pelliculé

Ibuprofen 400 mg Film-coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 72/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

France ELAIAPHARM 2881, Route des Crêtes BP 205 Valbonne 06904 Sophia Antipolis Cedex France

IBUPROFENE ELAIAPHARM 200 mg, comprimé pelliculé

Ibuprofen 200 mg Film-coated tablet Oral use

France ETHYPHARM 194, Bureaux de la Colline Bâtiment D 92213 Saint-Cloud Cedex France

IBUPROFENE ETHYPHARM L.P.300 mg, microgranules à libération prolongée en gélule

Ibuprofen 300 mg Prolonged-release capsule, hard

Oral use

France EVOLUPHARM rue Irène Caron Zone Industrielle d'Auneuil 60390 Auneuil France

IBUPROFENE EVOLUGEN 400 mg, comprimé pelliculé

Ibuprofen 400 mg Film-coated tablet Oral use

France Farmalider S.A. C/ Aragoneses, 15 Alcobendas (Madrid), 28108 Spain

IBUPROFENE FARMALIDER 400 mg, comprimé pelliculé

Ibuprofen 400 mg Film-coated tablet Oral use

France GIBAUD PHARMA 73, rue de la Tour 42002 Saint-Etienne Cedex 1 France

IBUPROFENE GIBAUD 200 mg, comprimé enrobé

Ibuprofen 200 mg Coated tablet Oral use

France PLUS PHARMACIE 26, boulevard Paul Vaillant-Couturier 94200 Ivry-sur-Seine France

IBUPROFENE ISOMED 200 mg, comprimé enrobé

Ibuprofen 200 mg Coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 73/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

France MYLAN SAS 117, allée des Parcs 69800 Saint-Priest France

IBUPROFENE MYLAN 200 mg, comprimé enrobé

Ibuprofen 200 mg Coated tablet Oral use

France MYLAN SAS 117, allée des Parcs 69800 Saint-Priest France

IBUPROFENE MYLAN 400 mg, comprimé effervescent

Ibuprofen 400 mg Effervescent tablet Oral use

France MYLAN SAS 117, allée des Parcs 69800 Saint-Priest France

IBUPROFENE MYLAN 400 mg, comprimé pelliculé

Ibuprofen 400 mg Film-coated tablet Oral use

France MYLAN SAS 117, allée des Parcs 69800 Saint-Priest France

IBUPROFENE MYLAN CONSEIL 200 mg, comprimé pelliculé

Ibuprofen 200 mg Film-coated tablet Oral use

France MYLAN SAS 117, allée des Parcs 69800 Saint-Priest France

IBUPROFENE MYLAN CONSEIL 400 mg, comprimé pelliculé

Ibuprofen 400 mg Film-coated tablet Oral use

France LABORATOIRES NEPENTHES 13, avenue Paul Langevin ZA de la patte d'oie 95220 Herblay France

IBUPROFENE NEPENTHES 200 mg, comprimé pelliculé

Ibuprofen 200 mg Film-coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 74/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

France LABORATOIRES NEPENTHES 13, avenue Paul Langevin ZA de la patte d'oie 95220 Herblay France

IBUPROFENE NEPENTHES 400 mg, comprimé pelliculé

Ibuprofen 400 mg Film-coated tablet Oral use

France Biogaran Boulevard Charles de Gaulle 15 92700 Colombes France

IBUPROFENE NOR 400 mg, comprimé pelliculé

Ibuprofen 400 mg Film-coated tablet Oral use

France OPENING PHARMA FRANCE 15, rue Taitbout 75009 Paris France

IBUPROFENE OPENING PHARMA 200 mg, comprimé pelliculé

Ibuprofen 200 mg Film-coated tablet Oral use

France Biogaran Boulevard Charles de Gaulle 15 92700 Colombes France

IBUPROFENE PHR LAB 400 mg, comprimé pelliculé

Ibuprofen 400 mg Film-coated tablet Oral use

France RANBAXY PHARMACIE GENERIQUES 11-15 Quai Dion Bouton 92800 Puteaux France

IBUPROFENE RANBAXY MEDICATION OFFICINALE 200 mg, comprimé pelliculé

Ibuprofen 200 mg Film-coated tablet Oral use

France RANBAXY PHARMACIE GENERIQUES 11-15 Quai Dion Bouton 92800 Puteaux France

IBUPROFENE RANBAXY MEDICATION OFFICINALE 400 mg, comprimé pelliculé

Ibuprofen 400 mg Film-coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 75/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

France ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany

IBUPROFENE RATIOPHARM 200 mg, comprimé enrobé

Ibuprofen 200 mg Coated tablet Oral use

France TEVA SANTE Esplanade du Général de Gaulle 110 92931 Paris La Défense Cedex France

IBUPROFENE RATIOPHARM 400 mg, comprimé pelliculé

Ibuprofen 400 mg Film-coated tablet Oral use

France TEVA SANTE Esplanade du Général de Gaulle 110 92931 Paris La Défense Cedex France

IBUPROFENE RATIOPHARM CONSEIL 200 mg, comprimé enrobé

Ibuprofen 200 mg Coated tablet Oral use

France TEVA SANTE Esplanade du Général de Gaulle 110 92931 Paris La Défense Cedex France

IBUPROFENE RATIOPHARM CONSEIL 400 mg, comprimé pelliculé

Ibuprofen 400 mg Film-coated tablet Oral use

France Biogaran Boulevard Charles de Gaulle 15 92700 Colombes France

IBUPROFENE REF 200 mg, comprimé pelliculé

Ibuprofen 200 mg Coated tablet Oral use

France RANBAXY PHARMACIE GENERIQUES 11-15 Quai Dion Bouton 92800 Puteaux France

IBUPROFENE RPG 400 mg, comprimé pelliculé

Ibuprofen 400 mg Film-coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 76/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

France SANDOZ 49, avenue Georges Pompidou 92300 Levallois-Perret France

IBUPROFENE SANDOZ 200 mg, comprimé enrobé

Ibuprofen 200 mg Coated tablet Oral use

France SANDOZ 49, avenue Georges Pompidou 92300 Levallois-Perret France

IBUPROFENE SANDOZ 200 mg, comprimé pelliculé

Ibuprofen 200 mg Film-coated tablet Oral use

France SANDOZ 49, avenue Georges Pompidou 92300 Levallois-Perret France

IBUPROFENE SANDOZ 400 mg, comprimé enrobé

Ibuprofen 400 mg Coated tablet Oral use

France SANDOZ 49, avenue Georges Pompidou 92300 Levallois-Perret France

IBUPROFENE SANDOZ 400 mg, comprimé pelliculé

Ibuprofen 400 mg Film-coated tablet Oral use

France SANDOZ 49, avenue Georges Pompidou 92300 Levallois-Perret France

IBUPROFENE SANDOZ CONSEIL 200 mg, comprimé enrobé

Ibuprofen 200 mg Coated tablet Oral use

France SANDOZ 49, avenue Georges Pompidou 92300 Levallois-Perret France

IBUPROFENE SANDOZ CONSEIL 400 mg, comprimé pelliculé

Ibuprofen 400 mg Film-coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 77/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

France TEVA SANTE Esplanade du Général de Gaulle 110 92931 Paris La Défense Cedex France

IBUPROFENE TEVA 200 mg, comprimé enrobé

Ibuprofen 200 mg Coated tablet Oral use

France TEVA SANTE Esplanade du Général de Gaulle 110 92931 Paris La Défense Cedex France

IBUPROFENE TEVA 400 mg, comprimé pelliculé

Ibuprofen 400 mg Film-coated tablet Oral use

France TEVA SANTE Esplanade du Général de Gaulle 110 92931 Paris La Défense Cedex France

IBUPROFENE TEVA CONSEIL 200 mg, comprimé enrobé

Ibuprofen 200 mg Coated tablet Oral use

France PFIZER HOLDING FRANCE 23-25, avenue du Docteur Lannelongue 75014 Paris France

IBUPROFENE UNION INTERPHARMACEUTIQUE ATLANTIQUE 200 mg, comprimé pelliculé

Ibuprofen 200 mg Film-coated tablet Oral use

France PFIZER HOLDING FRANCE 23-25, avenue du Docteur Lannelongue 75014 Paris France

IBUPROFENE UNION INTERPHARMACEUTIQUE ATLANTIQUE 400 mg, comprimé pelliculé

Ibuprofen 400 mg Film-coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 78/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

France PFIZER HOLDING FRANCE 23-25, avenue du Docteur Lannelongue 75014 Paris France

IBUPROFENE UPJOHN 200 mg, comprimé pelliculé

Ibuprofen 200 mg Film-coated tablet Oral use

France PFIZER SANTE FAMILIALE 23-25, avenue du Docteur Lannelongue 75014 Paris France

IBUPROFENE WYETH SANTE FAMILIALE 400 mg, comprimé effervescent

Ibuprofen 400 mg Effervescent tablet Oral use

France ZYDUS FRANCE 25, rue des Peupliers ZAC Les Hautes Pâtures - Parc d’Activités des Peupliers 92000 Nanterre France

IBUPROFENE ZF 400 mg, comprimé pelliculé

Ibuprofen 400 mg Film-coated tablet Oral use

France ZYDUS FRANCE 25, rue des Peupliers ZAC Les Hautes Pâtures - Parc d’Activités des Peupliers 92000 Nanterre France

IBUPROFENE ZYDUS 200 mg, comprimé enrobé

Ibuprofen 200 mg Coated tablet Oral use

France ZYDUS FRANCE 25, rue des Peupliers ZAC Les Hautes Pâtures - Parc d’Activités des Peupliers 92000 Nanterre France

IBUPROFENE ZYDUS 400 mg, comprimé pelliculé

Ibuprofen 400 mg Film-coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 79/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

France ZYDUS FRANCE 25, rue des Peupliers ZAC Les Hautes Pâtures - Parc d’Activités des Peupliers 92000 Nanterre France

IBUPROFENE ZYDUS FRANCE 200 mg, comprimé pelliculé

Ibuprofen 200 mg Film-coated tablet Oral use

France ZYDUS FRANCE 25, rue des Peupliers ZAC Les Hautes Pâtures - Parc d’Activités des Peupliers 92000 Nanterre France

IBUPROFENE ZYDUS FRANCE 400 mg, comprimé pelliculé

Ibuprofen 400 mg Film-coated tablet Oral use

France Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland

IBUTABS 200 mg, comprimé pelliculé

Ibuprofen 200 mg Film-coated tablet Oral use

France Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland

IBUTABS 400 mg, comprimé pelliculé

Ibuprofen 400 mg Film-coated tablet Oral use

France URGO 42, rue de Longvic BP 157 21304 Chenôve Cedex France

INTRALGIS 200 mg, comprimé pelliculé

Ibuprofen 200 mg Film-coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 80/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

France PFIZER HOLDING FRANCE 23-25, avenue du Docteur Lannelongue 75014 Paris France

MOTRIN 200 mg, comprimé pelliculé

Ibuprofen 200 mg Film-coated tablet Oral use

France PFIZER HOLDING FRANCE 23-25, avenue du Docteur Lannelongue 75014 Paris France

MOTRIN 400 mg, comprimé pelliculé

Ibuprofen 400 mg Film-coated tablet Oral use

France RECKITT BENCKISER HEALTHCARE FRANCE 15, rue Ampère 91748 Massy Cedex France

NUREFLEX 200 mg, comprimé enrobé

Ibuprofen 200 mg Coated tablet Oral use

France RECKITT BENCKISER HEALTHCARE FRANCE 15, rue Ampère 91748 Massy Cedex France

NUREFLEX 400 mg, comprimé enrobé

Ibuprofen 400 mg Coated tablet Oral use

France RECKITT BENCKISER HEALTHCARE FRANCE 15, rue Ampère 91748 Massy Cedex France

NUREFLEX 400 mg, granulés effervescents en sachet-dose

Ibuprofen 400 mg Effervescent granules Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 81/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

France RECKITT BENCKISER HEALTHCARE FRANCE 15, rue Ampère 91748 Massy Cedex France

NUREFLEX L.P. 300 mg, gélule à libération prolongée

Ibuprofen 300 mg Prolonged-release capsule, hard

Oral use

France RECKITT BENCKISER HEALTHCARE FRANCE 15, rue Ampère 91748 Massy Cedex France

NUROFEN 200 mg, capsule molle

Ibuprofen 200 mg Capsule, soft Oral use

France RECKITT BENCKISER HEALTHCARE FRANCE 15, rue Ampère 91748 Massy Cedex France

NUROFEN 200 mg, comprimé enrobé

Ibuprofen 200 mg Coated tablet Oral use

France RECKITT BENCKISER HEALTHCARE FRANCE 15, rue Ampère 91748 Massy Cedex France

NUROFEN 200 mg, comprimé orodispersible

Ibuprofen 200 mg Orodispersible tablet Oral use

France RECKITT BENCKISER HEALTHCARE FRANCE 15, rue Ampère 91748 Massy Cedex France

NUROFEN 400 mg, capsule molle

Ibuprofen 400 mg Capsule, soft Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 82/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

France RECKITT BENCKISER HEALTHCARE FRANCE 15, rue Ampère 91748 Massy Cedex France

NUROFEN 400 mg, comprimé enrobé

Ibuprofen 400 mg Coated tablet Oral use

France RECKITT BENCKISER HEALTHCARE FRANCE 15, rue Ampère 91748 Massy Cedex France

NUROFEN RHUME, comprimé pelliculé

Ibuprofen pseudoephedrine

200 mg Film-coated tablet Oral use

France RECKITT BENCKISER HEALTHCARE FRANCE 15, rue Ampère 91748 Massy Cedex France

NUROFENCAPS 200 mg, capsule molle

Ibuprofen 200 mg Capsule, soft Oral use

France RECKITT BENCKISER HEALTHCARE FRANCE 15, rue Ampère 91748 Massy Cedex France

NUROFENCAPS 400 mg, capsule molle

Ibuprofen 400 mg Capsule, soft Oral use

France RECKITT BENCKISER HEALTHCARE FRANCE 15, rue Ampère 91748 Massy Cedex France

NUROFENFEM 400 mg, comprimé pelliculé

Ibuprofen lysinate 400 mg Film-coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 83/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

France RECKITT BENCKISER HEALTHCARE FRANCE 15, rue Ampère 91748 Massy Cedex France

NUROFENFLASH 200 mg, comprimé pelliculé

Ibuprofen 200 mg Film-coated tablet Oral use

France RECKITT BENCKISER HEALTHCARE FRANCE 15, rue Ampère 91748 Massy Cedex France

NUROFENFLASH 400 mg, comprimé pelliculé

Ibuprofen 400 mg Film-coated tablet Oral use

France RECKITT BENCKISER HEALTHCARE FRANCE 15, rue Ampère 91748 Massy Cedex France

NUROFENFLASH 400 mg, poudre pour solution buvable en sachet

Ibuprofen 400 mg Powder for oral solution

Oral use

France RECKITT BENCKISER HEALTHCARE FRANCE 15, rue Ampère 91748 Massy Cedex France

NUROFENTABS 200 mg, comprimé orodispersible

Ibuprofen 200 mg Orodispersible tablet Oral use

France RECKITT BENCKISER HEALTHCARE FRANCE 15, rue Ampère 91748 Massy Cedex France

NUROFLASH 200 mg, capsule molle

Ibuprofen 200 mg Capsule, soft Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 84/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

France WYETH SANTE FAMILIALE Coeur Défense - Tour A - La Défense 4 110, Esplanade du Général de Gaulle 92931 Paris La Défense Cedex France

RHINADVIL RHUME IBUPROFENE/PSEUDOEPHEDRINE, comprimé enrobé

Ibuprofen pseudoephedrine

200 mg Coated tablet Oral use

France PFIZER SANTE FAMILIALE 23-25, avenue du Docteur Lannelongue 75014 Paris France

RHINADVILTAB, comprimé enrobé

Ibuprofen pseudoephedrine

200 mg Coated tablet Oral use

France RECKITT BENCKISER HEALTHCARE FRANCE 15, rue Ampère 91748 Massy Cedex France

RHINUREFLEX, comprimé pelliculé

Ibuprofen pseudoephedrine

200 mg Film-coated tablet Oral use

France SANOFI AVENTIS FRANCE 1-13, boulevard Romain Rolland 75014 Paris France

SOLUFEN 200 mg, gélule

Ibuprofen 200 mg Capsule, hard Oral use

France ZAMBON FRANCE 13, rue René Jacques 92138 Issy-les-Moulineaux Cedex France

SPEDIFEN 200 mg, comprimé

Ibuprofen 200 mg Tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 85/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

France ZAMBON FRANCE 13, rue René Jacques 92138 Issy-les-Moulineaux Cedex France

SPEDIFEN 200 mg, granulés pour solution buvable en sachet-dose

Ibuprofen 200 mg Granules for oral solution

Oral use

France ZAMBON FRANCE 13, rue René Jacques 92138 Issy-les-Moulineaux Cedex France

SPEDIFEN 400 mg, comprimé pelliculé

Ibuprofen 400 mg Film-coated tablet Oral use

France ZAMBON FRANCE 13, rue René Jacques 92138 Issy-les-Moulineaux Cedex France

SPEDIFEN 400 mg, granulés pour solution buvable en sachet-dose

Ibuprofen 400 mg Granules for oral solution

Oral use

France ZAMBON FRANCE 13, rue René Jacques 92138 Issy-les-Moulineaux Cedex France

SPIFEN 200 mg, comprimé

Ibuprofen 200 mg Tablet Oral use

France ZAMBON FRANCE 13, rue René Jacques 92138 Issy-les-Moulineaux Cedex France

SPIFEN 200 mg, granulés pour solution buvable en sachet-dose

Ibuprofen 200 mg Granules for oral solution

Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 86/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

France ZAMBON FRANCE 13, rue René Jacques 92138 Issy-les-Moulineaux Cedex France

SPIFEN 400 mg, comprimé pelliculé

Ibuprofen 400 mg Film-coated tablet Oral use

France ZAMBON FRANCE 13, rue René Jacques 92138 Issy-les-Moulineaux Cedex France

SPIFEN 400 mg, granulés pour solution buvable en sachet-dose

Ibuprofen 400 mg Granules for oral solution

Oral use

France Bristol Myers Squibb 3, rue Joseph Monier 92500 Rueil-Malmaison France

UPFEN 200 mg, comprimé pelliculé

Ibuprofen 200 mg Film-coated tablet Oral use

Germany 1 A Pharma GmbH Keltenring 1 + 3 82041 Oberhaching Germany

Ibuprofen - 1 A Pharma 20 mg/ml Suspension zum Einnehmen

Ibuprofen 20 mg Oral suspension Oral use

Germany 1 A Pharma GmbH Keltenring 1 + 3 82041 Oberhaching Germany

Ibu 600 - 1 A Pharma Ibuprofen 600 mg Film-coated tablet Oral use

Germany 1 A Pharma GmbH Keltenring 1 + 3 82041 Oberhaching Germany

Ibu 400 - 1 A Pharma Ibuprofen 400 mg Film-coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 87/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Germany 1 A Pharma GmbH Keltenring 1 + 3 82041 Oberhaching Germany

Ibu 400 akut - 1 A Pharma

Ibuprofen 400 mg Film-coated tablet Oral use

Germany 1 A Pharma GmbH Keltenring 1 + 3 82041 Oberhaching Germany

Ibu 800 ret - 1 A Pharma

Ibuprofen 800 mg Prolonged-release tablet

Oral use

Germany 1 A Pharma GmbH Keltenring 1 + 3 82041 Oberhaching Germany

Ibu 800 - 1 A Pharma Ibuprofen 800 mg Film-coated tablet Oral use

Germany 1 A Pharma GmbH Keltenring 1 + 3 82041 Oberhaching Germany

Ibuprofen - 1 A Pharma 40 mg/ml Suspension zum Einnehmen

Ibuprofen 40 mg Oral suspension Oral use

Germany Abbott Arzneimittel GmbH Freundallee 9A 30173 Hannover Germany

Brufen 40 mg/ml Suspension zum Einnehmen

Ibuprofen 40 mg Oral suspension Oral use

Germany AbZ-Pharma GmbH Graf-Arco-Str. 3 89079 Ulm Germany

Ibuprofen AbZ 2 % Saft

Ibuprofen 20 mg/ml Syrup Oral use

Germany AbZ-Pharma GmbH Graf-Arco-Str. 3 89079 Ulm Germany

Ibuprofen AbZ 600 mg Filmtablette

Ibuprofen 600 mg Film-coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 88/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Germany AbZ-Pharma GmbH Graf-Arco-Str. 3 89079 Ulm Germany

Ibu-Lysin AbZ Migräne 684 mg Filmtabletten

Ibuprofen 400 mg Film-coated tablet Oral use

Germany AbZ-Pharma GmbH Graf-Arco-Str. 3 89079 Ulm Germany

Ibuprofen-CT 4 % Kindersaft

Ibuprofen 40 mg/ml Syrup Oral use

Germany AbZ-Pharma GmbH Graf-Arco-Str. 3 89079 Ulm Germany

Ibuprofen AbZ 800 mg Filmtabletten

Ibuprofen 800 mg Film-coated tablet Oral use

Germany AbZ-Pharma GmbH Graf-Arco-Str. 3 89079 Ulm Germany

Ibu-Lysin-CT 342 mg Filmtabletten

Ibuprofen 200 mg Film-coated tablet Oral use

Germany AbZ-Pharma GmbH Graf-Arco-Str. 3 89079 Ulm Germany

Ibuprofen-CT 200 mg Filmtabletten

Ibuprofen 200 mg Film-coated tablet Oral use

Germany AbZ-Pharma GmbH Graf-Arco-Str. 3 89079 Ulm Germany

ibuprofen-ct 600 mg Filmtabletten

Ibuprofen 600 mg Film-coated tablet Oral use

Germany AbZ-Pharma GmbH Graf-Arco-Str. 3 89079 Ulm Germany

Ibu-Lysin-CT 684 mg Filmtabletten

Ibuprofen 400 mg Film-coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 89/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Germany AbZ-Pharma GmbH Graf-Arco-Str. 3 89079 Ulm Germany

Ibuprofen AbZ 4 % Saft

Ibuprofen 40 mg/ml Syrup Oral use

Germany AbZ-Pharma GmbH Graf-Arco-Str. 3 89079 Ulm Germany

ibuprofen-ct 400 mg Filmtablette

Ibuprofen 400 mg Film-coated tablet Oral use

Germany AbZ-Pharma GmbH Graf-Arco-Str. 3 89079 Ulm Germany

ibuprofen-ct 500 mg Zäpfchen

Ibuprofen 500 mg Suppository Rectal use

Germany AbZ-Pharma GmbH Graf-Arco-Str. 3 89079 Ulm Germany

ibuprofen-ct 400 mg Retardkapsel

Ibuprofen 400 mg Prolonged-release capsule, hard

Oral use

Germany AbZ-Pharma GmbH Graf-Arco-Str. 3 89079 Ulm Germany

Ibuprofen-CT 800 mg Retardtabletten

Ibuprofen 800 mg Prolonged-release tablet

Oral use

Germany acis Arzneimittel GmbH Lil-Dagover-Ring 7 82031 Grünwald Germany

Ibu-acis 600 mg Filmtabletten

Ibuprofen 600 mg Film-coated tablet Oral use

Germany acis Arzneimittel GmbH Lil-Dagover-Ring 7 82031 Grünwald Germany

Ibu-acis 800 mg retard

Ibuprofen 800 mg Prolonged-release tablet

Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 90/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Germany Actavis Deutschland GmbH & Co. KG Willy-Brandt-Allee 2 81829 München Germany

Ibuprofen-Actavis 600 mg Filmtabletten

Ibuprofen 600 mg Film-coated tablet Oral use

Germany Actavis Deutschland GmbH & Co. KG Willy-Brandt-Allee 2 81829 München Germany

Ibuprofen-Actavis Granulat 400 mg

Ibuprofen 400 mg Granules for oral solution

Oral use

Germany Actavis Deutschland GmbH & Co. KG Willy-Brandt-Allee 2 81829 München Germany

Ibuprofen-Actavis 400 mg Filmtabletten

Ibuprofen 400 mg Film-coated tablet Oral use

Germany Actavis Deutschland GmbH & Co. KG Willy-Brandt-Allee 2 81829 München Germany

Ibuprofen-Actavis Granulat 600 mg

Ibuprofen 600 mg Granules for oral solution

Oral use

Germany Actavis Deutschland GmbH & Co. KG Willy-Brandt-Allee 2 81829 München Germany

Ibuprofen-Actavis 800 mg Filmtabletten

Ibuprofen 800 mg Film-coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 91/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Germany Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland

Ibuprofen-Actavis 200 mg Filmtabletten

Ibuprofen 200 mg Film-coated tablet Oral use

Germany ADL Pharma GmbH Borsigstr. 3 71263 Weil der Stadt Germany

Ibuprofen PB 400 mg Ibuprofen 400 mg Film-coated tablet Oral use

Germany ADL Pharma GmbH Borsigstr. 3 71263 Weil der Stadt Germany

Ibuprofen PB 600 mg Ibuprofen 600 mg Film-coated tablet Oral use

Germany ALIUD PHARMA GmbH Gottlieb-Daimler-Str. 19 89150 Laichingen Germany

Ibuprofen AL 40 mg/ml Suspension zum Einnehmen

Ibuprofen 40 mg Oral suspension Oral use

Germany ALIUD PHARMA GmbH Gottlieb-Daimler-Str. 19 89150 Laichingen Germany

Ibuprofen AL 400 Ibuprofen 400 mg Film-coated tablet Oral use

Germany ALIUD PHARMA GmbH Gottlieb-Daimler-Str. 19 89150 Laichingen Germany

Ibuprofen AL 800 retard

Ibuprofen 800 mg Prolonged-release tablet

Oral use

Germany ALIUD PHARMA GmbH Gottlieb-Daimler-Str. 19 89150 Laichingen Germany

Ibuprofen AL 800 Ibuprofen 800 mg Film-coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 92/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Germany ALIUD PHARMA GmbH Gottlieb-Daimler-Str. 19 89150 Laichingen Germany

Ibuprofen AL 600 Ibuprofen 600 mg Film-coated tablet Oral use

Germany ALIUD PHARMA GmbH Gottlieb-Daimler-Str. 19 89150 Laichingen Germany

Ibuprofen AL 600 Zäpfchen

Ibuprofen natrium 694 mg Suppository Rectal use

Germany Aspire Pharma Limited 102 High Street GB-GU7 1DS GODALMING, SURREY United Kingdom

Ibuprofen ASPIRE 40 mg/ml Suspension zum Einnehmen

Ibuprofen 40 mg Oral suspension Oral use

Germany axcount Generika GmbH Max-Planck-Str. 36b 61381 Friedrichsdorf Germany

Ibuprofen Axcount 800 mg retard

Ibuprofen 800 mg Prolonged-release tablet

Oral use

Germany axcount Generika GmbH Max-Planck-Str. 36b 61381 Friedrichsdorf Germany

Ibuprofen axcount 400 mg akut

Ibuprofen 400 mg Film-coated tablet Oral use

Germany axcount Generika GmbH Max-Planck-Str. 36b 61381 Friedrichsdorf Germany

Fibraflex 800 mg Ibuprofen 800 mg Film-coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 93/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Germany axcount Generika GmbH Max-Planck-Str. 36b 61381 Friedrichsdorf Germany

Ibuprofen axcount 200 mg akut

Ibuprofen 200 mg Film-coated tablet Oral use

Germany axcount Generika GmbH Max-Planck-Str. 36b 61381 Friedrichsdorf Germany

Ibuprofen Axcount 600 mg

Ibuprofen 600 mg Film-coated tablet Oral use

Germany AxiCorp Pharma GmbH Max-Planck-Str. 36b 61381 Friedrichsdorf Germany

ibutop 400 mg Schmerztabletten

Ibuprofen 400 mg Film-coated tablet Oral use

Germany AxiCorp Pharma GmbH Max-Planck-Str. 36b 61381 Friedrichsdorf Germany

ibutop 200 mg Schmerztabletten

Ibuprofen 200 mg Film-coated tablet Oral use

Germany Banner Pharmacaps Europe B.V. De Posthoornstraat 7 5048 AS Tilburg The Netherlands

Ibuprofen Banner 400 mg Weichkapseln

Ibuprofen 400 mg Capsule, soft Oral use

Germany Bayer Vital GmbH Kaiser-Wilhelm-Allee 70 51373 Leverkusen Germany

Aktren Spezial Ibuprofen 400 mg Capsule, soft Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 94/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Germany Bayer Vital GmbH Kaiser-Wilhelm-Allee 70 51373 Leverkusen Germany

Aktren forte Ibuprofen 400 mg Film-coated tablet Oral use

Germany Bayer Vital GmbH Kaiser-Wilhelm-Allee 70 51373 Leverkusen Germany

Aktren Mobil Ibuprofen 400 mg Film-coated tablet Oral use

Germany Bayer Vital GmbH Kaiser-Wilhelm-Allee 70 51373 Leverkusen Germany

Aktren Ibuprofen 200 mg Coated tablet Oral use

Germany Bayer Vital GmbH Kaiser-Wilhelm-Allee 70 51373 Leverkusen Germany

Aktren Ibuprofen 200 mg Coated tablet Oral use

Germany bene - Arzneimittel GmbH Herterichstr. 1 - 3 81479 München Germany

ib-u-ron 75 mg Zäpfchen

Ibuprofen 75 mg Suppository Rectal use

Germany bene - Arzneimittel GmbH Herterichstr. 1 - 3 81479 München Germany

Ibuprofen bene 150 mg Zäpfchen

Ibuprofen 150 mg Suppository Rectal use

Germany bene - Arzneimittel GmbH Herterichstr. 1 - 3 81479 München Germany

ib-u-ron akut 400 mg Weichkapseln

Ibuprofen 400 mg Capsule, soft Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 95/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Germany bene - Arzneimittel GmbH Herterichstr. 1 - 3 81479 München Germany

ib-u-ron 150 mg Zäpfchen

Ibuprofen 150 mg Suppository Rectal use

Germany bene - Arzneimittel GmbH Herterichstr. 1 - 3 81479 München Germany

Ibuprofen bene 75 mg Zäpfchen

Ibuprofen 75 mg Suppository Rectal use

Germany Berlin-Chemie AG Glienicker Weg 125 12489 Berlin Germany

EUDORLIN Extra Ibuprofen-Schmerztabletten

Ibuprofen 400 mg Film-coated tablet Oral use

Germany Berlin-Chemie AG Glienicker Weg 125 12489 Berlin Germany

MENSOTON gegen Regelschmerzen

Ibuprofen 200 mg Film-coated tablet Oral use

Germany Berlin-Chemie AG Glienicker Weg 125 12489 Berlin Germany

Eudorlin Ibuprofen 40 mg/ml Suspension zum Einnehmen

Ibuprofen 40 mg/ml Oral suspension Oral use

Germany Berlin-Chemie AG Glienicker Weg 125 12489 Berlin Germany

Eudorlin Ibuprofen 20 mg/ml Suspension zum Einnehmen

Ibuprofen 20 mg/ml Oral suspension Oral use

Germany Berlin-Chemie AG Glienicker Weg 125 12489 Berlin Germany

EUDORLIN Migräne Ibuprofen 400 mg Film-coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 96/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Germany betapharm Arzneimittel GmbH Kobelweg 95 86156 Augsburg Germany

Ibubeta retard Ibuprofen 800 mg Prolonged-release tablet

Oral use

Germany betapharm Arzneimittel GmbH Kobelweg 95 86156 Augsburg Germany

Ibubeta 800 Ibuprofen 800 mg Film-coated tablet Oral use

Germany betapharm Arzneimittel GmbH Kobelweg 95 86156 Augsburg Germany

Ibubeta 600 Ibuprofen 600 mg Film-coated tablet Oral use

Germany betapharm Arzneimittel GmbH Kobelweg 95 86156 Augsburg Germany

Ibubeta 400 Ibuprofen 400 mg Film-coated tablet Oral use

Germany Blanco-Pharma GmbH Oasenweg 3 25474 Ellerbek Germany

Ibusan 400 mg Filmtabletten

Ibuprofen 400 mg Film-coated tablet Oral use

Germany Boehringer Ingelheim International GmbH Binger Str. 148 - 173 55216 Ingelheim Germany

Ibuprofen Boehringer Ingelheim 400 mg Weichkapsel

Ibuprofen 400 mg Capsule, soft Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 97/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Germany Boehringer Ingelheim International GmbH Binger Str. 148 - 173 55216 Ingelheim Germany

BoxaGrippal 200 mg/ 30 mg

Ibuprofen pseudoephedrine hydrochloride

200 mg 30 mg

Film-coated tablet Oral use

Germany Boehringer Ingelheim International GmbH Binger Str. 148 - 173 55216 Ingelheim Germany

Thomapyrin TENSION Ibuprofen 400 mg Film-coated tablet Oral use

Germany Boehringer Ingelheim International GmbH Binger Str. 148 - 173 55216 Ingelheim Germany

TOMIBU Ibuprofen 400 mg Film-coated tablet Oral use

Germany Bronzactiv Pharma GmbH Carl-von-Linde-Str. 30 85716 Unterschleißheim Germany

Ibuaktiv 200 mg Ibuprofen lysine 342 mg Effervescent tablet Oral use

Germany Denk Pharma GmbH & Co. KG Prinzregentenstr. 79 81675 München Germany

Ibuprofen Denk 600 mg Filmtabletten

Ibuprofen 600 mg Film-coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 98/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Germany Deutsche Chefaro Pharma Gesellschaft mit beschränkter Haftung Derendorfer Allee 6 40476 Düsseldorf Germany

Optalidon Ibu 200 mg

Ibuprofen 200 mg Film-coated tablet Oral use

Germany Dexcel Pharma GmbH Carl-Zeiss-Str. 2 63755 Alzenau Germany

Ibu Atid 400 mg Filmtabletten

Ibuprofen 400 mg Film-coated tablet Oral use

Germany Dexcel Pharma GmbH Carl-Zeiss-Str. 2 63755 Alzenau Germany

IbuDex 400 mg Ibuprofen 400 mg Film-coated tablet Oral use

Germany Dexcel Pharma GmbH Carl-Zeiss-Str. 2 63755 Alzenau Germany

Ibuprofen Atid 600 mg

Ibuprofen 600 mg Film-coated tablet Oral use

Germany Dexcel Pharma GmbH Carl-Zeiss-Str. 2 63755 Alzenau Germany

Ibuprofen Atid 800 mg

Ibuprofen 800 mg Film-coated tablet Oral use

Germany Dexcel Pharma GmbH Carl-Zeiss-Str. 2 63755 Alzenau Germany

IbuDex 200 mg Ibuprofen 200 mg Film-coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 99/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Germany Dolorgiet GmbH & Co. KG Otto-von-Guericke-Str. 1 53757 Sankt Augustin Germany

Dolgit Schmerzdragees

Ibuprofen 200 mg Coated tablet Oral use

Germany Dolorgiet GmbH & Co. KG Otto-von-Guericke-Str. 1 53757 Sankt Augustin Germany

Schmerz-Dolgit Ibuprofen 400 mg Capsule, soft Oral use

Germany Dolorgiet GmbH & Co. KG Otto-von-Guericke-Str. 1 53757 Sankt Augustin Germany

Dolgit 200 Ibuprofen 200 mg Coated tablet Oral use

Germany Dolorgiet GmbH & Co. KG Otto-von-Guericke-Str. 1 53757 Sankt Augustin Germany

Dolgit 800 Ibuprofen 800 mg Coated tablet Oral use

Germany Dolorgiet GmbH & Co. KG Otto-von-Guericke-Str. 1 53757 Sankt Augustin Germany

Dolgit 400 Ibuprofen 400 mg Coated tablet Oral use

Germany Dolorgiet GmbH & Co. KG Otto-von-Guericke-Str. 1 53757 Sankt Augustin Germany

Dolgit Schmerzkapseln gegen Schmerzen und Fieber

Ibuprofen 400 mg Capsule, soft Oral use

Germany Dolorgiet GmbH & Co. KG Otto-von-Guericke-Str. 1 53757 Sankt Augustin Germany

Dolgit 600 Ibuprofen 600 mg Coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 100/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Germany Dr. R. Pfleger Chemische Fabrik GmbH Dr.-Robert-Pfleger-Str. 12 96052 Bamberg Germany

Gyno-Neuralgin Ibuprofen 400 mg Film-coated tablet Oral use

Germany Dr. R. Pfleger Chemische Fabrik GmbH Dr.-Robert-Pfleger-Str. 12 96052 Bamberg Germany

Neuralgin extra Ibu-Lysinat

Ibuprofen 400 mg Coated tablet Oral use

Germany Dr. R. Pfleger Chemische Fabrik GmbH Dr.-Robert-Pfleger-Str. 12 96052 Bamberg Germany

Ibuprofen Pfleger 400 mg Filmtabletten

Ibuprofen 400 mg Coated tablet Oral use

Germany Dr. Kade Pharmazeutische Fabrik GmbH Rigistr. 2 12277 Berlin Germany

Urem forte Ibuprofen 400 mg Coated tablet Oral use

Germany Dr. Kade Pharmazeutische Fabrik GmbH Rigistr. 2 12277 Berlin Germany

Ibu KD 400 mg Ibuprofen 400 mg Coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 101/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Germany Dr. Kade Pharmazeutische Fabrik GmbH Rigistr. 2 12277 Berlin Germany

Ibu KD 800 mg Ibuprofen 800 mg Coated tablet Oral use

Germany Dr. Kade Pharmazeutische Fabrik GmbH Rigistr. 2 12277 Berlin Germany

Ibu KD 600 mg Ibuprofen 600 mg Coated tablet Oral use

Germany Dr. Kade Pharmazeutische Fabrik GmbH Rigistr. 2 12277 Berlin Germany

Ibu KD 400 mg akut Ibuprofen 400 mg Coated tablet Oral use

Germany Fair-Med Healthcare GmbH Planckstr. 13 22765 Hamburg Germany

Ibuprofen FAIR-MED Healthcare 600 mg Filmtabletten

Ibuprofen 600 mg Film-coated tablet Oral use

Germany Fair-Med Healthcare GmbH Planckstr. 13 22765 Hamburg Germany

Ibuprofen FAIR-MED Healthcare 400 mg Filmtabletten

Ibuprofen 400 mg Film-coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 102/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Germany Fair-Med Healthcare GmbH Planckstr. 13 22765 Hamburg Germany

Ibuprofen FAIR-MED Healthcare 200 mg Filmtabletten

Ibuprofen 200 mg Film-coated tablet Oral use

Germany Farmalider S.A. C/ Aragoneses, 15 Alcobendas (Madrid), 28108 Spain

Ibuprofen LIDERFARM 20 mg/ml Suspension zum Einnehmen

Ibuprofen 20 mg Oral suspension Oral use

Germany Farmalider S.A. C/ Aragoneses, 15 Alcobendas (Madrid), 28108 Spain

Ibuprofen LIDERFARM 40 mg/ml Suspension zum Einnehmen

Ibuprofen 40 mg Oral suspension Oral use

Germany Farmalider S.A. C/ Aragoneses, 15 Alcobendas (Madrid), 28108 Spain

Ibuprofen LIDERFARM 40 mg/ml Suspension zum Einnehmen

Ibuprofen 40 mg Oral suspension Oral use

Germany Farmalider S.A. C/ Aragoneses, 15 Alcobendas (Madrid), 28108 Spain

Ibuprofen LIDERFARM 40 mg/ml Suspension zum Einnehmen

Ibuprofen 40 mg Oral suspension Oral use

Germany Farmalider S.A. C/ Aragoneses, 15 Alcobendas (Madrid), 28108 Spain

Ibuprofen LIDERFARM 20 mg/ml Suspension zum Einnehmen

Ibuprofen 20 mg/ml Oral suspension Oral use

Germany Farmalider S.A. C/ Aragoneses, 15 Alcobendas (Madrid), 28108 Spain

Ibuprofen LIDERFARM 20 mg/ml Suspension zum Einnehmen

Ibuprofen 20 mg/ml Oral suspension Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 103/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Germany Galpharm Healthcare Limited EX33 2DL Wrafton Braunton Devon United Kingdom

Ibuprofen Galpharm 400 mg Filmtabletten

Ibuprofen 400 mg Film-coated tablet Oral use

Germany Galpharm Healthcare Limited EX33 2DL Wrafton Braunton Devon United Kingdom

Ibuprofen Galpharm 200 mg Filmtabletten

Ibuprofen 200 mg Film-coated tablet Oral use

Germany Gebro Pharma GmbH Bahnhofbichl 13 6391 Fieberbrunn Austria

Dolomagon 400 mg Filmtabletten

Dexibuprofen 400 mg Film-coated tablet Oral use

Germany Gebro Pharma GmbH Bahnhofbichl 13 6391 Fieberbrunn Austria

Dolomagon 300 mg Filmtabletten

Dexibuprofen 300 mg Film-coated tablet Oral use

Germany Georg Simons GmbH Eckenheimer Landstr. 100-104 60318 Frankfurt am Main Germany

Dismenol N Ibuprofen 200 mg Film-coated tablet Oral use

Germany Hemopharm GmbH Königsteiner Str. 2 61350 Bad Homburg v.d.H. Germany

Ibu-Hemopharm 200mg Brausetabletten

Ibuprofen lysine 342 mg Effervescent tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 104/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Germany Hemopharm GmbH Königsteiner Str. 2 61350 Bad Homburg v.d.H. Germany

Ibu-Hemopharm 400mg Filmtabletten

Ibuprofen 400 mg Film-coated tablet Oral use

Germany Hennig Arzneimittel GmbH & Co. KG Liebigstr. 1 65439 Flörsheim Germany

Esprenit 800 mg retard Retardtabletten

Ibuprofen 800 mg Prolonged-release tablet

Oral use

Germany Hennig Arzneimittel GmbH & Co. KG Liebigstr. 1 65439 Flörsheim Germany

Esprenit 600mg Filmtabletten

Ibuprofen 600 mg Film-coated tablet Oral use

Germany Hennig Arzneimittel GmbH & Co. KG Liebigstr. 1 65439 Flörsheim Germany

Esprenit 400mg Filmtabletten

Ibuprofen 400 mg Film-coated tablet Oral use

Germany Hennig Arzneimittel GmbH & Co. KG Liebigstr. 1 65439 Flörsheim Germany

Esprenit-Suppos Ibuprofen sodium 694 mg Suppository Rectal use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 105/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Germany Heumann Pharma GmbH & Co. Generika KG Südwestpark 50 90449 Nürnberg Germany

Ibuprofen Heumann Schmerztabletten 400mg Filmtabletten

Ibuprofen 400 mg Film-coated tablet Oral use

Germany Heumann Pharma GmbH & Co. Generika KG Südwestpark 50 90449 Nürnberg Germany

Ibuprofen Heumann 800mg Filmtabletten

Ibuprofen 800 mg Film-coated tablet Oral use

Germany Heumann Pharma GmbH & Co. Generika KG Südwestpark 50 90449 Nürnberg Germany

Ibuprofen Heumann 200mg Filmtabletten

Ibuprofen 200 mg Film-coated tablet Oral use

Germany Heumann Pharma GmbH & Co. Generika KG Südwestpark 50 90449 Nürnberg Germany

Ibuprofen Heumann 600mg Filmtabletten

Ibuprofen 600 mg Film-coated tablet Oral use

Germany Hexal AG Industriestr. 25 83607 Holzkirchen Germany

Ibu-LysinHexal 684 mg Filmtabletten

Ibuprofen 400 mg Film-coated tablet Oral use

Germany Hexal AG Industriestr. 25 83607 Holzkirchen Germany

Ibuhexal 400 Ibuprofen 400 mg Film-coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 106/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Germany Hexal AG Industriestr. 25 83607 Holzkirchen Germany

Ibuhexal 600 Ibuprofen sodium 694 mg Suppository Rectal use

Germany Hexal AG Industriestr. 25 83607 Holzkirchen Germany

Ibuhexal 800 Ibuprofen 800 mg Film-coated tablet Oral use

Germany Hexal AG Industriestr. 25 83607 Holzkirchen Germany

Ibuhexal 600 Ibuprofen 600 mg Film-coated tablet Oral use

Germany Hexal AG Industriestr. 25 83607 Holzkirchen Germany

Ibuhexal retard Ibuprofen 800 mg Prolonged-release tablet

Oral use

Germany KSK-Pharma Vertriebs AG Finkenstr. 1 76327 Pfinztal-Berghausen Germany

ibu 200 KSK Ibuprofen 200 mg Film-coated tablet Oral use

Germany KSK-Pharma Vertriebs AG Finkenstr. 1 76327 Pfinztal-Berghausen Germany

ibu-KSK 600mg Ibuprofen 600 mg Film-coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 107/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Germany Laboratoires Ethypharm Zone Industrielle 21, rue Saint Matthieu 78550 Houdan France

Ethypharm Ibuprofen Sparklets 200mg

Ibuprofen 200 mg Granules Oral use

Germany Laboratoires Ethypharm Zone Industrielle 21, rue Saint Matthieu 78550 Houdan France

Ethypharm Ibuprofen Sparklets 100mg

Ibuprofen 100 mg Granules Oral use

Germany McNeil GmbH & Co.oHG Johnson & Johnson Platz 2 41470 Neuss Germany

Dolormin Schmerztabletten

Ibuprofen 200 mg Film-coated tablet Oral use

Germany McNeil GmbH & Co.oHG Johnson & Johnson Platz 2 41470 Neuss Germany

Dolormin Migräne schnell lösliches Granulat

Ibuprofen 200 mg Effervescent granules Oral use

Germany McNeil GmbH & Co.oHG Johnson & Johnson Platz 2 41470 Neuss Germany

Dolormin bei Erkältungsschmerzen und Fieber

Ibuprofen 200 mg Effervescent granules Oral use

Germany McNeil GmbH & Co.oHG Johnson & Johnson Platz 2 41470 Neuss Germany

Dolormin Schmerztabletten

Ibuprofen 342 mg Film-coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 108/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Germany McNeil GmbH & Co.oHG Johnson & Johnson Platz 2 41470 Neuss Germany

Dolormin Migräne Zäpfchen

Ibuprofen sodium 694 mg Suppository Rectal use

Germany McNeil GmbH & Co.oHG Johnson & Johnson Platz 2 41470 Neuss Germany

Tispol Ibu-DD Ibuprofen 400 mg Film-coated tablet Oral use

Germany McNeil GmbH & Co.oHG Johnson & Johnson Platz 2 41470 Neuss Germany

Ibu 342 Lysinat JJ Ibuprofen 342 mg Film-coated tablet Oral use

Germany McNeil GmbH & Co.oHG Johnson & Johnson Platz 2 41470 Neuss Germany

Dolormin Migräne Filmtabletten

Ibuprofen 400 mg Film-coated tablet Oral use

Germany McNeil GmbH & Co.oHG Johnson & Johnson Platz 2 41470 Neuss Germany

Dolormin instant schnell lösliches Granulat

Ibuprofen 200 mg Effervescent granules Oral use

Germany McNeil GmbH & Co.oHG Johnson & Johnson Platz 2 41470 Neuss Germany

Dolormin extra Ibuprofen lysine 684 mg Film-coated tablet Oral use

Germany McNeil GmbH & Co.oHG Johnson & Johnson Platz 2 41470 Neuss Germany

Dolormin extra Ibuprofen lysine 684 mg Film-coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 109/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Germany Medphano Arzneimittel GmbH Maienbergstr. 10-12 15562 Rüdersdorf Germany

Ibuprofen-mp 600 Ibuprofen 600 mg Film-coated tablet Oral use

Germany Medphano Arzneimittel GmbH Maienbergstr. 10-12 15562 Rüdersdorf Germany

Miralgin 400 mg Filmtabletten

Ibuprofen 400 mg Film-coated tablet Oral use

Germany Mepha Investigacao, Desenvolvimento e Fabricacao Farmaceutica, Lda. Lagos Park, Edificio 5A, Piso 2 2740-298 PORTO SALVO Portugal

Irfen 200 mg Filmtabletten

Ibuprofen 200 mg Film-coated tablet Oral use

Germany Mepha Investigacao, Desenvolvimento e Fabricacao Farmaceutica, Lda. Lagos Park, Edificio 5A, Piso 2 2740-298 PORTO SALVO Portugal

Irfen 400 mg Filmtabletten

Ibuprofen 400 mg Film-coated tablet Oral use

Germany Mibe GmbH Arzneimittel Münchener Str. 15 06796 Brehna Germany

Fibraflex 600 mg Ibuprofen 600 mg Film-coated tablet Oral use

Germany Mibe GmbH Arzneimittel Münchener Str. 15 06796 Brehna Germany

Jenaprofen 600 mg Ibuprofen 600 mg Film-coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 110/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Germany Mibe GmbH Arzneimittel Münchener Str. 15 06796 Brehna Germany

Fibraflex 800 mg retard

Ibuprofen 800 mg Prolonged-release tablet

Oral use

Germany Mibe GmbH Arzneimittel Münchener Str. 15 06796 Brehna Germany

Fibraflex 400 mg Ibuprofen 400 mg Film-coated tablet Oral use

Germany Mibe GmbH Arzneimittel Münchener Str. 15 06796 Brehna Germany

Jenaprofen 400 mg Ibuprofen 400 mg Film-coated tablet Oral use

Germany Mylan dura GmbH Wittichstr. 6 64295 Darmstadt Germany

Ibuprofen dura 800 mg Filmtabletten

Ibuprofen 800 mg Film-coated tablet Oral use

Germany Mylan dura GmbH Wittichstr. 6 64295 Darmstadt Germany

Ibuprofen dura 400 mg Filmtabletten

Ibuprofen 400 mg Film-coated tablet Oral use

Germany Mylan dura GmbH Wittichstr. 6 64295 Darmstadt Germany

Ibuprofen dura 600mg Filmtabletten

Ibuprofen 600 mg Film-coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 111/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Germany Pfizer Consumer Healthcare GmbH Linkstr. 10 10785 Berlin Germany

Spalt Kopfschmerz Ibuprofen 200 mg Capsule, soft Oral use

Germany Pfizer Consumer Healthcare GmbH Linkstr. 10 10785 Berlin Germany

Spalt Migräne Ibuprofen 400 mg Capsule, soft Oral use

Germany Pfizer Consumer Healthcare GmbH Linkstr. 10 10785 Berlin Germany

Spalt Mobil Ibuprofen 400 mg Capsule, soft Oral use

Germany Pfizer Consumer Healthcare GmbH Linkstr. 10 10785 Berlin Germany

SpaltGrippal 30 mg/200 mg überzogene Tabletten

Ibuprofen pseudoephedrine hydrochloride

200 mg 30 mg

Film-coated tablet Oral use

Germany Pfizer Consumer Healthcare GmbH Linkstr. 10 10785 Berlin Germany

Spalt Forte Ibuprofen 400 mg Capsule, soft Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 112/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Germany ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany

Ibuprofen-ratio 200 mg Filmtabletten

Ibuprofen 200 mg Film-coated tablet Oral use

Germany ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany

Ibu-ratiopharm 800 mg Retardtabletten

Ibuprofen 800 mg Prolonged-release tablet

Oral use

Germany ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany

Ibu-ratiopharm 400 mg akut Schmerztabletten

Ibuprofen 400 mg Film-coated tablet Oral use

Germany ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany

Ibu-ratiopharm 800 mg Filmtabletten

Ibuprofen 800 mg Film-coated tablet Oral use

Germany ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany

IBU-LYSIN-ratiopharm 342 mg Filmtabletten

Ibuprofen lysine 342 mg Film-coated tablet Oral use

Germany ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany

IBU-ratiopharm Fiebersaft für Kinder 2 %

Ibuprofen 20 mg/ml Syrup oral use

Germany ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany

IBU-ratiopharm Fiebersaft für Kinder 4 %

Ibuprofen 40 mg/ml Syrup oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 113/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Germany ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany

IBU-ratiopharm Lysinat Schmerztabletten 500 mg

Ibuprofen lysine 500 mg Film-coated tablet Oral use

Germany ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany

IBU-LYSIN-ratiopharm 684 mg Filmtabletten

Ibuprofen lysine 684 mg Film-coated tablet Oral use

Germany ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany

Ibu-ratiopharm 600 mg Filmtabletten

Ibuprofen 600 mg Film-coated tablet Oral use

Germany ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany

Ibuprofen-ratio 400 mg Filmtabletten

Ibuprofen 400 mg Film-coated tablet Oral use

Germany ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany

Ibu-ratiopharm 400 mg Filmtabletten

Ibuprofen 400 mg Film-coated tablet Oral use

Germany Reckitt Benckiser Deutschland GmbH Theodor-Heuss-Anlage 12 68165 Mannheim Germany

Nurofen Ibuprofen 400 mg überzogene Tabletten

Ibuprofen 400 mg Coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 114/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Germany Reckitt Benckiser Deutschland GmbH Theodor-Heuss-Anlage 12 68165 Mannheim Germany

Nurofen 40 mg/ml Suspension zum Einnehmen

Ibuprofen 40 mg/ml Oral suspension Oral use

Germany Reckitt Benckiser Deutschland GmbH Theodor-Heuss-Anlage 12 68165 Mannheim Germany

Nurofen Liquid 200 mg Weichkapseln

Ibuprofen 200 mg Capsule, soft Oral use

Germany Reckitt Benckiser Deutschland GmbH Theodor-Heuss-Anlage 12 68165 Mannheim Germany

Nurofen 200 mg Schmelztabletten Mint

Ibuprofen 200 mg Orodispersible tablet Oral use

Germany Reckitt Benckiser Deutschland GmbH Theodor-Heuss-Anlage 12 68165 Mannheim Germany

Nurofen-Ibuprofen 200 mg Schmelztabletten Mint

Ibuprofen 200 mg Orodispersible tablet Oral use

Germany Reckitt Benckiser Deutschland GmbH Theodor-Heuss-Anlage 12 68165 Mannheim Germany

Nurofen 200 mg Schmelztabletten Lemon

Ibuprofen 200 mg Orodispersible tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 115/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Germany Reckitt Benckiser Deutschland GmbH Theodor-Heuss-Anlage 12 68165 Mannheim Germany

Nurofen-Ibuprofen 200 mg Schmelztabletten Lemon

Ibuprofen 200 mg Orodispersible tablet Oral use

Germany Reckitt Benckiser Deutschland GmbH Theodor-Heuss-Anlage 12 68165 Mannheim Germany

Nurofen Immedia 400 mg Pulver zur Herstellung einer Lösung zum Einnehmen

Ibuprofen lysine 683,34 mg Powder for oral solution

Oral use

Germany Reckitt Benckiser Deutschland GmbH Theodor-Heuss-Anlage 12 68165 Mannheim Germany

Nurofen Schmerz- und Fiebersaft Erdbeer 40 mg/ml Suspension zum Einnehmen

Ibuprofen 40 mg/ml Oral suspension Oral use

Germany Reckitt Benckiser Deutschland GmbH Theodor-Heuss-Anlage 12 68165 Mannheim Germany

Nurofen Immedia 200 mg Weichkapseln

Ibuprofen 200 mg Capsule, soft Oral use

Germany Reckitt Benckiser Deutschland GmbH Theodor-Heuss-Anlage 12 68165 Mannheim Germany

Nurofen Immedia 400 mg Filmtabletten

Ibuprofen lysine 684 mg Film-coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 116/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Germany Recordati Pharma GmbH Eberhard-Finckh-Str. 55 89075 Ulm Germany

Imbun Zäpfchen Ibuprofen lysine 500 mg Suppository Rectal use

Germany Recordati Pharma GmbH Eberhard-Finckh-Str. 55 89075 Ulm Germany

Imbun retard Ibuprofen 800 mg Prolonged-release tablet

Oral use

Germany Recordati Pharma GmbH Eberhard-Finckh-Str. 55 89075 Ulm Germany

Imbun 500mg Filmtabletten

Ibuprofen lysine 500 mg Film-coated tablet Oral use

Germany Recordati Pharma GmbH Eberhard-Finckh-Str. 55 89075 Ulm Germany

Imbun 1000mg Filmtabletten

Ibuprofen lysine 1000 mg Film-coated tablet Oral use

Germany Recordati Pharma GmbH Eberhard-Finckh-Str. 55 89075 Ulm Germany

Imbun 800 mg Retardtabletten

Ibuprofen 800 mg Prolonged-release tablet

Oral use

Germany Sandoz Pharmaceuticals GmbH Raiffeisenstr. 11 83607 Holzkirchen Germany

Ibuprofen Sandoz 800 mg Retardtabletten

Ibuprofen 800 mg Prolonged-release tablet

Oral use

Germany Sandoz Pharmaceuticals GmbH Raiffeisenstr. 11 83607 Holzkirchen Germany

Anco 600mg Filmtabletten

Ibuprofen 600 mg Film-coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 117/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Germany Sandoz Pharmaceuticals GmbH Raiffeisenstr. 11 83607 Holzkirchen Germany

Ibuprofen Sandoz 600 mg Filmtabletten

Ibuprofen 600 mg Film-coated tablet Oral use

Germany STADA Arzneimittel AG Stadastr. 2-18 61118 Bad Vilbel Germany

Ibusustad 40 mg/ml Suspension zum Einnehmen

Ibuprofen 40 mg Oral suspension Oral use

Germany STADA GmbH Stadastr. 2-18 61118 Bad Vilbel Germany

Ibudolor 400 mg Filmtabletten

Ibuprofen 400 mg Film-coated tablet Oral use

Germany STADA GmbH Stadastr. 2-18 61118 Bad Vilbel Germany

Ibudolor 200 mg Filmtabletten

Ibuprofen 200 mg Film-coated tablet Oral use

Germany STADA GmbH Stadastr. 2-18 61118 Bad Vilbel Germany

Ibudolor 40 mg/ml Suspension zum Einnehmen

Ibuprofen 40 mg Oral suspension Oral use

Germany STADA GmbH Stadastr. 2-18 61118 Bad Vilbel Germany

Pfeil Zahnschmerz-Tabletten forte 400mg Filmtabletten

Ibuprofen 400 mg Film-coated tablet Oral use

Germany Stadapharm GmbH Stadastr. 2-18 61118 Bad Vilbel Germany

Ibuprofen STADA 40 mg/ml Suspension zum Einnehmen

Ibuprofen 40 mg Oral suspension Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 118/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Germany Stadapharm GmbH Stadastr. 2-18 61118 Bad Vilbel Germany

Ibuprofen Stada 600 mg Filmtabletten

Ibuprofen 600 mg Film-coated tablet Oral use

Germany Stadapharm GmbH Stadastr. 2-18 61118 Bad Vilbel Germany

Ibuprofen STADA 400mg Filmtabletten

Ibuprofen 400 mg Film-coated tablet Oral use

Germany Stadapharm GmbH Stadastr. 2-18 61118 Bad Vilbel Germany

Ibuprofen STADA 600 mg Zäpfchen

Ibuprofen sodium 694 mg Suppository Rectal use

Germany Stadapharm GmbH Stadastr. 2-18 61118 Bad Vilbel Germany

Ibuprofen STADA 800 mg Retardtabletten

Ibuprofen 800 mg Prolonged-release tablet

Oral use

Germany Strathmann GmbH & Co. KG Sellhopsweg 1 22459 Hamburg Germany

Deltaran 200 mg Filmtabletten

Dexibuprofen 200 mg Film-coated tablet Oral use

Germany Strathmann GmbH & Co. KG Sellhopsweg 1 22459 Hamburg Germany

Deltaran 300 mg Filmtabletten

Dexibuprofen 300 mg Film-coated tablet Oral use

Germany Strathmann GmbH & Co. KG Sellhopsweg 1 22459 Hamburg Germany

Deltaran 400 mg Filmtabletten

Dexibuprofen 400 mg Film-coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 119/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Germany TAD Pharma GmbH Heinz-Lohmann-Str. 5 27472 Cuxhaven Germany

ibuTAD 800mg retard Ibuprofen 800 mg Prolonged-release tablet

Oral use

Germany TAD Pharma GmbH Heinz-Lohmann-Str. 5 27472 Cuxhaven Germany

ibuTAD 600mg Ibuprofen 600 mg Film-coated tablet Oral use

Germany TAD Pharma GmbH Heinz-Lohmann-Str. 5 27472 Cuxhaven Germany

IbuTAD 800mg Ibuprofen 800 mg Film-coated tablet Oral use

Germany TAD Pharma GmbH Heinz-Lohmann-Str. 5 27472 Cuxhaven Germany

IbuTAD 400 mg gegen Schmerzen

Ibuprofen 400 mg Film-coated tablet Oral use

Germany TAD Pharma GmbH Heinz-Lohmann-Str. 5 27472 Cuxhaven Germany

ibuTAD 400mg Ibuprofen 400 mg Film-coated tablet Oral use

Germany Temmler Pharma GmbH & Co. KG Temmlerstr. 2 35039 Marburg Germany

Novogent 400mg Trinktabletten

Ibuprofen 400 mg Dispersible tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 120/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Germany Temmler Pharma GmbH & Co. KG Temmlerstr. 2 35039 Marburg Germany

Ibuprofen Temmler 200 mg

Ibuprofen 200 mg Tablet Oral use

Germany Temmler Pharma GmbH & Co. KG Temmlerstr. 2 35039 Marburg Germany

Novogent 600mg Trinktabletten

Ibuprofen 600 mg Tablet Oral use

Germany Temmler Pharma GmbH & Co. KG Temmlerstr. 2 35039 Marburg Germany

Ibuprofen Temmler 400 mg

Ibuprofen 400 mg Soluble tablet Oral use

Germany Temmler Pharma GmbH & Co. KG Temmlerstr. 2 35039 Marburg Germany

Novogent 800mg Trinktabletten

Ibuprofen 800 mg Tablet Oral use

Germany Temmler Werke GmbH Weihenstephaner Str. 28 81673 München Germany

Ibuflam 800 mg Retardtabletten

Ibuprofen 800 mg Prolonged-release tablet

Oral use

Germany Temmler Werke GmbH Weihenstephaner Str. 28 81673 München Germany

dolomo-IBU TN Ibuprofen 400 mg 600 mg

Film-coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 121/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Germany Temmler Werke GmbH Weihenstephaner Str. 28 81673 München Germany

Ibuprofen Klinge 600mg

Ibuprofen 600 mg Film-coated tablet Oral use

Germany Temmler Werke GmbH Weihenstephaner Str. 28 81673 München Germany

Ibuklaph 800 mg Ibuprofen 800 mg Film-coated tablet Oral use

Germany TEOFARMA S.R.L. Via F.Ili Cervi 8 27010 Valle Salimbene Italia

Tabalon 400mg Ibuprofen 400 mg Film-coated tablet Oral use

Germany Togal-Werk AG Kardinal-Faulhaber-Str. 5 80333 München Germany

Togal Ibuprofen AKUT 400mg Filmtabletten

Ibuprofen 400 mg Film-coated tablet Oral use

Germany TUSSIN Pharma GmbH Menchestr. 22a 35274 Kirchhain Germany

Ibu-Attritin forte Ibuprofen 600 mg Film-coated tablet Oral use

Germany TUSSIN Pharma GmbH Menchestr. 22a 35274 Kirchhain Germany

Ibu-Attritin N Ibuprofen 400 mg Film-coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 122/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Germany Procter & Gamble Service GmbH Zweigniederlassung Wick Pharma Sulzbacher Str. 40 65824 Schwalbach / Taunus Germany

WICK DuoGrippal 200mg/30 mg Filmtabletten

Ibuprofen pseudoephedrine hydrochloride

200 mg 30 mg

Film-coated tablet Oral use

Germany Winthrop Arzneimittel GmbH Brüningstr. 50 65926 Frankfurt am Main Germany

Ibuflam 400mg Lichtenstein

Ibuprofen 400 mg Film-coated tablet Oral use

Germany Winthrop Arzneimittel GmbH Brüningstr. 50 65926 Frankfurt am Main Germany

Ibuflam 600mg Lichtenstein

Ibuprofen 600 mg Film-coated tablet Oral use

Germany Winthrop Arzneimittel GmbH Brüningstr. 50 65926 Frankfurt am Main Germany

Ibuflam-Lysin 400 mg Filmtabletten

Ibuprofen 400 mg Film-coated tablet Oral use

Germany Winthrop Arzneimittel GmbH Brüningstr. 50 65926 Frankfurt am Main Germany

Ibuflam 4% Ibuprofen 200 mg Oral suspension Oral use

Germany Winthrop Arzneimittel GmbH Brüningstr. 50 65926 Frankfurt am Main Germany

Ibuflam akut 400 mg Filmtabletten

Ibuprofen 400 mg Film-coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 123/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Germany Winthrop Arzneimittel GmbH Brüningstr. 50 65926 Frankfurt am Main Germany

Ibuflam 800mg Lichtenstein

Ibuprofen 800 mg Film-coated tablet Oral use

Germany Wörwag Pharma GmbH & Co. KG Calwer Str. 7 71034 Böblingen Germany

Dignoflex 400 Ibuprofen 400 mg Film-coated tablet Oral use

Germany Wörwag Pharma GmbH & Co. KG Calwer Str. 7 71034 Böblingen Germany

Dignoflex 600 Ibuprofen 400 mg Film-coated tablet Oral use

Germany Wörwag Pharma GmbH & Co. KG Calwer Str. 7 71034 Böblingen Germany

Dignoflex 800 retard Ibuprofen 800 mg Prolonged-release tablet

Oral use

Germany Wörwag Pharma GmbH & Co. KG Calwer Str. 7 71034 Böblingen Germany

Dignoflex 400mg retard

Ibuprofen 400 mg Prolonged-release tablet

Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 124/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Germany Wrafton Laboratories Limited Trading as Perrigo New Lane EX33 2DL Braunton, Devon Great Britain

Ibuprofen Perrigo 200 mg Filmtabletten

Ibuprofen 200 mg Film-coated tablet Oral use

Germany Wrafton Laboratories Limited Trading as Perrigo New Lane EX33 2DL Braunton, Devon Great Britain

Ibuprofen Perrigo 400 mg Filmtabletten

Ibuprofen 400 mg Film-coated tablet Oral use

Germany Zambon GmbH Fraunhoferstr. 18b 82152 Planegg-Martinsried Germany

SPIDIFEN 400 mg Filmtabletten

Ibuprofen 400 mg Film-coated tablet Oral use

Greece Abbott Laboratories Ellas ABEE Agiou Dimitriou 63 174 56 Alimos Greece

BRUFEN Ibuprofen 400 mg Coated tablet Oral use

Greece Abbott Laboratories Ellas ABEE Agiou Dimitriou 63 174 56 Alimos Greece

BRUFEN Ibuprofen 800 mg Film-coated tablet Oral use

Greece Abbott Laboratories Ellas ABEE Agiou Dimitriou 63 174 56 Alimos Greece

BRUFEN Ibuprofen 800 mg Slow-release film-coated tablet

Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 125/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Greece Abbott Laboratories Ellas ABEE Agiou Dimitriou 63 174 56 Alimos Greece

BRUFEN Ibuprofen 20 mg/ml Syrup Oral use

Greece Abbott Laboratories Ellas ABEE Agiou Dimitriou 63 174 56 Alimos Greece

BRUFEN Ibuprofen 200 mg Coated tablet Oral use

Greece Abbott Laboratories Ellas ABEE Agiou Dimitriou 63 174 56 Alimos Greece

BRUFEN Ibuprofen 600 mg Film-coated tablet Oral use

Greece Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland

IBUPROFEN/ACTAVIS Ibuprofen 200 mg Film-coated tablet Oral use

Greece Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland

IBUPROFEN/ACTAVIS Ibuprofen 600 mg Film-coated tablet Oral use

Greece Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland

IBUPROFEN/ACTAVIS Ibuprofen 800 mg Film-coated tablet Oral use

Greece Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland

IBUPROFEN/ACTAVIS Ibuprofen 400 mg Film-coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 126/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Greece Boehringer Ingelheim International GmbH P.O.BOX 200 D-6507 Ingelheim am Rhein Germany

MUCOCOLD Ibuprofen pseudoephedrine hydrochloride

200 mg 30 mg

Film-coated tablet Oral use

Greece Pfizer Ellas Α.Ε. Mesogeion 243, 154 51, Neo Psihiko Greece

ADVIL Ibuprofen 400 mg Film-coated tablet Oral use

Greece Pfizer Ellas Α.Ε. Mesogeion 243, 154 51, Neo Psihiko Greece

ADVIL Ibuprofen 200 mg Capsule, soft Oral use

Greece Pfizer Ellas Α.Ε. Mesogeion 243, 154 51, Neo Psihiko Greece

ADVIL Ibuprofen 200 mg Coated tablet Oral use

Greece Pfizer Ellas Α.Ε. Mesogeion 243, 154 51, Neo Psihiko Greece

ADVIL Ibuprofen 400 mg Capsule, soft Oral use

Greece IOUL & EIR TSETI FAR/KA ERGASTIRIA ABEE D.T. "INTERMED ABEE" Kalyftaki 27, 145 64, Kifisia Greece

ALGOFREN Ibuprofen 400 mg Effervescent granules Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 127/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Greece IOUL & EIR TSETI FAR/KA ERGASTIRIA ABEE D.T. "INTERMED ABEE" Kalyftaki 27, 145 64, Kifisia Greece

ALGOFREN Ibuprofen 600 mg Effervescent granules Oral use

Greece IOUL & EIR TSETI FAR/KA ERGASTIRIA ABEE D.T. "INTERMED ABEE" Kalyftaki 27, 145 64, Kifisia Greece

ALGOFREN Ibuprofen 600 mg Film-coated tablet Oral use

Greece IOUL & EIR TSETI FAR/KA ERGASTIRIA ABEE D.T. "INTERMED ABEE" Kalyftaki 27, 145 64, Kifisia Greece

ALGOFREN Ibuprofen 500 mg Suppository Rectal use

Greece IOUL & EIR TSETI FAR/KA ERGASTIRIA ABEE D.T. "INTERMED ABEE" Kalyftaki 27, 145 64, Kifisia Greece

ALGOFREN Ibuprofen 400 mg Effervescent granules Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 128/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Greece IOUL & EIR TSETI FAR/KA ERGASTIRIA ABEE D.T. "INTERMED ABEE" Kalyftaki 27, 145 64, Kifisia Greece

ALGOFREN Ibuprofen 200 mg Effervescent granules Oral use

Greece IOUL & EIR TSETI FAR/KA ERGASTIRIA ABEE D.T. "INTERMED ABEE" Kalyftaki 27, 145 64, Kifisia Greece

ALGOFREN Ibuprofen 200 mg Effervescent tablet Oral use

Greece IOUL & EIR TSETI FAR/KA ERGASTIRIA ABEE D.T. "INTERMED ABEE" Kalyftaki 27, 145 64, Kifisia Greece

ALGOFREN Ibuprofen 200 mg Film-coated tablet Oral use

Greece Reckitt Benckiser Hellas Chemical ABEE Taki Kavalieratou 7 Street 14564 Kato Kifissia Athens Greece

NUROFEN (MINT) Ibuprofen 200 mg Orodispersible tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 129/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Greece Reckitt Benckiser Hellas Chemical ABEE Taki Kavalieratou 7 Street 14564 Kato Kifissia Athens Greece

NUROFEN COLD AND FLU

Ibuprofen pseudoephedrine hydrochloride

200 mg 30 mg

Film-coated tablet Oral use

Greece Reckitt Benckiser Hellas Chemical ABEE Taki Kavalieratou 7 Street 14564 Kato Kifissia Athens Greece

NUROFEN (LEMON) Ibuprofen 200 mg Orodispersible tablet Oral use

Greece Reckitt Benckiser Hellas Chemical ABEE Taki Kavalieratou 7 Street 14564 Kato Kifissia Athens Greece

NUROFEN Ibuprofen 400 mg Capsule, soft Oral use

Greece Reckitt Benckiser Hellas Chemical ABEE Taki Kavalieratou 7 Street 14564 Kato Kifissia Athens Greece

NUROFEN LIQUID CAPSULES

Ibuprofen 200 mg Capsule, soft Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 130/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Greece Reckitt Benckiser Hellas Chemical ABEE Taki Kavalieratou 7 Street 14564 Kato Kifissia Athens Greece

NUROFEN Ibuprofen 200 mg Coated tablet Oral use

Greece Reckitt Benckiser Hellas Chemical ABEE Taki Kavalieratou 7 Street 14564 Kato Kifissia Athens Greece

NUROFEN Ibuprofen 200 mg Capsule, soft Oral use

Greece Reckitt Benckiser Hellas Chemical ABEE Taki Kavalieratou 7 Street 14564 Kato Kifissia Athens Greece

NUROFEN EXPRESS Ibuprofen 256 mg Coated tablet Oral use

Greece Reckitt Benckiser Hellas Chemical ABEE Taki Kavalieratou 7 Street 14564 Kato Kifissia Athens Greece

NUROFEN EXPRESS Ibuprofen 512 mg Coated tablet Oral use

Greece GALENICA A.E. Eleftherias 4, 14564, Kifissia, Greece

SERACTIL Dexibuprofen 300 mg Film-coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 131/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Greece GALENICA A.E. Eleftherias 4, 14564, Kifissia, Greece

SERACTIL Dexibuprofen 400 mg Film-coated tablet Oral use

Hungary Pfizer Corporation Austria GmbH Floridsdorfer Hauptstraße 1 1210 Wien Austria

ADVIL ULTRA FORTE lágy kapszula

Ibuprofen 400 mg Capsule, soft Oral use

Hungary Pfizer Corporation Austria GmbH Floridsdorfer Hauptstraße 1 1210 Wien Austria

ADVIL ULTRA lágy kapszula

Ibuprofen 200 mg Capsule, soft Oral use

Hungary SANOFI-AVENTIS Magyarország Kereskedelmi és Szolgáltató zRt. 1045 Budapest, Tó u. 1-5. Hungary

ALGOFLEX 200 mg filmtabletta

Ibuprofen 200 mg Film-coated tablet Oral use

Hungary SANOFI-AVENTIS Magyarország Kereskedelmi és Szolgáltató zRt. 1045 Budapest, Tó u. 1-5. Hungary

ALGOFLEX 400 mg filmtabletta

Ibuprofen 400 mg Film-coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 132/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Hungary SANOFI-AVENTIS Magyarország Kereskedelmi és Szolgáltató zRt. 1045 Budapest, Tó u. 1-5. Hungary

ALGOFLEX FORTE filmtabletta

Ibuprofen 600 mg Film-coated tablet Oral use

Hungary SANOFI-AVENTIS Magyarország Kereskedelmi és Szolgáltató zRt. 1045 Budapest, Tó u. 1-5. Hungary

ALGOFLEX Izom+Ízület 300 mg retard kemény kapszula

Ibuprofen 300 mg Prolonged-release capsule, hard

Oral use

Hungary SANOFI-AVENTIS Magyarország Kereskedelmi és Szolgáltató zRt. 1045 Budapest, Tó u. 1-5. Hungary

ALGOFLEX NORMA 400 mg filmtabletta

Ibuprofen 400 mg Film-coated tablet Oral use

Hungary SANOFI-AVENTIS Magyarország Kereskedelmi és Szolgáltató zRt. 1045 Budapest, Tó u. 1-5. Hungary

ALGOFLEX RAPID 400 mg filmtabletta

Ibuprofen 400 mg Film-coated tablet Oral use

Hungary SANOFI-AVENTIS Magyarország Kereskedelmi és Szolgáltató zRt. 1045 Budapest, Tó u. 1-5. Hungary

ALGOFLEX-M tabletta Ibuprofen drotaverine

400 mg Tablet oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 133/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Hungary Abbott Laboratories Magyarország Kft. 1095 Budapest Lechner Ödön fasor 7. Hungary

Brufen 400 mg pezsgőgranulátum

Ibuprofen 400 mg Effervescent granules Oral use

Hungary Abbott Laboratories Magyarország Kft. 1095 Budapest Lechner Ödön fasor 7. Hungary

BRUFEN 800 mg retard tabletta

Ibuprofen 800 mg Prolonged-release tablet

Oral use

Hungary Abbott Laboratories Magyarország Kft. 1095 Budapest Lechner Ödön fasor 7. Hungary

BRUFEN cukormentes 40 mg/ml belsőleges szuszpenzió

Ibuprofen 40 mg/ml Oral suspension Oral use

Hungary Dolorgiet GmbH & Co. KG Otto-von-Guericke-Str. 1 53757 Sankt Augustin Germany

DOLGIT AKUT 400 mg lágy kapszula

Ibuprofen 400 mg Capsule, soft Oral use

Hungary Dolorgiet GmbH & Co. KG Otto-von-Guericke-Str. 1 53757 Sankt Augustin Germany

DOLGIT MAX 800 mg filmtabletta

Ibuprofen 800 mg Film-coated tablet Oral use

Hungary Vitabalans Oy Varastokatu 8 13500 Hämeenlinna Finland

IBUMAX 200 mg filmtabletta

Ibuprofen 200 mg Film-coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 134/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Hungary Vitabalans Oy Varastokatu 8 13500 Hämeenlinna Finland

IBUMAX 400 mg filmtabletta

Ibuprofen 400 mg Film-coated tablet Oral use

Hungary Vitabalans Oy Varastokatu 8 13500 Hämeenlinna Finland

IBUMAX 600 mg filmtabletta

Ibuprofen 600 mg Film-coated tablet Oral use

Hungary Vitabalans Oy Varastokatu 8 13500 Hämeenlinna Finland

IBUMAX 800 mg filmtabletta

Ibuprofen 800 mg Film-coated tablet Oral use

Hungary APC Instytut Sp. z o.o. Grójecka st. 22/24 lok. 4 02-301 Warsaw Poland

IBUPROFEN APC 200 mg filmtabletta

Ibuprofen 200 mg Film-coated tablet Oral use

Hungary APC Instytut Sp. z o.o. Grójecka st. 22/24 lok. 4 02-301 Warsaw Poland

IBUPROFEN APC 400 mg filmtabletta

Ibuprofen 400 mg Film-coated tablet Oral use

Hungary Boehringer Ingelheim International GmbH Binger Straße 173 55216 Ingelheim am Rhein Germany

IBUPROFEN BOEHRINGER INGELHEIM 400 mg lágy kapszula

Ibuprofen 400 mg Capsule, soft Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 135/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Hungary Galpharm Healthcare Limited Hugh House Upper Cliffe Road Barnsley, South Yorkshire S75 3SP Dodworth Dodworth Bussiness Park United Kingdom

IBUPROFEN GALPHARM 200 mg filmtabletta

Ibuprofen 200 mg Film-coated tablet Oral use

Hungary Galpharm Healthcare Limited Hugh House Upper Cliffe Road Barnsley, South Yorkshire S75 3SP Dodworth Dodworth Bussiness Park United Kingdom

IBUPROFEN GALPHARM 400 mg filmtabletta

Ibuprofen 400 mg Film-coated tablet Oral use

Hungary Pharmaceutical Works Polfa in Pabianice Joint-Stock Co. Marszałka J. Piłsudskiego St. 5 95-200 Pabianice Poland

IBUPROFEN POLFA 200 mg bevont tabletta

Ibuprofen 200 mg Coated tablet Oral use

Hungary Rockspring Healthcare Limited 38/40 Chamberlayne Road London NW10 3JE United Kingdom

IBUPROFEN ROCKSPRING 600 mg pezsgőgranulátum

Ibuprofen 600 mg Effervescent granules Oral use

Hungary ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany

IBUPROFEN-RATIOPHARM 200 mg filmtabletta

Ibuprofen 200 mg Film-coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 136/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Hungary ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany

IBUPROFEN-RATIOPHARM 400 mg filmtabletta

Ibuprofen 400 mg Film-coated tablet Oral use

Hungary Berlin-Chemie AG Glienicker Weg 125 12489 Berlin Germany

IBUSTAR 400 mg filmtabletta

Ibuprofen 400 mg Film-coated tablet Oral use

Hungary PANNONPHARMA Gyógyszergyártó Kft. 7720 Pécsvárad Pannonpharma út 1. Hungary

MELFEN 200 mg bevont tabletta

Ibuprofen 200 mg Coated tablet Oral use

Hungary PANNONPHARMA Gyógyszergyártó Kft. 7720 Pécsvárad Pannonpharma út 1. Hungary

MELFEN 400 mg bevont tabletta

Ibuprofen 400 mg Coated tablet Oral use

Hungary Boehringer Ingelheim International GmbH Binger Straße 173 55216 Ingelheim am Rhein Germany

MUCOGRIP 200 mg/30 mg filmtabletta

Ibuprofen pseudoephedrine

200 mg 30 mg

Film-coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 137/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Hungary Reckitt Benckiser Healthcare International Limited Bath Road 103-105 Berkshire SL1 3UH Slough United Kingdom

NUROFEN 200 mg bevont tabletta

Ibuprofen 200 mg Coated tablet Oral use

Hungary Reckitt Benckiser Healthcare International Limited Bath Road 103-105 Berkshire SL1 3UH Slough United Kingdom

NUROFEN COLD and FLU 200 mg/30 mg filmtabletta

Ibuprofen pseudoephedrine

200 mg 30 mg

Film-coated tablet Oral use

Hungary Reckitt Benckiser Healthcare International Limited Bath Road 103-105 Berkshire SL1 3UH Slough United Kingdom

NUROFEN eperízű 20 mg/ml belsőleges szuszpenzió gyermekeknek

Ibuprofen 20 mg/ml Oral suspension Oral use

Hungary Reckitt Benckiser Healthcare International Limited Bath Road 103-105 Berkshire SL1 3UH Slough United Kingdom

NUROFEN FORTE 400 mg bevont tabletta

Ibuprofen 400 mg Coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 138/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Hungary Reckitt Benckiser Healthcare International Limited Bath Road 103-105 Berkshire SL1 3UH Slough United Kingdom

NUROFEN NON-AQUA 200 mg szájban diszpergálódó tabletta

Ibuprofen 200 mg Orodispersible tablet Oral use

Hungary Reckitt Benckiser Healthcare International Limited Bath Road 103-105 Berkshire SL1 3UH Slough United Kingdom

NUROFEN RAPID 200 mg lágy kapszula

Ibuprofen 200 mg Capsule, soft Oral use

Hungary Reckitt Benckiser Healthcare International Limited Bath Road 103-105 Berkshire SL1 3UH Slough United Kingdom

NUROFEN RAPID bevont tabletta

Ibuprofen 200 mg Coated tablet Oral use

Hungary Reckitt Benckiser Healthcare International Limited Bath Road 103-105 Berkshire SL1 3UH Slough United Kingdom

NUROFEN RAPID FORTE 400 mg lágy kapszula

Ibuprofen 400 mg Capsule, soft Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 139/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Hungary Reckitt Benckiser Healthcare International Limited Bath Road 103-105 Berkshire SL1 3UH Slough United Kingdom

NUROFEN RAPID FORTE 400 mg por belsőleges oldathoz

Ibuprofen 400 mg Powder for oral solution

Oral use

Hungary Reckitt Benckiser Healthcare International Limited Bath Road 103-105 Berkshire SL1 3UH Slough United Kingdom

NUROFEN RAPID FORTE bevont tabletta

Ibuprofen 400 mg Coated tablet Oral use

Hungary TEVA Gyógyszergyár zRt. 4042 Debrecen Pallagi út 13. Hungary

RAPIDOPHEN 200 mg granulátum belsőleges oldathoz

Ibuprofen 200 mg Granules for oral solution

Oral use

Hungary TEVA Gyógyszergyár zRt. 4042 Debrecen Pallagi út 13. Hungary

RAPIDOPHEN 200 mg lágy kapszula

Ibuprofen 200 mg Capsule, soft Oral use

Hungary TEVA Gyógyszergyár zRt. 4042 Debrecen Pallagi út 13. Hungary

RAPIDOPHEN 400 mg granulátum belsőleges oldathoz

Ibuprofen 400 mg Granules for oral solution

Oral use

Hungary TEVA Gyógyszergyár zRt. 4042 Debrecen Pallagi út 13. Hungary

RAPIDOPHEN 400 mg lágy kapszula

Ibuprofen 400 mg Capsule, soft Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 140/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Hungary TEVA Gyógyszergyár zRt. 4042 Debrecen Pallagi út 13. Hungary

RAPIDOPHEN 600 mg granulátum belsőleges oldathoz

Ibuprofen 600 mg Granules for oral solution

Oral use

Hungary TEVA Gyógyszergyár zRt. 4042 Debrecen Pallagi út 13. Hungary

RAPIDOPHEN BABY 20 mg/ml belsőleges szuszpenzió

Ibuprofen 20 mg/ml Oral suspension Oral use

Hungary SANOFI-AVENTIS Magyarország Kereskedelmi és Szolgáltató zRt. 1045 Budapest, Tó u. 1-5. Hungary

RHINATHIOL COLD 200 mg/30 mg filmtabletta

Ibuprofen pseudoephedrine

200 mg 30 mg

film-coated tablet oral use

Hungary Zambon S.p.A. Via Lillo del Duca 10 20091, Bresso (Mi) Italy

SPEDIFEN 400 mg filmtabletta

Ibuprofen 400 mg Film-coated tablet Oral use

Hungary Zambon S.p.A. Via Lillo del Duca 10 20091, Bresso (Mi) Italy

SPEDIFEN 400 mg granulátum

Ibuprofen 400 mg Granules Oral use

Hungary Zambon S.p.A. Via Lillo del Duca 10 20091, Bresso (Mi) Italy

SPEDIFEN 600 mg granulátum

Ibuprofen 600 mg Granules Oral use

Hungary Gebro Pharma GmbH 13 Bahnhofbichl 6391 Fieberbrunn Austria

Seractil 400 mg filmtabletta

Dexibuprofen 400 mg Film-coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 141/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Hungary Gebro Pharma GmbH 13 Bahnhofbichl 6391 Fieberbrunn Austria

Seractil Dolo 200 mg filmtabletta

Dexibuprofen 200 mg Film-coated tablet Oral use

Hungary Gebro Pharma GmbH 13 Bahnhofbichl 6391 Fieberbrunn Austria

Seractil Dolo 300 mg filmtabletta

Dexibuprofen 300 mg Film-coated tablet Oral use

Iceland Alvogen IPCo S.àr.l. Rue Heienhaff, 5 L-1736, Senningerberg Luxemburg

Alvofen Express Ibuprofen 200 mg Capsule, soft Oral use

Iceland Alvogen IPCo S.àr.l. Rue Heienhaff, 5 L-1736, Senningerberg Luxemburg

Alvofen Express Ibuprofen 400 mg Capsule, soft Oral use

Iceland Orion Corporation Orionintie 1 FIN-02200 Espoo Finland

Burana Ibuprofen 200 mg Film-coated tablet Oral use

Iceland Orion Corporation Orionintie 1 FIN-02200 Espoo Finland

Burana Ibuprofen 400 mg Film-coated tablet Oral use

Iceland Orion Corporation Orionintie 1 FIN-02200 Espoo Finland

Burana Ibuprofen 600 mg Film-coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 142/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Iceland Bristol Laboratories Limited, Unit 3, Canalside Northbridge Road, Berkhamstead, Hertfordshire HP4 1EG United Kingdom

Ibuprofen Bril Ibuprofen 200 mg Film-coated tablet Oral use

Iceland Bristol Laboratories Limited, Unit 3, Canalside Northbridge Road, Berkhamstead, Hertfordshire HP4 1EG United Kingdom

Ibuprofen Bril Ibuprofen 400 mg Film-coated tablet Oral use

Iceland Bristol Laboratories Limited, Unit 3, Canalside Northbridge Road, Berkhamstead, Hertfordshire HP4 1EG United Kingdom

Ibuprofen Bril Ibuprofen 600 mg Film-coated tablet Oral use

Iceland ratiopharm Oy Keilaranta 10 02150 Espoo Finland

Ibuxin Ibuprofen 200 mg Film-coated tablet Oral use

Iceland ratiopharm Oy Keilaranta 10 02150 Espoo Finland

Ibuxin Ibuprofen 400 mg Film-coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 143/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Iceland ratiopharm Oy Keilaranta 10 02150 Espoo Finland

Ibuxin Ibuprofen 600 mg Film-coated tablet Oral use

Iceland ratiopharm Oy Keilaranta 10 02150 Espoo Finland

Ibuxin Ibuprofen 800 mg Film-coated tablet Oral use

Iceland ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany

ibuxin rapid Ibuprofen 400 mg Film-coated tablet Oral use

Iceland Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland

Íbúfen Ibuprofen 200 mg Film-coated tablet Oral use

Iceland Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland

Íbúfen Ibuprofen 400 mg Film-coated tablet Oral use

Iceland Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland

Íbúfen Ibuprofen 600 mg Film-coated tablet Oral use

Iceland Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland

Íbúfen Ibuprofen 800 mg Film-coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 144/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Iceland Portfarma ehf. Borgartúni 26 105 Reykjavík Iceland

Íbúprófen Portfarma Ibuprofen 400 mg Film-coated tablet Oral use

Ireland GlaxoSmithKline Consumer Healthcare (Ireland) Limited Stonemasons Way Rathfarnham Dublin 16 Ireland

Actiprofen 200mg Tablets

Ibuprofen 200 mg Film-coated tablet Oral use

Ireland Pfizer Healthcare Ireland 9 Riverwalk National Digital Park Citywest Business Campus Dublin 24 Ireland

Advil 200mg Tablets Ibuprofen 200 mg Coated tablet Oral use

Ireland Pfizer Healthcare Ireland 9 Riverwalk National Digital Park Citywest Business Campus Dublin 24 Ireland

Advil Cold and Flu Coated Tablets

Ibuprofen pseudoephedrine hydrochloride

200 mg 30 mg

Coated tablet Oral use

Ireland Pfizer Healthcare Ireland 9 Riverwalk National Digital Park Citywest Business Campus Dublin 24 Ireland

Advil Liquigels, 200mg Capsules

Ibuprofen 200 mg Capsule, soft Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 145/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Ireland GlaxoSmithKline Consumer Healthcare (Ireland) Limited Stonemasons Way Rathfarnham Dublin 16 Ireland

Apfen Plus 200mg / 12.8mg Film-Coated Tablets

Ibuprofen codeine phosphate hemihydrate

200 mg 12.8 mg

Film-coated tablet Oral use

Ireland Abbott Laboratories Ireland Ltd. Kingswood Drive 4051 Citywest Business Campus Dublin 24 Ireland

Brufen 400mg film-coated tablets

Ibuprofen 400 mg Film-coated tablet Oral use

Ireland Abbott Laboratories Ireland Ltd. Kingswood Drive 4051 Citywest Business Campus Dublin 24 Ireland

Brufen 600mg film-coated tablets

Ibuprofen 600 mg Film-coated tablet Oral use

Ireland Abbott Laboratories Ireland Ltd. Kingswood Drive 4051 Citywest Business Campus Dublin 24 Ireland

Brufen 400mg Effervescent Granules

Ibuprofen 400 mg Effervescent granules Oral use

Ireland Abbott Laboratories Ireland Ltd. Kingswood Drive 4051 Citywest Business Campus Dublin 24 Ireland

Brufen Paediatric 100 mg / 5 ml Oral Suspension.

Ibuprofen 20 mg/ml Oral suspension Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 146/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Ireland Abbott Laboratories Ireland Ltd. Kingswood Drive 4051 Citywest Business Campus Dublin 24 Ireland

Brufen Retard 800mg Prolonged Release Tablets

Ibuprofen 800 mg Prolonged-release tablet

Oral use

Ireland Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland

Buplex 200mg film-coated tablets

Ibuprofen 200 mg Film-coated tablet Oral use

Ireland Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland

Buplex 400mg film-coated tablets

Ibuprofen 400 mg Film-coated tablet Oral use

Ireland Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland

Buplex Rx 200 mg film-coated tablets

Ibuprofen 200 mg Film-coated tablet Oral use

Ireland Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland

Buplex Rx 400 mg film-coated tablets

Ibuprofen 400 mg Film-coated tablet Oral use

Ireland Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland

Buplex Rx 600 mg film-coated tablets

Ibuprofen 600 mg Film-coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 147/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Ireland Clonmel Healthcare Ltd. Waterford Road, Co. Tipperary Ireland

Easofen 200mg Film-Coated Tablets.

Ibuprofen 200 mg Film-coated tablet Oral use

Ireland Clonmel Healthcare Ltd. Waterford Road, Co. Tipperary Ireland

Easofen Max Strength 400 mg Film-coated Tablets

Ibuprofen 400 mg Film-coated tablet Oral use

Ireland Pinewood Laboratories Limited Ballymacarbry, Clonmel Co Tipperary Ireland

Fenopine 200 mg Film-coated Tablets.

Ibuprofen 200 mg Film-coated tablet Oral use

Ireland Pinewood Laboratories Limited Ballymacarbry, Clonmel Co Tipperary Ireland

Fenopine 400 mg Film-coated Tablets.

Ibuprofen 400 mg Film-coated tablet Oral use

Ireland Pinewood Laboratories Limited Ballymacarbry, Clonmel Co Tipperary Ireland

Fenopine 600 mg Film-Coated Tablets.

Ibuprofen 600 mg Film-coated tablet Oral use

Ireland Abbott Laboratories Ireland Ltd. Kingswood Drive 4051 Citywest Business Campus Dublin 24 Ireland

Ibuprofen 200mg Effervescent Granules

Ibuprofen 200 mg Effervescent granules Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 148/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Ireland McDermott Laboratories Ltd t/a Gerard Laboratories 35/36 Baldoyle Industrial Estate Grange Road Dublin 13 Ireland

Ibuprofen 200mg film-coated tablets

Ibuprofen 200 mg Film-coated tablet Oral use

Ireland McDermott Laboratories Ltd t/a Gerard Laboratories 35/36 Baldoyle Industrial Estate Grange Road Dublin 13 Ireland

Ibuprofen 400mg film-coated tablets

Ibuprofen 400 mg Film-coated tablet Oral use

Ireland Abbott Laboratories Ireland Ltd. Kingswood Drive 4051 Citywest Business Campus Dublin 24 Ireland

Ibuprofen 600mg Effervescent Granules

Ibuprofen 600 mg Effervescent granules Oral use

Ireland The Boots Company PLC 1 Thane Road West Nottingham NG2 3AA United Kingdom

Ibuprofen and Codeine 200 mg/ 12.8 mg film-coated Tablets

Ibuprofen codeine phosphate hemihydrate

200 mg 12.8 mg

Film-coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 149/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Ireland Galpharm Healthcare Limited Hugh House Upper Cliffe Road Barnsley, South Yorkshire S75 3SP Dodworth Dodworth Bussiness Park United Kingdom

Ibuprofen Galpharm 200mg Film-coated Tablets

Ibuprofen 200 mg Film-coated tablet Oral use

Ireland Galpharm Healthcare Limited Hugh House Upper Cliffe Road Barnsley, South Yorkshire S75 3SP Dodworth Dodworth Bussiness Park United Kingdom

Ibuprofen Galpharm Max 400mg Film-coated Tablets

Ibuprofen 400 mg Film-coated tablet Oral use

Ireland Clonmel Healthcare Ltd. Waterford Road, Co. Tipperary Ireland

Melfen 200mg Film-coated tablets

Ibuprofen 200 mg Film-coated tablet Oral use

Ireland Clonmel Healthcare Ltd. Waterford Road, Co. Tipperary Ireland

Melfen 400mg Film-coated tablets

Ibuprofen 400 mg Film-coated tablet Oral use

Ireland Reckitt Benckiser Ireland Ltd. 7 Riverwalk Citywest Business Campus Dublin 24 Ireland

Nurofen 200 mg Coated Tablets

Ibuprofen 200 mg Coated Tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 150/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Ireland Reckitt Benckiser Ireland Ltd. 7 Riverwalk Citywest Business Campus Dublin 24 Ireland

Nurofen 200mg Effervescent Tablets

Ibuprofen 200 mg Effervescent tablet Oral use

Ireland Crookes Healthcare Ltd., Thane Road West 1 Nottingham NG2 3AA United Kingdom

Nurofen Advance 200 mg Tablets.

Ibuprofen 200 mg Film-coated tablet Oral use

Ireland Reckitt Benckiser Ireland Ltd. 7 Riverwalk Citywest Business Campus Dublin 24 Ireland

Nurofen Advance Maximum Strength 400mg oral powder

Ibuprofen 400 mg Powder for oral solution

Oral use

Ireland Reckitt Benckiser Ireland Ltd. 7 Riverwalk Citywest Business Campus Dublin 24 Ireland

Nurofen Cold & Flu Film-coated Tablets

Ibuprofen pseudoephedrine hydrochloride

200 mg 30 mg

Film-coated tablet Oral use

Ireland Reckitt Benckiser Ireland Ltd. 7 Riverwalk Citywest Business Campus Dublin 24 Ireland

Nurofen Express 200 mg Tablets

Ibuprofen 200 mg Coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 151/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Ireland Reckitt Benckiser Ireland Ltd. 7 Riverwalk Citywest Business Campus Dublin 24 Ireland

Nurofen Express Maximum Strength 400 mg Tablets

Ibuprofen 400 mg Coated tablet Oral use

Ireland Reckitt Benckiser Ireland Ltd. 7 Riverwalk Citywest Business Campus Dublin 24 Ireland

Nurofen 200mg Liquid Capsules

Ibuprofen 200 mg Capsule, soft Oral use

Ireland Reckitt Benckiser Ireland Ltd. 7 Riverwalk Citywest Business Campus Dublin 24 Ireland

Nurofen 400mg Liquid Capsules

Ibuprofen 400 mg Capsule, soft Oral use

Ireland Reckitt Benckiser Ireland Ltd. 7 Riverwalk Citywest Business Campus Dublin 24 Ireland

Nurofen Long Lasting 300 mg Prolonged Release Hard Capsules

Ibuprofen 300 mg Prolonged-release capsule, hard

Oral use

Ireland Reckitt Benckiser Ireland Ltd. 7 Riverwalk Citywest Business Campus Dublin 24 Ireland

Nurofen Plus Tablets Ibuprofen codeine phosphate hemihydrate

200 mg 12.8 mg

Film-coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 152/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Ireland Pfizer Healthcare Ireland 9 Riverwalk National Digital Park Citywest Business Campus Dublin 24 Ireland

Seclodin 400mg Tablets

Ibuprofen 400 mg Tablet Oral use

Ireland Pfizer Healthcare Ireland 9 Riverwalk National Digital Park Citywest Business Campus Dublin 24 Ireland

Seclodin 400mg Soft Capsules

Ibuprofen 400 mg Capsule, soft Oral use

Italy Abbott S.r.l., S.R. 148 Pontina Km 52 snc Campoverde di Aprilia 04011 Latina Italy

BRUFEN Ibuprofen 600 mg Effervescent granules Oral use

Italy Abbott S.r.l., S.R. 148 Pontina Km 52 snc Campoverde di Aprilia 04011 Latina Italy

BRUFEN Ibuprofen 800 mg Film-coated prolonged-release tablet

Oral use

Italy Abbott S.r.l., S.R. 148 Pontina Km 52 snc Campoverde di Aprilia 04011 Latina Italy

BRUFEN Ibuprofen 400 mg Film-coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 153/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Italy Abbott S.r.l., S.R. 148 Pontina Km 52 snc Campoverde di Aprilia 04011 Latina Italy

BRUFEN Ibuprofen 600 mg Film-coated tablet Oral use

Italy Abbott S.r.l., S.R. 148 Pontina Km 52 snc Campoverde di Aprilia 04011 Latina Italy

BRUFEN Ibuprofen 20 mg/ml Oral suspension Oral use

Italy Laboratorio Farmaceutico sit Specialita' Igienico Terapeutiche S.R.L., Via Cavour 70 27035 Mede - Pavia Italy

ALGOFEN Ibuprofen 200 mg Film-coated tablet Oral use

Italy Reckitt Benckiser Healthcare International Limited Bath Road 103-105 Berkshire SL1 3UH Slough United Kingdom

NUROFEN Ibuprofen 200 mg Film-coated tablet Oral use

Italy Reckitt Benckiser Healthcare International Limited Bath Road 103-105 Berkshire SL1 3UH Slough United Kingdom

NUROFEN Ibuprofen 400 mg Film-coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 154/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Italy SANDOZ S.P.A. Largo U. Boccioni 1 21040 Origgio (VA) Italy

IBUPROFENE SANDOZ

Ibuprofen 200 mg Film-coated tablet Oral use

Italy Aziende Chimiche Riunite Angelini Francesco A.C.R.A.F. S.p.A. Viale Amelia 70 00181 Rome Italy

MOMENT Ibuprofen 200 mg Film-coated tablet Oral use

Italy Aziende Chimiche Riunite Angelini Francesco A.C.R.A.F. S.p.A. Viale Amelia 70 00181 Rome Italy

MOMENT Ibuprofen 200 mg/ml Oral drops, solution Oral use

Italy Aziende Chimiche Riunite Angelini Francesco A.C.R.A.F. S.p.A. Viale Amelia 70 00181 Rome Italy

MOMENT Ibuprofen 200 mg Granules for oral solution

Oral use

Italy Aziende Chimiche Riunite Angelini Francesco A.C.R.A.F. S.p.A. Viale Amelia 70 00181 Rome Italy

MOMENT Ibuprofen 200 mg Effervescent tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 155/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Italy Aziende Chimiche Riunite Angelini Francesco A.C.R.A.F. S.p.A. Viale Amelia 70 00181 Rome Italy

MOMENT Ibuprofen 200 mg Chewable tablet Oral use

Italy Aziende Chimiche Riunite Angelini Francesco A.C.R.A.F. S.p.A. Viale Amelia 70 00181 Rome Italy

MOMENT Ibuprofen 200 mg Capsule, soft Oral use

Italy JOHNSON & JOHNSON S.P.A., Via Ardeatina Km 23,500 00040 Santa Palomba - Pomezia (RM) - Italy

ANTALGIL Ibuprofen 200 mg Tablet Oral use

Italy SPA ITALIANA LABORATORI BOUTY Via Vanvitelli, 4 20129 Milano Italy

CALMINE Ibuprofen 200 mg Film-coated tablet Oral use

Italy Zambin Italia S.R.L. Via Lillo del Duca 10 20091, Bresso (Mi) Italy

SPIDIDOL ANALGESICO

Ibuprofen 200 mg Effervescent tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 156/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Italy Zambin Italia S.R.L. Via Lillo del Duca 10 20091, Bresso (Mi) Italy

SPIDIDOL ANALGESICO

Ibuprofen 200 mg Granules for oral solution

Oral use

Italy Zambin Italia S.R.L. Via Lillo del Duca 10 20091, Bresso (Mi) Italy

SPIDIDOL ANALGESICO

Ibuprofen 200 mg/ml Oral drops, solution Oral use

Italy Boehringer Ingelheim Italia S.P.A. Via Lorenzini, 8 20139 Milano Italy

BUSCOFEN Ibuprofen 200 mg Film-coated tablet Oral use

Italy Boehringer Ingelheim Italia S.P.A. Via Lorenzini, 8 20139 Milano Italy

BUSCOFEN Ibuprofen 200 mg Capsule, soft Oral use

Italy Boehringer Ingelheim Italia S.P.A. Via Lorenzini, 8 20139 Milano Italy

BUSCOFEN Ibuprofen 200 mg Granules for oral solution

Oral use

Italy Novartis Consumer Health S.P.A., Largo Umberto Boccioni 1 21040 Origgio (VA) Italy

CIBALGINA DUE FAST

Ibuprofen 200 mg Gastro-resistant tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 157/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Italy Bracco S.P.A. Via Egidio Folli 50 20134 Milano Italy

DOLOFAST Ibuprofen 200 mg Tablet Oral use

Italy Bracco S.P.A. Via Egidio Folli 50 20134 Milano Italy

DOLOFAST Ibuprofen 200 mg/ml Oral drops, solution Oral use

Italy Angenerico S.P.A. Via Nocera Umbra 75 Roma Italy

IBUPROFENE ANGENERICO

Ibuprofen 200 mg Film-coated tablet Oral use

Italy Angenerico S.P.A. Via Nocera Umbra 75 Roma Italy

IBUPROFENE ANGENERICO

Ibuprofen 200 mg/ml Oral drops, solution Oral use

Italy FARMAKOPEA S.P.A. Via Cavriana 14 Milano Italy

SUBITENE Ibuprofen 200 mg Effervescent tablet Oral use

Italy FARMAKOPEA S.P.A. Via Cavriana 14 Milano Italy

SUBITENE Ibuprofen 200 mg Granules for oral solution

Oral use

Italy FARMAKOPEA S.P.A. Via Cavriana 14 Milano Italy

SUBITENE Ibuprofen 400 mg Granules for oral solution

Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 158/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Italy FARMAKOPEA S.P.A. Via Cavriana 14 Milano Italy

SUBITENE Ibuprofen 200 mg Film-coated tablet Oral use

Italy Aziende Chimiche Riunite Angelini Francesco A.C.R.A.F. S.p.A. Viale Amelia 70 00181 Rome Italy

MOMENTACT Ibuprofen 400 mg Film-coated tablet Oral use

Italy Aziende Chimiche Riunite Angelini Francesco A.C.R.A.F. S.p.A. Viale Amelia 70 00181 Rome Italy

MOMENTACT Ibuprofen 400 mg Capsule, soft Oral use

Italy Aziende Chimiche Riunite Angelini Francesco A.C.R.A.F. S.p.A. Viale Amelia 70 00181 Rome Italy

MOMENTACT ANALGESICO

Ibuprofen 400 mg Granules for oral solution

Oral use

Italy Reckitt Benckiser Healthcare International Limited Bath Road 103-105 Berkshire SL1 3UH Slough United Kingdom

NUROSOLV Ibuprofen 200 mg Orodispersible tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 159/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Italy LABORATORI ALTER S.R.L. Via Egadi 7 20144 Milano Italy

IBUPROFENE ALTER Ibuprofen 400 mg Film-coated tablet Oral use

Italy LABORATORI ALTER S.R.L. Via Egadi 7 20144 Milano Italy

IBUPROFENE ALTER Ibuprofen 600 mg Film-coated tablet Oral use

Italy Reckitt Benckiser Healthcare International Limited Bath Road 103-105 Berkshire SL1 3UH Slough United Kingdom

NUROFENELLE Ibuprofen 200 mg Film-coated tablet Oral use

Italy Reckitt Benckiser Healthcare International Limited Bath Road 103-105 Berkshire SL1 3UH Slough United Kingdom

NUROFENELLE Ibuprofen 400 mg Film-coated tablet Oral use

Italy ABC Farmaceutici S.P.A. Corso Vittorio Emanuele II 72 10121 Torino Italy

KENDO Ibuprofen 200 mg/ml Oral drops, solution Oral use

Italy RATIOPHARM ITALIA S.R.L. Viale Monza 270 20128 Milano Italy

IBUPROFENE RATIOPHARM ITALIA

Ibuprofen 400 mg Film-coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 160/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Italy ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany

IBUPROFENE RATIOPHARM

Ibuprofen 200 mg Film-coated tablet Oral use

Italy Aziende Chimiche Riunite Angelini Francesco A.C.R.A.F. S.p.A. Viale Amelia 70 00181 Rome Italy

MOMENFLOGO Ibuprofen 600 mg Granules for oral solution

Oral use

Italy Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland

ZORENDOL Ibuprofen 200 mg Film-coated tablet Oral use

Italy Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland

ZORENDOL Ibuprofen 400 mg Film-coated tablet Oral use

Italy Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland

IBUPROFENE ACTAVIS

Ibuprofen 400 mg Film-coated tablet Oral use

Italy E-PHARMA TRENTO S.P.A. Via Provina, 2 38123 Frazione Ravina - Trento Italy

IBUPROFENE E-PHARMA TRENTO

Ibuprofen 400 mg Granules for oral solution

Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 161/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Italy Boots Pharmaceuticals S.R.L. Via Cesarea 11/10 16121 Genova Italy

DOLIPRO Ibuprofen 200 mg Film-coated tablet Oral use

Italy Boots Pharmaceuticals S.R.L. Via Cesarea 11/10 16121 Genova Italy

DOLIPRO Ibuprofen 400 mg Film-coated tablet Oral use

Italy Aziende Chimiche Riunite Angelini Francesco A.C.R.A.F. S.p.A. Viale Amelia 70 00181 Rome Italy

IBUPROFENE ANGELINI

Ibuprofen 600 mg Granules for oral solution

Oral use

Italy LABORATORI ALTER S.R.L. Via Egadi 7 20144 Milano Italy

SAKITOL Ibuprofen 400 mg Film-coated tablet Oral use

Italy DOC GENERICI SRL Via Turati, 40 20121 Milano Italy

IBUPROFENE DOC GENERICI

Ibuprofen 600 mg Effervescent granules Oral use

Italy Boehringer Ingelheim International GmbH Binger Straße 173 55216 Ingelheim am Rhein Germany

BUSCOFENACT Ibuprofen 400 mg Capsule, soft Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 162/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Italy Reckitt Benckiser Healthcare International Limited Bath Road 103-105 Berkshire SL1 3UH Slough United Kingdom

NUROFENCAPS Ibuprofen 400 mg Capsule, soft Oral use

Italy DOC GENERICI SRL Via Turati, 40 20121 Milano Italy

IBUPROFEN DOC GENERICS

Ibuprofen 20 mg/ml Oral suspension Oral use

Italy POLIFARMA BENESSERE S.R.L. Via Laurentine, 289 00142 Roma Italy

VIAMAL FEBBRE E DOLORE

Ibuprofen 200 mg Film-coated tablet Oral use

Italy POLIFARMA BENESSERE S.R.L. Via Laurentine, 289 00142 Roma Italy

VIAMAL FEBBRE E DOLORE

Ibuprofen 400 mg Film-coated tablet Oral use

Italy THERABEL GIENNE PHARMA S.P.A. Via Roberto Koch 1/2 20152 Milano Italy

SERACTIL Dexibuprofen 200 mg Film-coated tablet Oral use

Italy THERABEL GIENNE PHARMA S.P.A. Via Roberto Koch 1/2 20152 Milano Italy

SERACTIL Dexibuprofen 300 mg Film-coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 163/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Italy THERABEL GIENNE PHARMA S.P.A. Via Roberto Koch 1/2 20152 Milano Italy

SERACTIL Dexibuprofen 400 mg Film-coated tablet Oral use

Italy THERABEL GIENNE PHARMA S.P.A. Via Roberto Koch 1/2 20152 Milano Italy

SERACTIL Dexibuprofen 300 mg Powder for oral suspension

Oral use

Italy THERABEL GIENNE PHARMA S.P.A. Via Roberto Koch 1/2 20152 Milano Italy

SERACTIL Dexibuprofen 400 mg Powder for oral suspension

Oral use

Italy Bruno Farmaceutici S.p.A. Via delle Ande, 15 00144 Roma Italy

FENEXTRA Dexibuprofen 400 mg Film-coated tablet Oral use

Italy Bruno Farmaceutici S.p.A. Via delle Ande, 15 00144 Roma Italy

FENEXTRA Dexibuprofen 300 mg Granules for oral suspension

Oral use

Italy Bruno Farmaceutici S.p.A. Via delle Ande, 15 00144 Roma Italy

FENEXTRA Dexibuprofen 400 mg Granules for oral suspension

Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 164/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Italy Boehringer Ingelheim International GmbH Binger Straße 173 55216 Ingelheim am Rhein Germany

IBUPROFENE E PSEUDOEFEDRINA BOEHRINGER INGELHEIM

Ibuprofen pseudoephedrine

200 mg 30 mg

Film-coated tablet Oral use

Italy L. MOLTENI & C. DEI F.LLI ALITTI SOCIETA' DI ESERCIZIO S.P.A. Strada Statale 67 Tosco Romagnola 50018 Frazione Granatieri Scandicci - Firenze Italy

ACIRIL Ibuprofen lysine 500 mg Tablet Oral use

Italy L. MOLTENI & C. DEI F.LLI ALITTI SOCIETA' DI ESERCIZIO S.P.A. Strada Statale 67 Tosco Romagnola 50018 Frazione Granatieri Scandicci - Firenze Italy

ACIRIL Ibuprofen lysine 400 mg/3ml Powder and solution for injection

Parenteral use

Italy Laboratorio Italiano Biochimico Farmaceutico Lisapharma S.P.A. Via Licinio 11 22036 Erba Como Italy

ARFEN Ibuprofen lysine 500 mg Tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 165/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Italy Laboratorio Italiano Biochimico Farmaceutico Lisapharma S.P.A. Via Licinio 11 22036 Erba Como Italy

ARFEN Ibuprofen lysine 400 mg/3ml Solution for injection Parenteral use

Italy Carlo Erba O.T.C. S.R.L. Via Ardeatina Km 23 500 - Frazione LOC. Santa Palomba 00040 Pomezia Italy

IBUPROFENE CARLO ERBA

Ibuprofen lysine 200 mg Film-coated tablet Oral use

Italy Carlo Erba O.T.C. S.R.L. Via Ardeatina Km 23 500 - Frazione LOC. Santa Palomba 00040 Pomezia Italy

IBUPROFENE CARLO ERBA

Ibuprofen lysine 400 mg Film-coated tablet Oral use

Italy Reckitt Benckiser Healthcare International Limited Bath Road 103-105 Berkshire SL1 3UH Slough United Kingdom

NUROFENIMMEDIA Ibuprofen lysine 200 mg Film-coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 166/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Latvia CIPLA (UK) LIMITED The Old Post House Heath Road, Surrey Weybridge, KT13 8TS, United Kingdom

Ibugesic 400 mg film-coated tablets

Ibuprofen 400 mg Film-coated tablet Oral use

Latvia CIPLA (UK) LIMITED The Old Post House Heath Road, Surrey Weybridge, KT13 8TS, United Kingdom

Ibugesic 600 mg film-coated tablets

Ibuprofen 600 mg Film-coated tablet Oral use

Latvia Lannacher Heilmittel GmbH Schlossplatz 1 A-8502 Lannach Austria

Ibuprofen Lannacher 600 mg film-coated tablets

Ibuprofen 600 mg Film-coated tablet Oral use

Latvia Lannacher Heilmittel GmbH Schlossplatz 1 A-8502 Lannach Austria

Ibuprofen Lannacher 400 mg film-coated tablets

Ibuprofen 400 mg Film-coated tablet Oral use

Latvia Rockspring Healthcare Limited 38/40 Chamberlayne Road London NW10 3JE United Kingdom

Ibuprofen/Codeine Phosphate Rockspring 400 mg/30 mg film-coated tablets

Ibuprofen codeine phosphate hemihydrate

400 mg 30 mg

Film-coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 167/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Latvia Rockspring Healthcare Limited 38/40 Chamberlayne Road London NW10 3JE United Kingdom

Ibuprofen Rockspring 200 mg effervescent granules

Ibuprofen 200 mg Effervescent granules Oral use

Latvia Rockspring Healthcare Limited 38/40 Chamberlayne Road London NW10 3JE United Kingdom

Ibuprofen Rockspring 600 mg effervescent granules

Ibuprofen 600 mg Effervescent granules Oral use

Latvia Mepha Lda. Lagoas Park, 2740-298 Porto Salvo Portugal

Ibuprofen Mepha 400 mg film-coated tablets

Ibuprofen 400 mg Film-coated tablet Oral use

Latvia Reckitt Benckiser (Poland) S.A. ul. Okunin 1 05-100 Nowy Dwor Mazowiecki Poland

Nurofen Forte Express 400 mg coated tablets

Ibuprofen 400 mg Coated tablet Oral use

Latvia Reckitt Benckiser (Poland) S.A. ul. Okunin 1 05-100 Nowy Dwor Mazowiecki Poland

Nurofen Express 200 mg coated tablets

Ibuprofen 200 mg Coated tablet Oral use

Latvia Reckitt Benckiser (Poland) S.A. ul. Okunin 1 05-100 Nowy Dwor Mazowiecki Poland

Nurofen Forte 400 mg coated tablets

Ibuprofen 400 mg Coated tablet Oral use

Latvia Reckitt Benckiser (Poland) S.A. ul. Okunin 1 05-100 Nowy Dwor Mazowiecki Poland

Nurofen 200 mg film-coated tablets

Ibuprofen 200 mg Film-coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 168/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Latvia Reckitt Benckiser (Poland) S.A. ul. Okunin 1 05-100 Nowy Dwor Mazowiecki Poland

Nurofen Antigrip 200 mg/30 mg coated tablets

Ibuprofen pseudoephedrine hydrochloride

200 mg 30 mg

Coated tablet Oral use

Latvia Reckitt Benckiser (Poland) S.A. ul. Okunin 1 05-100 Nowy Dwor Mazowiecki Poland

Nurofen Ultra Express 200 mg capsules, soft

Ibuprofen 200 mg Capsule, soft Oral use

Latvia STIROLBIOFARM BALTIKUM SIA, Rasas 5 Riga Latvia

Ibuprofen Stirol 300 mg capsules

Ibuprofen 300 mg Capsule, hard Oral use

Latvia AS Grindeks Krustpils 53 LV-1057 Riga Latvia

Ibuprofen - Grindeks 400 mg film-coated tablets

Ibuprofen 400 mg Film-coated tablet Oral use

Latvia AS Grindeks Krustpils 53 LV-1057 Riga Latvia

Ibuprofen - Grindeks 200 mg film-coated tablets

Ibuprofen 200 mg Film-coated tablet Oral use

Latvia AS “Olainfarm” Rupnicu iela 5 Olaine LV-2114 Latvia

Ignol 400 mg film-coated tablets

Ibuprofen 400 mg Film-coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 169/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Latvia AS “Olainfarm” Rupnicu iela 5 Olaine LV-2114 Latvia

Ibuprofen 200 mg film-coated tablets

Ibuprofen 200 mg Film-coated tablet Oral use

Latvia Berlin-Chemie AG Glienicker Weg 125 12489 Berlin Germany

Ibustar 400 mg film-coated tablets

Ibuprofen 400 mg Film-coated tablet Oral use

Latvia STADA Arzneimittel AG Stadastr. 2-18 61118 Bad Vilbel Germany

Ibudolor 200 mg coated tablets

Ibuprofen 200 mg Coated tablet Oral use

Latvia Il Ideal Trade Links Sukileliu pr. 78-40 LT-49360 Kaunas Lithuania

Ibufanti 100 mg/5 ml oral suspension

Ibuprofen 20 mg/ml Oral suspension Oral use

Latvia ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany

Ibuprofen-ratiopharm 400 mg film-coated tablets

Ibuprofen 400 mg Film-coated tablet Oral use

Latvia ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany

Butifen 400 mg film-coated tablets

Ibuprofen 400 mg Film-coated tablet Oral use

Latvia Abbott Laboratories Baltics SIA Mukusalas 101 Riga LV 1004 Latvia

Brufen 400 mg effervescent granules

Ibuprofen 400 mg Effervescent granules Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 170/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Latvia Abbott Laboratories Baltics SIA Mukusalas 101 Riga LV 1004 Latvia

Brufen 200 mg film-coated tablets

Ibuprofen 200 mg Film-coated tablet Oral use

Latvia Abbott Laboratories Baltics SIA Mukusalas 101 Riga LV 1004 Latvia

Brufen 20 mg/ml oral suspension

Ibuprofen 20 mg/ml Oral suspension Oral use

Latvia Abbott Laboratories Baltics SIA Mukusalas 101 Riga LV 1004 Latvia

Brufen 800 mg prolonged-release tablets

Ibuprofen 800 mg Prolonged-release tablet

Oral use

Latvia Abbott Laboratories Baltics SIA Mukusalas 101 Riga LV 1004 Latvia

Brufen 400 mg film-coated tablets

Ibuprofen 400 mg Film-coated tablet Oral use

Latvia UAB “INTELI GENERICS NORD”, Seimyniskiu g. 3 Vilnius, LT-09312 Lithuania

Ibuprofen Inteli 100 mg/5 ml oral suspension

Ibuprofen 20 mg/ml Oral suspension Oral use

Latvia Zentiva, k.s. U kabelovny 130 102 37 Praha 10 Dolní Měcholupy Czech Republic

Ibuprofen Zentiva 400 mg film-coated tablets

Ibuprofen 400 mg Film-coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 171/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Latvia Zentiva, k.s. U kabelovny 130 102 37 Praha 10 Dolní Měcholupy Czech Republic

Ibuprofen Zentiva 200 mg film-coated tablets

Ibuprofen 200 mg Film-coated tablet Oral use

Latvia Takeda Pharma AS Jaama 55B Polva 63308 Estonia

Ibumetin 200 mg film-coated tablets

Ibuprofen 200 mg Film-coated tablet Oral use

Latvia Takeda Pharma AS Jaama 55B Polva 63308 Estonia

Ibumetin 400 mg film-coated tablets

Ibuprofen 400 mg Film-coated tablet Oral use

Latvia Zentiva, k.s. U kabelovny 130 102 37 Praha 10 Dolní Měcholupy Czech Republic

Ibalgin Fast 400 mg film-coated tablets

Ibuprofen 400 mg Film-coated tablet Oral use

Latvia Vitabalans Oy Varastokatu 8 13500 Hämeenlinna Finland

Ibumax 200 mg film-coated tablets

Ibuprofen 200 mg Film-coated tablet Oral use

Latvia Vitabalans Oy Varastokatu 8 13500 Hämeenlinna Finland

Ibumax 400 mg film-coated tablets

Ibuprofen 400 mg Film-coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 172/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Latvia Vitabalans Oy Varastokatu 8 13500 Hämeenlinna Finland

Ibumax 600 mg film-coated tablets

Ibuprofen 600 mg Film-coated tablet Oral use

Lithuania Abbott Laboratories Baltics SIA Mukusalas 101 Riga LV 1004 Latvia

Abfen Ibuprofen 40 mg/ml Oral suspension Oral use

Lithuania Abbott Laboratories Baltics SIA Mukusalas 101 Riga LV 1004 Latvia

Brufen Ibuprofen 200 mg Film-coated tablet Oral use

Lithuania Abbott Laboratories Baltics SIA Mukusalas 101 Riga LV 1004 Latvia

Brufen Ibuprofen 400 mg Film-coated tablet Oral use

Lithuania Abbott Laboratories Baltics SIA Mukusalas 101 Riga LV 1004 Latvia

Brufen Ibuprofen 800 mg Prolonged-release tablet

Oral use

Lithuania Abbott Laboratories Baltics SIA Mukusalas 101 Riga LV 1004 Latvia

Brufen Ibuprofen 400 mg Effervescent granules Oral use

Lithuania Abbott Laboratories Baltics SIA Mukusalas 101 Riga LV 1004 Latvia

Brufen Ibuprofen 20 mg/ml Oral suspension Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 173/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Lithuania ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany

Butifen Ibuprofen 400 mg Film-coated tablet Oral use

Lithuania STADA Arzneimittel AG Stadastr. 2-18 61118 Bad Vilbel Germany

IBUDOLOR Ibuprofen 200 mg Film-coated tablet Oral use

Lithuania Vitabalans Oy Varastokatu 8 13500 Hämeenlinna Finland

IBUMAX Ibuprofen 200 mg Film-coated tablet Oral use

Lithuania Vitabalans Oy Varastokatu 8 13500 Hämeenlinna Finland

IBUMAX Ibuprofen 400 mg Film-coated tablet Oral use

Lithuania Vitabalans Oy Varastokatu 8 13500 Hämeenlinna Finland

IBUMAX Ibuprofen 600 mg Film-coated tablet Oral use

Lithuania Pabianickie Zakłady Farmaceutyczne Polfa S.A. Marszalka Pilsudskiego st. 5 95-200 Pabianice Poland

IBUPROFEN Polfa Ibuprofen 200 mg Coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 174/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Lithuania AS Grindeks Krustpils 53 LV-1057 Riga Latvia

IBUPROFEN-GRINDEKS

Ibuprofen 200 mg Film-coated tablet Oral use

Lithuania US Pharmacia Sp. z o.o. Ziebicka st. 40 50-507 Wroclaw Poalnd

IBUPROM Ibuprofen 200 mg Coated tablet Oral use

Lithuania US Pharmacia Sp. z o.o. Ziebicka st. 40 50-507 Wroclaw Poalnd

IBUPROM Ibuprofen 400 mg Film-coated tablet Oral use

Lithuania Zentiva, k.s. U kabelovny 130 102 37 Praha 10 Dolní Měcholupy Czech Republic

Ibalgin Fast Ibuprofen 400 mg Film-coated tablet Oral use

Lithuania Takeda Pharma AS Jaama 55B Polva 63308 Estonia

Ibumetin Ibuprofen 200 mg Film-coated tablet Oral use

Lithuania Takeda Pharma AS Jaama 55B Polva 63308 Estonia

Ibumetin Ibuprofen 400 mg Film-coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 175/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Lithuania Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland

Ibuprofen Actavis Ibuprofen 200 mg Film-coated tablet Oral use

Lithuania Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland

Ibuprofen Actavis Ibuprofen 400 mg Film-coated tablet Oral use

Lithuania Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland

Ibuprofen Actavis Ibuprofen 600 mg Film-coated tablet Oral use

Lithuania Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland

Ibuprofen Actavis Ibuprofen 800 mg Film-coated tablet Oral use

Lithuania Lannacher Heilmittel GmbH Schlossplatz 1 A-8502 Lannach Austria

Ibuprofen Lannacher Ibuprofen 400 mg Film-coated tablet Oral use

Lithuania Lannacher Heilmittel GmbH Schlossplatz 1 A-8502 Lannach Austria

Ibuprofen Lannacher Ibuprofen 600 mg Film-coated tablet Oral use

Lithuania Mepha Lda. Lagoas Park, 2740-298 Porto Salvo Portugal

Ibuprofen Mepha Ibuprofen 400 mg Film-coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 176/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Lithuania Rockspring Healthcare Limited 38/40 Chamberlayne Road London NW10 3JE United Kingdom

Ibuprofen Rockspring Ibuprofen 200 mg Effervescent granules Oral use

Lithuania Rockspring Healthcare Limited 38/40 Chamberlayne Road London NW10 3JE United Kingdom

Ibuprofen Rockspring Ibuprofen 600 mg Effervescent granules Oral use

Lithuania Zentiva, k.s. U kabelovny 130 102 37 Praha 10 Dolní Měcholupy Czech Republic

Ibuprofen Zentiva Ibuprofen 200 mg Film-coated tablet Oral use

Lithuania Zentiva, k.s. U kabelovny 130 102 37 Praha 10 Dolní Měcholupy Czech Republic

Ibuprofen Zentiva Ibuprofen 400 mg Film-coated tablet Oral use

Lithuania US Pharmacia Sp. z o.o. Ziebicka st. 40 50-507 Wroclaw Poalnd

Ibuprom Express Ibuprofen 400 mg Capsule, soft Oral use

Lithuania Berlin-Chemie AG Glienicker Weg 125 12489 Berlin Germany

Ibustar Ibuprofen 400 mg Film-coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 177/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Lithuania Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland

Ifenin Ibuprofen 200 mg Film-coated tablet Oral use

Lithuania Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland

Ifenin Ibuprofen 400 mg Film-coated tablet Oral use

Lithuania Reckitt Benckiser (Poland) S.A. ul. Okunin 1 05-100 Nowy Dwor Mazowiecki Poland

NUROFEN Ibuprofen 200 mg Coated tablet Oral use

Lithuania Reckitt Benckiser (Poland) S.A. ul. Okunin 1 05-100 Nowy Dwor Mazowiecki Poland

NUROFEN EXPRESS Ibuprofen 200 mg Coated tablet Oral use

Lithuania Reckitt Benckiser (Poland) S.A. ul. Okunin 1 05-100 Nowy Dwor Mazowiecki Poland

NUROFEN FORTE Ibuprofen 400 mg Coated tablet Oral use

Lithuania Reckitt Benckiser (Poland) S.A. ul. Okunin 1 05-100 Nowy Dwor Mazowiecki Poland

NUROFEN FORTE EXPRESS

Ibuprofen 400 mg Coated tablet Oral use

Lithuania Reckitt Benckiser (Poland) S.A. ul. Okunin 1 05-100 Nowy Dwor Mazowiecki Poland

Nurofen Ultra Express

Ibuprofen 200 mg Capsule, soft Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 178/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Lithuania UAB Corpus Medica Sukilėlių pr. 61 LT-49333 Kaunas Lithuania

TVINGESTIN Ibuprofen 400 mg Film-coated tablet Oral use

Luxembourg Pfizer bv Rivium Westlaan 142 2909 LD, Capelle a/d Ijssel The Netherlands

Advil Mono Liquid Caps

Ibuprofen 200 mg Effervescent tablet Oral use

Luxembourg Pfizer bv Rivium Westlaan 142 2909 LD, Capelle a/d Ijssel The Netherlands

Advil Mono Liquid Caps

Ibuprofen 200 mg Capsule, soft Oral use

Luxembourg Abbott Laboratoires Avenue Einstein 14 1300 Wavre Belgium

Brufen forte Ibuprofen 600 mg Coated tablet Oral use

Luxembourg Abbott Laboratoires Avenue Einstein 14 1300 Wavre Belgium

Brufen granules Ibuprofen 600 mg Effervescent granules Oral use

Luxembourg Abbott Laboratoires Avenue Einstein 14 1300 Wavre Belgium

Brufen retard Ibuprofen 800 mg Prolonged-release tablet

Oral use

Luxembourg Abbott Laboratoires Avenue Einstein 14 1300 Wavre Belgium

Brufen Ibuprofen 400 mg Coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 179/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Luxembourg Abbott Laboratoires Avenue Einstein 14 1300 Wavre Belgium

Brufen granules Ibuprofen 400 mg Effervescent granules Oral use

Luxembourg Abbott Laboratoires Avenue Einstein 14 1300 Wavre Belgium

Brufen suspension buvable

Ibuprofen 40 mg/ml Oral suspension Oral use

Luxembourg Simons Georg GmbH Eckenheimer Landstr 100 60318 Frankfurt/Main Germany

Dismenol N Ibuprofen 200 mg Coated tablet Oral use

Luxembourg Dolorgiet GmbH & Co. KG Otto-von-Guericke-Str. 1 53757 Sankt Augustin Germany

Dolgit Ibuprofen 600 mg Coated tablet Oral use

Luxembourg Dolorgiet GmbH & Co. KG Otto-von-Guericke-Str. 1 53757 Sankt Augustin Germany

Dolgit Ibuprofen 800 mg Coated tablet Oral use

Luxembourg Socobom nv/sa Avenue Louise 149b24 1050 Bruxelles Belgium

Dolofin Ibuprofen 200 mg Coated tablet Oral use

Luxembourg Socobom nv/sa Avenue Louise 149b24 1050 Bruxelles Belgium

Dolofin Ibuprofen 200 mg Coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 180/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Luxembourg Socobom nv/sa Avenue Louise 149b24 1050 Bruxelles Belgium

Dolofin Ibuprofen 200 mg Coated tablet Oral use

Luxembourg Will-Pharma S.A. Rue du Manil 80 1301 Wavre Belgium

Epsilon Ibuprofen 400 mg Coated tablet Oral use

Luxembourg ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany

Ibu Ratiopharm Lysinat

Ibuprofen lysine 500 mg Coated tablet Oral use

Luxembourg Abz-Pharma GmbH Graf-Arco-Str. 3 89079 Ulm Germany

Ibu-Lysin Abz Migraene

Ibuprofen lysine 684 mg Coated tablet Oral use

Luxembourg ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany

Ibu-Lysin Ratiopharm Ibuprofen lysine 684 mg Coated tablet Oral use

Luxembourg ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany

Ibu-Lysin Ratiopharm Ibuprofen lysine 342 mg Coated tablet Oral use

Luxembourg CT Arzneimittel GmbH Graf-Arco-Str. 3 89079 Ulm Germany

Ibu-Lysin CT Ibuprofen lysine 684 mg Coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 181/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Luxembourg CT Arzneimittel GmbH Graf-Arco-Str. 3 89079 Ulm Germany

Ibu-Lysin CT Ibuprofen lysine 342 mg Coated tablet Oral use

Luxembourg ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany

Ibu-Ratiopharm Ibuprofen 200 mg Coated tablet Oral use

Luxembourg ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany

Ibu-Ratiopharm Ibuprofen 400 mg Coated tablet Oral use

Luxembourg ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany

Ibu-Ratiopharm Ibuprofen 600 mg Coated tablet Oral use

Luxembourg ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany

Ibu-Ratiopharm Ibuprofen 800 mg Prolonged-release tablet

Oral use

Luxembourg Hexal AG Industriestrasse 25 83607 Holzkirchen Germany

Ibuhexal retard Ibuprofen 800 mg Prolonged-release tablet

Oral use

Luxembourg Hexal AG Industriestrasse 25 83607 Holzkirchen Germany

Ibuhexal Ibuprofen 400 mg Coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 182/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Luxembourg Hexal AG Industriestrasse 25 83607 Holzkirchen Germany

Ibuhexal Ibuprofen 600 mg Coated tablet Oral use

Luxembourg Hexal AG Industriestrasse 25 83607 Holzkirchen Germany

Ibuhexal Ibuprofen 800 mg Coated tablet Oral use

Luxembourg ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany

Ibuprofen ratio Ibuprofen 200 mg Coated tablet Oral use

Luxembourg ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany

Ibuprofen ratio Ibuprofen 400 mg Coated tablet Oral use

Luxembourg CT Arzneimittel GmbH Graf-Arco-Str. 3 89079 Ulm Germany

Ibuprofen ct Ibuprofen 500 mg Suppository Rectal use

Luxembourg Eurogenerics NV Esplanade Heysel b22 1020 Bruxelles Belgium

Ibuprofen EG Ibuprofen 40 mg/ml Oral suspension Oral use

Luxembourg Eurogenerics NV Esplanade Heysel b22 1020 Bruxelles Belgium

Ibuprofen EG Ibuprofen 400 mg Coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 183/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Luxembourg Eurogenerics NV Esplanade Heysel b22 1020 Bruxelles Belgium

Ibuprofen EG Ibuprofen 600 mg Coated tablet Oral use

Luxembourg Eurogenerics NV Esplanade Heysel b22 1020 Bruxelles Belgium

Ibuprofen EG Ibuprofen 800 mg Prolonged-release tablet

Oral use

Luxembourg Boehringer Ingelheim International GmbH Binger Straße 173 55216 Ingelheim am Rhein Germany

Ibuprofen Boehringer Ingelheim

Ibuprofen 400 mg Capsule, soft Oral use

Luxembourg Mylan bvba/sprl Terhulpsesteenweg 6a 1560 Hoeilaart Belgium

Ibuprofen Lysine Mylan

Ibuprofen lysine 200 mg Coated tablet Oral use

Luxembourg Mylan bvba/sprl Terhulpsesteenweg 6a 1560 Hoeilaart Belgium

Ibuprofen Lysine Mylan

Ibuprofen lysine 400 mg Coated tablet Oral use

Luxembourg Mylan bvba/sprl Terhulpsesteenweg 6a 1560 Hoeilaart Belgium

Ibuprofen Lysine Mylan Pharma

Ibuprofen lysine 200 mg Coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 184/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Luxembourg Mylan bvba/sprl Terhulpsesteenweg 6a 1560 Hoeilaart Belgium

Ibuprofen Lysine Mylan Pharma

Ibuprofen lysine 400 mg Coated tablet Oral use

Luxembourg Sandoz nv/sa Telecom Gardens Medialaan 40 1800 Vilvoorde Belgium

Ibuprofen Sandoz Ibuprofen 40 mg/ml Oral suspension Oral use

Luxembourg Abbott S.A-N.V. Avenue Einstein 14 1300 Wavre Belgium

Malafene 100mg/5ml Ibuprofen 20 mg/ml Syrup Oral use

Luxembourg Reckitt Benckiser Healthcare nv/sa Allée de la recherche 20 1070 Bruxelles Belgium

Nurofen fastcaps Ibuprofen 200 mg Capsule, soft Oral use

Luxembourg Reckitt Benckiser Healthcare nv/sa Allée de la recherche 20 1070 Bruxelles Belgium

Nurofen fastpowder Ibuprofen 400 mg Powder for oral solution

Oral use

Luxembourg Reckitt Benckiser Healthcare nv/sa Allée de la recherche 20 1070 Bruxelles Belgium

Nurofen fasttabs Ibuprofen 684 mg Film-coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 185/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Luxembourg Reckitt Benckiser Healthcare nv/sa Allée de la recherche 20 1070 Bruxelles Belgium

Nurofen Ibuprofen 200 mg Coated tablet Oral use

Luxembourg Reckitt Benckiser Healthcare nv/sa Allée de la recherche 20 1070 Bruxelles Belgium

Nurofen 400 Ibuprofen 400 mg Coated tablet Oral use

Luxembourg Reckitt Benckiser Healthcare nv/sa Allée de la recherche 20 1070 Bruxelles Belgium

Nurofen lysine Ibuprofen lysine 342 mg Film-coated tablet Oral use

Luxembourg Reckitt Benckiser Healthcare nv/sa Allée de la recherche 20 1070 Bruxelles Belgium

Nurofen lysine Ibuprofen lysine 684 mg Film-coated tablet Oral use

Luxembourg Johnson & Johnson Consumer SA/NV Antwerpseweg 15-17 2340 Beerse Belgium

Perdofemina Ibuprofen lysine 684 mg Film-coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 186/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Luxembourg Johnson & Johnson Consumer SA/NV Antwerpseweg 15-17 2340 Beerse Belgium

Perdophen Ibuprofen lysine 684 mg Coated tablet Oral use

Luxembourg Dolorgiet GmbH & Co. KG Otto-von-Guericke-Str. 1 53757 Sankt Augustin Germany

Schmerz-Dolgit Ibuprofen 400 mg Capsule, soft Oral use

Luxembourg Zambon SA/NV E.Demunterlaan 1/9 1090 Brussels Belgium

Spidifen Ibuprofen 200 mg Granules for oral solution

Oral use

Luxembourg Zambon SA/NV E.Demunterlaan 1/9 1090 Brussels Belgium

Spidifen Ibuprofen 200 mg Tablet Oral use

Luxembourg Zambon SA/NV E.Demunterlaan 1/9 1090 Brussels Belgium

Spidifen Ibuprofen 200 mg Effervescent tablet Oral use

Luxembourg Zambon SA/NV E.Demunterlaan 1/9 1090 Brussels Belgium

Spidifen Ibuprofen 400 mg Film-coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 187/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Malta Galpharm Healthcare Limited Hugh House Upper Cliffe Road Barnsley, South Yorkshire S75 3SP Dodworth Dodworth Bussiness Park United Kingdom

Junior Ibuprofen Suspension

Ibuprofen 20 mg/ml Oral suspension Oral use

Malta Mepha Lda. Lagoas Park, 2740-298 Porto Salvo Portugal

Irfen-200 Quiktabs Ibuprofen 200 mg Film-coated tablet Oral use

Malta Crookes Healthcare Limited Nottingham site, Thane Road, Nottingham, NG90 2DB United Kingdom

Nurofen 200mg Ibuprofen 200 mg Coated tablet Oral use

Malta Reckitt Benckiser Healthcare International Ltd. Thane Road Nottingham NG90 2DB United Kingdom

Nurofen Express Capsules, Soft 200mg

Ibuprofen 200 mg Capsule, soft Oral use

Malta Fair-Med Healthcare GmbH Planckstr. 13 22765 Hamburg Germany

Ibuprofen FAIR-MED 200 mg film-coated tablet

Ibuprofen 200 mg Film-coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 188/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Malta A. C. R. A. F. SpA (Aziende Chimiche Riunite Angelini Francesco) Viale Amelia 70, Rome 00181, Italy

Moment 200 Ibuprofen 200 mg Coated tablet Oral use

Malta Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland

Ibuprofen Actavis 200mg Film-Coated Tablets

Ibuprofen 200 mg Coated tablet Oral use

Malta Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland

Ibufen Coated Tablets 200mg

Ibuprofen 200 mg Coated tablet Oral use

Malta A. C. R. A. F. SpA (Aziende Chimiche Riunite Angelini Francesco) Viale Amelia 70, Rome 00181, Italy

Moment 200 Ibuprofen 200 mg/ml Oral drops, solution Oral use

Malta Fair-Med Healthcare GmbH Planckstr. 13 22765 Hamburg Germany

Ibuprofen FAIR-MED 400 mg film-coated tablet

Ibuprofen 400 mg Film-coated tablet Oral use

Malta Goldshield Pharmaceuticals Ltd NLA Tower 12-16 Addiscombe Road Croydon Surrey CR0 OXT United Kingdom

Fenbid Spansule Capsules

Ibuprofen 300 mg Modified-release capsule

Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 189/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Malta Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland

Ibuprofen Actavis 400mg Film-Coated Tablets

Ibuprofen 400 mg Coated tablet Oral use

Malta Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland

Ibufen Coated Tablets 400mg

Ibuprofen 400 mg Coated tablet Oral use

Malta Dolorgiet GmbH & Co. KG Otto-von-Guericke-Str. 1 53757 Sankt Augustin Germany

Dolgit 600 Ibuprofen 600 mg Coated tablet Oral use

Malta Fair-Med Healthcare GmbH Planckstr. 13 22765 Hamburg Germany

Ibuprofen FAIR-MED 600 mg film-coated tablet

Ibuprofen 600 mg Film-coated tablet Oral use

Malta Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland

Ibuprofen Actavis 600mg Film-Coated Tablets

Ibuprofen 600 mg Coated tablet Oral use

Malta Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland

Ibuprofen Actavis 800mg Film-Coated Tablets

Ibuprofen 800 mg Coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 190/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Malta Omega Pharma, 1st Floor Vauxhall Bridge Road 32 London SW1V 2SA United Kingdom

Solpadeine Migraine Ibuprofen & Codeine Tablets

Ibuprofen codeine phosphate hemihydrate

200 mg Film-coated tablet Oral use

Malta Crookes Healthcare Ltd., Thane Road West 1 Nottingham NG2 3AA United Kingdom

Nurofen Plus Ibuprofen codeine phosphate hemihydrate

200 mg Tablet Oral use

Malta Pfizer Healthcare Ireland 9 Riverwalk National Digital Park Citywest Business Campus Dublin 24 Ireland

Advil Cold & Flu Coated Tablets

Ibuprofen pseudoephedrine hydrochloride

200 mg Coated tablet Oral use

Malta Reckitt Benckiser Healthcare (UK) Ltd. Dansom Lane Hull HU8 7DS United Kingdom

Lemsip Flu 12Hr Ibuprofen + Pseudoephedrine

Ibuprofen pseudoephedrine hydrochloride

300 mg Modified-release capsule

Oral use

Malta Dr. Max Pharma Ltd. First Floor Roxburge House, Regent Street 273-287 W1B 2HA London United Kingdom

Ibuprofen Dr. Max 200mg

Ibuprofen 200 mg Film-coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 191/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Malta Dr. Max Pharma Ltd. First Floor Roxburge House, Regent Street 273-287 W1B 2HA London United Kingdom

Ibuprofen Dr. Max 400mg

Ibuprofen 400 mg Film-coated tablet Oral use

Norway Nordic Drugs AB Box 30035 200 61 limhamn Sweden

Seractiv Dexibuprofen 300 mg Film-coated tablet Oral use

Norway Nordic Drugs AB Box 30035 200 61 limhamn Sweden

Seractiv Dexibuprofen 400 mg Film-coated tablet Oral use

Norway Abbott Scandinavia AB P.O Box 1498 SE-171 29 Solna Sweden

Brufen Retard Ibuprofen 800 mg Prolonged-release tablet

Oral use

Norway Orion Corporation P.O. Box 65, FI-02101 Espoo, Finland

Burana Ibuprofen 600 mg Film-coated tablet Oral use

Norway Orion Corporation P.O. Box 65, FI-02101 Espoo, Finland

Burana Ibuprofen 800 mg Film-coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 192/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Norway Orion Corporation P.O. Box 65, FI-02101 Espoo, Finland

Burana Ibuprofen 200 mg Film-coated tablet Oral use

Norway Orion Corporation P.O. Box 65, FI-02101 Espoo, Finland

Burana Ibuprofen 400 mg Film-coated tablet Oral use

Norway Infirst Healthcare Ltd. Strand 265 London WC2R 1BH United Kingdom

Flarin Ibuprofen 400 mg Capsule, soft Oral use

Norway Infirst Healthcare Ltd. Strand 265 London WC2R 1BH United Kingdom

Flarin Ibuprofen 200 mg Capsule, soft Oral use

Norway Vitabalans Oy Varastokatu 8 13500 Hämeenlinna Finland

Ibumax Ibuprofen 400 mg Film-coated tablet Oral use

Norway Vitabalans Oy Varastokatu 8 13500 Hämeenlinna Finland

Ibumax Ibuprofen 200 mg Film-coated tablet Oral use

Norway Vitabalans Oy Varastokatu 8 13500 Hämeenlinna Finland

Ibumax Ibuprofen 600 mg Film-coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 193/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Norway Takeda Nycomed AS, P.O. Box 205, NO-1372 Asker Norway

Ibumetin Ibuprofen 600 mg Tablet Oral use

Norway Takeda Nycomed AS, P.O. Box 205, NO-1372 Asker Norway

Ibumetin Ibuprofen 400 mg Tablet Oral use

Norway Takeda Nycomed AS, P.O. Box 205, NO-1372 Asker Norway

Ibumetin Ibuprofen 200 mg Tablet Oral use

Norway Takeda Nycomed AS, P.O. Box 205, NO-1372 Asker Norway

Ibumetin Ibuprofen 20 mg/ml Oral suspension Oral use

Norway Farmalider S.A. C/ Aragoneses, 15 Alcobendas (Madrid), 28108 Spain

Ibuprofen Farmalider Ibuprofen 40 mg/ml Oral suspension Oral use

Norway Farmalider S.A. C/ Aragoneses, 15 Alcobendas (Madrid), 28108 Spain

Ibuprofen Farmalider Ibuprofen 20 mg/ml Oral suspension Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 194/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Norway Galpharm Healthcare Limited Hugh House Upper Cliffe Road Barnsley, South Yorkshire S75 3SP Dodworth Dodworth Bussiness Park United Kingdom

Ibuprofen Orion Ibuprofen 400 mg Film-coated tablet Oral use

Norway Galpharm Healthcare Limited Hugh House Upper Cliffe Road Barnsley, South Yorkshire S75 3SP Dodworth Dodworth Bussiness Park United Kingdom

Ibuprofen Orion Ibuprofen 200 mg Film-coated tablet Oral use

Norway ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany

Ibuprofen ratiopharm Ibuprofen 400 mg Film-coated tablet Oral use

Norway ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany

Ibuprofen ratiopharm Ibuprofen 200 mg Film-coated tablet Oral use

Norway ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany

Ibuprofen ratiopharm Ibuprofen 600 mg Film-coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 195/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Norway ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany

Ibuprox Ibuprofen 400 mg Film-coated tablet Oral use

Norway ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany

Ibuprox Ibuprofen 200 mg Film-coated tablet Oral use

Norway Weifa AS, P.O.Box 6733 Etterstad NO-0609 Oslo Norway

Ibux Ibuprofen 600 mg Suppository Rectal use

Norway Weifa AS, P.O.Box 6733 Etterstad NO-0609 Oslo Norway

Ibux Ibuprofen 600 mg Film-coated tablet Oral use

Norway Weifa AS, P.O.Box 6733 Etterstad NO-0609 Oslo Norway

Ibux Ibuprofen 400 mg Film-coated tablet Oral use

Norway Weifa AS, P.O.Box 6733 Etterstad NO-0609 Oslo Norway

Ibux Ibuprofen 200 mg Film-coated tablet Oral use

Norway Weifa AS, P.O.Box 6733 Etterstad NO-0609 Oslo Norway

Ibux Ibuprofen 200 mg Capsule, soft Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 196/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Norway Weifa AS, P.O.Box 6733 Etterstad NO-0609 Oslo Norway

Ibux Ibuprofen 400 mg Capsule, soft Oral use

Norway Weifa AS, P.O.Box 6733 Etterstad NO-0609 Oslo Norway

Ibux Ibuprofen 20 mg/ml Oral suspension Oral use

Norway Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland

Ifenin Ibuprofen 400 mg Film-coated tablet Oral use

Norway Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland

Ifenin Ibuprofen 200 mg Film-coated tablet Oral use

Poland 123ratio Sp. z o.o. 53 Emilii Plater st. 00-113 Warsaw, Poland

Irfen Ibuprofen 200 mg Film-coated tablet Oral use

Poland 123ratio Sp. z o.o. 53 Emilii Plater st. 00-113 Warsaw, Poland

Irfen Ibuprofen 400 mg Film-coated tablet Oral use

Poland Abbott Laboratories Poland Sp. z o.o. Postepu st. 21B 02-676 Warsaw Poland

Brufen Ibuprofen 400 mg Effervescent granules Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 197/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Poland Abbott Laboratories Poland Sp. z o.o. Postepu st. 21B 02-676 Warsaw Poland

Brufen Ibuprofen 200 mg Film-coated tablet Oral use

Poland Abbott Laboratories Poland Sp. z o.o. Postepu st. 21B 02-676 Warsaw Poland

Brufen Ibuprofen 400 mg Film-coated tablet Oral use

Poland Abbott Laboratories Poland Sp. z o.o. Postepu st. 21B 02-676 Warsaw Poland

Brufen Ibuprofen 20 mg/ml Oral suspension Oral use

Poland Abbott Laboratories Poland Sp. z o.o. Postepu st. 21B 02-676 Warsaw Poland

Brufen Forte Ibuprofen 40 mg/ml Oral suspension Oral use

Poland Abbott Laboratories Poland Sp. z o.o. Postepu st. 21B 02-676 Warsaw Poland

Ibuprofen Rockspring Ibuprofen 200 mg Effervescent granules Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 198/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Poland Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland

Ifenin Ibuprofen 200 mg Film-coated tablet Oral use

Poland Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland

Ifenin Forte Ibuprofen 400 mg Film-coated tablet Oral use

Poland Aflofarm Farmacja Polska Sp. z o.o. Partyzancka st. 133/151 95-200 Pabianice, Poand

Ibuprofen AFL Ibuprofen 200 mg Coated tablet Oral use

Poland Aflofarm Farmacja Polska Sp. z o.o. Partyzancka st. 133/151 95-200 Pabianice, Poand

Ibuprofen Aflofarm Ibuprofen 400 mg Coated tablet Oral use

Poland Aflofarm Farmacja Polska Sp. z o.o. Partyzancka st. 133/151 95-200 Pabianice, Poand

Ibuprofen Aflofarm Ibuprofen 200 mg Coated tablet Oral use

Poland Aflofarm Farmacja Polska Sp. z o.o. Partyzancka st. 133/151 95-200 Pabianice, Poand

Kidofen Duo Ibuprofen paracetamol

(100 mg + 125 mg)/5 ml

Oral suspension Oral use

Poland APC Instytut Sp. z o.o. Grójecka st. 22/24 lok. 4 02-301 Warsaw Poland

Galprofen Ibuprofen 200 mg Coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 199/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Poland APC Instytut Sp. z o.o. Grójecka st. 22/24 lok. 4 02-301 Warsaw Poland

Galprofen Max Ibuprofen 400 mg Coated tablet Oral use

Poland APC Instytut Sp. z o.o. Grójecka st. 22/24 lok. 4 02-301 Warsaw Poland

Ibuprofen APC Ibuprofen 200 mg Coated tablet Oral use

Poland APC Instytut Sp. z o.o. Grójecka st. 22/24 lok. 4 02-301 Warsaw Poland

Ibuprofen APC Max Ibuprofen 400 mg Coated tablet Oral use

Poland APC Instytut Sp. z o.o. Grójecka st. 22/24 lok. 4 02-301 Warsaw Poland

Tesprofen Ibuprofen 200 mg Coated tablet Oral use

Poland Banner Pharmacaps Europe B.V. De Posthoornstraat 7 5048 AS Tilburg The Netherlands

Ibuprofen Banner Ibuprofen 400 mg Capsule, soft Oral use

Poland Berlin-Chemie AG Glienicker Weg 125 12489 Berlin Germany

MIG Ibuprofen 400 mg Film-coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 200/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Poland Berlin-Chemie AG Glienicker Weg 125 12489 Berlin Germany

MIG dla dzieci Forte o smaku truskawkowym

Ibuprofen 40 mg/ml Oral suspension Oral use

Poland Biofarm Sp. z o.o. Wałbrzyska st. 13 60-198 Poznan Poland

Seractil Dexibuprofen 200 mg Film-coated tablet Oral use

Poland Biofarm Sp. z o.o. Wałbrzyska st. 13 60-198 Poznan Poland

Seractil Dexibuprofen 400 mg Film-coated tablet Oral use

Poland Bio-Profil Polska Sp. z o.o. 135 Trakt Lubelsi st. 04-790 Warsaw Poalnd

Rinafen Zatoki Ibuprofen pseudoephedrine hydrochloride

200 mg 30 mg

Tablet Oral use

Poland Boehringer Ingelheim International GmbH Binger Straße 173 55216 Ingelheim am Rhein Germany

Buscofem Ibuprofen 400 mg Capsule, soft Oral use

Poland Fair-Med Healthcare GmbH Planckstr. 13 22765 Hamburg Germany

Ibuprofen Fair-Med Ibuprofen 200 mg Film-coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 201/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Poland Fair-Med Healthcare GmbH Planckstr. 13 22765 Hamburg Germany

Ibuprofen Fair-Med Ibuprofen 400 mg Film-coated tablet Oral use

Poland Fair-Med Healthcare GmbH Planckstr. 13 22765 Hamburg Germany

Ibuprofen Fair-Med Ibuprofen 600 mg Film-coated tablet Oral use

Poland Farmalider S.A. C/ Aragoneses, 15 Alcobendas (Madrid), 28108 Spain

Ibuprofen Farmalider Ibuprofen 20 mg/ml Oral suspension Oral use

Poland Farmalider S.A. C/ Aragoneses, 15 Alcobendas (Madrid), 28108 Spain

Ibuprofen Liderfarm Ibuprofen 20 mg/ml Oral suspension Oral use

Poland Galpharm Healthcare Limited Hugh House Upper Cliffe Road Barnsley, South Yorkshire S75 3SP Dodworth Dodworth Bussiness Park United Kingdom

Ibuprofen Galpharm Ibuprofen 200 mg Film-coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 202/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Poland Galpharm Healthcare Limited Hugh House Upper Cliffe Road Barnsley, South Yorkshire S75 3SP Dodworth Dodworth Bussiness Park United Kingdom

Ibuprofen Galpharm Ibuprofen 400 mg Film-coated tablet Oral use

Poland Laboratorium Galenowe Olsztyn Sp. z o.o. Spóldzielcza st. 25A 11-001 Dywity Poland

Ibuprofen LGO Ibuprofen 400 mg Film-coated tablet Oral use

Poland Laboratorium Galenowe Olsztyn Sp. z o.o. Spóldzielcza st. 25A 11-001 Dywity Poland

Ibuprofen LGO Ibuprofen 200 mg Film-coated tablet Oral use

Poland Orion Corporation Orionintie 1 FIN-02200 Espoo Finland

Iburion Ibuprofen 800 mg Film-coated tablet Oral use

Poland Orion Corporation Orionintie 1 FIN-02200 Espoo Finland

Iburion Ibuprofen 200 mg Film-coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 203/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Poland Orion Corporation Orionintie 1 FIN-02200 Espoo Finland

Iburion Ibuprofen 400 mg Film-coated tablet Oral use

Poland Orion Corporation Orionintie 1 FIN-02200 Espoo Finland

Iburion Ibuprofen 600 mg Film-coated tablet Oral use

Poland Pabianickie Zakłady Farmaceutyczne Polfa S.A. Marszalka Pilsudskiego st. 5 95-200 Pabianice Poland

Ibupar Ibuprofen 200 mg Coated tablet Oral use

Poland Pabianickie Zakłady Farmaceutyczne Polfa S.A. Marszalka Pilsudskiego st. 5 95-200 Pabianice Poland

Ibupar forte Ibuprofen 400 mg Film-coated tablet Oral use

Poland Pabianickie Zakłady Farmaceutyczne Polfa S.A. Marszalka Pilsudskiego st. 5 95-200 Pabianice Poland

Ibuprofen-Pabi Ibuprofen 200 mg Coated tablet Oral use

Poland Polfarmex S.A. 9 Józefów st, 99-300 Kutno, Poland

Aprofen Ibuprofen 200 mg Film-coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 204/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Poland Polfarmex S.A. 9 Józefów st, 99-300 Kutno, Poland

Ibuprofen Polfarmex Ibuprofen 200 mg Film-coated tablet Oral use

Poland Przedsiębiorstwo Produkcji Farmaceutycznej HASCO-LEK S.A. 242E Żmigroddzka st,. 51-131 Wroclaw, Poland

Ibum Ibuprofen 200 mg Capsule, soft Oral use

Poland Przedsiębiorstwo Produkcji Farmaceutycznej HASCO-LEK S.A. 242E Żmigroddzka st,. 51-131 Wroclaw, Poland

Ibum Ibuprofen 20 mg/ml Oral suspension Oral use

Poland Przedsiębiorstwo Produkcji Farmaceutycznej HASCO-LEK S.A. 242E Żmigroddzka st,. 51-131 Wroclaw, Poland

Ibum Ibuprofen 20 mg/ml Oral suspension Oral use

Poland Przedsiębiorstwo Produkcji Farmaceutycznej HASCO-LEK S.A. 242E Żmigroddzka st,. 51-131 Wroclaw, Poland

Ibum Forte Ibuprofen 400 mg Capsule, soft Oral use

Poland Przedsiębiorstwo Produkcji Farmaceutycznej HASCO-LEK S.A. 242E Żmigroddzka st,. 51-131 Wroclaw, Poland

Ibum Forte Minicaps Ibuprofen 400 mg Capsule, soft Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 205/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Poland Przedsiębiorstwo Produkcji Farmaceutycznej HASCO-LEK S.A. 242E Żmigroddzka st,. 51-131 Wroclaw, Poland

Ibum Grip Ibuprofen pseudoephedrine hydrochloride

200 mg 30 mg

Film-coated tablet Oral use

Poland Przedsiębiorstwo Produkcji Farmaceutycznej HASCO-LEK S.A. 242E Żmigroddzka st,. 51-131 Wroclaw, Poland

Ibum Zatoki Ibuprofen pseudoephedrine hydrochloride

200 mg 30 mg

Film-coated tablet Oral use

Poland Przedsiębiorstwo Produkcji Farmaceutycznej HASCO-LEK S.A. 242E Żmigroddzka st,. 51-131 Wroclaw, Poland

Ibuprofen Hasco Ibuprofen 200 mg Capsule, soft Oral use

Poland ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany

Bufenik Ibuprofen 40 mg/ml Syrup Oral use

Poland Reckitt Benckiser (Poland) S.A. ul. Okunin 1 05-100 Nowy Dwor Mazowiecki Poland

Nurofen Ibuprofen 200 mg Film-coated tablet Oral use

Poland Reckitt Benckiser (Poland) S.A. ul. Okunin 1 05-100 Nowy Dwor Mazowiecki Poland

Nurofen Caps Ibuprofen 400 mg Capsule, soft Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 206/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Poland Reckitt Benckiser (Poland) S.A. ul. Okunin 1 05-100 Nowy Dwor Mazowiecki Poland

Nurofen dla dzieci Forte

Ibuprofen 40 mg/ml Oral suspension Oral use

Poland Reckitt Benckiser (Poland) S.A. ul. Okunin 1 05-100 Nowy Dwor Mazowiecki Poland

Nurofen dla dzieci o smaku truskawkowym

Ibuprofen 20 mg/ml Oral suspension Oral use

Poland Reckitt Benckiser (Poland) S.A. ul. Okunin 1 05-100 Nowy Dwor Mazowiecki Poland

Nurofen Express Ibuprofen 200 mg Film-coated tablet Oral use

Poland Reckitt Benckiser (Poland) S.A. ul. Okunin 1 05-100 Nowy Dwor Mazowiecki Poland

Nurofen Express Femina

Ibuprofen 200 mg Capsule, soft Oral use

Poland Reckitt Benckiser (Poland) S.A. ul. Okunin 1 05-100 Nowy Dwor Mazowiecki Poland

Nurofen Express Forte rozpuszczalny

Ibuprofen 400 mg Oral powder Oral use

Poland Reckitt Benckiser (Poland) S.A. ul. Okunin 1 05-100 Nowy Dwor Mazowiecki Poland

Nurofen Express TAB 200 mg

Ibuprofen 200 mg Film-coated tablet Oral use

Poland Reckitt Benckiser (Poland) S.A. ul. Okunin 1 05-100 Nowy Dwor Mazowiecki Poland

Nurofen Express TAB 400 mg

Ibuprofen 400 mg Film-coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 207/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Poland Reckitt Benckiser (Poland) S.A. ul. Okunin 1 05-100 Nowy Dwor Mazowiecki Poland

Nurofen Forte Ibuprofen 400 mg Film-coated tablet Oral use

Poland Reckitt Benckiser (Poland) S.A. ul. Okunin 1 05-100 Nowy Dwor Mazowiecki Poland

Nurofen Forte Caps Ibuprofen 400 mg Capsule, soft Oral use

Poland Reckitt Benckiser (Poland) S.A. ul. Okunin 1 05-100 Nowy Dwor Mazowiecki Poland

Nurofen Forte Express

Ibuprofen 400 mg Film-coated tablet Oral use

Poland Reckitt Benckiser (Poland) S.A. ul. Okunin 1 05-100 Nowy Dwor Mazowiecki Poland

Nurofen na ból pleców

Ibuprofen 300 mg Prolonged-realease capsule

Oral use

Poland Reckitt Benckiser (Poland) S.A. ul. Okunin 1 05-100 Nowy Dwor Mazowiecki Poland

Nurofen Plus Ibuprofen codeine phosphate

200 mg 12,8 mg

Film-coated tablet Oral use

Poland Reckitt Benckiser (Poland) S.A. ul. Okunin 1 05-100 Nowy Dwor Mazowiecki Poland

Nurofen Ultra Forte do rozpuszczania

Ibuprofen 400 mg Oral powder Oral use

Poland Reckitt Benckiser (Poland) S.A. ul. Okunin 1 05-100 Nowy Dwor Mazowiecki Poland

Nurofen Ultrafast Ibuprofen 200 mg Capsule, soft Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 208/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Poland Reckitt Benckiser (Poland) S.A. ul. Okunin 1 05-100 Nowy Dwor Mazowiecki Poland

Nurofen Zatoki Ibuprofen pseudoephedrine hydrochloride

200 mg 30 mg

Film-coated tablet Oral use

Poland Reckitt Benckiser (Poland) S.A. ul. Okunin 1 05-100 Nowy Dwor Mazowiecki Poland

Nurofen Ultima Ibuprofen paracetamol

200 mg 500 mg

Film-coated tablet Oral use

Poland Rockspring Healthcare Limited 38/40 Chamberlayne Road London NW10 3JE United Kingdom

Ibuprofen + Codeine phosphate hemihydrate Rockspring

Ibuprofen codeine phosphate hemihydrate

400 mg 30 mg

Film-coated tablet Oral use

Poland US Pharmacia Sp. z o.o. Ziebicka st. 40 50-507 Wroclaw Poalnd

Acatar Zatoki Ibuprofen pseudoephedrine hydrochloride

200 mg 30 mg

Film-coated tablet Oral use

Poland US Pharmacia Sp. z o.o. Ziebicka st. 40 50-507 Wroclaw Poalnd

Acatar Zatoki Tabs Ibuprofen pseudoephedrine hydrochloride

200 mg 6,1 mg

Coated tablet Oral use

Poland US Pharmacia Sp. z o.o. Ziebicka st. 40 50-507 Wroclaw Poalnd

Ibuprom Ibuprofen 200 mg Film-coated tablet Oral use

Poland US Pharmacia Sp. z o.o. Ziebicka st. 40 50-507 Wroclaw Poalnd

Ibuprom DUO Ibuprofen 400 mg Film-coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 209/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Poland US Pharmacia Sp. z o.o. Ziebicka st. 40 50-507 Wroclaw Poalnd

Ibuprom Max Ibuprofen 400 mg Coated tablet Oral use

Poland US Pharmacia Sp. z o.o. Ziebicka st. 40 50-507 Wroclaw Poalnd

Ibuprom Max Sprint Ibuprofen 400 mg Capsule, soft Oral use

Poland US Pharmacia Sp. z o.o. Ziebicka st. 40 50-507 Wroclaw Poalnd

Ibuprom Sprint Caps Ibuprofen 200 mg Capsule, soft Oral use

Poland US Pharmacia Sp. z o.o. Ziebicka st. 40 50-507 Wroclaw Poalnd

Ibuprom Zatoki Ibuprofen pseudoephedrine hydrochloride

200 mg 30 mg

Film-coated tablet Oral use

Poland US Pharmacia Sp. z o.o. Ziebicka st. 40 50-507 Wroclaw Poalnd

Ibuprom Zatoki Tabs Ibuprofen phenylephrine hydrochloride

200 mg 6,1 mg

Coated tablet Oral use

Poland Vitabalans Oy Varastokatu 8 13500 Hämeenlinna Finland

Ibumax 200 mg Ibuprofen 200 mg Film-coated tablet Oral use

Poland Vitabalans Oy Varastokatu 8 13500 Hämeenlinna Finland

Ibumax 400 mg Ibuprofen 400 mg Film-coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 210/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Poland Vitabalans Oy Varastokatu 8 13500 Hämeenlinna Finland

Ibumax Forte 600 mg Ibuprofen 600 mg Film-coated tablet Oral use

Poland Wrafton Laboratories Limited Exeter Road Wrafton, Braunton Devon EX33 2DL United Kingdom

Ibuprofen Lysine Perrigo

Ibuprofen 400 mg Film-coated tablet Oral use

Poland Wrafton Laboratories Limited Exeter Road Wrafton, Braunton Devon EX33 2DL United Kingdom

Ibuprofen Lysine Perrigo

Ibuprofen 200 mg Film-coated tablet Oral use

Poland Zakłady Farmaceutyczne POLPHARMA S.A. Pelpinska St. 19 83-200 Starogard Gdanski Poland

Ibufen dla dzieci FORTE o smaku truskawkowym

Ibuprofen 40 mg/ml Oral suspension Oral use

Poland Zakłady Farmaceutyczne POLPHARMA S.A. Pelpinska St. 19 83-200 Starogard Gdanski Poland

Ibufen Junior Ibuprofen 200 mg Capsule, soft Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 211/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Poland Zakłady Farmaceutyczne POLPHARMA S.A. Pelpinska St. 19 83-200 Starogard Gdanski Poland

Metafen Ibuprofen paracetamol

200 mg 325 mg

Tablet Oral use

Poland Zakłady Farmaceutyczne POLPHARMA S.A. Pelpinska St. 19 83-200 Starogard Gdanski Poland

Metafen Zatoki Ibuprofen pseudoephedrine hydrochloride

200 mg 30 mg

Tablet Oral use

Poland Zambon S.p.A. Via Lillo del Duca 10 20091, Bresso (Mi) Italy

Spedifen 400 Ibuprofen 400 mg Film-coated tablet Oral use

Poland Zentiva, k.s. U kabelovny 130 102 37 Praha 10 Dolní Měcholupy Czech Republic

Ibalgin Ibuprofen 200 mg Film-coated tablet Oral use

Poland Zentiva, k.s. U kabelovny 130 102 37 Praha 10 Dolní Měcholupy Czech Republic

Ibalgin Fast Ibuprofen 400 mg Film-coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 212/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Poland Zentiva, k.s. U kabelovny 130 102 37 Praha 10 Dolní Měcholupy Czech Republic

Ibalgin Maxi Ibuprofen 400 mg Film-coated tablet Oral use

Poland Zentiva, k.s. U kabelovny 130 102 37 Praha 10 Dolní Měcholupy Czech Republic

Modafen Ibuprofen pseudoephedrine hydrochloride

200 mg 30 mg

Film-coated tablet Oral use

Poland Zentiva, k.s. U kabelovny 130 102 37 Praha 10 Dolní Měcholupy Czech Republic

Modafen Grip Ibuprofen phenylephrine hydrochloride

200 mg 5 mg

Film-coated tablet Oral use

Portugal Abbott Laboratórios, Lda. Estrada de Alfragide, 67 - Alfrapark - Edificio D 2610-008 Amadora Portugal

Brufen Ibuprofen 200 mg Effervescent granules Oral use

Portugal Abbott Laboratórios, Lda. Estrada de Alfragide, 67 - Alfrapark - Edificio D 2610-008 Amadora Portugal

Brufen Ibuprofen 200 mg Film-coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 213/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Portugal Abbott Laboratórios, Lda. Estrada de Alfragide, 67 - Alfrapark - Edificio D 2610-008 Amadora Portugal

Brufen Ibuprofen 600 mg Effervescent granules Oral use

Portugal Abbott Laboratórios, Lda. Estrada de Alfragide, 67 - Alfrapark - Edificio D 2610-008 Amadora Portugal

Brufen Ibuprofen 400 mg Effervescent granules Oral use

Portugal Abbott Laboratórios, Lda. Estrada de Alfragide, 67 - Alfrapark - Edificio D 2610-008 Amadora Portugal

Brufen Ibuprofen 600 mg Film-coated tablet Oral use

Portugal Abbott Laboratórios, Lda. Estrada de Alfragide, 67 - Alfrapark - Edificio D 2610-008 Amadora Portugal

Brufen Ibuprofen 400 mg Film-coated tablet Oral use

Portugal Abbott Laboratórios, Lda. Estrada de Alfragide, 67 - Alfrapark - Edificio D 2610-008 Amadora Portugal

Brufen Retard Ibuprofen 800 mg Prolonged-release tablet

Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 214/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Portugal Abbott Laboratórios, Lda. Estrada de Alfragide, 67 - Alfrapark - Edificio D 2610-008 Amadora Portugal

Brufen Sem Açúcar Ibuprofen 40 mg/ml Oral suspension Oral use

Portugal Abbott Laboratórios, Lda. Estrada de Alfragide, 67 - Alfrapark - Edificio D 2610-008 Amadora Portugal

Brufen Suspensão Ibuprofen 20 mg/ml Oral suspension Oral use

Portugal Boehringer Ingelheim, Lda. Avenida de Pádua, 11 1800-294 Lisboa Portugal

Buskofem Ibuprofen 200 mg Capsule, soft Oral use

Portugal Boehringer Ingelheim International GmbH Binger Straße 173 55216 Ingelheim am Rhein Germany

Buskofem Ibuprofen 400 mg Capsule, soft Oral use

Portugal Laboratórios Basi - Indústria Farmacêutica, S.A Parque Industrial Manuel Lourenço Ferreira, Lote 15 3450-232 Mortágua Portugal

Dimidon Ibuprofen 400 mg Film-coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 215/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Portugal Novartis Consumer Health - Produtos Farmacêuticos e Nutrição, Lda. Avenida Professor Doutor Cavaco Silva, 10 E, Taguspark 2740-255 Porto Salvo Portugal

Dolocyl Ibuprofen 200 mg Coated tablet Oral use

Portugal Jaba Recordati, S. A. Lagoas Park, Edificio 5, Torre C, Piso 3 2740-298 Porto Salvo Portugal

Dolomate 200 Ibuprofen 200 mg Powder for oral suspension

Oral use

Portugal Zambon - Produtos Farmacêuticos, Lda. Rua Comandante Enrique Maya, 1 1500-192 Lisboa Portugal

Faspic 200 Ibuprofen 200 mg Granules for oral solution

Oral use

Portugal Zambon - Produtos Farmacêuticos, Lda. Rua Comandante Enrique Maya, 1 1500-192 Lisboa Portugal

Faspic 400 Ibuprofen 400 mg Granules for oral solution

Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 216/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Portugal Zambon - Produtos Farmacêuticos, Lda. Rua Comandante Enrique Maya, 1 1500-192 Lisboa Portugal

Faspic 600 Ibuprofen 600 mg Granules for oral solution

Oral use

Portugal Zambon - Produtos Farmacêuticos, Lda. Rua Comandante Enrique Maya, 1 1500-192 Lisboa Portugal

Fenpic Ibuprofen 400 mg Film-coated tablet Oral use

Portugal Confar - Consórcio Farmacêutico, Lda. Rua Félix Correia, 1-B 1500-271 Lisboa Portugal

Frenidor Ibuprofen 200 mg Coated tablet Oral use

Portugal Confar - Consórcio Farmacêutico, Lda. Rua Félix Correia, 1-B 1500-271 Lisboa Portugal

Frenidor Ibuprofen 200 mg Granules Oral use

Portugal Bene Farmacêutica, Lda. Avenida D. João II, Lote 1.06.2.2.C - 1º B 1990-095 Lisboa Portugal

Ib-u-ron Ibuprofen 600 mg Film-coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 217/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Portugal Bene Farmacêutica, Lda. Avenida D. João II, Lote 1.06.2.2.C - 1º B 1990-095 Lisboa Portugal

Ib-u-ron Ibuprofen 40 mg/ml Oral suspension Oral use

Portugal Bene Farmacêutica, Lda. Avenida D. João II, Lote 1.06.2.2.C - 1º B 1990-095 Lisboa Portugal

Ib-u-ron Ibuprofen 400 mg Film-coated tablet Oral use

Portugal Premier - Promoção de Produtos Farmacêutcos, Lda. Estrada de Alfragide, 67 - Alfrapark, Edificio D 2610-008 Amadora Portugal

Ibuprofeno Abbott Ibuprofen 600 mg Film-coated tablet Oral use

Portugal Premier - Promoção de Produtos Farmacêutcos, Lda. Estrada de Alfragide, 67 - Alfrapark, Edificio D 2610-008 Amadora Portugal

Ibuprofeno Abbott Ibuprofen 400 mg Film-coated tablet Oral use

Portugal Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland

Ibuprofeno Actavis Ibuprofen 800 mg Film-coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 218/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Portugal Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland

Ibuprofeno Actavis Ibuprofen 400 mg Film-coated tablet Oral use

Portugal Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland

Ibuprofeno Actavis Ibuprofen 200 mg Film-coated tablet Oral use

Portugal Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland

Ibuprofeno Actavis Ibuprofen 600 mg Film-coated tablet Oral use

Portugal Alter, S.A. Estrada Marco do Grilo - Zemouto 2830 Coina Portugal

Ibuprofeno Alter 400 mg Comprimidos revestidos

Ibuprofen 400 mg Film-coated tablet Oral use

Portugal Alter, S.A. Estrada Marco do Grilo - Zemouto 2830 Coina Portugal

Ibuprofeno Alter 600 mg Comprimidos Revestidos

Ibuprofen 600 mg Film-coated tablet Oral use

Portugal Laboratórios Azevedos - Indústria Farmacêutica, S.A. Edifícios Azevedos - Estrada Nacional 117-2, Alfragide 2614-504 Amadora Portugal

Ibuprofeno Azevedos 400 mg Comprimidos

Ibuprofen 400 mg Film-coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 219/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Portugal Laboratórios Azevedos - Indústria Farmacêutica, S.A. Edifícios Azevedos - Estrada Nacional 117-2, Alfragide 2614-504 Amadora Portugal

Ibuprofeno Azevedos 600 mg Comprimidos

Ibuprofen 600 mg Film-coated tablet Oral use

Portugal Ciclum Farma Unipessoal, Lda. Quinta da Fonte, Rua Vitor Câmara, 2 - Edifício D. Amélia, Piso 1, Ala B 2770-229 Paço de Arcos Portugal

Ibuprofeno Ciclum Ibuprofen 600 mg Film-coated tablet Oral use

Portugal Ciclum Farma Unipessoal, Lda. Quinta da Fonte, Rua Vitor Câmara, 2 - Edifício D. Amélia, Piso 1, Ala B 2770-229 Paço de Arcos Portugal

Ibuprofeno Ciclum Ibuprofen 400 mg Film-coated tablet Oral use

Portugal Cinfa Portugal, Lda. Av. Tomás Ribeiro, 43 - Bloco 2, 3º F - Edifício Neopark 2790-221 Carnaxide Portugal

Ibuprofeno Cinfa Ibuprofen 400 mg Film-coated tablet Oral use

Portugal Cinfa Portugal, Lda. Av. Tomás Ribeiro, 43 - Bloco 2, 3º F - Edifício Neopark 2790-221 Carnaxide Portugal

Ibuprofeno Cinfa Ibuprofen 600 mg Film-coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 220/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Portugal Farmalider S.A. C/ Aragoneses, 15 Alcobendas (Madrid), 28108 Spain

Ibuprofeno Codramol Ibuprofen 200 mg Granules for oral solution

Oral use

Portugal Farmalider S.A. C/ Aragoneses, 15 Alcobendas (Madrid), 28108 Spain

Ibuprofeno Codramol Ibuprofen 400 mg Film-coated tablet Oral use

Portugal Farmalider S.A. C/ Aragoneses, 15 Alcobendas (Madrid), 28108 Spain

Ibuprofeno Codramol Ibuprofen 600 mg Film-coated tablet Oral use

Portugal Farmalider S.A. C/ Aragoneses, 15 Alcobendas (Madrid), 28108 Spain

Ibuprofeno Farmalider

Ibuprofen 200 mg Granules for oral solution

Oral use

Portugal Farmoz - Sociedade Técnico Medicinal, S.A. Rua da Tapada Grande, 2 Abrunheira 2710-089 Sintra Portugal

Ibuprofeno Farmoz Ibuprofen 200 mg Film-coated tablet Oral use

Portugal Farmoz - Sociedade Técnico Medicinal, S.A. Rua da Tapada Grande, 2 Abrunheira 2710-089 Sintra Portugal

Ibuprofeno Farmoz Ibuprofen 400 mg Film-coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 221/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Portugal Generis Farmacêutica, S.A. Rua João de Deus, 19 2700-487 Amadora Portugal

Ibuprofeno Generis Ibuprofen 600 mg Granules for oral solution

Oral use

Portugal Generis Farmacêutica, S.A. Rua João de Deus, 19 2700-487 Amadora Portugal

Ibuprofeno Generis Ibuprofen 400 mg Granules for oral solution

Oral use

Portugal Generis Farmacêutica, S.A. Rua João de Deus, 19 2700-487 Amadora Portugal

Ibuprofeno Generis Ibuprofen 200 mg Coated tablet Oral use

Portugal Generis Farmacêutica, S.A. Rua João de Deus, 19 2700-487 Amadora Portugal

Ibuprofeno Generis 20 mg/ml Suspensão oral

Ibuprofen 20 mg/ml Oral suspension Oral use

Portugal Generis Farmacêutica, S.A. Rua João de Deus, 19 2700-487 Amadora Portugal

Ibuprofeno Generis 400 mg Comprimidos

Ibuprofen 400 mg Film-coated tablet Oral use

Portugal Generis Farmacêutica, S.A. Rua João de Deus, 19 2700-487 Amadora Portugal

Ibuprofeno Generis 600 mg Comprimidos Revestidos

Ibuprofen 600 mg Coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 222/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Portugal Germed Farmacêutica, Lda. Rua Alto do Montijo, 13 - 1º Dto - Edifício Monsanto 2790-012 Portela de Carnaxide Portugal

Ibuprofeno Germed Ibuprofen 400 mg Film-coated tablet Oral use

Portugal Germed Farmacêutica, Lda. Rua Alto do Montijo, 13 - 1º Dto - Edifício Monsanto 2790-012 Portela de Carnaxide Portugal

Ibuprofeno Germed Ibuprofen 600 mg Film-coated tablet Oral use

Portugal Labesfal Genéricos, S.A. Avenida Dr. Afonso Costa, 1370 3465-051 Campo de Besteiros Portugal

Ibuprofeno Labesfal Ibuprofen 200 mg Film-coated tablet Oral use

Portugal Labesfal Genéricos, S.A. Avenida Dr. Afonso Costa, 1370 3465-051 Campo de Besteiros Portugal

Ibuprofeno Labesfal Ibuprofen 400 mg Film-coated tablet Oral use

Portugal Labesfal Genéricos, S.A. Avenida Dr. Afonso Costa, 1370 3465-051 Campo de Besteiros Portugal

Ibuprofeno Labesfal Ibuprofen 600 mg Film-coated tablet Oral use

Portugal Laboratórios Basi - Indústria Farmacêutica, S.A Parque Industrial Manuel Lourenço Ferreira, Lote 15 3450-232 Mortágua Portugal

Ibuprofeno Mer Ibuprofen 600 mg Coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 223/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Portugal Laboratórios Basi - Indústria Farmacêutica, S.A Parque Industrial Manuel Lourenço Ferreira, Lote 15 3450-232 Mortágua Portugal

Ibuprofeno Mer Ibuprofen 400 mg Coated tablet Oral use

Portugal OM Pharma, S.A. R. da Indústria, 2 - Quinta Grande 2610 - 088 Amadora - Lisboa Portugal

Ibuprofeno OM Pharma

Ibuprofen 200 mg Film-coated tablet Oral use

Portugal Pharmakern Portugal - Produtos Farmacêuticos, Sociedade Unipessoal, Lda. Edifício Atlas II, Av. José Gomes Ferreira, N.º 11 - 3º, Sala 31 - Miraflores 1495-139 Algés Portugal

Ibuprofeno Odipe Ibuprofen 400 mg Film-coated tablet Oral use

Portugal Pharmakern Portugal - Produtos Farmacêuticos, Sociedade Unipessoal, Lda. Edifício Atlas II, Av. José Gomes Ferreira, N.º 11 - 3º, Sala 31 - Miraflores 1495-139 Algés Portugal

Ibuprofeno Odipe Ibuprofen 600 mg Film-coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 224/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Portugal Sanofi - Produtos Farmacêuticos, Lda. Empreendimento Lagoas Park Edifício 7, 3º Piso 2740-244 Porto Salvo Portugal

Ibuprofeno Phagecon Ibuprofen 400 mg Film-coated tablet Oral use

Portugal Sanofi - Produtos Farmacêuticos, Lda. Empreendimento Lagoas Park Edifício 7, 3º Piso 2740-244 Porto Salvo Portugal

Ibuprofeno Phagecon Ibuprofen 200 mg Film-coated tablet Oral use

Portugal Pharmakern Portugal - Produtos Farmacêuticos, Sociedade Unipessoal, Lda. Edifício Atlas II, Av. José Gomes Ferreira, N.º 11 - 3º, Sala 31 - Miraflores 1495-139 Algés Portugal

Ibuprofeno Pharmakern

Ibuprofen 20 mg/ml Oral suspension Oral use

Portugal Pharmakern Portugal - Produtos Farmacêuticos, Sociedade Unipessoal, Lda. Edifício Atlas II, Av. José Gomes Ferreira, N.º 11 - 3º, Sala 31 - Miraflores 1495-139 Algés Portugal

Ibuprofeno Pharmakern

Ibuprofen 400 mg Effervescent granules Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 225/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Portugal Pharmakern Portugal - Produtos Farmacêuticos, Sociedade Unipessoal, Lda. Edifício Atlas II, Av. José Gomes Ferreira, N.º 11 - 3º, Sala 31 - Miraflores 1495-139 Algés Portugal

Ibuprofeno Pharmakern

Ibuprofen 200 mg Effervescent granules Oral use

Portugal Pharmakern Portugal - Produtos Farmacêuticos, Sociedade Unipessoal, Lda. Edifício Atlas II, Av. José Gomes Ferreira, N.º 11 - 3º, Sala 31 - Miraflores 1495-139 Algés Portugal

Ibuprofeno Pharmakern

Ibuprofen 200 mg Film-coated tablet Oral use

Portugal Pharmakern Portugal - Produtos Farmacêuticos, Sociedade Unipessoal, Lda. Edifício Atlas II, Av. José Gomes Ferreira, N.º 11 - 3º, Sala 31 - Miraflores 1495-139 Algés Portugal

Ibuprofeno Pharmakern

Ibuprofen 600 mg Effervescent granules Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 226/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Portugal Pharmakern Portugal - Produtos Farmacêuticos, Sociedade Unipessoal, Lda. Edifício Atlas II, Av. José Gomes Ferreira, N.º 11 - 3º, Sala 31 - Miraflores 1495-139 Algés Portugal

Ibuprofeno Pharmakern

Ibuprofen 400 mg Film-coated tablet Oral use

Portugal Pharmakern Portugal - Produtos Farmacêuticos, Sociedade Unipessoal, Lda. Edifício Atlas II, Av. José Gomes Ferreira, N.º 11 - 3º, Sala 31 - Miraflores 1495-139 Algés Portugal

Ibuprofeno Pharmakern

Ibuprofen 600 mg Film-coated tablet Oral use

Portugal Farmalider S.A. C/ Aragoneses, 15 Alcobendas (Madrid), 28108 Spain

Ibuprofeno Poindol Ibuprofen 600 mg Film-coated tablet Oral use

Portugal Farmalider S.A. C/ Aragoneses, 15 Alcobendas (Madrid), 28108 Spain

Ibuprofeno Poindol Ibuprofen 400 mg Film-coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 227/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Portugal Ratiopharm - Comércio e Indústria de Produtos Farmacêuticos, Lda. Lagoas Park, Edifício 5 A, Piso 2 2740-245 Porto Salvo Portugal

Ibuprofeno Ratiopharm

Ibuprofen 200 mg Film-coated tablet Oral use

Portugal Ratiopharm - Comércio e Indústria de Produtos Farmacêuticos, Lda. Lagoas Park, Edifício 5 A, Piso 2 2740-245 Porto Salvo Portugal

Ibuprofeno Ratiopharm 400 mg Comprimidos Revestidos

Ibuprofen 400 mg Film-coated tablet Oral use

Portugal Ratiopharm - Comércio e Indústria de Produtos Farmacêuticos, Lda. Lagoas Park, Edifício 5 A, Piso 2 2740-245 Porto Salvo Portugal

Ibuprofeno Ratiopharm 600 mg Comprimidos Revestidos

Ibuprofen 600 mg Film-coated tablet Oral use

Portugal Sandoz Farmacêutica, Lda. Avenida Professor Doutor Cavaco Silva, 10E - Taguspark 2740-255 Porto Salvo Portugal

Ibuprofeno Sandoz Ibuprofen 400 mg Film-coated tablet Oral use

Portugal Sandoz Farmacêutica, Lda. Avenida Professor Doutor Cavaco Silva, 10E - Taguspark 2740-255 Porto Salvo Portugal

Ibuprofeno Sandoz Ibuprofen 600 mg Film-coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 228/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Portugal Sandoz Farmacêutica, Lda. Avenida Professor Doutor Cavaco Silva, 10E - Taguspark 2740-255 Porto Salvo Portugal

Ibuprofeno Sandoz Ibuprofen 200 mg Film-coated tablet Oral use

Portugal ToLife - Produtos Farmacêuticos, S.A. Avenida do Forte, 3 - Edificio Suécia III, Piso 1 2794-093 Carnaxide Portugal

Ibuprofeno Tolife Ibuprofen 200 mg Film-coated tablet Oral use

Portugal ToLife - Produtos Farmacêuticos, S.A. Avenida do Forte, 3 - Edificio Suécia III, Piso 1 2794-093 Carnaxide Portugal

Ibuprofeno Tolife Ibuprofen 400 mg Film-coated tablet Oral use

Portugal ToLife - Produtos Farmacêuticos, S.A. Avenida do Forte, 3 - Edificio Suécia III, Piso 1 2794-093 Carnaxide Portugal

Ibuprofeno Tolife Ibuprofen 600 mg Granules for oral solution

Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 229/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Portugal ToLife - Produtos Farmacêuticos, S.A. Avenida do Forte, 3 - Edificio Suécia III, Piso 1 2794-093 Carnaxide Portugal

Ibuprofeno Tolife Ibuprofen 400 mg Granules for oral solution

Oral use

Portugal ToLife - Produtos Farmacêuticos, S.A. Avenida do Forte, 3 - Edificio Suécia III, Piso 1 2794-093 Carnaxide Portugal

Ibuprofeno Tolife Ibuprofen 600 mg Film-coated tablet Oral use

Portugal Sanofi-Aventis - Produtos Farmacêuticos, Lda. Empreendimento Lagoas Park, Edifício 7 - 3º Piso 2740-244 Porto Salvo Portugal

Ibuprofeno Zentiva Ibuprofen 400 mg Film-coated tablet Oral use

Portugal Actavis A/S Sucursal Rua Virgílio Correia, 11 - A 1600-219 Lisboa Portugal

Ifenin Ibuprofen 400 mg Film-coated tablet Oral use

Portugal Actavis A/S Sucursal Rua Virgílio Correia, 11 - A 1600-219 Lisboa Portugal

Ifenin Ibuprofen 200 mg Film-coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 230/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Portugal Farbio - Produtos Farmacêuticos Unipessoal, Lda. Largo Alexandre Herculano, 2 7050-110 Montemor-O-Novo Portugal

Kifen Ibuprofen 200 mg Dispersible tablet Oral use

Portugal Angelini Farmacêutica, Lda. Rua João Chagas, 53 - 3º 1499-040 Cruz Quebrada - Dafundo Portugal

Moment 200 Ibuprofen 200 mg Coated tablet Oral use

Portugal Laboratorio de Aplicaciones Farmacodinamicas, S.A. C/ Grassot, 16 08025 Barcelona Spain

NORVECTAN 400 Ibuprofen 400 mg Powder for oral suspension

Oral use

Portugal Laboratorio de Aplicaciones Farmacodinamicas, S.A. C/ Grassot, 16 08025 Barcelona Spain

NORVECTAN 600 Ibuprofen 600 mg Powder for oral suspension

Oral use

Portugal Distrifarma - Companhia de Distribuição Farmacêutica, S.A. Estrada Consiglieri Pedroso, 80 - Lt. 3 - Armz. 1/12 - Queluz de Baixo 2745-553 Barcarena Portugal

Nolofene Ibuprofen 200 mg Coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 231/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Portugal Reckitt Benckiser Healthcare, Lda. Rua D. Cristovão da Gama 1 - 1º C/D 1400-113 Lisboa Portugal

Nurofen Ibuprofen 40 mg/ml Oral suspension Oral use

Portugal Reckitt Benckiser Healthcare, Lda. Rua D. Cristovão da Gama 1 - 1º C/D 1400-113 Lisboa Portugal

Nurofen Ibuprofen 200 mg Coated tablet Oral use

Portugal Reckitt Benckiser Healthcare, Lda. Rua D. Cristovão da Gama 1 - 1º C/D 1400-113 Lisboa Portugal

Nurofen Ibuprofen 200 mg Capsule, soft Oral use

Portugal Reckitt Benckiser Healthcare, Lda. Rua D. Cristovão da Gama 1 - 1º C/D 1400-113 Lisboa Portugal

Nurofen 400 Ibuprofen 400 mg Coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 232/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Portugal Reckitt Benckiser Healthcare, Lda. Rua D. Cristovão da Gama 1 - 1º C/D 1400-113 Lisboa Portugal

Nurofen Della Ibuprofen 400 mg Coated tablet Oral use

Portugal Reckitt Benckiser Healthcare, Lda. Rua D. Cristovão da Gama 1 - 1º C/D 1400-113 Lisboa Portugal

Nurofen Zavance Ibuprofen 400 mg Capsule, soft Oral use

Portugal Reckitt Benckiser Healthcare, Lda. Rua D. Cristovão da Gama 1 - 1º C/D 1400-113 Lisboa Portugal

Nurofen Zavance Ibuprofen 200 mg Coated tablet Oral use

Portugal Omega Pharma Portuguesa, Unipessoal, Lda. Av. Tomás Ribeiro 43, Edifício Neopark, Bloco 1 - 3ºC 2790-221 Carnaxide Portugal

Ozonol Ibuprofen 200 mg Coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 233/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Portugal Laboratórios Azevedos - Indústria Farmacêutica, S.A. Edifícios Azevedos - Estrada Nacional 117-2, Alfragide 2614-504 Amadora Portugal

Solufen Ibuprofen 20 mg/ml Oral suspension Oral use

Portugal Laboratórios Azevedos - Indústria Farmacêutica, S.A. Edifícios Azevedos - Estrada Nacional 117-2, Alfragide 2614-504 Amadora Portugal

Solufen Ibuprofen 200 mg Capsule, hard Oral use

Portugal Zambon - Produtos Farmacêuticos, Lda. Rua Comandante Enrique Maya, 1 1500-192 Lisboa Portugal

Spidifen Ibuprofen 200 mg Granules for oral solution

Oral use

Portugal Zambon - Produtos Farmacêuticos, Lda. Rua Comandante Enrique Maya, 1 1500-192 Lisboa Portugal

Spidifen Ibuprofen 600 mg Granules for oral solution

Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 234/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Portugal Zambon - Produtos Farmacêuticos, Lda. Rua Comandante Enrique Maya, 1 1500-192 Lisboa Portugal

Spidifen Ibuprofen 400 mg Granules for oral solution

Oral use

Portugal Zambon - Produtos Farmacêuticos, Lda. Rua Comandante Enrique Maya, 1 1500-192 Lisboa Portugal

Spidifen 400 mg Comprimidos

Ibuprofen 400 mg Film-coated tablet Oral use

Portugal Zambon - Produtos Farmacêuticos, Lda. Rua Comandante Enrique Maya, 1 1500-192 Lisboa Portugal

Spidifen Limão Ibuprofen 400 mg Granules for oral solution

Oral use

Portugal Generis Farmacêutica, S.A. Rua João de Deus, 19 2700-487 Amadora Portugal

Tricalma Ibuprofen 200 mg Coated tablet Oral use

Portugal Laboratório Medinfar - Produtos Farmacêuticos, S.A. Rua Manuel Ribeiro de Pavia, 1 - 1º - Venda Nova 2700-547 Amadora Portugal

Trifene Ibuprofen 20 mg/ml Oral suspension Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 235/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Portugal Medinfar Consumer Health - Produtos Farmacêuticos, Lda. Rua Henrique Paiva Couceiro, 27 - Venda Nova 2700-451 Amadora Portugal

Trifene 200 Ibuprofen 200 mg Film-coated tablet Oral use

Portugal Laboratório Medinfar - Produtos Farmacêuticos, S.A. Rua Manuel Ribeiro de Pavia, 1 - 1º - Venda Nova 2700-547 Amadora Portugal

Trifene 400 Ibuprofen 400 mg Coated tablet Oral use

Portugal Laboratório Medinfar - Produtos Farmacêuticos, S.A. Rua Manuel Ribeiro de Pavia, 1 - 1º - Venda Nova 2700-547 Amadora Portugal

Trifene 400 Ibuprofen 400 mg Film-coated tablet Oral use

Portugal Laboratório Medinfar - Produtos Farmacêuticos, S.A. Rua Manuel Ribeiro de Pavia, 1 - 1º - Venda Nova 2700-547 Amadora Portugal

Trifene 600 Ibuprofen 600 mg Coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 236/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Portugal Medinfar Consumer Health - Produtos Farmacêuticos, Lda. Rua Henrique Paiva Couceiro, 27 - Venda Nova 2700-451 Amadora Portugal

Trifene Dispersível Ibuprofen 200 mg Dispersible tablet Oral use

Portugal Laboratório Medinfar - Produtos Farmacêuticos, S.A. Rua Manuel Ribeiro de Pavia, 1 - 1º - Venda Nova 2700-547 Amadora Portugal

Trifene Efervescente Ibuprofen 200 mg Effervescent tablet Oral use

Portugal Zambon S.p.A. Via Lillo del Duca 10 20091, Bresso (Mi) Italy

Zafen Ibuprofen 400 mg Film-coated tablet Oral use

Portugal Labialfarma - Laboratório de Produtos Farmacêuticos e Nutracêuticos, S.A. Edifício Labialfarma, 1 - Felgueira 3450-336 Sobral - Mortágua Portugal

Zip-A-Dol Ibuprofen 200 mg Capsule, hard Oral use

Portugal Jaba Recordati, S. A. Lagoas Park, Edificio 5, Torre C, Piso 3 2740-298 Porto Salvo Portugal

Seractil Dexibuprofen 200 mg Film-coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 237/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Portugal Jaba Recordati, S. A. Lagoas Park, Edificio 5, Torre C, Piso 3 2740-298 Porto Salvo Portugal

Seractil Dexibuprofen 300 mg Film-coated tablet Oral use

Portugal Jaba Recordati, S. A. Lagoas Park, Edificio 5, Torre C, Piso 3 2740-298 Porto Salvo Portugal

Seractil Dexibuprofen 400 mg Film-coated tablet Oral use

Romania Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland

ADAGIN 200 mg IBUPROFEN 200 mg Film-coated tablet Oral use

Romania Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland

ADAGIN 400 mg IBUPROFEN 400 mg Film-coated tablet Oral use

Romania Pfizer Corporation Austria GmbH Floridsdorfer Hauptstraße 1 1210 Wien Austria

ADVIL IBUPROFEN 200 mg Coated tablet Oral use

Romania Pfizer Corporation Austria GmbH Floridsdorfer Hauptstraße 1 1210 Wien Austria

ADVIL ULTRA IBUPROFEN 400 mg Capsule, soft Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 238/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Romania Zentiva, k.s. U kabelovny 130 102 37 Praha 10 Dolní Měcholupy Czech Republic

ALGIN BABY 100 mg/5 ml

IBUPROFEN 20 mg/ml Oral suspension Oral use

Romania Abbott Scandinavia AB P.O Box 1498 SE-171 29 Solna Sweden

BRUFEN 20 mg/ml IBUPROFEN 20 mg/ml Oral suspension Oral use

Romania Abbott Scandinavia AB P.O Box 1498 SE-171 29 Solna Sweden

BRUFEN 400 mg IBUPROFEN 400 mg Film-coated tablet Oral use

Romania Abbott Scandinavia AB P.O Box 1498 SE-171 29 Solna Sweden

BRUFEN 400 mg IBUPROFEN 400 mg Effervescent granules Oral use

Romania Abbott Scandinavia AB P.O Box 1498 SE-171 29 Solna Sweden

BRUFEN RETARD 800 mg

IBUPROFEN 800 mg Prolonged-release tablet

Oral use

Romania S.C. SOLACIUM PHARMA S.R.L. Str. Calea Rahovei nr. 266-268 Corp 60, Etaj 2, Sector 5 Bucuresti Romania

EFISEN M 200 mg IBUPROFEN 200 mg Film-coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 239/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Romania Zambon S.p.A. Via Lillo del Duca 10 20091, Bresso (Mi) Italy

FASPIC 400 mg IBUPROFEN 400 mg Granules for oral solution

Oral use

Romania Zambon S.p.A. Via Lillo del Duca 10 20091, Bresso (Mi) Italy

FASPIC 600 IBUPROFEN 600 mg Granules for oral solution

Oral use

Romania Zambon S.p.A. Via Lillo del Duca 10 20091, Bresso (Mi) Italy

FASPIC® 400 mg IBUPROFEN 400 mg Film-coated tablet Oral use

Romania Zentiva, k.s. U kabelovny 130 102 37 Praha 10 Dolní Měcholupy Czech Republic

IBALGIN IBUPROFEN 200 mg Film-coated tablet Oral use

Romania Zentiva, k.s. U kabelovny 130 102 37 Praha 10 Dolní Měcholupy Czech Republic

ANTINEVRALGIC MULTIEFECT

IBUPROFEN 400 mg Film-coated tablet Oral use

Romania Zentiva, k.s. U kabelovny 130 102 37 Praha 10 Dolní Měcholupy Czech Republic

IBALGIN FORTE IBUPROFEN 400 mg Film-coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 240/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Romania Zentiva, k.s. U kabelovny 130 102 37 Praha 10 Dolní Měcholupy Czech Republic

IBALGIN RAPID IBUPROFEN 400 mg Film-coated tablet Oral use

Romania S.C. ANTIBIOTICE S.A. Str. Valea Lupului nr.1, Iaşi Romania

IBUFEN 200 mg IBUPROFEN 200 mg Film-coated tablet Oral use

Romania S.C. ARENA GROUP S.A. Str. Ştefan Mihăileanu nr.31, Sector 2, Bucureşti România

IBUPROFEN ARENA 200 mg

IBUPROFEN 200 mg Capsule, hard Oral use

Romania S.C. ARENA GROUP S.A. Str. Ştefan Mihăileanu nr.31, Sector 2, Bucureşti România

IBUPROFEN ARENA 400 mg

IBUPROFEN 400 mg Capsule, hard Oral use

Romania CIPLA (UK) LIMITED The Old Post House Heath Road, Surrey Weybridge, KT13 8TS, United Kingdom

IBUPROFEN CIPLA 200

IBUPROFEN 200 mg Film-coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 241/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Romania CIPLA (UK) LIMITED The Old Post House Heath Road, Surrey Weybridge, KT13 8TS, United Kingdom

IBUPROFEN CIPLA 400

IBUPROFEN 400 mg Film-coated tablet Oral use

Romania CIPLA (UK) LIMITED The Old Post House Heath Road, Surrey Weybridge, KT13 8TS, United Kingdom

IBUPROFEN CIPLA 600

IBUPROFEN 600 mg Film-coated tablet Oral use

Romania Abbott Scandinavia AB P.O Box 1498 SE-171 29 Solna Sweden

ABFEN 200 mg/5 ml suspensie orală

IBUPROFEN 40 mg/ml Oral suspension Oral use

Romania Berlin-Chemie AG Glienicker Weg 125 12489 Berlin Germany

MIG 40 mg/ ml IBUPROFEN 40 mg/ml Oral suspension Oral use

Romania Abbott Scandinavia AB P.O Box 1498 SE-171 29 Solna Sweden

IBUPROFEN ROCKSPRING 200 mg

IBUPROFEN 200 mg Effervescent granules Oral use

Romania Abbott Scandinavia AB P.O Box 1498 SE-171 29 Solna Sweden

IBUPROFEN ROCKSPRING 600 mg

IBUPROFEN 600 mg Effervescent granules Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 242/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Romania S.C. Sandoz S.R.L. Str. Livezeni, Nr. 7A 540472 Târgu Mureş Romania

IBUPROFEN SANDOZ 20 mg/ml

IBUPROFEN 20 mg/ml Oral suspension Oral use

Romania S.C. Sandoz S.R.L. Str. Livezeni, Nr. 7A 540472 Târgu Mureş Romania

IBUPROFEN SANDOZ 40 mg/ml

IBUPROFEN 40 mg/ml Oral suspension Oral use

Romania US Pharmacia Sp. z o.o. Ziebicka st. 40 50-507 Wroclaw Poalnd

IBUPROM IBUPROFEN 200 mg Coated tablet Oral use

Romania Alvogen IPCo S.àr.l. Rue Heienhaff, 5 L-1736, Senningerberg Luxemburg

INFLANOR 200 mg IBUPROFEN 200 mg Capsule, soft Oral use

Romania Alvogen IPCo S.àr.l. Rue Heienhaff, 5 L-1736, Senningerberg Luxemburg

INFLANOR FORTE 400 mg

IBUPROFEN 400 mg Capsule, soft Oral use

Romania S.C. LAROPHARM S.R.L. Şoseaua Alexandriei nr. 145 A, Bragadiru judeţul Ilfov Romania

LAROFEN 200 mg IBUPROFEN 200 mg Film-coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 243/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Romania GLAXOSMITHKLINE CONSUMER HEALTHCARE S.R.L. Str. Costache Negri, Nr. 1-5 Opera Center One Etaj 6 (Zona 2), Sector 5 Bucureşti România

PANAFEN 200 mg IBUPROFEN 200 mg Capsule, hard Oral use

Romania GLAXOSMITHKLINE CONSUMER HEALTHCARE S.R.L. Str. Costache Negri, Nr. 1-5 Opera Center One Etaj 6 (Zona 2), Sector 5 Bucureşti România

PANAFEN 400 mg IBUPROFEN 400 mg Capsule, hard Oral use

Romania Berlin-Chemie AG Glienicker Weg 125 12489 Berlin Germany

MIG-400 IBUPROFEN 400 mg Film-coated tablet Oral use

Romania Reckitt Benckiser Healthcare International Limited Bath Road 103-105 Berkshire SL1 3UH Slough United Kingdom

NUROFEN EXPRESS 200 mg

IBUPROFEN 200 mg Capsule, soft Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 244/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Romania Reckitt Benckiser Healthcare International Limited Bath Road 103-105 Berkshire SL1 3UH Slough United Kingdom

NUROFEN EXPRESS 200 mg

IBUPROFEN 200 mg Capsule, soft Oral use

Romania Reckitt Benckiser Healthcare International Limited Bath Road 103-105 Berkshire SL1 3UH Slough United Kingdom

NUROFEN EXPRESS 400 mg

IBUPROFEN 400 mg Oral powder Oral use

Romania Reckitt Benckiser Healthcare International Limited Bath Road 103-105 Berkshire SL1 3UH Slough United Kingdom

NUROFEN EXPRESS FORTE 400 mg

IBUPROFEN 400 mg Capsule, soft Oral use

Romania Reckitt Benckiser Healthcare International Limited Bath Road 103-105 Berkshire SL1 3UH Slough United Kingdom

NUROFEN FORTE IBUPROFEN 400 mg Capsule, hard Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 245/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Romania Reckitt Benckiser Healthcare International Limited Bath Road 103-105 Berkshire SL1 3UH Slough United Kingdom

NUROFEN IMMEDIA ULTRA 400 mg

IBUPROFEN 400 mg Capsule, hard Oral use

Romania Reckitt Benckiser Healthcare International Limited Bath Road 103-105 Berkshire SL1 3UH Slough United Kingdom

NUROFEN® 200 mg IBUPROFEN 200 mg Capsule, hard Oral use

Romania US Pharmacia Sp. z o.o. Ziebicka st. 40 50-507 Wroclaw Poalnd

PADUDEN FORTE 400 mg

IBUPROFEN 400 mg Capsule, hard Oral use

Romania S.C. TERAPIA S.A. Str. Fabricii, nr. 124 Cluj-Napoca Romania

PADUDEN® 200 mg IBUPROFEN 200 mg Capsule, hard Oral use

Romania S.C. TERAPIA S.A. Str. Fabricii, nr. 124 Cluj-Napoca Romania

PADUDEN® SR 300 mg

IBUPROFEN 300 mg Prolonged-release capsule, hard

Oral use

Romania S.C. AC HELCOR S.R.L. Str. Dr.Victor Babeş Nr. 50 Baia Mare Romania

REUPROFEN 200 mg IBUPROFEN 200 mg Film-coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 246/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Romania S.C. AC HELCOR S.R.L. Str. Dr.Victor Babeş Nr. 50 Baia Mare Romania

REUPROFEN 400 mg IBUPROFEN 400 mg Film-coated tablet Oral use

Romania MEDOCHEMIE Ltd., Constantinopoleos Street 1-10, Limassol Cyprus

RUPAN 200 mg IBUPROFEN 200 mg Film-coated tablet Oral use

Romania Bayer S.R.L. Şos. Pipera Nr. 42, Etajele 1, 16, 17 Sector 2, Bucureşti Romania

SARIDON N 400 IBUPROFEN 400 mg Film-coated tablet Oral use

Romania Zentiva, k.s. U kabelovny 130 102 37 Praha 10 Dolní Měcholupy Czech Republic

MODAFEN Ibuprofen pseudoephedrine

200 mg 30 mg

Film-coated tablet Oral use

Romania US Pharmacia Sp. z o.o. Ziebicka st. 40 50-507 Wroclaw Poalnd

IBUPROM SINUS 200 mg/30 mg

Ibuprofen pseudoephedrine

200 mg 30 mg

Coated tablet Oral use

Romania Boehringer Ingelheim International GmbH Binger Straße 173 55216 Ingelheim am Rhein Germany

MUCOGRIP 200 mg/30 mg

Ibuprofen pseudoephedrine

200 mg 30 mg

Film-coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 247/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Romania Rockspring Healthcare Limited 38/40 Chamberlayne Road London NW10 3JE United Kingdom

IBUPROFEN/CODEINA FOSFAT ROCKSPRING 400 mg/30 mg

Ibuprofen pseudoephedrine

400 mg 30 mg

Film-coated tablet Oral use

Slovak Republic

Pfizer Corporation Austria GmbH Floridsdorfer Hauptstraße 1 1210 Wien Austria

ADVIL RAPID Ibuprofen 400 mg Capsule, soft Oral use

Slovak Republic

Abbott Laboratories Slovakia s.r.o. Karadžičova 10 821 11 Bratislava Slovakia

Brufen 400 Ibuprofen 400 mg Film-coated tablet Oral use

Slovak Republic

Abbott Laboratories Slovakia s.r.o. Karadžičova 10 821 11 Bratislava Slovakia

Brufen 400 mg šumivý granulát

Ibuprofen 400 mg Effervescent granules Oral use

Slovak Republic

Abbott Laboratories Slovakia s.r.o. Karadžičova 10 821 11 Bratislava Slovakia

Brufen 600 Ibuprofen 600 mg Effervescent granules Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 248/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Slovak Republic

Abbott Laboratories Slovakia s.r.o. Karadžičova 10 821 11 Bratislava Slovakia

Brufen Forte sirup bez cukru 200 mg/5 ml perorálna suspenzia

Ibuprofen 40 mg/ml Oral suspension Oral use

Slovak Republic

Abbott Laboratories Slovakia s.r.o. Karadžičova 10 821 11 Bratislava Slovakia

Brufen retard 800 Ibuprofen 800 mg Film-coated prolonged-release tablet

Oral use

Slovak Republic

Abbott Laboratories Slovakia s.r.o. Karadžičova 10 821 11 Bratislava Slovakia

BRUFEN sirup Ibuprofen 20 mg/ml Syrup Oral use

Slovak Republic

Zentiva, k.s. U kabelovny 130 102 37 Praha 10 Dolní Měcholupy Czech Republic

Ibalgin 200 Ibuprofen 200 mg Film-coated tablet Oral use

Slovak Republic

Zentiva, k.s. U kabelovny 130 102 37 Praha 10 Dolní Měcholupy Czech Republic

Ibalgin 400 Ibuprofen 400 mg Film-coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 249/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Slovak Republic

Zentiva, k.s. U kabelovny 130 102 37 Praha 10 Dolní Měcholupy Czech Republic

Ibalgin 600 Ibuprofen 600 mg Film-coated tablet Oral use

Slovak Republic

Zentiva, k.s. U kabelovny 130 102 37 Praha 10 Dolní Měcholupy Czech Republic

IBALGIN FAST Ibuprofen 400 mg Film-coated tablet Oral use

Slovak Republic

Zentiva, k.s. U kabelovny 130 102 37 Praha 10 Dolní Měcholupy Czech Republic

Ibalgin Grip Ibuprofen phenylephrine

200 mg/5 mg

Film-coated tablet Oral use

Slovak Republic

Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland

Ibudolor 200 mg Ibuprofen 200 mg Film-coated tablet Oral use

Slovak Republic

Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland

Ibudolor 400 mg Ibuprofen 400 mg Film-coated tablet Oral use

Slovak Republic

Generics UK Albany Gate, Darkes Lane Potters Bar Hertfordshire EN6 1AG United Kingdom

Ibumyl Rapid 200 mg Ibuprofen 200 mg Film-coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 250/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Slovak Republic

Generics UK Albany Gate, Darkes Lane Potters Bar Hertfordshire EN6 1AG United Kingdom

Ibumyl Rapid 400 mg Ibuprofen 400 mg Film-coated tablet Oral use

Slovak Republic

STADA Arzneimittel AG Stadastr. 2-18 61118 Bad Vilbel Germany

Ibuprofen 400 STADA Ibuprofen 400 mg Film-coated tablet Oral use

Slovak Republic

Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland

Ibuprofen Actavis 200 mg

Ibuprofen 200 mg Film-coated tablet Oral use

Slovak Republic

Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland

Ibuprofen Actavis 400 mg

Ibuprofen 400 mg Film-coated tablet Oral use

Slovak Republic

Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland

Ibuprofen Actavis 600 mg

Ibuprofen 600 mg Film-coated tablet Oral use

Slovak Republic

Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland

Ibuprofen Actavis 800 mg

Ibuprofen 800 mg Film-coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 251/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Slovak Republic

Dr. Max Pharma Ltd. First Floor Roxburge House, Regent Street 273-287 W1B 2HA London United Kingdom

Ibuprofen Dr.Max 200 mg filmom obalené tablety

Ibuprofen 200 mg Film-coated tablet Oral use

Slovak Republic

Dr. Max Pharma Ltd. First Floor Roxburge House, Regent Street 273-287 W1B 2HA London United Kingdom

Ibuprofen Dr.Max 400 mg filmom obalené tablety

Ibuprofen 400 mg Film-coated tablet Oral use

Slovak Republic

Galpharm Healthcare Limited Hugh House Upper Cliffe Road Barnsley, South Yorkshire S75 3SP Dodworth Dodworth Bussiness Park United Kingdom

Ibuprofen Galpharm 200 mg obalené tablety

Ibuprofen 200 mg Coated tablet Oral use

Slovak Republic

Galpharm Healthcare Limited Hugh House Upper Cliffe Road Barnsley, South Yorkshire S75 3SP Dodworth Dodworth Bussiness Park United Kingdom

Ibuprofen Galpharm 400 mg obalené tablety

Ibuprofen 400 mg Coated tablet Oral use

Slovak Republic

Rockspring Healthcare Limited 38/40 Chamberlayne Road London NW10 3JE United Kingdom

Ibuprofen Rockspring 200 mg šumivý granulát

Ibuprofen 200 mg Effervescent granules Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 252/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Slovak Republic

Vitabalans Oy Varastokatu 8 13500 Hämeenlinna Finland

Ibutabs 200 mg Ibuprofen 200 mg Film-coated tablet Oral use

Slovak Republic

Vitabalans Oy Varastokatu 8 13500 Hämeenlinna Finland

Ibutabs 400 mg Ibuprofen 400 mg Film-coated tablet Oral use

Slovak Republic

Vitabalans Oy Varastokatu 8 13500 Hämeenlinna Finland

Ibutabs 600 mg Ibuprofen 600 mg Film-coated tablet Oral use

Slovak Republic

Vitabalans Oy Varastokatu 8 13500 Hämeenlinna Finland

Ibutabs 800 mg Ibuprofen 800 mg Film-coated tablet Oral use

Slovak Republic

Berlin-Chemie AG Glienicker Weg 125 12489 Berlin Germany

MIG-400 Ibuprofen 400 mg Film-coated tablet Oral use

Slovak Republic

Zentiva, k.s. U kabelovny 130 102 37 Praha 10 Dolní Měcholupy Czech Republic

MODAFEN Ibuprofen pseudoephedrine

200 mg Film-coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 253/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Slovak Republic

Reckitt Benckiser Healthcare International Limited Bath Road 103-105 Berkshire SL1 3UH Slough United Kingdom

NUROFEN 200 mg Ibuprofen 200 mg Coated tablet Oral use

Slovak Republic

Reckitt Benckiser Healthcare International Limited Bath Road 103-105 Berkshire SL1 3UH Slough United Kingdom

NUROFEN 400 mg Ibuprofen 400 mg Coated tablet Oral use

Slovak Republic

Reckitt Benckiser Healthcare International Limited Bath Road 103-105 Berkshire SL1 3UH Slough United Kingdom

Nurofen Expres 200 mg

Ibuprofen 200 mg Coated tablet Oral use

Slovak Republic

Reckitt Benckiser Healthcare International Limited Bath Road 103-105 Berkshire SL1 3UH Slough United Kingdom

Nurofen Expres 400 mg

Ibuprofen 400 mg Coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 254/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Slovak Republic

Reckitt Benckiser Healthcare International Limited Bath Road 103-105 Berkshire SL1 3UH Slough United Kingdom

Nurofen Instant 400 mg perorálny prášok

Ibuprofen 400 mg Oral powder Oral use

Slovak Republic

Reckitt Benckiser Healthcare International Limited Bath Road 103-105 Berkshire SL1 3UH Slough United Kingdom

Nurofen Rapid 200 mg Capsules

Ibuprofen 200 mg Capsule, soft Oral use

Slovak Republic

Reckitt Benckiser Healthcare International Limited Bath Road 103-105 Berkshire SL1 3UH Slough United Kingdom

NUROFEN Rapid 400 mg Capsules

Ibuprofen 400 mg Capsule, soft Oral use

Slovak Republic

Reckitt Benckiser Healthcare International Limited Bath Road 103-105 Berkshire SL1 3UH Slough United Kingdom

NUROFEN STOPGRIP Ibuprofen pseudoephedrine

200 mg Film-coated tablet Oral use

Slovak Republic

Sandoz Pharmaceuticals d.d., Verovškova 57 1000 Ljubljana Slovenia

TEMPASA JUNIOR 4% Ibuprofen 40 mg/ml Oral suspension Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 255/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Slovenia KRKA d.d Šmarješka cesta 6 8000 Novo mesto Slovenia

Bonifen 200 mg filmsko obložene tablete

Ibuprofen 200 mg Film-coated tablet Oral use

Slovenia Abbott Laboratories d.o.o. Dolenjska cesta 242c 1000 Ljubljana Slovenia

Brufen 20 mg/ml peroralna suspenzija

Ibuprofen 20 mg/ml Oral suspension Oral use

Slovenia Abbott Laboratories d.o.o. Dolenjska cesta 242c 1000 Ljubljana Slovenia

Brufen 200 mg filmsko obložene tablete

Ibuprofen 200 mg Film-coated tablet Oral use

Slovenia Abbott Laboratories d.o.o. Dolenjska cesta 242c 1000 Ljubljana Slovenia

Brufen 400 mg filmsko obložene tablete

Ibuprofen 400 mg Film-coated tablet Oral use

Slovenia Abbott Laboratories d.o.o. Dolenjska cesta 242c 1000 Ljubljana Slovenia

Brufen 400 mg šumeča zrnca

Ibuprofen 400 mg Effervescent granules Oral use

Slovenia Abbott Laboratories d.o.o. Dolenjska cesta 242c 1000 Ljubljana Slovenia

Brufen 600 mg filmsko obložene tablete

Ibuprofen 600 mg Film-coated tablet Oral use

Slovenia Abbott Laboratories d.o.o. Dolenjska cesta 242c 1000 Ljubljana Slovenia

Brufen retard 800 mg tablete s podaljšanim sproščanjem

Ibuprofen 800 mg Prolonged-release tablet

Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 256/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Slovenia Abbott Laboratories d.o.o. Dolenjska cesta 242c 1000 Ljubljana Slovenia

Brufen z okusom jagode 40 mg/ml peroralna suspenzija

Ibuprofen 40 mg/ml Oral suspension Oral use

Slovenia LEK d.d. Verovškova 57 1526 Ljubljana Slovenia

Diverin 400 mg filmsko obložene tablete

Ibuprofen 400 mg Film-coated tablet Oral use

Slovenia LEK d.d. Verovškova 57 1526 Ljubljana Slovenia

Diverin za otroke 40 mg/ml peroralna suspenzija z okusom jagode

Ibuprofen 40 mg/ml Oral suspension Oral use

Slovenia Vitabalans Oy Varastokatu 8 13500 Hämeenlinna Finland

Ibacut 200 mg filmsko obložene tablete

Ibuprofen 200 mg Film-coated tablet Oral use

Slovenia Vitabalans Oy Varastokatu 8 13500 Hämeenlinna Finland

Ibacut 400 mg filmsko obložene tablete

Ibuprofen 400 mg Film-coated tablet Oral use

Slovenia sanofi-aventis d.o.o. Dunajska cesta 151 1000 Ljubljana Slovenia

Ibalgin NEO 400 mg filmsko obložene tablete

Ibuprofen 400 mg Film-coated tablet Oral use

Slovenia Belupo, d.o.o. Dvoržakova 6 1000 Ljubljana Slovenia

Ibubel 200 mg filmsko obložene tablete

Ibuprofen 200 mg Film-coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 257/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Slovenia Belupo, d.o.o. Dvoržakova 6 1000 Ljubljana Slovenia

Ibubel 400 mg filmsko obložene tablete

Ibuprofen 400 mg Film-coated tablet Oral use

Slovenia Belupo, d.o.o. Dvoržakova 6 1000 Ljubljana Slovenia

Ibuprofen Belupo 20 mg/ml peroralna suspenzija

Ibuprofen 20 mg/ml Oral suspension Oral use

Slovenia Belupo, d.o.o. Dvoržakova 6 1000 Ljubljana Slovenia

IBUPROFEN BELUPO 400 mg filmsko obložene tablete

Ibuprofen 400 mg Film-coated tablet Oral use

Slovenia Belupo, d.o.o. Dvoržakova 6 1000 Ljubljana Slovenia

IBUPROFEN BELUPO 600 mg filmsko obložene tablete

Ibuprofen 600 mg Film-coated tablet Oral use

Slovenia Belupo, d.o.o. Dvoržakova 6 1000 Ljubljana Slovenia

IBUPROFEN BELUPO 800 mg filmsko obložene tablete

Ibuprofen 800 mg Film-coated tablet Oral use

Slovenia Rockspring Healthcare Limited 38/40 Chamberlayne Road London NW10 3JE United Kingdom

Ibuprofen Rockspring 200 mg šumeča zrnca

Ibuprofen 200 mg Effervescent granules Oral use

Slovenia Rockspring Healthcare Limited 38/40 Chamberlayne Road London NW10 3JE United Kingdom

Ibuprofen Rockspring 600 mg šumeča zrnca

Ibuprofen 600 mg Effervescent granules Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 258/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Slovenia Rockspring Healthcare Limited 38/40 Chamberlayne Road London NW10 3JE United Kingdom

Ibuprofen Vitabalans 200 mg filmsko obložene tablete

Ibuprofen 200 mg Film-coated tablet Oral use

Slovenia Vitabalans Oy Varastokatu 8 13500 Hämeenlinna Finland

Ibuprofen Vitabalans 400 mg filmsko obložene tablete

Ibuprofen 400 mg Film-coated tablet Oral use

Slovenia Vitabalans Oy Varastokatu 8 13500 Hämeenlinna Finland

Ibuprofen Vitabalans 600 mg filmsko obložene tablete

Ibuprofen 600 mg Film-coated tablet Oral use

Slovenia Vitabalans Oy Varastokatu 8 13500 Hämeenlinna Finland

Ibuprofen Vitabalans 800 mg filmsko obložene tablete

Ibuprofen 800 mg Film-coated tablet Oral use

Slovenia Reckitt Benckiser Healthcare International Limited Bath Road 103-105 Berkshire SL1 3UH Slough United Kingdom

Nurofen 200 mg obložene tablete

Ibuprofen 200 mg Film-coated tablet Oral use

Slovenia Reckitt Benckiser Healthcare International Limited Bath Road 103-105 Berkshire SL1 3UH Slough United Kingdom

Nurofen Immedia 200 mg mehke kapsule

Ibuprofen 200 mg Capsule, soft Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 259/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Spain ISDIN, S.A. Provençals, 33 08019 Barcelona Spain

ALGIASDIN 600 mg comprimidos recubiertos con película

Ibuprofen 600 mg Film-coated tablet Oral use

Spain ISDIN, S.A. Provençals, 33 08019 Barcelona Spain

ALGIASDIN RETARD 600 mg comprimidos recubiertos de liberación prolongada

Ibuprofen 600 mg Coated tablet Oral use

Spain LABORATORIOS BARCINO, S.A. Provençals, 33 08019 Barcelona Spain

BEXISTAR 600 mg comprimidos recubiertos con película

Ibuprofen 600 mg Film-coated tablet Oral use

Spain Abbott Laboratories, S.A. Avda. de Burgos, 91 28050 Madrid Spain

DALSY 400 mg comprimidos recubiertos con película

Ibuprofen 400 mg Film-coated tablet Oral use

Spain Johnson and Johnson, S.A. Pº de las 12 Estrellas, 5-7 Campo de las Naciones 28042 Madrid Spain

DOCTRIL 400 FORTE BLISTER

Ibuprofen 400 mg Coated tablet Oral use

Spain ZAMBON, S.A. Maresme, s/n Polígono Urvasa 08130 Sta. Perpetua de la Mogoda (Barcelona) Spain

ESPIDIDOL 400 mg comprimidos efervescentes

Ibuprofen 400 mg Effervescent tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 260/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Spain ZAMBON, S.A. Maresme, s/n Polígono Urvasa 08130 Sta. Perpetua de la Mogoda (Barcelona) Spain

ESPIDIDOL 400 mg comprimidos recubiertos

Ibuprofen 400 mg Coated tablet Oral use

Spain ZAMBON, S.A. Maresme, s/n Polígono Urvasa 08130 Sta. Perpetua de la Mogoda (Barcelona) Spain

ESPIDIFEN 400 mg comprimidos recubiertos

Ibuprofen arginine 400 mg Coated tablet Oral use

Spain Ferrer Internacional, S.A. Gran Vía Carlos III, 94 08028 Barcelona Spain

GELOFENO 200 mg comprimidos

Ibuprofen 200 mg Tablet Oral use

Spain Ferrer Internacional, S.A. Gran Vía Carlos III, 94 08028 Barcelona Spain

GELOFENO 400 mg comprimidos

Ibuprofen 400 mg Tablet Oral use

Spain Ferrer Internacional, S.A. Gran Vía Carlos III, 94 08028 Barcelona Spain

GELOFENO 600 mg comprimidos

Ibuprofen 400 mg Tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 261/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Spain LABORATORIOS CINFA, S.A. Olaz-Chipi, 10 Polígono Industrial Areta 31620 Huarte-Pamplona (Navarra) Spain

IBUFEN 400 mg comprimidos recubiertos con película

Ibuprofen 400 mg Film-coated tablet Oral use

Spain TEVA PHARMA, S.L.U. Anabel Segura, 11, Edificio Albatros B, 1ª planta 28108 Alcobendas (Madrid) Spain

IBUMAC 600 mg comprimidos

Ibuprofen 600 mg Film-coated tablet Oral use

Spain KERN PHARMA, S.L. Venus, 72. Poligono Industrial Colon II. Tarrasa Barcelona 08228 Spain

IBUPROFENO ABEX 400 mg comprimidos recubiertos con película EFG

Ibuprofen 400 mg Film-coated tablet Oral use

Spain KERN PHARMA, S.L. Venus, 72. Poligono Industrial Colon II. Tarrasa Barcelona 08228 Spain

IBUPROFENO ABEX 600 mg comprimidos recubiertos con película EFG

Ibuprofen 600 mg Film-coated tablet Oral use

Spain Bexal Farmaceutica, S.A. Centro Empresarial Osa Mayor Avda. Osa Mayor, 4 - Area B 28023 Aravaca (Madrid) Spain

IBUPROFENO ACOST 600 mg comprimidos recubiertos con película EFG

Ibuprofen 600 mg Film-coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 262/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Spain Ctavis Spain, S.A. Avda. de Burgos, 16-D 28036 Madrid Spain

IBUPROFENO ACTAVIS 600 mg comprimidos recubiertos con película EFG

Ibuprofen 600 mg Film-coated tablet Oral use

Spain ALMUS FARMACEUTICA, S.A. Avda. Verge de Montserrat, 6 08820 El Prat de Llobregat (Barcelona) Spain

IBUPROFENO ALMUS 600 mg comprimidos recubiertos con película EFG

Ibuprofen 600 mg Film-coated tablet Oral use

Spain LABORATORIOS ALTER, S.A. Mateo Inurria, 30 28036 Madrid Spain

IBUPROFENO ALTER 600 mg comprimdos recubiertos con película EFG

Ibuprofen 600 mg Film-coated tablet Oral use

Spain APOTEX ESPAÑA, S.L. Caléndula, 93, Minipark III edificio G, 2ª planta 28290 Las Matas (Madrid) Spain

IBUPROFENO APOTEX 600 mg comprimidos recubiertos con película EFG

Ibuprofen 600 mg Film-coated tablet Oral use

Spain ASTREL PHARMA, S.L. Vía de las Dos Castilla 9C portal 2-3ºC 28224 Madrid Spain

IBUPROFENO ASTREL 400 mg comprimidos recubiertos

Ibuprofen 400 mg Film-coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 263/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Spain LABORATORIOS COMBIX, S.L.U. Badajoz, 2, Edificio 2 28223 Pozuelo de Alarcón (Madrid) Spain

IBUPROFENO PHARMA COMBIX 600 mg comprimidos recubiertos con película EFG

Ibuprofen 600 mg Film-coated tablet Oral use

Spain LABORATORIOS CINFA, S.A. Olaz-Chipi, 10 Polígono Industrial Areta 31620 Huarte-Pamplona (Navarra) Spain

IBUPROFENO CINFA 600 mg comprimidos recubiertos con película EFG

Ibuprofen 600 mg Film-coated tablet Oral use

Spain Farmalider S.A. C/ Aragoneses, 15 Alcobendas (Madrid), 28108 Spain

IBUPROFENO CODRAMOL 400 mg comprimidos recubiertos con película EFG

Ibuprofen 400 mg Film-coated tablet Oral use

Spain LABORATORIOS COMBIX, S.L.U. Badajoz, 2, Edificio 2 28223 Pozuelo de Alarcón (Madrid) Spain

IBUPROFENO COMBIX 600 mg comprimidos recubiertos con película EFG

Ibuprofen 600 mg Film-coated tablet Oral use

Spain LABORATORIOS PEREZ GIMENEZ, S.A. Polígono Industrial Los Mochos Polígono 8-parcela 20. Crta. A-431, Km. 19 14720 Almodovar del Río (Córdoba) Spain

IBUPROFENO CUVE 600 mg comprimidos EFG

Ibuprofen 600 mg Film-coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 264/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Spain LABORATORIOS DAVUR, S.L. Teide, 4-planta baja. Poligono Empresarial La Marina, San Sebastián de los Reyes (Madrid) 28703 Spain

IBUPROFENO DAVUR 600 mg comprimidos recubiertos con película EFG

Ibuprofen 600 mg Film-coated tablet Oral use

Spain DERMOGEN FARMA, S.A. San Rafael, 3 28108 Alcobendas (Madrid) Spain

IBUPROFENO DERMOGEN 400 mg comprimidos recubiertos

Ibuprofen 400 mg Film-coated tablet Oral use

Spain DERMOGEN FARMA, S.A. San Rafael, 3 28108 Alcobendas (Madrid) Spain

IBUPROFENO DERMOGENERIS 400 mg comprimidos recubiertos con película EFG

Ibuprofen 400 mg Film-coated tablet Oral use

Spain LABORATORIOS FRANCISCO DURBAN, S.A. Calle IX nº 75-76 Polígono Industrial La Redonda 04710 El Ejido (Almería) Spain

IBUPROFENO DURBAN 400 mg comprimidos

Ibuprofen 400 mg Tablet Oral use

Spain Enol Pharmaceutical Research, S.L. Plaza Ferrocarriles Económicos de Asturias, 6 33011 Oviedo Spain

IBUPROFENO ENOL 600 m comprimidos recubiertos con película EFG

Ibuprofen 600 mg Film-coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 265/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Spain Farline Comercializadora de Productos Farmaceuticos, S.A. Santa Engracia, 31 28010 Madrid Spain

IBUPROFENO FARLINE 400 mg comprimidos bucodispersables

Ibuprofen 400 mg Film-coated tablet Oral use

Spain Farmalider S.A. C/ Aragoneses, 15 Alcobendas (Madrid), 28108 Spain

IBUPROFENO LIDERFARM 600 mg comprimidos recubiertos con película EFG

Ibuprofen 400 mg Film-coated tablet Oral use

Spain Farmalider S.A. C/ Aragoneses, 15 Alcobendas (Madrid), 28108 Spain

IBUPROFENO FARMALID 600 mg comprimidos recubiertos con película EFG

Ibuprofen 600 mg Film-coated tablet Oral use

Spain LABORATORIOS ALTER, S.A. Mateo Inurria, 30 28036 Madrid Spain

IBUPROFENO FARMALTER 600 mg comprimidos recubiertos con película EFG

Ibuprofen 600 mg Film-coated tablet Oral use

Spain LABORATORIOS GAYOSO, S.L. Hierro, 79 28850 Torrejón de Árdoz (Madrid) Spain

IBUPROFENO GAYOSO 400 mg comprimidos bucodispersables

Ibuprofen 400 mg Orodispersible tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 266/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Spain Genericos Juventus Limited Julian Camarillo, 37 28037 Madrid Spain

IBUPROFENO GENÉRICOS JUVENTUS 600 mg comprimidos recubiertos con película EFG

Ibuprofen 600 mg Film-coated tablet Oral use

Spain LABORATORIOS CINFA, S.A. Olaz-Chipi, 10 Polígono Industrial Areta 31620 Huarte-Pamplona (Navarra) Spain

IBUPROFENO GOIBELA 600 mg comprimidos recubiertos con película EFG

Ibuprofen 600 mg Film-coated tablet Oral use

Spain KERN PHARMA, S.L. Venus, 72. Poligono Industrial Colon II. Tarrasa (Barcelona) 08228 Spain

IBUPROFENO KERN PHARMA 400 mg comprimidos EFG

Ibuprofen 400 mg Coated tablet Oral use

Spain KERN PHARMA, S.L. Venus, 72. Poligono Industrial Colon II. Tarrasa (Barcelona) 08228 Spain

IBUPROFENO KERN PHARMA 600 mg comprimidos EFG

Ibuprofen 600 mg Coated tablet Oral use

Spain Korhispana, S.L. Carretera de Castellvell, 24 43206 Reus (Tarragona) Spain

IBUPROFENO KORHISPANA 600 mg comprimidos recubiertos con película EFG

Ibuprofen 600 mg Film-coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 267/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Spain LABORATORIOS LLORENS, S.A. Ciudad de Balaguer, 7-11 08022 Barcelona Spain

IBUPROFENO LLORENS 600 mg comprimdos recubiertos EFG

Ibuprofen 600 mg Film-coated tablet Oral use

Spain MABO FARMA, S.A. Carretera M-300, Km. 30,500 28802 Alcalá de Henares (Madrid) Spain

IBUPROFENO MABO 600 mg comprimidos recubiertos con película EFG

Ibuprofen 600 mg Film-coated tablet Oral use

Spain MYLAN PHARMACEUTICALS, S.L. Plom 2-4, 5º planta 08038 Barcelona Spain

IBUPROFENO MYLAN 600 mg comprimdos recubiertos EFG

Ibuprofen 600 MG Coated tablet Oral use

Spain MYLAN PHARMACEUTICALS, S.L. Plom 2-4, 5º planta 08038 Barcelona Spain

IBUPROFENO MYLAN PHARMACEUTICALS 600 mg comprimidos recubiertos con película EFG

Ibuprofen 600 mg Film-coated tablet Oral use

Spain LABORATORIOS NORMON, S.A. Ronda de Valdecarrizo, 6 28760 Tres Cantos (Madrid) Spain

IBUPROFENO NORMON 400 mg comprimidos recubiertos con película EFG

Ibuprofen 400 mg Film-coated tablet Oral use

Spain LABORATORIOS NORMON, S.A. Ronda de Valdecarrizo, 6 28760 Tres Cantos (Madrid) Spain

IBUPROFENO NORMON 600 mg comprimidos recubiertos con película EFG

Ibuprofen 600 mg Film-coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 268/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Spain LABORATORIOS ASOCIADOS NUPEL, S.L. Rua Carpinteiros, 25 Polígono Industrial Ceao 27003 Lugo Spain

IBUPROFENO NUPEL 600 mg comprimidos

Ibuprofen 600 mg Film-coated tablet Oral use

Spain ONEDOSE PHARMA, S.L. Ca l'Alegre de Dalt, 28-30 08024 Barcelona Spain

IBUPROFENO ONEDOSE 600 mg comprimidos recubiertos con película EFG

Ibuprofen 600 mg Film-coated tablet Oral use

Spain LABORATORIOS CINFA, S.A. Olaz-Chipi, 10 Polígono Industrial Areta 31620 Huarte-Pamplona (Navarra) Spain

IBUPROFENO OSODENT 600 mg comprimidos recubiertos con película EFG

Ibuprofen 600 mg Film-coated tablet Oral use

Spain PENSA PHARMA, S.A.U. Jorge Comín (médico pediatra), 3 46015 Valencia Spain

IBUPROFENO PENSA 400 mg comprimidos recubiertos con película EFG

Ibuprofen 400 mg Film-coated tablet Oral use

Spain PENSA PHARMA, S.A.U. Jorge Comín (médico pediatra), 3 46015 Valencia Spain

IBUPROFENO PENSA 600 mg comprimidos recubiertos con película EFG

Ibuprofen 600 mg Film-coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 269/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Spain PENSA PHARMA, S.A.U. Jorge Comín (médico pediatra), 3 46015 Valencia Spain

IBUPROFENO PENSA PHARMA 600 mg comrpimidos recubiertos con película EFG

Ibuprofen 600 mg Film-coated tablet Oral use

Spain LABORATORIOS RANBAXY, S.L. Passeig de Gracia, 9 08007 Barcelona Spain

IBUPROFENO RANBAXY 600 mg comprimidos recubiertos EFG

Ibuprofen 600 mg Coated tablet Oral use

Spain RATIOPHARM ESPAÑA, S.A. Avda. de Burgos, 16 D-5ª planta 28036 Madrid Spain

IBUPROFENO RATIOPHARM 600 mg comprimidos recubiertos con película EFG

Ibuprofen 600 mg Film-coated tablet Oral use

Spain SANDOZ FARMACÉUTICA, S.A. Avda. Osa Mayor 28023 Aravaca (Madrid) Spain

IBUPROFENO SANDOZ 600 mg comprimidos recubiertos con película EFG

Ibuprofen 600 mg Film-coated tablet Oral use

Spain SMART PHARMA Andrés Mellado, 76 28015 Madrid Spain

IBUPROFENO SMART 600 mg comprimidos recubiertos EFG

Ibuprofen 600 mg Coated tablet Oral use

Spain LABORATORIO STADA, S.A. Frederic Mompou, 5 08960 Sant Just Desvern (Barcelona) Spain

IBUPROFENO STADA 600 mg comprimidos recubiertos con película EFG

Ibuprofen 600 mg Film-coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 270/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Spain STADA GENERICOS, S.L. Frederic Mompou, 5 08960 Sant Just Desvern (Barcelona) Spain

IBUPROFENO STADA GENERICOS 400 mg comprimidos recubiertos EFG

Ibuprofen 400 mg Coated tablet Oral use

Spain STADA GENERICOS, S.L. Frederic Mompou, 5 08960 Sant Just Desvern (Barcelona) Spain

IBUPROFENO STADA GENERICOS 600 mg comprimidos recubiertos EFG

Ibuprofen 600 mg Coated tablet Oral use

Spain TARBIS FARMA, S.L. Gran Via Carlos III, 94, Barcelona, 08028 Spain

IBUPROFENO TARBIS 600 mg comprimidos recubiertos con película EFG

Ibuprofen 600 mg Film-coated tablet Oral use

Spain TEVA PHARMA, S.L.U. Anabel Segura, 11, Edificio Albatros B, 1ª planta 28108 Alcobendas (Madrid) Spain

IBUPROFENO TEVA 400 mg comprimidos recubiertos con película EFG

Ibuprofen 400 mg Film-coated tablet Oral use

Spain TEVA PHARMA, S.L.U. Anabel Segura, 11, Edificio Albatros B, 1ª planta 28108 Alcobendas (Madrid) Spain

IBUPROFENO TEVA 600 mg comprimidos recubiertos con película EFG

Ibuprofen 600 mg Film-coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 271/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Spain Aristo Pharma Iberia, S.L. Solana, 26 28850 Torrejón de Ardoz (Madrid) Spain

IBUPROFENO UR 600 mg comprimidos recubiertos con película EFG

Ibuprofen 600 mg Film-coated tablet Oral use

Spain Zentiva, k.s. U kabelovny 130 102 37 Praha 10 Dolní Měcholupy Czech Republic

IBUPROFENO ZENTIVA 400 mg comprimidos recubiertos con película EFG

Ibuprofen 400 mg Film-coated tablet Oral use

Spain Zentiva, k.s. U kabelovny 130 102 37 Praha 10 Dolní Měcholupy Czech Republic

IBUPROFENO ZENTIVA 600 mg comprimidos recubiertos con película EFG

Ibuprofen 600 mg Film-coated tablet Oral use

Spain Reckitt Benckiser Healthcare S.A. Mataró, 28. Granollers (Barcelona), 08403 Spain

JUNIFEN 200 mg comprimidos bucodispersables sabor limón

Ibuprofen 200 mg Orodispersible tablet Oral use

Spain Farmalider S.A. C/ Aragoneses, 15 Alcobendas (Madrid), 28108 Spain

LIDERFEME 400 mg comprimidos

Ibuprofen 400 mg Film-coated tablet Oral use

Spain Abbott Laboratories, S.A. Avda. de Burgos, 91 28050 Madrid Spain

NEOBRUFEN 400 mg comprimidos recubiertos con película EFG

Ibuprofen 400 mg Film-coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 272/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Spain Abbott Laboratories, S.A. Avda. de Burgos, 91 28050 Madrid Spain

NEOBRUFEN 600 mg comprimidos recubiertos con película EFG

Ibuprofen 600 mg Film-coated tablet Oral use

Spain Abbott Laboratories, S.A. Avda. de Burgos, 91 28050 Madrid Spain

NEOBRUFEN RETARD 800 mg comprimidos de liberación prolongada

Ibuprofen 800 mg Coated tablet Oral use

Spain LACER, S.A. Sardenya, 350 08025 Barcelona Spain

NODOLFEN 400 mg comprimidos

Ibuprofen 400 mg Tablet Oral use

Spain Reckitt Benckiser Healthcare S.A. Mataró, 28. Granollers (Barcelona), 08403 Spain

NUROFEN (SODIO) 400 mg comprimidos recubiertos

Ibuprofen sodium 400 mg Coated tablet Oral use

Spain Reckitt Benckiser Healthcare S.A. Mataró, 28. Granollers (Barcelona), 08403 Spain

NUROFEN 400 mg comprimidos recubiertos

Ibuprofen 400 mg Film-coated tablet Oral use

Spain RATIOPHARM ESPAÑA, S.A. Avda. de Burgos, 16 D-5ª planta 28036 Madrid Spain

RATIODOL 400 mg comprimidos bucodispersables

Ibuprofen 400 mg Orodispersible tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 273/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Spain Angelini Farmaceutica, S.A. Osi 7-9 Barcelona 08034 Spain

TODALGIL 400 mg comprimidos recubiertos con película

Ibuprofen 400 mg Film-coated tablet Oral use

Spain ONEDOSE PHARMA, S.L. Ca l'Alegre de Dalt, 28-30 08024 Barcelona Spain

UNODOL 400 mg comprimidos recubiertos con película EFG

Ibuprofen 400 mg Film-coated tablet Oral use

Spain LABORATORIOS ERN, S.A. Pedro IV, 499 Barcelona 08020 Spain

APIROFENO 40 mg/ml SUSPENSION ORAL

Ibuprofen 40 mg/ml Oral suspension Oral use

Spain Angelini Farmaceutica, S.A. Osi 7-9 Barcelona 08034 Spain

DADOSEL 20 mg/ml SUSPENSIÓN ORAL

Ibuprofen 20 mg/ml Oral suspension Oral use

Spain Abbott Laboratories, S.A. Avda. de Burgos, 91 28050 Madrid Spain

DALSY 20 mg/ml SUSPENSION ORAL

Ibuprofen 20 mg/ml Oral suspension Oral use

Spain Abbott Laboratories, S.A. Avda. de Burgos, 91 28050 Madrid Spain

DALSY 40 mg/ml SUSPENSION ORAL

Ibuprofen 40 mg/ml Oral suspension Oral use

Spain Farmalider S.A. C/ Aragoneses, 15 Alcobendas (Madrid), 28108 Spain

IBUFARMALID 200 mg SUSPENSION ORAL

Ibuprofen 200 mg Oral suspension Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 274/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Spain Farmalider S.A. C/ Aragoneses, 15 Alcobendas (Madrid), 28108 Spain

IBUFARMALID 400 mg SUSPENSION ORAL

Ibuprofen 400 mg Oral suspension Oral use

Spain Farmalider S.A. C/ Aragoneses, 15 Alcobendas (Madrid), 28108 Spain

IBUFARMALID 600 mg SUSPENSION ORAL

Ibuprofen 600 mg Oral suspension Oral use

Spain KERN PHARMA, S.L. Venus, 72. Poligono Industrial Colon II. Tarrasa (Barcelona) 08228 Spain

IBUKERN 200 MG SUSPENSIÓN ORAL

Ibuprofen 200 mg Oral suspension Oral use

Spain KERN PHARMA, S.L. Venus, 72. Poligono Industrial Colon II. Tarrasa (Barcelona) 08228 Spain

IBUKERN 400 MG SUSPENSION ORAL

Ibuprofen 400 mg Oral suspension Oral use

Spain KERN PHARMA, S.L. Venus, 72. Poligono Industrial Colon II. Tarrasa (Barcelona) 08228 Spain

IBUKERN 600 MG SUSPENSION ORAL

Ibuprofen 600 mg Oral suspension Oral use

Spain Laboratorio Aldo Union, S.A. Baronesa de Malda, 73 Esplugues de Llobregat Barcelona 08950 Spain

IBUPROFENO ALDO-UNIÓN 20 mg/ml SUSPENSIÓN ORAL EFG

Ibuprofen 20 mg/ml Oral suspension Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 275/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Spain LABORATORIOS CINFA, S.A. Olaz-Chipi, 10 Polígono Industrial Areta 31620 Huarte-Pamplona (Navarra) Spain

IBUPROFENO CINFA 100 mg/ 5 ml SUSPENSION ORAL EFG

Ibuprofen 20 mg/ml Oral suspension Oral use

Spain LABORATORIOS CINFA, S.A. Olaz-Chipi, 10 Polígono Industrial Areta 31620 Huarte-Pamplona (Navarra) Spain

IBUPROFENO CINFA 40 MG/ML SUSPENSION ORAL EFG

Ibuprofen 40 mg/ml Oral suspension Oral use

Spain Farmalider S.A. C/ Aragoneses, 15 Alcobendas (Madrid), 28108 Spain

IBUPROFENO CODRAMOL 20 mg / ml SUSPENSION ORAL EFG

Ibuprofen 20 mg/ml Oral suspension Oral use

Spain LABORATORIOS DAVUR, S.L. Teide, 4-planta baja. Poligono Empresarial La Marina, San Sebastián de los Reyes (Madrid) 28703 Spain

IBUPROFENO DAVUR 20 mg/ ml SUSPENSIÓN ORAL EFG

Ibuprofen 20 mg/ml Oral suspension Oral use

Spain DERMOGEN FARMA, S.A. San Rafael, 3 28108 Alcobendas (Madrid) Spain

IBUPROFENO DERMOGEN 400 mg SUSPENSION ORAL

Ibuprofen 400 mg Oral suspension Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 276/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Spain Farmalider S.A. C/ Aragoneses, 15 Alcobendas (Madrid), 28108 Spain

IBUPROFENO FARMALID 20 mg/ml SUSPENSION ORAL EFG

Ibuprofen 20 mg/ml Oral suspension Oral use

Spain FARMASIERRA LABORATORIOS, S.L. Ctra. Irún, km.26,200 San Sebastián de los Reyes (Madrid) 28700 Spain

IBUPROFENO FARMASIERRA 20 mg/ml SUSPENSION ORAL

Ibuprofen 20 mg/ml Oral suspension Oral use

Spain KERN PHARMA, S.L. Venus, 72. Poligono Industrial Colon II. Tarrasa (Barcelona) 08228 Spain

IBUPROFENO KERN PHARMA 40 MG/ML SUSPENSION ORAL EFG

Ibuprofen 40 mg/ml Oral suspension Oral use

Spain KERN PHARMA, S.L. Venus, 72. Poligono Industrial Colon II. Tarrasa (Barcelona) 08228 Spain

IBUPROFENO KERN PHARMA 20 mg/ml SUSPENSION ORAL EFG

Ibuprofen 20 mg/ml Oral suspension Oral use

Spain LABORATORIOS NORMON, S.A. Ronda de Valdecarrizo, 6, Tres Cantos (Madrid), 28670 Spain

IBUPROFENO NORMON 20 mg/ml SUSPENSION ORAL EFG

Ibuprofen 20 mg/ml Oral suspension Oral use

Spain LABORATORIOS NORMON, S.A. Ronda de Valdecarrizo, 6, Tres Cantos (Madrid), 28670 Spain

IBUPROFENO NORMON 40 mg/ml SUSPENSION ORAL EFG

Ibuprofen 40 mg/ml Oral suspension Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 277/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Spain SANDOZ FARMACÉUTICA, S.A. Avda. Osa Mayor 28023 Aravaca (Madrid) Spain

IBUPROFENO SANDOZ 100 mg/5 ml SUSPENSION ORAL

Ibuprofen 20 mg/ml Oral suspension Oral use

Spain SANDOZ FARMACÉUTICA, S.A. Avda. Osa Mayor 28023 Aravaca (Madrid) Spain

IBUPROFENO SANDOZ 40 mg/ml SUSPENSION ORAL

Ibuprofen 40 mg/ml Oral suspension Oral use

Spain Reckitt Benckiser Healthcare S.A. Mataró, 28. Granollers (Barcelona), 08403 Spain

JUNIBU 40 MG/ML SUSPENSION ORAL EFG

Ibuprofen 40 mg/ml Oral suspension Oral use

Spain Reckitt Benckiser Healthcare S.A. Mataró, 28. Granollers (Barcelona), 08403 Spain

JUNIPRO 20 MG/ML SUSPENSION ORAL EFG

Ibuprofen 20 mg/ml Oral suspension Oral use

Spain DERMOGEN FARMA, S.A. San Rafael, 3 28108 Alcobendas (Madrid) Spain

LEVEDOL 100 mg/5 ml SUSPENSION ORAL

Ibuprofen 20 mg/ml Oral suspension Oral use

Spain Farmalider S.A. C/ Aragoneses, 15 Alcobendas (Madrid), 28108 Spain

LIDERFEME 400 mg SUSPENSION ORAL

Ibuprofen 400 mg Oral suspension Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 278/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Spain ITALFARMACO San Rafael, 3 28108 Alcobendas (Madrid) Spain

IBLASIN 20mg/ml SUSPENSION ORAL

Ibuprofen 20 mg/ml Oral suspension Oral use

Spain ITALFARMACO San Rafael, 3 28108 Alcobendas (Madrid) Spain

IBLASIN 40 mg/ml SUSPENSION ORAL

Ibuprofen 40 mg/ml Oral suspension Oral use

Spain Reckitt Benckiser Healthcare S.A. Mataró, 28. Granollers (Barcelona), 08403 Spain

NUROFEN 40 MG/ML SUSPENSION ORAL

Ibuprofen 40 mg/ml Oral suspension Oral use

Spain Laboratorio Aldo Union, S.A. Baronesa de Malda, 73 Esplugues de Llobregat Barcelona 08950 Spain

PAIDOFEBRIL 20 mg/ml SUSPENSIÓN ORAL

Ibuprofen 20 mg/ml Oral suspension Oral use

Spain LABORATORIOS JUVENTUS, S.A. Julián Camarillo, 37 Madrid, 28037 Spain

PIREXIN 20 mg/ml SUSPENSION ORAL

Ibuprofen 20 mg/ml Oral suspension Oral use

Spain LABORATORIOS JUVENTUS, S.A. Julián Camarillo, 37 Madrid, 28037 Spain

PIREXIN 200 mg/5 ml SUSPENSION ORAL

Ibuprofen 40 mg/ml Oral suspension Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 279/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Spain RATIOPHARM ESPAÑA, S.A. Avda. de Burgos, 16 D-5ª planta 28036 Madrid Spain

RATIODOL 20 mg/ ml SUSPENSION ORAL

Ibuprofen 20 mg/ml Oral suspension Oral use

Spain FARDI, S.A. (APLICACIONES FARMACODINAMICAS) Grassot, 16 Barcelona, 08025, Spain

ALGIDRIN 600 POLVO PARA SUSPENSION ORAL

Ibuprofen lysinate 600 mg Powder for oral suspension

Oral use

Spain FARDI, S.A. (APLICACIONES FARMACODINAMICAS) Grassot, 16 Barcelona, 08025, Spain

ALGIFAST 400 mg POLVO PARA SUSPENSION ORAL

Ibuprofen lysinate 400 mg Powder for oral suspension

Oral use

Spain FARDI, S.A. (APLICACIONES FARMACODINAMICAS) Grassot, 16 Barcelona, 08025, Spain

ALOGESIA 600 POLVO PARA SUSPENSION ORAL

Ibuprofen lysinate 600 mg Powder for oral suspension

Oral use

Spain FARDI, S.A. (APLICACIONES FARMACODINAMICAS) Grassot, 16 Barcelona, 08025, Spain

DOLORAC 600 mg POLVO PARA SUSPENSION ORAL

Ibuprofen lysinate 600 mg Powder for oral suspension

Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 280/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Spain FARDI, S.A. (APLICACIONES FARMACODINAMICAS) Grassot, 16 Barcelona, 08025, Spain

NORVECTAN 600 POLVO PARA SUSPENSION ORAL

Ibuprofen lysinate 600 mg Powder for oral suspension

Oral use

Spain PHARMADIET, S.L.U. C/ Blanquers, 85 Banyoles, 17820 Spain

FENOSPIN 400 mg POLVO PARA SOLUCION ORAL

Ibuprofen lysinate 400 mg Powder for oral solution

Oral use

Spain Reckitt Benckiser Healthcare S.A. Mataró, 28. Granollers (Barcelona), 08403 Spain

NUROFEN FAST (LISINA) 400 MG POLVO PARA SOLUCION ORAL

Ibuprofen lysinate 400 mg Powder for oral solution

Oral use

Spain Abbott Laboratories, S.A. Avda. de Burgos, 91 28050 Madrid Spain

DALSY 200 mg GRANULADO EFERVESCENTE

Ibuprofen 200 mg Effervescent granules Oral use

Spain Abbott Laboratories, S.A. Avda. de Burgos, 91 28050 Madrid Spain

DALSY 400 MG GRANULADO EFERVESCENTE

Ibuprofen 400 mg Effervescent granules Oral use

Spain Abbott Laboratories, S.A. Avda. de Burgos, 91 28050 Madrid Spain

IBUPROFENO ABBOTT 600 GRANULADO EFERVESCENTE EFG

Ibuprofen 600 mg Effervescent granules Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 281/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Spain KERN PHARMA, S.L. Venus, 72. Poligono Industrial Colon II. Tarrasa (Barcelona) 08228 Spain

IBUPROFENO ABEX 600 MG GRANULADO EFERVESCENTE EFG

Ibuprofen 600 mg Effervescent granules Oral use

Spain KERN PHARMA, S.L. Venus, 72. Poligono Industrial Colon II. Tarrasa (Barcelona) 08228 Spain

IBUPROFENO KERN PHARMA 200 mg GRANULADO EFERVESCENTE EFG

Ibuprofen 200 mg Effervescent granules Oral use

Spain KERN PHARMA, S.L. Venus, 72. Poligono Industrial Colon II. Tarrasa (Barcelona) 08228 Spain

IBUPROFENO KERN PHARMA 600 mg GRANULADO EFERVESCENTE EFG

Ibuprofen 600 mg Effervescent granules Oral use

Spain PENSA PHARMA, S.A.U. Jorge Comín (médico pediatra), 3 46015 Valencia Spain

IBUPROFENO PENSA 600 mg GRANULADO EFERVESCENTE EFG

Ibuprofen 600 mg Effervescent granules Oral use

Spain Abbott Laboratories, S.A. Avda. de Burgos, 91 28050 Madrid Spain

NEOBRUFEN 600 mg GRANULADO EFERVESCENTE

Ibuprofen 600 mg Effervescent granules Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 282/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Spain ZAMBON, S.A. Maresme, s/n Polígono Urvasa 08130 Sta. Perpetua de la Mogoda (Barcelona) Spain

ESCARMINE 600 mg GRANULADO PARA SOLUCION ORAL SABOR MENTA

Ibuprofen arginine 600 mg Granules for oral solution

Oral use

Spain ZAMBON, S.A. Maresme, s/n Polígono Urvasa 08130 Sta. Perpetua de la Mogoda (Barcelona) Spain

ESCARMINE 600 mg GRANULADO PARA SOLUCION ORAL SABOR LIMON

Ibuprofen arginine 600 mg Granules for oral solution

Oral use

Spain ZAMBON, S.A. Maresme, s/n Polígono Urvasa 08130 Sta. Perpetua de la Mogoda (Barcelona) Spain

ESPIDIDOL 400 mg GRANULADO PARA SOLUCION ORAL SABOR LIMON

Ibuprofen arginine 400 mg Granules for oral solution

Oral use

Spain ZAMBON, S.A. Maresme, s/n Polígono Urvasa 08130 Sta. Perpetua de la Mogoda (Barcelona) Spain

ESPIDIDOL 400 mg GRANULADO PARA SOLUCION ORAL SABOR MENTA

Ibuprofen arginine 400 mg Granules for oral solution

Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 283/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Spain ZAMBON, S.A. Maresme, s/n Polígono Urvasa 08130 Sta. Perpetua de la Mogoda (Barcelona) Spain

ESPIDIFEN 400 mg GRANULADO PARA SOLUCION ORAL SABOR ALBARICOQUE

Ibuprofen arginine 400 mg Granules for oral solution

Oral use

Spain ZAMBON, S.A. Maresme, s/n Polígono Urvasa 08130 Sta. Perpetua de la Mogoda (Barcelona) Spain

ESPIDIFEN 400 mg GRANULADO PARA SOLUCION ORAL SABOR MENTA

Ibuprofen arginine 400 mg Granules for oral solution

Oral use

Spain ZAMBON, S.A. Maresme, s/n Polígono Urvasa 08130 Sta. Perpetua de la Mogoda (Barcelona) Spain

ESPIDIFEN 600 mg GRANULADO PARA SOLUCION ORAL SABOR ALBARICOQUE

Ibuprofen arginine 600 mg Granules for oral solution

Oral use

Spain ZAMBON, S.A. Maresme, s/n Polígono Urvasa 08130 Sta. Perpetua de la Mogoda (Barcelona) Spain

ESPIDIFEN 600 mg GRANULADO PARA SOLUCION ORAL SABOR LIMON EFG

Ibuprofen arginine 600 mg Granules for oral solution

Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 284/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Spain ZAMBON, S.A. Maresme, s/n Polígono Urvasa 08130 Sta. Perpetua de la Mogoda (Barcelona) Spain

ESPIDIFEN 600 mg GRANULADO PARA SOLUCION ORAL SABOR MENTA EFG

Ibuprofen arginine 600 mg Granules for oral solution

Oral use

Spain Farmalider S.A. C/ Aragoneses, 15 Alcobendas (Madrid), 28108 Spain

FEBRIROL 200 MG GRANULADO PARA SOLUCION ORAL

Ibuprofen arginine 200 mg Granules for oral solution

Oral use

Spain LABORATORIOS CINFA, S.A. Olaz-Chipi, 10 Polígono Industrial Areta 31620 Huarte-Pamplona (Navarra) Spain

IBUPROFENO (ARGININA) CINFA 400 mg GRANULADO PARA SOLUCION ORAL EFG

Ibuprofen arginine 400 mg Granules for oral solution

Oral use

Spain LABORATORIOS CINFA, S.A. Olaz-Chipi, 10 Polígono Industrial Areta 31620 Huarte-Pamplona (Navarra) Spain

IBUPROFENO (ARGININA) CINFA 600 mg GRANULADO PARA SOLUCION ORAL EFG

Ibuprofen arginine 600 mg Granules for oral solution

Oral use

Spain LABORATORIOS CINFA, S.A. Olaz-Chipi, 10 Polígono Industrial Areta 31620 Huarte-Pamplona (Navarra) Spain

IBUPROFENO (ARGININA) CINFAMED 400 mg GRANULADO PARA SOLUCION ORAL EFG

Ibuprofen arginine 400 mg Granules for oral solution

Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 285/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Spain LABORATORIOS CINFA, S.A. Olaz-Chipi, 10 Polígono Industrial Areta 31620 Huarte-Pamplona (Navarra) Spain

IBUPROFENO (ARGININA) CINFAMED 600 mg GRANULADO PARA SOLUCION ORAL EFG

Ibuprofen arginine 600 mg Granules for oral solution

Oral use

Spain Farmalider S.A. C/ Aragoneses, 15 Alcobendas (Madrid), 28108 Spain

IBUPROFENO (ARGININA) CODRAMOL 400 mg GRANULADO PARA SOLUCION ORAL EFG

Ibuprofen arginine 400 mg Granules for oral solution

Oral use

Spain Farmalider S.A. C/ Aragoneses, 15 Alcobendas (Madrid), 28108 Spain

IBUPROFENO (ARGININA) CODRAMOL 600 mg GRANULADO PARA SOLUCION ORAL EFG

Ibuprofen arginine 600 mg Granules for oral solution

Oral use

Spain LABORATORIOS COMBIX, S.L.U. Badajoz, 2, Edificio 2 28223 Pozuelo de Alarcón (Madrid) Spain

IBUPROFENO (ARGININA) COMBIX 600 mg GRANULADO PARA SOLUCION ORAL EFG

Ibuprofen arginine 600 mg Granules for oral solution

Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 286/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Spain LABORATORIOS PEREZ GIMENEZ, S.A. Polígono Industrial Los Mochos Polígono 8-parcela 20. Crta. A-431, Km. 19 14720 Almodovar del Río (Córdoba) Spain

IBUPROFENO (ARGININA) CUVE 600 mg GRANULADO PARA SOLUCION ORAL EFG

Ibuprofen arginine 600 mg Granules for oral solution

Oral use

Spain Farmalider S.A. C/ Aragoneses, 15 Alcobendas (Madrid), 28108 Spain

IBUPROFENO (ARGININA) FARMALIDER 200 MG GRANULADO PARA SOLUCION ORAL

Ibuprofen arginine 200 mg Granules for oral solution

Oral use

Spain KERN PHARMA, S.L. Venus, 72. Poligono Industrial Colon II. Tarrasa (Barcelona) 08228 Spain

IBUPROFENO (ARGININA) KERN PHARMA 600 mg GRANULADO PARA SOLUCION ORAL EFG

Ibuprofen arginine 600 mg Granules for oral solution

Oral use

Spain MYLAN PHARMACEUTICALS, S.L. Plom 2-4, 5º planta 08038 Barcelona Spain

IBUPROFENO (ARGININA) MYLAN 600 mg GRANULADO PARA SOLUCION ORAL EFG

Ibuprofen arginine 600 mg Granules for oral solution

Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 287/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Spain LABORATORIOS NORMON, S.A. Ronda de Valdecarrizo, 6, Tres Cantos (Madrid), 28670 Spain

IBUPROFENO (ARGININA) NORMON 400 mg GRANULADO PARA SOLUCION ORAL EFG

Ibuprofen arginine 400 mg Granules for oral solution

Oral use

Spain LABORATORIOS NORMON, S.A. Ronda de Valdecarrizo, 6, Tres Cantos (Madrid), 28670 Spain

IBUPROFENO (ARGININA) NORMON 600 mg GRANULADO PARA SOLUCION ORAL EFG

Ibuprofen arginine 600 mg Granules for oral solution

Oral use

Spain PENSA PHARMA, S.A.U. Jorge Comín (médico pediatra), 3 46015 Valencia Spain

IBUPROFENO (ARGININA) PENSA 600 mg GRANULADO PARA SOLUCION ORAL EFG

Ibuprofen arginine 600 mg Granules for oral solution

Oral use

Spain RATIOPHARM ESPAÑA, S.A. Avda. de Burgos, 16 D-5ª planta 28036 Madrid Spain

IBUPROFENO (ARGININA) RATIOPHARM 600 mg GRANULADO PARA SOLUCION ORAL EFG

Ibuprofen arginine 600 mg Granules for oral solution

Oral use

Spain SANDOZ FARMACÉUTICA, S.A. Avda. Osa Mayor 28023 Aravaca (Madrid) Spain

IBUPROFENO (ARGININA) SANDOZ 600 mg GRANULADO PARA SOLUCION ORAL EFG

Ibuprofen arginine 600 mg Granules for oral solution

Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 288/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Spain LABORATORIO STADA, S.A. Frederic Mompou, 5 08960 Sant Just Desvern (Barcelona) Spain

IBUPROFENO (ARGININA) STADA 600 mg GRANULADO PARA SOLUCION ORAL EFG

Ibuprofen arginine 600 mg Granules for oral solution

Oral use

Spain TARBIS FARMA, S.L. Gran Via Carlos III, 94, Barcelona, 08028 Spain

IBUPROFENO (ARGININA) TARBIS 600 mg GRANULADO PARA SOLUCION ORAL EFG

Ibuprofen arginine 600 mg Granules for oral solution

Oral use

Spain TECNIMEDE ESPAÑA INDUSTRIA FARMACEUTICA, S.A. Avda. de Bruselas, 13, 3º D.Edificio América. Polígono Arroyo de la Vega, Alcobendas (Madrid), 28108 Spain

IBUPROFENO (ARGININA) TECNIGEN 600 mg GRANULADO PARA SOLUCION ORAL EFG

Ibuprofen arginine 600 mg Granules for oral solution

Oral use

Spain TEVA PHARMA, S.L.U. Anabel Segura, 11, Edificio Albatros B, 1ª planta 28108 Alcobendas (Madrid) Spain

IBUPROFENO (ARGININA) TEVA 600 mg GRANULADO PARA SOLUCIÓN ORAL EFG

Ibuprofen 600 mg Granules for oral solution

Oral use

Spain Zentiva, k.s. U kabelovny 130 102 37 Praha 10 Dolní Měcholupy Czech Republic

IBUPROFENO (ARGININA) ZENTIVA 600 mg GRANULADO PARA SOLUCION ORAL EFG

Ibuprofen arginine 600 mg Granules for oral solution

Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 289/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Spain LABORATORIOS NORMON, S.A. Ronda de Valdecarrizo, 6, Tres Cantos (Madrid), 28670, Spain

NORMODOL 400 mg GRANULADO PARA SOLUCION ORAL EFG

Ibuprofen arginine 400 mg Granules for oral solution

Oral use

Spain Farmalider S.A. C/ Aragoneses, 15 Alcobendas (Madrid), 28108 Spain

POINDOL 200 MG GRANULADO PARA SOLUCION ORAL

Ibuprofen arginine 200 mg Granules for oral solution

Oral use

Spain ROBAPHARM ESPAÑA, S.A. Ramon Trias Fargas, 7-11, Barcelona, 08005 Spain

SAETIL 400 mg GRANULADO PARA SOLUCION ORAL

Ibuprofen arginine 400 mg Granules for oral solution

Oral use

Spain ROBAPHARM ESPAÑA, S.A. Ramon Trias Fargas, 7-11, Barcelona, 08005 Spain

SAETIL 600 mg GRANULADO PARA SOLUCION ORAL

Ibuprofen arginine 600 mg Granules for oral solution

Oral use

Spain Boehringer Ingelheim International GmbH Binger Straße 173 55216 Ingelheim am Rhein Germany

BUSCAFEM 400 MG CAPSULAS BLANDAS EFG

Ibuprofen 400 mg Capsule, soft Oral use

Spain Ceninter, S.A. Avda. San Pablo, 27 Coslada (Madrid), 28823 Spain

DOLENCAR 200 mg CAPSULAS BLANDAS

Ibuprofen 200 mg Capsule, soft Oral use

Spain Ceninter, S.A. Avda. San Pablo, 27 Coslada (Madrid), 28823 Spain

DOLENCAR 400 mg CAPSULAS BLANDAS

Ibuprofen 400 mg Capsule, soft Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 290/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Spain Juste, S.A.Q.F. Avda. San Pablo, 27 Coslada (Madrid) 28823 Spain

DOLTRA 200 mg CAPSULAS BLANDAS

Ibuprofen 200 mg Capsule, soft Oral use

Spain Juste, S.A.Q.F. Avda. San Pablo, 27 Coslada (Madrid) 28823 Spain

DOLTRA 400 mg CAPSULAS BLANDAS

Ibuprofen 400 mg Capsule, soft Oral use

Spain Reckitt Benckiser Healthcare S.A. Mataró, 28. Granollers (Barcelona), 08403 Spain

NUROFEN 400 mg CAPSULAS BLANDAS

Ibuprofen 400 mg Capsule, soft Oral use

Spain LABORATORIOS GEBRO PHARMA, S.A. Avenida Tibidabo, 29 08022 Barcelona Spain

ATRISCAL 300 mg comprimidos recubiertos con película

Dexibuprofen 300 mg Film-coated tablet Oral use

Spain LABORATORIOS GEBRO PHARMA, S.A. Avenida Tibidabo, 29 08022 Barcelona Spain

ATRISCAL 400 mg comprimidos recubiertos con película

Dexibuprofen 400 mg Film-coated tablet Oral use

Spain LABORATORIOS GEBRO PHARMA, S.A. Avenida Tibidabo, 29 08022 Barcelona Spain

SERACTIL 400 mg comprimidos recubiertos con película

Dexibuprofen 400 mg Film-coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 291/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Spain FARMASIERRA LABORATORIOS, S.L. Ctra. Irún, km.26,200 San Sebastián de los Reyes (Madrid) 28700 Spain

ASTEFOR 400 mg/30 mg comprimidos recubiertos con película

Ibuprofen codeine phosphate hemihydrate

400 mg 30 mg

Film-coated tablet Oral use

Spain Abbott Laboratories, S.A. Avda. de Burgos, 91 28050 Madrid Spain

NEOBRUFEN CON CODEÍNA 400 mg/30 mg comprimidos recubiertos con película

Ibuprofen codeine phosphate hemihydrate

400 mg 30 mg

Film-coated tablet Oral use

Spain Cantabria Pharma, S.L. Ribera del Loira, 46 edificio 2 28042 Madrid Spain

NIDOL 400 mg/30 mg comprimidos recubiertos con película

Ibuprofen codeine phosphate hemihydrate

400 mg 30 mg

Film-coated tablet Oral use

Spain Boehringer Ingelheim International GmbH Binger Straße 173 55216 Ingelheim am Rhein Germany

BISOLFREN 200 mg/30 mg comprimidos recubiertos con película

Ibuprofen pseudoephedrine hydrochloride

200 mg 30 mg

Film-coated tablet Oral use

Spain FARMASIERRA LABORATORIOS, S.L. Ctra. Irún, km.26,200 San Sebastián de los Reyes (Madrid) 28700 Spain

ASTEFOR 400 mg/30 mg GRANULADO PARA SUSPENSION ORAL

Ibuprofen codeine phosphate hemihydrate

400 mg 30 mg

Granules for oral suspension

Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 292/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Spain KERN PHARMA, S.L. Venus, 72. Poligono Industrial Colon II. Tarrasa (Barcelona) 08228 Spain

IBUKERN (ARGININA) CODEINA 200 MG/ML + 10 MG/ML SOLUCION ORAL

Ibuprofen arginine codeine phosphate hemihydrate

200 mg/ml 10 mg/ml

Oral solution Oral use

Spain Farmalider S.A. C/ Aragoneses, 15 Alcobendas (Madrid), 28108 Spain

IBUCOD 200 MG/ML + 10 MG/ML SOLUCION ORAL

Ibuprofen arginine codeine phosphate hemihydrate

200 mg/ml 10 mg/ml

Oral solution Oral use

Spain LABORATORIOS SALVAT, S.A. Gall, 30-36 Esplugues de Llobregat (Barcelona) 08950 Spain

SALVARINA CAPSULAS

Ibuprofen caffeine dimenhydrinate

200 mg 50 mg 15 mg

Capsule, hard Oral use

Sweden Recip AB P.O Box 906 SE-170 09 Solna Sweden

Alindrin Ibuprofen 600 mg Film-coated tablet Oral use

Sweden Recip AB P.O Box 906 SE-170 09 Solna Sweden

Alindrin Ibuprofen 200 mg Film-coated tablet Oral use

Sweden Recip AB P.O Box 906 SE-170 09 Solna Sweden

Alindrin Ibuprofen 400 mg Film-coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 293/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Sweden Mundipharma AB, Mölndalsvägen 30 B SE-412 63 Göteborg, Sweden

Ardinex Ibuprofen codeine phosphate hemihydrate

200 mg 30 mg

Tablet Oral use

Sweden Abbott Scandinavia AB P.O Box 1498 SE-171 29 Solna Sweden

Brufen Ibuprofen 400 mg Effervescent granules Oral use

Sweden Abbott Scandinavia AB P.O Box 1498 SE-171 29 Solna Sweden

Brufen Ibuprofen 200 mg Film-coated tablet Oral use

Sweden Abbott Scandinavia AB P.O Box 1498 SE-171 29 Solna Sweden

Brufen Ibuprofen 400 mg Film-coated tablet Oral use

Sweden Abbott Scandinavia AB P.O Box 1498 SE-171 29 Solna Sweden

Brufen Ibuprofen 20 mg/ml Oral suspension Oral use

Sweden Abbott Scandinavia AB P.O Box 1498 SE-171 29 Solna Sweden

Brufen Ibuprofen 600 mg Film-coated tablet Oral use

Sweden Abbott Scandinavia AB P.O Box 1498 SE-171 29 Solna Sweden

Brufen Retard Ibuprofen 800 mg Prolonged-release tablet

Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 294/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Sweden Orion Corporation Orionintie 1 FIN-02200 Espoo Finland

Burana Ibuprofen 800 mg Film-coated tablet Oral use

Sweden Orion Corporation Orionintie 1 FIN-02200 Espoo Finland

Burana Ibuprofen 200 mg Film-coated tablet Oral use

Sweden Orion Corporation Orionintie 1 FIN-02200 Espoo Finland

Burana Ibuprofen 400 mg Film-coated tablet Oral use

Sweden Orion Corporation Orionintie 1 FIN-02200 Espoo Finland

Burana Ibuprofen 600 mg Film-coated tablet Oral use

Sweden Orion Corporation Orionintie 1 FIN-02200 Espoo Finland

Burana Comp Ibuprofen codeine phosphate hemihydrate

200 mg 30 mg

Film-coated tablet Oral use

Sweden Orion Corporation Orionintie 1 FIN-02200 Espoo Finland

Burana Comp Ibuprofen codeine phosphate hemihydrate

400 mg/60 mg

Film-coated tablet Oral use

Sweden Infirst Healthcare Ltd. Strand 265 London WC2R 1BH United Kingdom

Flarin Ibuprofen 200 mg Capsule, soft Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 295/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Sweden Infirst Healthcare Ltd. Strand 265 London WC2R 1BH United Kingdom

Flarin Ibuprofen 400 mg Capsule, soft Oral use

Sweden Vitabalans Oy Varastokatu 8 FI-13500 Tavastehus Finland

Ibumax Ibuprofen 200 mg Film-coated tablet Oral use

Sweden Vitabalans Oy Varastokatu 8 FI-13500 Tavastehus Finland

Ibumax Ibuprofen 400 mg Film-coated tablet Oral use

Sweden Vitabalans Oy Varastokatu 8 FI-13500 Tavastehus Finland

Ibumax Ibuprofen 600 mg Film-coated tablet Oral use

Sweden Takeda Pharma AB P.O Box 3131 SE-169 03 Solna Sweden

Ibumetin Ibuprofen 200 mg Tablet Oral use

Sweden Takeda Pharma AB P.O Box 3131 SE-169 03 Solna Sweden

Ibumetin Ibuprofen 400 mg Tablet Oral use

Sweden Takeda Pharma AB P.O Box 3131 SE-169 03 Solna Sweden

Ibumetin Ibuprofen 600 mg Tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 296/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Sweden Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland

Ibuprofen Actavis Ibuprofen 200 mg Film-coated tablet Oral use

Sweden Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland

Ibuprofen Actavis Ibuprofen 400 mg Film-coated tablet Oral use

Sweden Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland

Ibuprofen Actavis Ibuprofen 600 mg Film-coated tablet Oral use

Sweden Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland

Ibuprofen Actavis Ibuprofen 800 mg Film-coated tablet Oral use

Sweden Apofri AB P.O Box 120 SE-182 12 Danderyd Sweden

Ibuprofen Apofri Ibuprofen 200 mg Film-coated tablet Oral use

Sweden Apofri AB P.O Box 120 SE-182 12 Danderyd Sweden

Ibuprofen Apofri Ibuprofen 400 mg Film-coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 297/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Sweden Banner Pharmacaps Europe B.V. De Posthoornstraat 7 5048 AS Tilburg The Netherlands

Ibuprofen Banner Ibuprofen 400 mg Capsule, soft Oral use

Sweden Farmalider S.A. C/ Aragoneses, 15 Alcobendas (Madrid), 28108 Spain

Ibuprofen Farmalider Ibuprofen 20 mg/ml Oral suspension Oral use

Sweden Farmalider S.A. C/ Aragoneses, 15 Alcobendas (Madrid), 28108 Spain

Ibuprofen Farmalider Ibuprofen 40 mg/ml Oral suspension Oral use

Sweden Orifarm Generics A/S Energivej 15 POB 69 DK-5260 Odense S Denmark

Ibuprofen Orifarm Ibuprofen 200 mg Film-coated tablet Oral use

Sweden Orifarm Generics A/S Energivej 15 POB 69 DK-5260 Odense S Denmark

Ibuprofen Orifarm Ibuprofen 400 mg Film-coated tablet Oral use

Sweden Orifarm Generics A/S Energivej 15 POB 69 DK-5260 Odense S Denmark

Ibuprofen Orifarm Ibuprofen 600 mg Film-coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 298/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Sweden ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany

Ibuprofen ratiopharm Ibuprofen 200 mg Film-coated tablet Oral use

Sweden ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany

Ibuprofen ratiopharm Ibuprofen 400 mg Film-coated tablet Oral use

Sweden Apofri AB P.O Box 120 SE-182 12 Danderyd Sweden

Ibuzin Ibuprofen lysine 400 mg Film-coated tablet Oral use

Sweden Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland

Ifenin Ibuprofen 200 mg Film-coated tablet Oral use

Sweden Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland

Ifenin Ibuprofen 400 mg Film-coated tablet Oral use

Sweden McNeil Sweden AB SE-169 90 Solna Sweden

Ipren Ibuprofen 200 mg Film-coated tablet Oral use

Sweden McNeil Sweden AB SE-169 90 Solna Sweden

Ipren Ibuprofen 400 mg Film-coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 299/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

Sweden McNeil Sweden AB SE-169 90 Solna Sweden

Ipren Ibuprofen 400 mg Capsule, soft Oral use

Sweden Nordic Drugs AB Box 30035 200 61 limhamn Sweden

Tradil Dexibuprofen 300 mg Film-coated tablet Oral use

Sweden Nordic Drugs AB Box 30035 200 61 limhamn Sweden

Tradil Dexibuprofen 400 mg Film-coated tablet Oral use

The Netherlands

Abbott B.V Wegalaan 9 2132 JD HOOFDDORP The Netherlands

Brufen Bruis, bruisgranulaat in sachets 600 mg

Ibuprofen 600 mg Effervescent granules Oral use

The Netherlands

Abbott B.V Wegalaan 9 2132 JD HOOFDDORP The Netherlands

Brufen Retard, tabletten met gereguleerde afgifte 800 mg

Ibuprofen 800 mg Prolonged-release tablet

Oral use

The Netherlands

Abbott B.V Wegalaan 9 2132 JD HOOFDDORP The Netherlands

Brufen 400 mg bruisgranulaat

Ibuprofen 400 mg Effervescent granules Oral use

The Netherlands

Accord Healthcare Ltd Sage House, 319 Pinner Road HA1 4 HF North Harrow Middlesex United Kingdom

Ibuprofen Accord 200 mg, filmomhulde tabletten

Ibuprofen 200 mg Film-coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 300/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

The Netherlands

Accord Healthcare Ltd Sage House, 319 Pinner Road HA1 4 HF North Harrow Middlesex United Kingdom

Ibuprofen Accord 400 mg, filmomhulde tabletten

Ibuprofen 400 mg Film-coated tablet Oral use

The Netherlands

Actavis B.V. Baarnsche Dijk 1 3741 LN Baarn The Netherlands

Ibuprofen Actavis Liquid Caps 400 mg, capsule, zacht

Ibuprofen 400 mg Capsule, soft Oral use

The Netherlands

Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland

Ibuprofen Actavis 200 mg, filmomhulde tabletten

Ibuprofen 200 mg Film-coated tablet Oral use

The Netherlands

Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland

Ibuprofen Actavis 400 mg, filmomhulde tabletten

Ibuprofen 400 mg Film-coated tablet Oral use

The Netherlands

Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland

Ibuprofen Actavis 400 mg, filmomhulde tabletten

Ibuprofen 400 mg Film-coated tablet Oral use

The Netherlands

Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland

Ibuprofen Actavis 600 mg, filmomhulde tabletten

Ibuprofen 600 mg Film-coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 301/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

The Netherlands

Albert Heijn BV Provinciale weg 11 1506 MA Zaandam The Netherlands

Albert Heijn Ibuprofen 200 mg , omhulde tabletten

Ibuprofen 200 mg Coated tablet Oral use

The Netherlands

Albert Heijn BV Provinciale weg 11 1506 MA Zaandam The Netherlands

Albert Heijn Ibuprofen 400 mg , omhulde tabletten

Ibuprofen 400 mg Coated tablet Oral use

The Netherlands

Apotex Europe B.V. Darwinweg 20 2333 CR Leiden The Netherlands

Ibuprofen Apotex 200 mg, omhulde tabletten

Ibuprofen 200 mg Coated tablet Oral use

The Netherlands

Apotex Europe B.V. Darwinweg 20 2333 CR Leiden The Netherlands

Ibuprofen Apotex 200 mg, tabletten

Ibuprofen 200 mg Film-coated tablet Oral use

The Netherlands

Apotex Europe B.V. Darwinweg 20 2333 CR Leiden The Netherlands

Ibuprofen Apotex 400 mg capsules, zacht

Ibuprofen 400 mg Capsule, soft Oral use

The Netherlands

Apotex Europe B.V. Darwinweg 20 2333 CR Leiden The Netherlands

Ibuprofen Apotex 400 mg, omhulde tabletten

Ibuprofen 400 mg Film-coated tablet Oral use

The Netherlands

Apotex Europe B.V. Darwinweg 20 2333 CR Leiden The Netherlands

Ibuprofen Apotex 400 mg, omhulde tabletten

Ibuprofen 400 mg Coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 302/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

The Netherlands

Apotex Europe B.V. Darwinweg 20 2333 CR Leiden The Netherlands

Ibuprofen Apotex 400 mg, tabletten

Ibuprofen 400 mg Film-coated tablet Oral use

The Netherlands

Apotex Europe B.V. Darwinweg 20 2333 CR Leiden The Netherlands

Ibuprofen Apotex 500 mg, zetpillen

Ibuprofen 500 mg Suppository Rectal use

The Netherlands

Apotex Europe B.V. Darwinweg 20 2333 CR Leiden The Netherlands

Ibuprofen Apotex 600 mg, omhulde tabletten

Ibuprofen 600 mg Film-coated tablet Oral use

The Netherlands

Apotex Europe B.V. Darwinweg 20 2333 CR Leiden The Netherlands

Ibuprofen Apotex 600 mg, tabletten

Ibuprofen 600 mg Film-coated tablet Oral use

The Netherlands

Apotex Europe B.V. Darwinweg 20 2333 CR Leiden The Netherlands

Ibuprofen liquid caps Apotex 400 mg, capsules, zacht

Ibuprofen 400 mg Capsule, soft Oral use

The Netherlands

Banner Pharmacaps Europe B.V. De Posthoornstraat 7 5048 AS Tilburg The Netherlands

Ibuprofen Banner 100 mg, kauwcapsules, zacht

Ibuprofen 100 mg Chewable capsule, soft Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 303/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

The Netherlands

Banner Pharmacaps Europe B.V. De Posthoornstraat 7 5048 AS Tilburg The Netherlands

Ibuprofen Banner 400 mg capsules, zacht

Ibuprofen 400 mg Capsule, soft Oral use

The Netherlands

Bayer B.V. Energieweg 1 3641 RT Mijdrecht The Netherlands

Saridon ibuprofen 200 mg, filmomhulde tabletten

Ibuprofen 200 mg Film-coated tablet Oral use

The Netherlands

Bayer B.V. Energieweg 1 3641 RT Mijdrecht The Netherlands

Sarixell 400 mg, filmomhulde tabletten

Ibuprofen 400 mg Film-coated tablet Oral use

The Netherlands

Centrafarm B.V. Nieuwe Donk 3 4879 AC Etten Leur The Netherlands

Ibuprofen CF 600 mg, omhulde tabletten

Ibuprofen 600 mg Film-coated tablet Oral use

The Netherlands

Centrafarm B.V. Nieuwe Donk 3 4879 AC Etten Leur The Netherlands

Ibuprofen CF 400 mg, omhulde tabletten

Ibuprofen 400 mg Film-coated tablet Oral use

The Netherlands

ETOS B.V. Provincialeweg 11 1506 MA Zaandam The Netherlands

Etos Ibuprofen Liquid caps 400 mg, capsules, zacht

Ibuprofen 400 mg Capsule, soft Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 304/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

The Netherlands

Fair-Med Healthcare GmbH Planckstr. 13 22765 Hamburg Germany

Ibuprofen FAIR-MED 200 mg filmomhulde tabletten

Ibuprofen 200 mg Film-coated tablet Oral use

The Netherlands

Fair-Med Healthcare GmbH Planckstr. 13 22765 Hamburg Germany

Ibuprofen FAIR-MED 400 mg filmomhulde tabletten

Ibuprofen 400 mg Film-coated tablet Oral use

The Netherlands

Fair-Med Healthcare GmbH Planckstr. 13 22765 Hamburg Germany

Ibuprofen FAIR-MED 600 mg filmomhulde tabletten

Ibuprofen 600 mg Film-coated tablet Oral use

The Netherlands

Galpharm Healthcare Limited Hugh House Upper Cliffe Road Barnsley, South Yorkshire S75 3SP Dodworth Dodworth Bussiness Park United Kingdom

Ibuprofen Galpharm 200 mg, filmomhulde tabletten

Ibuprofen 200 mg Film-coated tablet Oral use

The Netherlands

Galpharm Healthcare Limited Hugh House Upper Cliffe Road Barnsley, South Yorkshire S75 3SP Dodworth Dodworth Bussiness Park United Kingdom

Ibuprofen Galpharm 400 mg, filmomhulde tabletten

Ibuprofen 400 mg Film-coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 305/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

The Netherlands

GenRx B.V. Dijkgraaf 30 6921 RL Duiven The Netherlands

Ibuprofen 400 mg, tabletten

Ibuprofen 400 mg Film-coated tablet Oral use

The Netherlands

GenRx B.V. Dijkgraaf 30 6921 RL Duiven The Netherlands

Ibuprofen 600 mg, tabletten

Ibuprofen 600 mg Film-coated tablet Oral use

The Netherlands

Healthypharm B.V. Nieuwe Donk 3 4879 AC Etten-Leur The Netherlands

Ibuprofen HTP liquid caps 400 mg, capsules, zacht

Ibuprofen 400 mg Capsule, soft Oral use

The Netherlands

Healthypharm B.V. Nieuwe Donk 3 4879 AC Etten-Leur The Netherlands

Ibuprofen HTP 200 mg, omhulde tabletten

Ibuprofen 200 mg Film-coated tablet Oral use

The Netherlands

Healthypharm B.V. Nieuwe Donk 3 4879 AC Etten-Leur The Netherlands

Ibuprofen HTP 400 mg, omhulde tabletten

Ibuprofen 400 mg Film-coated tablet Oral use

The Netherlands

Healthypharm B.V. Nieuwe Donk 3 4879 AC Etten-Leur The Netherlands

Ibuprofen liquid caps 400 mg HTP Huismerk, capsules, zacht

Ibuprofen 400 mg Capsule, soft Oral use

The Netherlands

HEMA B.V. NDSM-straat 10 1033 SB Amsterdam The Netherlands

HEMA Ibuprofen 200 mg, omhulde tabletten

Ibuprofen 200 mg Film-coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 306/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

The Netherlands

HEMA B.V. NDSM-straat 10 1033 SB Amsterdam The Netherlands

Hema Ibuprofen 200 mg, omhulde tabletten

Ibuprofen 200 mg Coated tablet Oral use

The Netherlands

HTP Huisapotheek B.V. Nieuwe Donk 3 4879 AC Etten-Leur The Netherlands

Ibuprofen 200 mg HTP Huisapotheek, omhulde tabletten

Ibuprofen 200 mg Coated tablet Oral use

The Netherlands

HTP Huisapotheek B.V. Nieuwe Donk 3 4879 AC Etten-Leur The Netherlands

Ibuprofen 400 mg HTP Huisapotheek, omhulde tabletten

Ibuprofen 400 mg Coated tablet Oral use

The Netherlands

Infirst Healthcare Ltd. Strand 265 London WC2R 1BH United Kingdom

Flarin 200 mg capsules, zacht

Ibuprofen 200 mg Capsule, soft Oral use

The Netherlands

Infirst Healthcare Ltd. Strand 265 London WC2R 1BH United Kingdom

Flarin 400 mg capsules, zacht

Ibuprofen 400 mg Capsule, soft Oral use

The Netherlands

Jumbo Supermarkten B.V. Rijksweg 15 5462 CE Veghel The Netherlands

JUMBO Ibuprofen 200 mg, omhulde tabletten

Ibuprofen 200 mg Film-coated tablet Oral use

The Netherlands

Leidapharm B.V. Archimedesweg 2 2333 CN Leiden The Netherlands

Leidapharm Ibuprofen 400mg Liquid Caps, capsules, zacht

Ibuprofen 400 mg Capsule, soft Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 307/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

The Netherlands

MAE Holding BV Amsterdamsestraatweg 22 1391 AB Abcoude The Netherlands

Ibuprofen MAE 200 mg, filmomhulde tabletten

Ibuprofen 200 mg Film-coated tablet Oral use

The Netherlands

MAE Holding BV Amsterdamsestraatweg 22 1391 AB Abcoude The Netherlands

Ibuprofen Triangle Pharma 200 mg, omhulde tabletten

Ibuprofen 200 mg Coated tablet Oral use

The Netherlands

MAE Holding BV Amsterdamsestraatweg 22 1391 AB Abcoude The Netherlands

Kruidvat Ibuprofen Liquid Caps 400 mg, capsules, zacht

Ibuprofen 400 mg Capsule, soft Oral use

The Netherlands

MAE Holding BV Amsterdamsestraatweg 22 1391 AB Abcoude The Netherlands

Trekpleister Ibuprofen Liquid Caps 400 mg, capsules, zacht

Ibuprofen 400 mg Capsule, soft Oral use

The Netherlands

Manston Pharma Limited 3 Montpelier Avenue, Bexley DA5 3AP Kent United Kingdom

Ibuprofen Manston 200 mg, filmomhulde tabletten

Ibuprofen 200 mg Film-coated tablet Oral use

The Netherlands

Manston Pharma Limited 3 Montpelier Avenue, Bexley DA5 3AP Kent United Kingdom

Ibuprofen Manston 400 mg, filmomhulde tabletten

Ibuprofen 400 mg Film-coated tablet Oral use

The Netherlands

Manston Pharma Limited 3 Montpelier Avenue, Bexley DA5 3AP Kent United Kingdom

Ibuprofen Manston 600 mg, filmomhulde tabletten

Ibuprofen 600 mg Film-coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 308/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

The Netherlands

Mediq Farma B.V. Hertogswetering 159 3543 AS Utrecht The Netherlands

Ibuprofen Mdq 200 mg, omhulde tabletten

Ibuprofen 200 mg Coated tablet Oral use

The Netherlands

Mediq Farma B.V. Hertogswetering 159 3543 AS Utrecht The Netherlands

Ibuprofen Mdq 400 mg, omhulde tabletten

Ibuprofen 400 mg Coated tablet Oral use

The Netherlands

Mylan B.V. Dieselweg 25 3752 LB Bunschoten The Netherlands

Ibuprofen (als lysine) Mylan OTC 200 mg, filmomhulde tabletten

Ibuprofen lysine 342 mg Film-coated tablet Oral use

The Netherlands

Mylan B.V. Dieselweg 25 3752 LB Bunschoten The Netherlands

Ibuprofen (als lysine) Mylan OTC 400 mg, filmomhulde tabletten

Ibuprofen lysine 684 mg Film-coated tablet Oral use

The Netherlands

Mylan B.V. Dieselweg 25 3752 LB Bunschoten The Netherlands

Ibuprofen (als lysine) Mylan 200 mg, filmomhulde tabletten

Ibuprofen lysine 342 mg Film-coated tablet Oral use

The Netherlands

Mylan B.V. Dieselweg 25 3752 LB Bunschoten The Netherlands

Ibuprofen (als lysine) Mylan 400 mg, filmomhulde tabletten

Ibuprofen lysine 684 mg Film-coated tablet Oral use

The Netherlands

Mylan B.V. Dieselweg 25 3752 LB Bunschoten The Netherlands

Ibuprofen Mylan 200 mg, omhulde tabletten

Ibuprofen 200 mg Film-coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 309/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

The Netherlands

Mylan B.V. Dieselweg 25 3752 LB Bunschoten The Netherlands

Ibuprofen Mylan 400 mg, omhulde tabletten

Ibuprofen 400 mg Film-coated tablet Oral use

The Netherlands

Mylan B.V. Dieselweg 25 3752 LB Bunschoten The Netherlands

Ibuprofen Mylan 600 mg, omhulde tabletten

Ibuprofen 600 mg Film-coated tablet Oral use

The Netherlands

Nedac Sorbo B.V. Innovatie 1 6921 RN Duiven The Netherlands

NEDAC SORBO Ibuprofen 200 mg, omhulde tabletten

Ibuprofen 200 mg Coated tablet Oral use

The Netherlands

Nedac Sorbo B.V. Innovatie 1 6921 RN Duiven The Netherlands

NEDAC SORBO Ibuprofen 400 mg, omhulde tabletten

Ibuprofen 400 mg Coated tablet Oral use

The Netherlands

Nederlandse Service Apotheek Beheer B.V. Vonderweg 39a 7468 DC Enter The Netherlands

Ibuprofen SAM 200 mg, omhulde tabletten

Ibuprofen 200 mg Coated tablet Oral use

The Netherlands

Nederlandse Service Apotheek Beheer B.V. Vonderweg 39a 7468 DC Enter The Netherlands

Ibuprofen SAM 400 mg, omhulde tabletten

Ibuprofen 400 mg Coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 310/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

The Netherlands

Pfizer bv Rivium Westlaan 142 2909 LD, Capelle a/d Ijssel The Netherlands

Advil bruis met citrussmaak 200 mg, bruistabletten

Ibuprofen 200 mg Effervescent tablet Oral use

The Netherlands

Pfizer bv Rivium Westlaan 142 2909 LD, Capelle a/d Ijssel The Netherlands

Advil Bruis met citrussmaak 400 mg, bruistabletten

Ibuprofen 400 mg Effervescent tablet Oral use

The Netherlands

Pfizer bv Rivium Westlaan 142 2909 LD, Capelle a/d Ijssel The Netherlands

Advil, dragees 200 mg

Ibuprofen 200 mg Coated tablet Oral use

The Netherlands

Pfizer bv Rivium Westlaan 142 2909 LD, Capelle a/d Ijssel The Netherlands

Advil Liquid Caps 400, zachte capsules, 400 mg

Ibuprofen 400 mg Capsule, soft Oral use

The Netherlands

Pfizer bv Rivium Westlaan 142 2909 LD, Capelle a/d Ijssel The Netherlands

Advil Liquid-Caps 200, zachte capsules 200 mg

Ibuprofen 200 mg Capsule, soft Oral use

The Netherlands

Pfizer bv Rivium Westlaan 142 2909 LD, Capelle a/d Ijssel The Netherlands

Advil Ovaal 400, filmomhulde tabletten 400 mg

Ibuprofen 400 mg Film-coated tablet Oral use

The Netherlands

Pharmachemie B.V. Swensweg 5 2031 GA Haarlem The Netherlands

Ibuprofen bruis 600 mg PCH, bruisgranulaat

Ibuprofen 600 mg Effervescent granules Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 311/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

The Netherlands

Pharmachemie B.V. Swensweg 5 2031 GA Haarlem The Netherlands

Ibuprofen caps 200 mg PCH, capsule zacht

Ibuprofen 200 mg Capsule, soft Oral use

The Netherlands

Pharmachemie B.V. Swensweg 5 2031 GA Haarlem The Netherlands

Ibuprofen liquid caps 200 mg PCH, capsules, zacht

Ibuprofen 200 mg Capsule, soft Oral use

The Netherlands

Pharmachemie B.V. Swensweg 5 2031 GA Haarlem The Netherlands

Ibuprofen 200 PCH, omhulde tabletten 200 mg

Ibuprofen 200 mg Coated tablet Oral use

The Netherlands

Pharmachemie B.V. Swensweg 5 2031 GA Haarlem The Netherlands

Ibuprofen 400 PCH, omhulde tabletten 400 mg

Ibuprofen 400 mg Coated tablet Oral use

The Netherlands

Pharmachemie B.V. Swensweg 5 2031 GA Haarlem The Netherlands

Ibuprofen 500 PCH, zetpillen 500 mg

Ibuprofen 500 mg Suppository Rectal use

The Netherlands

Pharmachemie B.V. Swensweg 5 2031 GA Haarlem The Netherlands

Ibuprofen 600 PCH, omhulde tabletten 600 mg

Ibuprofen 600 mg Film-coated tablet Oral use

The Netherlands

Pharmamatch B.V. Egelenburg 2 1081 GK Amsterdam The Netherlands

Ibuprofen liquid caps 400 mg PharmaMatch, capsule zacht

Ibuprofen 400 mg Capsule, soft Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 312/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

The Netherlands

ratiopharm Nederland B.V. Florapark 4 2012 HK Haarlem The Netherlands

Ibuprofen ratiopharm 400 mg, filmomhulde tabletten

Ibuprofen 400 mg Film-coated tablet Oral use

The Netherlands

Reckitt Benckiser Healthcare B.V. Siriusdreef 14 2132 WT Hoofddorp The Netherlands

Nurofen Fastine Liquid Caps 400 mg, capsule, zacht

Ibuprofen 400 mg Capsule, soft Oral use

The Netherlands

Reckitt Benckiser Healthcare B.V. Siriusdreef 14 2132 WT Hoofddorp The Netherlands

Nurofen Omhulde Tabletten 200, omhulde tabletten 200 mg

Ibuprofen lysine 342 mg Film-coated tablet Oral use

The Netherlands

Reckitt Benckiser Healthcare B.V. Siriusdreef 14 2132 WT Hoofddorp The Netherlands

Nurofen Zavance Lea 200 mg liquid capsules, capsules, zacht

Ibuprofen 200 mg Capsule, soft Oral use

The Netherlands

Reckitt Benckiser Healthcare B.V. Siriusdreef 14 2132 WT Hoofddorp The Netherlands

Nurofen Zavance Lea 400 mg Liquid capsules, capsules

Ibuprofen 400 mg Capsule, soft Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 313/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

The Netherlands

Reckitt Benckiser Healthcare B.V. Siriusdreef 14 2132 WT Hoofddorp The Netherlands

Nurofen Zavance Oni 400 mg, poeder voor oraal gebruik

Ibuprofen lysine 683,34 mg Oral powder Oral use

The Netherlands

Reckitt Benckiser Healthcare B.V. Siriusdreef 14 2132 WT Hoofddorp The Netherlands

Nurofen Zavance Tex 200 mg tablet, omhulde tabletten

Ibuprofen sodium dihydrate

256 mg Coated tablet Oral use

The Netherlands

Reckitt Benckiser Healthcare B.V. Siriusdreef 14 2132 WT Hoofddorp The Netherlands

Nurofen Zavance Tex 200 mg tablet ovaal, omhulde tabletten

Ibuprofen sodium dihydrate

256 mg Coated tablet Oral use

The Netherlands

Reckitt Benckiser Healthcare B.V. Siriusdreef 14 2132 WT Hoofddorp The Netherlands

Nurofen Zavance Tex 400 mg tablet, omhulde tabletten

Ibuprofen sodium dihydrate

512 mg Coated tablet Oral use

The Netherlands

Reckitt Benckiser Healthcare B.V. Siriusdreef 14 2132 WT Hoofddorp The Netherlands

Nurofen 200 lemon smelttablet, smelttabletten 200 mg

Ibuprofen 200 mg Orodispersible tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 314/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

The Netherlands

Reckitt Benckiser Healthcare B.V. Siriusdreef 14 2132 WT Hoofddorp The Netherlands

Nurofen 200 tablet, omhulde tabletten 200 mg

Ibuprofen 200 mg Coated tablet Oral use

The Netherlands

Reckitt Benckiser Healthcare B.V. Siriusdreef 14 2132 WT Hoofddorp The Netherlands

Nurofen 200 tablet ovaal, omhulde tabletten 200 mg

Ibuprofen 200 mg Coated tablet Oral use

The Netherlands

Reckitt Benckiser Healthcare B.V. Siriusdreef 14 2132 WT Hoofddorp The Netherlands

Nurofen 400 orange bruisgranulaat, bruisgranulaat 400 mg per sachet

Ibuprofen 400 mg Effervescent granules Oral use

The Netherlands

Reckitt Benckiser Healthcare B.V. Siriusdreef 14 2132 WT Hoofddorp The Netherlands

Nurofen 400 tablet Female, filmomhulde tabletten 400mg

Ibuprofen lysine 684 mg Film-coated tablet Oral use

The Netherlands

Reckitt Benckiser Healthcare B.V. Siriusdreef 14 2132 WT Hoofddorp The Netherlands

Nurofen 400 tablet Migraine, filmomhulde tabletten 400 mg

Ibuprofen lysine 684 mg Film-coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 315/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

The Netherlands

Reckitt Benckiser Healthcare B.V. Siriusdreef 14 2132 WT Hoofddorp The Netherlands

Nurofen 400 tablet, omhulde tabletten 400 mg

Ibuprofen 400 mg Film-coated tablet Oral use

The Netherlands

RXT Amsterdamsestraatweg 22 1391 AB Abcoude The Netherlands

Ibuprofen RXT 200 mg, omhulde tabletten

Ibuprofen 200 mg Coated tablet Oral use

The Netherlands

Sameko Farma B.V. Archimedesweg 2 2333 CN Leiden The Netherlands

C1000 Ibuprofen 200 mg, omhulde tabletten

Ibuprofen 200 mg Coated tablet Oral use

The Netherlands

Sameko Farma B.V. Archimedesweg 2 2333 CN Leiden The Netherlands

Ibuprofen 200 mg Sameko, omhulde tabletten

Ibuprofen 200 mg Coated tablet Oral use

The Netherlands

Sameko Farma B.V. Archimedesweg 2 2333 CN Leiden The Netherlands

Ibuprofen 400 mg Sameko, omhulde tabletten

Ibuprofen 400 mg Coated tablet Oral use

The Netherlands

Sameko Farma B.V. Archimedesweg 2 2333 CN Leiden The Netherlands

Ibuprofen 400 mg Sameko, omhulde tabletten

Ibuprofen 400 mg Coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 316/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

The Netherlands

Sameko Farma B.V. Archimedesweg 2 2333 CN Leiden The Netherlands

Ibuprofen 400 mg Sameko, omhulde tabletten

Ibuprofen 400 mg Coated tablet Oral use

The Netherlands

Samenwerkende Apothekers Nederland B.V. Kralingseweg 201 3062 CE Rotterdam The Netherlands

Ibuprofen 200 mg omhulde tabletten Samenwerkende Apothekers, omhulde tabletten

Ibuprofen 200 mg Coated tablet Oral use

The Netherlands

Samenwerkende Apothekers Nederland B.V. Kralingseweg 201 3062 CE Rotterdam The Netherlands

Ibuprofen 400 mg omhulde tabletten Samenwerkende Apothekers, omhulde tabletten

Ibuprofen 400 mg Coated tablet Oral use

The Netherlands

Sandoz B.V. Veluwezoom 22 1327 AH Almere The Netherlands

Ibuprofen Sandoz 200 mg, capsules, zacht

Ibuprofen 200 mg Capsule, soft Oral use

The Netherlands

Sandoz B.V. Veluwezoom 22 1327 AH Almere The Netherlands

Ibuprofen Sandoz 400 mg, capsules, zacht

Ibuprofen 400 mg Capsule, soft Oral use

The Netherlands

SDG Farma B.V. Treubweg 11 1112 BA Diemen The Netherlands

Idyl Ibuprofen Liquid Caps 400 mg, capsules, zacht

Ibuprofen 400 mg Capsule, soft Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 317/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

The Netherlands

Teva Nederland B.V. Swensweg 5 2031 GA Haarlem The Netherlands

Ibuprofen Liquid caps 400 mg Teva, capsule, zacht

Ibuprofen 400 mg Capsule, soft Oral use

The Netherlands

Wrafton Laboratories Limited Exeter Road Wrafton Braunton Devon EX33 2DL United Kingdom

Ibuprofen Wrafton 200 mg, filmomhulde tabletten

Ibuprofen lysine 342 mg Film-coated tablet Oral use

The Netherlands

Wrafton Laboratories Limited Exeter Road Wrafton Braunton Devon EX33 2DL United Kingdom

Ibuprofen Wrafton 400 mg, filmomhulde tabletten

Ibuprofen lysine 684 mg Film-coated tablet Oral use

The Netherlands

Zambon Nederland B.V. Basicweg 14B 3821 BR Amersfoort The Netherlands

Zafen 200 bruistablet, bruistabletten 200 mg

IBUPROFEN ARGININE

200 mg Effervescent tablet Oral use

The Netherlands

Zambon Nederland B.V. Basicweg 14B 3821 BR Amersfoort The Netherlands

Zafen 400 granulaat, granulaat voor drank 400 mg

IBUPROFEN ARGININE

400 mg Granules for oral solution

Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 318/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

The Netherlands

Zambon Nederland B.V. Basicweg 14B 3821 BR Amersfoort The Netherlands

Zafen 400 Tablet, filmomhulde tabletten 400 mg

IBUPROFEN ARGININE

400 mg Film-coated tablet Oral use

The Netherlands

Zambon S.p.A. Via Lillo del Duca 10 20091, Bresso (Mi) Italy

Spidifen 400 tablet, filmomhulde tabletten 400 mg

IBUPROFEN ARGININE

400 mg Film-coated tablet Oral use

United Kingdom

Abbott Laboratories Limited Abbott House Vanwall Buisness Park Vanwall Road, Maidenhead Berkshire SL6 4XE United Kingdom

BRUFEN TABLETS 200MG

Ibuprofen 200 mg Coated tablet Oral use

United Kingdom

Abbott Laboratories Limited Abbott House Vanwall Buisness Park Vanwall Road, Maidenhead Berkshire SL6 4XE United Kingdom

BRUFEN TABLETS 400MG

Ibuprofen 400 mg Coated tablet Oral use

United Kingdom

Abbott Laboratories Limited Abbott House Vanwall Buisness Park Vanwall Road, Maidenhead Berkshire SL6 4XE United Kingdom

BRUFEN TABLETS 600MG

Ibuprofen 600 mg Coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 319/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

United Kingdom

Abbott Laboratories Limited Abbott House Vanwall Buisness Park Vanwall Road, Maidenhead Berkshire SL6 4XE United Kingdom

BRUFEN ORAL GRANULES 600MG

Ibuprofen 600 mg Granules Oral use

United Kingdom

Abbott Laboratories Limited Abbott House Vanwall Buisness Park Vanwall Road, Maidenhead Berkshire SL6 4XE United Kingdom

BRUFEN RETARD TABLETS 800MG

Ibuprofen 800 mg Modified-release tablet Oral use

United Kingdom

Abbott Laboratories Limited Abbott House Vanwall Buisness Park Vanwall Road, Maidenhead Berkshire SL6 4XE United Kingdom

BRUFEN SYRUP 100MG/5ML

Ibuprofen 20 mg/ml Syrup Oral use

United Kingdom

Abbott Laboratories Limited Abbott House Vanwall Buisness Park Vanwall Road, Maidenhead Berkshire SL6 4XE United Kingdom

BRUFEN EFFERVESCENT GRANULES 400 MG

Ibuprofen 400 mg Effervescent granules Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 320/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

United Kingdom

Abbott Laboratories Limited Abbott House Vanwall Buisness Park Vanwall Road, Maidenhead Berkshire SL6 4XE United Kingdom

ABBOTT LABS IBUPROFEN GRANULES 200 MG

Ibuprofen 200 mg Effervescent granules Oral use

United Kingdom

Abbott Laboratories Limited Abbott House Vanwall Buisness Park Vanwall Road, Maidenhead Berkshire SL6 4XE United Kingdom

ABBOTT LABS IBUPROFEN GRANULES 600 MG

Ibuprofen 600 mg Effervescent granules Oral use

United Kingdom

Accord Healthcare Limited 5th Floor Charles House Finchley Road 108-110 London NW3 5JJ United Kingdom

ACCORD HEALTHCARE IBUPROFEN TABLETS BP 200MG

Ibuprofen 200 mg Coated tablet Oral use

United Kingdom

Accord Healthcare Limited 5th Floor Charles House Finchley Road 108-110 London NW3 5JJ United Kingdom

ACCORD HEALTHCARE IBUPROFEN TABLETS BP 400 MG

Ibuprofen 400 mg Coated tablet Oral use

United Kingdom

Accord Healthcare Limited 5th Floor Charles House Finchley Road 108-110 London NW3 5JJ United Kingdom

ACCORD HEALTHCARE IBUPROFEN TABLETS BP 600 MG

Ibuprofen 600 mg Coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 321/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

United Kingdom

Actavis UK Limited Whiddon Valley Barnstaple Devon EX32 8NS United Kingdom

ACTAVIS IBUPROFEN TABLETS 200 MG

Ibuprofen 200 mg Coated tablet Oral use

United Kingdom

Actavis UK Limited Whiddon Valley Barnstaple Devon EX32 8NS United Kingdom

ACTAVIS IBUPROFEN TABLETS 400MG

Ibuprofen 400 mg Coated tablet Oral use

United Kingdom

Actavis UK Limited Whiddon Valley Barnstaple Devon EX32 8NS United Kingdom

ACTAVIS IBUPROFEN TABLETS 600MG

Ibuprofen 600 mg Coated tablet Oral use

United Kingdom

Activase Pharmaceuticals Limited Boumpoulinas Street 11 PO Box 27783 Nicosia CY-2433 Cyprus

ACTIVASE PHARMACEUTICALS IBUPROFEN TABLETS 200MG

Ibuprofen 200 mg Film-coated tablet Oral use

United Kingdom

Activase Pharmaceuticals Limited Boumpoulinas Street 11 PO Box 27783 Nicosia CY-2433 Cyprus

LIBROFEM TABLETS 200MG

Ibuprofen 200 mg Film-coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 322/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

United Kingdom

Aspar Pharmaceutcals Limited 29-30 Capitol Way Capitol Way Industrial Park Colindale London NW9 0EQ United Kingdom

ASPAR IBUPROFEN TABLETS BP 200MG

Ibuprofen 200 mg Coated tablet Oral use

United Kingdom

Aspar Pharmaceutcals Limited 29-30 Capitol Way Capitol Way Industrial Park Colindale London NW9 0EQ United Kingdom

ASPAR IBUPROFEN TABLETS 400MG

Ibuprofen 400 mg Coated tablet Oral use

United Kingdom

Aspar Pharmaceutcals Limited 29-30 Capitol Way Capitol Way Industrial Park Colindale London NW9 0EQ United Kingdom

ASPAR IBUPROFEN TABLETS 600MG

Ibuprofen 600 mg Coated tablet Oral use

United Kingdom

Aspar Pharmaceutcals Limited 29-30 Capitol Way Capitol Way Industrial Park Colindale London NW9 0EQ United Kingdom

ASPAR IBUPROFEN CAPLETS 200MG

Ibuprofen 200 mg Coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 323/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

United Kingdom

Aspar Pharmaceutcals Limited 29-30 Capitol Way Capitol Way Industrial Park Colindale London NW9 0EQ United Kingdom

ASPAR IBUPROFEN TABLETS BP 200MG

Ibuprofen 200 mg Coated tablet Oral use

United Kingdom

Aspar Pharmaceutcals Limited 29-30 Capitol Way Capitol Way Industrial Park Colindale London NW9 0EQ United Kingdom

ASPAR PHARMS IBUPROFEN TABLETS BP 400MG

Ibuprofen 400 mg Coated tablet Oral use

United Kingdom

Athlone Laboratories Limited, Ballymurray, Roscommon, Ireland

ATHLONE LABS IBUPROFEN TABLETS BP 200MG

Ibuprofen 200 mg Coated tablet Oral use

United Kingdom

Athlone Laboratories Limited, Ballymurray, Roscommon, Ireland

ATHLONE LABS IBUPROFEN TABLETS BP 400MG

Ibuprofen 400 mg Coated tablet Oral use

United Kingdom

Aurobindo Pharma Limited, Ares Block, Odyssey Business Park, West End Road Ruislip HA4 6QD United Kingdom

AUROBINDO PHARMA IBUPROFEN TABLETS BP 200MG

Ibuprofen 200 mg Coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 324/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

United Kingdom

Aurobindo Pharma Limited, Ares Block, Odyssey Business Park, West End Road Ruislip HA4 6QD United Kingdom

AUROBINDO PHARMA IBUPROFEN TABLETS BP 400MG

Ibuprofen 400 mg Coated tablet Oral use

United Kingdom

Aurobindo Pharma Limited, Ares Block, Odyssey Business Park, West End Road Ruislip HA4 6QD United Kingdom

AUROBINDO PHARMA IBUPROFEN TABLETS BP 600MG

Ibuprofen 600 mg Film-coated tablet Oral use

United Kingdom

Ayrton Saunders Limited North Way Wealworth Industrial Estate Andover, Hampshire SP10 5AZ United Kingdom

SOLUBLE CUPROFEN IBUPROFEN TABLETS 200MG

Ibuprofen 200 mg Effervescent tablet Oral use

United Kingdom

Ayrton Saunders Limited North Way Wealworth Industrial Estate Andover, Hampshire SP10 5AZ United Kingdom

DENTOGEN IBUPROFEN TABLETS BP 200MG

Ibuprofen 200 mg Film-coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 325/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

United Kingdom

Ayrton Saunders Limited North Way Wealworth Industrial Estate Andover, Hampshire SP10 5AZ United Kingdom

DENTOGEN SOLUBLE IBUPROFEN TABLETS 200MG

Ibuprofen 200 mg Effervescent tablet Oral use

United Kingdom

Ayrton Saunders Limited North Way Wealworth Industrial Estate Andover, Hampshire SP10 5AZ United Kingdom

AYRTON SAUNDERS IBUPROFEN TABLETS 200MG

Ibuprofen 200 mg Effervescent tablet Oral use

United Kingdom

Ayrton Saunders Limited North Way Wealworth Industrial Estate Andover, Hampshire SP10 5AZ United Kingdom

AYRTON SAUNDERS IBUPROFEN TABLETS 400MG

Ibuprofen 400 mg Effervescent tablet Oral use

United Kingdom

Ayrton Saunders Limited North Way Wealworth Industrial Estate Andover, Hampshire SP10 5AZ United Kingdom

CUFEN-EF IBUPROFEN TABLETS 200 MG

Ibuprofen 200 mg Effervescent tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 326/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

United Kingdom

Banner Pharmacaps Europe B.V. De Posthoornstraat 7 5048 AS Tilburg The Netherlands

BANNER PHARMACAPS IBUPROFEN LIQUID CAPSULE 200MG

Ibuprofen 200 mg Capsule, soft Oral use

United Kingdom

Banner Pharmacaps Europe B.V. De Posthoornstraat 7 5048 AS Tilburg The Netherlands

BANNER PHARMACAPS EUROPE BV IBUPROFEN CAPSULES, SOFT 400 MG

Ibuprofen 400 mg Capsule, soft Oral use

United Kingdom

Banner Pharmacaps Europe B.V. De Posthoornstraat 7 5048 AS Tilburg The Netherlands

BANNER PHARMACAPS IBUPROFEN CHEWABLE CAPSULES 100MG

Ibuprofen 100 mg Capsule, soft Oral use

United Kingdom

Bell Sons & Company (Druggists) Limited Gifford House Slaidburn Crescent Southport, Merseyside PR9 9AL United Kingdom

BELL SONS IBUPROFEN TABLETS 200MG

Ibuprofen 200 mg Coated tablet Oral use

United Kingdom

Bell Sons & Company (Druggists) Limited Gifford House Slaidburn Crescent Southport, Merseyside PR9 9AL United Kingdom

BELL SONS IBUPROFEN CAPSULES 200MG

Ibuprofen 200 mg Capsule, soft Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 327/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

United Kingdom

Boehringer Ingelheim International GmbH Binger Straße 173 55216 Ingelheim am Rhein Germany

LASYNAC TABLETS 200MG/30MG

Ibuprofen pseudoephedrine hydrochloride

200 mg 30 mg

Film-coated tablet Oral use

United Kingdom

Bristol Laboratories Limited, Unit 3, Canalside Northbridge Road, Berkhamstead, Hertfordshire HP4 1EG United Kingdom

BRISTOL LABS IBUPROFEN TABLETS 200MG

Ibuprofen 200 mg Coated tablet Oral use

United Kingdom

Bristol Laboratories Limited, Unit 3, Canalside Northbridge Road, Berkhamstead, Hertfordshire HP4 1EG United Kingdom

BRISTOL LABS IBUPROFEN TABLETS 400MG

Ibuprofen 400 mg Coated tablet Oral use

United Kingdom

Bristol Laboratories Limited, Unit 3, Canalside Northbridge Road, Berkhamstead, Hertfordshire HP4 1EG United Kingdom

BRISTOL LABS IBUPROFEN TABLETS 600MG

Ibuprofen 600 mg Film-coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 328/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

United Kingdom

Bristol Laboratories Limited, Unit 3, Canalside Northbridge Road, Berkhamstead, Hertfordshire HP4 1EG United Kingdom

EXTRA STRENGTH IBUPROFEN TABLETS 400MG

Ibuprofen 400 mg Coated tablet Oral use

United Kingdom

Bristol Laboratories Limited, Unit 3, Canalside Northbridge Road, Berkhamstead, Hertfordshire HP4 1EG United Kingdom

FENBID BIPHASIC CAPSULES 400MG

Ibuprofen 400 mg Modified-release capsule

Oral use

United Kingdom

Chelonia Healthcare Limited Boumpoulinas 11 3rd Floor Nicosia CY-1060 Cyprus

CHELONIA HEALTHCARE IBUPROFEN TABLETS 600MG

Ibuprofen 600 mg Film-coated tablet Oral use

United Kingdom

Chelonia Healthcare Limited Boumpoulinas 11 3rd Floor Nicosia CY-1060 Cyprus

EBUFAC TABLETS 400 MG

Ibuprofen 400 mg Coated tablet Oral use

United Kingdom

Chelonia Healthcare Limited Boumpoulinas 11 3rd Floor Nicosia CY-1060 Cyprus

MIGRAFEN TABLETS 200MG

Ibuprofen 200 mg Coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 329/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

United Kingdom

Chelonia Healthcare Limited Boumpoulinas 11 3rd Floor Nicosia CY-1060 Cyprus

MIGRAFEN TABLETS 200MG

Ibuprofen 200 mg Coated tablet Oral use

United Kingdom

Cipla (EU) Limited Hillbrow House Hillbrow Road Esher, Surrey KT10 9NW United Kingdom

STD CHEMICALS IBUPROFEN ORAL SUSPENSION 100 MG/ 5 ML

Ibuprofen 20 mg/ml Oral suspension Oral use

United Kingdom

Crescent Pharma Limited Units 3 and 4 Quidhampton Business Units Polhampton Lane Overton, Hampshire RG25 3ED United Kingdom

CRESCENT PHARMA IBUPROFEN TABLETS 200MG

Ibuprofen 200 mg Coated tablet Oral use

United Kingdom

Crescent Pharma Limited Units 3 and 4 Quidhampton Business Units Polhampton Lane Overton, Hampshire RG25 3ED United Kingdom

CRESCENT PHARMA IBUPROFEN TABLETS 400MG

Ibuprofen 400 mg Coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 330/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

United Kingdom

Crescent Pharma Limited Units 3 and 4 Quidhampton Business Units Polhampton Lane Overton, Hampshire RG25 3ED United Kingdom

CRESCENT PHARMA IBUPROFEN TABLETS 600MG

Ibuprofen 600 mg Coated tablet Oral use

United Kingdom

Crescent Pharma Limited Units 3 and 4 Quidhampton Business Units Polhampton Lane Overton, Hampshire RG25 3ED United Kingdom

CRESCENT PHARMA IBUPROFEN TABLETS BP 200 MG

Ibuprofen 200 mg Coated tablet Oral use

United Kingdom

Crescent Pharma Limited Units 3 and 4 Quidhampton Business Units Polhampton Lane Overton, Hampshire RG25 3ED United Kingdom

CRESCENT PHARMA IBUPROFEN TABLETS BP 400 MG

Ibuprofen 400 mg Coated tablet Oral use

United Kingdom

Crookes Healthcare Limited, Regulatory Department Wellcroft House, Wellcroft Road, Slough, Berkshire SL1 4AQ United Kingdom

NUROFEN RECOVERY Ibuprofen 200 mg Orodispersible tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 331/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

United Kingdom

Cupal Limited Regulatory Department Wellcroft House Wellcroft Road Slough, Berkshire SL1 4AQ United Kingdom

CUPROFEN TABLETS BP 200MG

Ibuprofen 200 mg Coated tablet Oral use

United Kingdom

Cupal Limited Regulatory Department Wellcroft House Wellcroft Road Slough, Berkshire SL1 4AQ United Kingdom

CUPROFEN TABLETS 400MG

Ibuprofen 400 mg Film-coated tablet Oral use

United Kingdom

Dalkeith Laboratories Limited 2 Park Street Woburn, Bedfordshire MK17 9PG United Kingdom

DALKEITH LABS IBUPROFEN TABLETS BP 600MG

Ibuprofen 600 mg Film-coated tablet Oral use

United Kingdom

Dexcel Pharma Limited, 7 Sopwith Way, Drayton Fields Industrial Estate, Daventry Northamptonshire NN11 8PB United Kingdom

DEXCEL IBUPROFEN LIQUID CAPSULES 200MG

Ibuprofen 200 mg Capsule, soft Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 332/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

United Kingdom

Dexcel Pharma Limited, 7 Sopwith Way, Drayton Fields Industrial Estate, Daventry Northamptonshire NN11 8PB United Kingdom

DEXCEL IBUPROFEN LIQUID CAPSULES 400MG

Ibuprofen 400 mg Capsule, soft Oral use

United Kingdom

East Midlands Pharma Limited 16 Rancliffe Avenue Keyworth, Nottinghamshire NG12 5HY United Kingdom

EAST MIDLANDS PHARMA IBUPROFEN MAXIMUM STRENGTH TABLETS 400MG

Ibuprofen 400 mg Coated tablet Oral use

United Kingdom

East Midlands Pharma Limited 16 Rancliffe Avenue Keyworth, Nottinghamshire NG12 5HY United Kingdom

EAST MIDLANDS PHARMA IBUPROFEN TABLETS 200MG

Ibuprofen 200 mg Coated tablet Oral use

United Kingdom

Ennogen Pharma Limited Unit G4, Riverside Industrial Estate Riverside Way Dartford DA1 5BS United Kingdom

ENNOGEN PHARMA IBUPROFEN TABLETS 200MG

Ibuprofen 200 mg Coated tablet Oral use

United Kingdom

Ennogen Pharma Limited Unit G4, Riverside Industrial Estate Riverside Way Dartford DA1 5BS United Kingdom

ENNOGEN PHARMA IBUPROFEN TABLETS 400MG

Ibuprofen 400 mg Coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 333/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

United Kingdom

Ennogen Pharma Limited Unit G4, Riverside Industrial Estate Riverside Way Dartford DA1 5BS United Kingdom

ENNOGEN PHARMA IBUPROFEN TABLETS 600MG

Ibuprofen 600 mg Coated tablet Oral use

United Kingdom

Ennogen Pharma Limited Unit G4, Riverside Industrial Estate Riverside Way Dartford DA1 5BS United Kingdom

IBULAR TABLETS 200MG

Ibuprofen 200 mg Coated tablet Oral use

United Kingdom

Ennogen Pharma Limited Unit G4, Riverside Industrial Estate Riverside Way Dartford DA1 5BS United Kingdom

IBULAR TABLETS 400 MG

Ibuprofen 400 mg Coated tablet Oral use

United Kingdom

Fannin (UK) Limited 42-46 Booth Drive Park Farm South Wellingborough NN8 6GT United Kingdom

FANNIN (UK) IBUPROFEN ORAL SUSPENSION 100MG/5ML

Ibuprofen 100 mg Oral suspension Oral use

United Kingdom

Fourrts (UK) Pharmacare Limited Chaul End Lane 30 Luton, Bedfordshire LU4 8EZ United Kingdom

FOURRTS UK PHARMAC IBUPROFEN TABLETS 200MG

Ibuprofen 200 mg Coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 334/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

United Kingdom

Fourrts (UK) Pharmacare Limited First Floor 2 Victoria Road Harpenden Hertfordshire AL5 4EA United Kingdom

FOURRTS UK PHARMAC IBUPROFEN TABLETS 200MG

Ibuprofen 200 mg Film-coated tablet Oral use

United Kingdom

Fourrts (UK) Pharmacare Limited First Floor 2 Victoria Road Harpenden Hertfordshire AL5 4EA United Kingdom

FOURRTS UK PHARMAC IBUPROFEN TABLETS 200MG

Ibuprofen 200 mg Film-coated tablet Oral use

United Kingdom

Fourrts (UK) Pharmacare Limited First Floor 2 Victoria Road Harpenden Hertfordshire AL5 4EA United Kingdom

FOURRTS UK PHARMAC IBUPROFEN TABLETS 400MG

Ibuprofen 400 mg Film-coated tablet Oral use

United Kingdom

Fourrts (UK) Pharmacare Limited Chaul End Lane 30 Luton, Bedfordshire LU4 8EZ United Kingdom

FOURRTS UK PHARMAC IBUPROFEN TABLETS 600MG

Ibuprofen 600 mg Film-coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 335/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

United Kingdom

Galpharm Healthcare Limited Hugh House Upper Cliffe Road Barnsley, South Yorkshire S75 3SP Dodworth Dodworth Bussiness Park United Kingdom

GALPHARM HEALTHCARE IBUPROFEN TABLETS 200MG

Ibuprofen 200 mg Coated tablet Oral use

United Kingdom

Galpharm Healthcare Limited Hugh House Upper Cliffe Road Barnsley, South Yorkshire S75 3SP Dodworth Dodworth Bussiness Park United Kingdom

GALPHARM HEALTHCARE IBUPROFEN TABLETS 200MG

Ibuprofen 200 mg Coated tablet ORAL USE

United Kingdom

Galpharm Healthcare Limited Hugh House Upper Cliffe Road Barnsley, South Yorkshire S75 3SP Dodworth Dodworth Bussiness Park United Kingdom

GALPHARM HEALTHCARE IBUPROFEN ORAL SUSPENSION 100MG/5ML

Ibuprofen 20 mg/ml Oral suspension Oral use

United Kingdom

Galpharm Healthcare Limited Hugh House Upper Cliffe Road Barnsley, South Yorkshire S75 3SP Dodworth Dodworth Bussiness Park United Kingdom

GALPHARM IBUPROFEN TABLETS 400MG

Ibuprofen 400 mg Coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 336/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

United Kingdom

Galpharm Healthcare Limited EX33 2DL Wrafton Braunton Devon United Kingdom

JUNIOR IBUPROFEN SUSPENSION 100MG/5ML

Ibuprofen 20 mg/ml Oral suspension Oral use

United Kingdom

Galpharm Healthcare Limited EX33 2DL Wrafton Braunton Devon United Kingdom

GALPHARM HEALTHCARE IBUPROFEN SUSPENSION 100MG/5ML

Ibuprofen 20 mg/ml Oral suspension Oral use

United Kingdom

Galpharm Healthcare Limited Hugh House Upper Cliffe Road Barnsley, South Yorkshire S75 3SP Dodworth Dodworth Bussiness Park United Kingdom

GALPHARM HEALTHCARE IBUPROFEN CAPSULES 300MG

Ibuprofen 300 mg Modified-release capsule

Oral use

United Kingdom

Galpharm Healthcare Limited Hugh House Upper Cliffe Road Barnsley, South Yorkshire S75 3SP Dodworth Dodworth Bussiness Park United Kingdom

GALPHARM HEALTHCARE IBUPROFEN CAPSULES 200MG

Ibuprofen 200 mg Capsule Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 337/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

United Kingdom

Galpharm Healthcare Limited Hugh House Upper Cliffe Road Barnsley, South Yorkshire S75 3SP Dodworth Dodworth Bussiness Park United Kingdom

GALPHARM HEALTHCARE IBUPROFEN CAPSULES 200MG

Ibuprofen 200 mg Capsule Oral use

United Kingdom

Galpharm Healthcare Limited Hugh House Upper Cliffe Road Barnsley, South Yorkshire S75 3SP Dodworth Dodworth Bussiness Park United Kingdom

GALPHARM HEALTHCARE IBUPROFEN LONG LASTING CAPSULES 200MG

Ibuprofen 200 mg Modified-release capsule, hard

Oral use

United Kingdom

Galpharm Healthcare Limited Hugh House Upper Cliffe Road Barnsley, South Yorkshire S75 3SP Dodworth Dodworth Bussiness Park United Kingdom

GALPHARM HEALTHCARE IBUPROFEN TABLETS 200 MG

Ibuprofen 200 mg Film-coated tablet Oral use

United Kingdom

Galpharm Healthcare Limited Hugh House Upper Cliffe Road Barnsley, South Yorkshire S75 3SP Dodworth Dodworth Bussiness Park United Kingdom

GALPHARM IBUPROFEN TABLETS 400 MG

Ibuprofen 400 mg Film-coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 338/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

United Kingdom

Generics UK Albany Gate, Darkes Lane Potters Bar Hertfordshire EN6 1AG United Kingdom

GENERICS UK IBUPROFEN TABLETS 200MG

Ibuprofen 200 mg Tablet Oral use

United Kingdom

Generics UK Albany Gate, Darkes Lane Potters Bar Hertfordshire EN6 1AG United Kingdom

GENERICS UK IBUPROFEN TABLETS 400MG

Ibuprofen 400 mg Tablet Oral use

United Kingdom

Generics UK Albany Gate, Darkes Lane Potters Bar Hertfordshire EN6 1AG United Kingdom

GENERICS UK IBUPROFEN TABLETS 600MG

Ibuprofen 600 mg Tablet Oral use

United Kingdom

Generics UK Albany Gate, Darkes Lane Potters Bar Hertfordshire EN6 1AG United Kingdom

GENERICS UK MIGRAINE RELIEF TABLETS 342 MG

Ibuprofen lysine 342 mg Film-coated tablet Oral use

United Kingdom

Horizon Pharma Gmbh Joseph Meyer Strasse 13-15 68167 Mannheim Germany

DUEXIS TABLETS Ibuprofen 800 mg Film-coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 339/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

United Kingdom

Intrapharm Laboratories Ltd The Granary The Courtyard Barns Choke Lane, Cookham Dean Maidenhead Berkshire SL6 6PT United Kingdom

INTRAPHARM LABS IBUPROFEN TABLETS 200MG

Ibuprofen 200 mg Coated tablet Oral use

United Kingdom

Intrapharm Laboratories Ltd The Granary The Courtyard Barns Choke Lane, Cookham Dean Maidenhead Berkshire SL6 6PT United Kingdom

INTRAPHARM LABORATORIES IBUPROFEN TABLETS BP 400 MG

Ibuprofen 400 mg Coated tablet Oral use

United Kingdom

Intrapharm Laboratories Ltd The Granary The Courtyard Barns Choke Lane, Cookham Dean Maidenhead Berkshire SL6 6PT United Kingdom

INTRAPHARM LABORATORIES IBUPROFEN TABLETS 200MG

Ibuprofen 200 mg Coated tablet Oral use

United Kingdom

m & a pharmachem ltd Allenby Laboratories Wigan Road Westhoughton Bolton BL5 2AL United Kingdom

M&A PHARMACHEM IBUPROFEN TABLETS BP 600MG

Ibuprofen 600 mg Tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 340/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

United Kingdom

m & a pharmachem ltd Allenby Laboratories Wigan Road Westhoughton Bolton BL5 2AL United Kingdom

M&A PHARMACHEM IBUPROFEN TABLETS BP 400MG

Ibuprofen 400 mg Tablet Oral use

United Kingdom

Max Remedies Limited Stoney Gate House 2 Greenfield Road Holmfirth W Yorkshire HD9 2JT United Kingdom

MAX REMEDIES IBUPROFEN TABLETS 200MG

Ibuprofen 200 mg Tablet Oral use

United Kingdom

Max Remedies Limited Stoney Gate House 2 Greenfield Road Holmfirth W Yorkshire HD9 2JT United Kingdom

MAX REMEDIES IBUPROFEN TABLETS 400MG

Ibuprofen 400 mg Coated tablet Oral use

United Kingdom

MCNeil Products Limited Johnson & Johnson Ltd UK Regulatory Department Foundation Park Roxborough Maidenhead Berkshire SL6 3UG United Kingdom

SUDAFED SINUS TABLETS PRESSURE & PAIN

Ibuprofen 100 mg Tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 341/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

United Kingdom

Mercury Pharma Group Ltd No 1 Croydon 12-16 Addiscombe Road Croydon Surrey CR0 0XT United Kingdom

FENBID Ibuprofen 300 mg Modified-release capsule

Oral use

United Kingdom

Mercury Pharmaceuticals Ltd Capital House King William Street 85 London EC4N 7BL United Kingdom

MERCURY PHARMS IBUPROFEN TABLETS BP 200MG

Ibuprofen 200 mg Coated tablet Oral use

United Kingdom

Mercury Pharmaceuticals Ltd Capital House King William Street 85 London EC4N 7BL United Kingdom

MERCURY PHARMS IBUPROFEN TABLETS BP 400MG

Ibuprofen 400 mg Coated tablet Oral use

United Kingdom

Mercury Pharmaceuticals Ltd Capital House King William Street 85 London EC4N 7BL United Kingdom

MERCURY PHARMS IBUPROFEN TABLETS BP 600MG

Ibuprofen 600 mg Coated tablet Oral use

United Kingdom

Mercury Pharmaceuticals Ltd Capital House King William Street 85 London EC4N 7BL United Kingdom

MERCURY PHARMS IBUPROFEN TABLETS BP 200MG

Ibuprofen 200 mg Coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 342/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

United Kingdom

Mercury Pharmaceuticals Ltd Capital House King William Street 85 London EC4N 7BL United Kingdom

MERCURY PHARMS IBUPROFEN TABLETS BP 200MG

Ibuprofen 200 mg Coated tablet Oral use

United Kingdom

Omega Pharma, 1st Floor Vauxhall Bridge Road 32 London SW1V 2SA United Kingdom

HEDEX IBUPROFEN TABLETS 200MG

Ibuprofen 200 mg Coated tablet Oral use

United Kingdom

Omega Pharma, 1st Floor Vauxhall Bridge Road 32 London SW1V 2SA United Kingdom

SOLPADEINE MIGRAINE IBUPROFEN & CODEINE TABLETS

Ibuprofen 200 mg Film-coated tablet Oral use

United Kingdom

Orbis Consumer Products Limited Cunard Road Park Royal London NW10 6PN United Kingdom

ORBIFEN COLD AND FLU ORAL SUSPENSION

Ibuprofen 100 mg Oral suspension Oral use

United Kingdom

Pfizer Consumer Healthcare Vanwall Road Maidenhead, Berkshire, SL6 4UB United Kingdom

ANADIN JOINT PAIN TABLETS 200MG

Ibuprofen 200 mg Coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 343/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

United Kingdom

Pfizer Consumer Healthcare Vanwall Road Maidenhead, Berkshire, SL6 4UB United Kingdom

ANADIN IBUPROFEN TABLETS 200MG

Ibuprofen 200 mg Coated tablet Oral use

United Kingdom

Pfizer Consumer Healthcare Vanwall Road Maidenhead, Berkshire, SL6 4UB United Kingdom

ADVIL TABLETS 400MG

Ibuprofen 400 mg Film-coated tablet Oral use

United Kingdom

Pfizer Consumer Healthcare Vanwall Road Maidenhead, Berkshire, SL6 4UB United Kingdom

ADVIL LIQUIGEL CAPSULES 200MG

Ibuprofen 200 mg Capsule Oral use

United Kingdom

Pfizer Consumer Healthcare Vanwall Road Maidenhead, Berkshire, SL6 4UB United Kingdom

ANADIN ULTRA CAPSULES 200MG

Ibuprofen 200 mg Capsule, soft Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 344/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

United Kingdom

Pfizer Consumer Healthcare Walton Oaks Dorking Road Tadworth, Surrey KT20 7NS United Kingdom

ADVIL LIQUI-GEL CAPSULES 400MG

Ibuprofen 400 mg Capsule, soft Oral use

United Kingdom

Pfizer Consumer Healthcare Vanwall Road Maidenhead, Berkshire, SL6 4UB United Kingdom

ANADIN ULTRA DOUBLE STRENGTH CAPSULES 400MG

Ibuprofen 400 mg Capsule, soft Oral use

United Kingdom

Pfizer Consumer Healthcare Vanwall Road Maidenhead, Berkshire, SL6 4UB United Kingdom

ADVIL TABLETS 200MG

Ibuprofen 200 mg Effervescent tablet Oral use

United Kingdom

Pfizer Consumer Healthcare Vanwall Road Maidenhead, Berkshire, SL6 4UB United Kingdom

ADVIL TABLETS 400MG

Ibuprofen 400 mg Effervescent tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 345/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

United Kingdom

Pfizer Consumer Healthcare Vanwall Road Maidenhead, Berkshire, SL6 4UB United Kingdom

ANADIN LIQUIFAST 200 MG EFFERVESCENT TABLETS

Ibuprofen 200 mg Effervescent tablet Oral use

United Kingdom

Pfizer Consumer Healthcare Vanwall Road Maidenhead, Berkshire, SL6 4UB United Kingdom

ANADIN LIQUIFAST TABLETS 400MG

Ibuprofen 400 mg Effervescent tablet Oral use

United Kingdom

PHARMVIT Limited 177 Bilton Road Perivale Middlesex UB6 7HQ United Kingdom

PHARMVIT IBUPROFEN TABLETS 200MG

Ibuprofen 200 mg Coated tablet Oral use

United Kingdom

PHARMVIT Limited 177 Bilton Road Perivale Middlesex UB6 7HQ United Kingdom

PHARMVIT IBUPROFEN TABLETS 400MG

Ibuprofen 400 mg Coated tablet Oral use

United Kingdom

PHARMVIT Limited 177 Bilton Road Perivale Middlesex UB6 7HQ United Kingdom

PHARMAVIT IBUPROFEN TABLETS 600MG

Ibuprofen 600 mg Coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 346/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

United Kingdom

Pinewood Laboratories Limited Ballymacarbry, Clonmel Co Tipperary Ireland

PINEWOOD LABS IBUPROFEN ORAL SUSPENSION 100MG/5ML

Ibuprofen 100 mg Oral suspension Oral use

United Kingdom

Pinewood Laboratories Limited Ballymacarbry, Clonmel Co Tipperary Ireland

PINEWOOD LABS IBUPROFEN ORAL SUSPENSION 100MG/5ML

Ibuprofen 100 mg Oral suspension Oral use

United Kingdom

Pinewood Laboratories Limited Ballymacarbry, Clonmel Co Tipperary Ireland

PINEWOOD LABS IBUPROFEN ORAL SUSPENSION 100MG/5ML

Ibuprofen 100 mg Oral suspension Oral use

United Kingdom

Pinewood Laboratories Limited Ballymacarbry, Clonmel Co Tipperary Ireland

PINEWOOD LABS IBUPROFEN ORAL SUSPENSION 200MG/5ML

Ibuprofen 200 mg Oral suspension Oral use

United Kingdom

Pinewood Laboratories Limited Ballymacarbry, Clonmel Co Tipperary Ireland

PINEWOOD LABS IBUPROFEN ORAL SUSPENSION 200MG/5ML

Ibuprofen 200 mg Oral suspension Oral use

United Kingdom

Pinewood Laboratories Limited Ballymacarbry, Clonmel Co Tipperary Ireland

PINEWOOD LABS IBUPROFEN ORAL SUSPENSION 200MG/5ML

Ibuprofen 200 mg Oral suspension Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 347/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

United Kingdom

Procter & Gamble (Health & Beauty Care) Limited The Heights, Brooklands Weybridge, Surrey KT13 0XP United Kingdom

PROCTER & GAMBLE H&BC IBUPROFEN + PSEUDOEPHEDRINE HYDROCHLORIDE TABLETS

Ibuprofen 200 mg Film-coated tablet Oral use

United Kingdom

Reckitt Benckiser Healthcare (UK) Ltd Regulatory Department Wellcroft House Wellcroft Road Slough, SL1 4AQ United Kingdom

NUROFEN EXPRESS 256 MG TABLETS

Ibuprofen 200 mg Tablet Oral use

United Kingdom

Reckitt Benckiser Healthcare (UK) Ltd Regulatory Department Wellcroft House Wellcroft Road Slough, SL1 4AQ United Kingdom

NUROFEN TABLETS 256MG

Ibuprofen 200 mg Tablet Oral use

United Kingdom

Reckitt Benckiser Healthcare (UK) Ltd Regulatory Department Wellcroft House Wellcroft Road Slough, SL1 4AQ United Kingdom

NUROFEN EXPRESS CAPLETS 256 MG

Ibuprofen 200 mg Tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 348/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

United Kingdom

Reckitt Benckiser Healthcare (UK) Ltd Regulatory Department Wellcroft House Wellcroft Road Slough, SL1 4AQ United Kingdom

NUROFEN COLD AND FLU TABLETS

Ibuprofen 200 mg Coated tablet Oral use

United Kingdom

Reckitt Benckiser Healthcare (UK) Ltd Regulatory Department Wellcroft House Wellcroft Road Slough, SL1 4AQ United Kingdom

NUROFEN PLUS Ibuprofen 200 mg Coated tablet Oral use

United Kingdom

Reckitt Benckiser Healthcare (UK) Ltd. Dansom Lane Hull HU8 7DS United Kingdom

NUROFEN BACK PAIN SUSTAINED RELEASE CAPSULES 300MG

Ibuprofen 300 mg Modified-release capsule

Oral use

United Kingdom

Reckitt Benckiser Healthcare (UK) Ltd Regulatory Department Wellcroft House Wellcroft Road Slough, SL1 4AQ United Kingdom

NUROFEN MIGRAINE PAIN

Ibuprofen lysine 342 mg Film-coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 349/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

United Kingdom

Reckitt Benckiser Healthcare (UK) Ltd Regulatory Department Wellcroft House Wellcroft Road Slough, SL1 4AQ United Kingdom

NUROFEN MELTLETS LEMON 200MG

Ibuprofen 200 mg Orodispersible tablet Oral use

United Kingdom

Reckitt Benckiser Healthcare (UK) Ltd Regulatory Department Wellcroft House Wellcroft Road Slough, SL1 4AQ United Kingdom

NUROFEN MAXIMUM STRENGTH MIGRAINE PAIN CAPLETS 684MG

Ibuprofen lysine 684 mg Tablet Oral use

United Kingdom

Reckitt Benckiser Healthcare (UK) Ltd Regulatory Department Wellcroft House Wellcroft Road Slough, SL1 4AQ United Kingdom

NUROFEN TABLETS 200MG

Ibuprofen 200 mg Coated tablet Oral use

United Kingdom

Reckitt Benckiser Healthcare (UK) Ltd Regulatory Department Wellcroft House Wellcroft Road Slough, SL1 4AQ United Kingdom

NUROFEN CAPLETS 200 MG

Ibuprofen 200 mg Coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 350/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

United Kingdom

Reckitt Benckiser Healthcare (UK) Ltd Regulatory Department Wellcroft House Wellcroft Road Slough, SL1 4AQ United Kingdom

NUROFEN CAPLETS 200MG

Ibuprofen 200 mg Coated tablet Oral use

United Kingdom

Reckitt Benckiser Healthcare (UK) Ltd Regulatory Department Wellcroft House Wellcroft Road Slough, SL1 4AQ United Kingdom

NUROFEN TABLETS 200MG

Ibuprofen 200 mg Coated tablet Oral use

United Kingdom

Reckitt Benckiser Healthcare (UK) Ltd Regulatory Department Wellcroft House Wellcroft Road Slough, SL1 4AQ United Kingdom

NUROFEN EXPRESS CAPLETS 256MG

Ibuprofen 200 mg Tablet Oral use

United Kingdom

Reckitt Benckiser Healthcare (UK) Ltd Regulatory Department Wellcroft House Wellcroft Road Slough, SL1 4AQ United Kingdom

NUROFEN EXPRESS TABLETS 512MG

Ibuprofen 400 mg Tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 351/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

United Kingdom

Reckitt Benckiser Healthcare (UK) Ltd Regulatory Department Wellcroft House Wellcroft Road Slough, SL1 4AQ United Kingdom

LEMSIP MAX ALL DAY COLD & FLU TABLETS

Ibuprofen 200 mg Tablet Oral use

United Kingdom

Reckitt Benckiser Healthcare (UK) Ltd Regulatory Department Wellcroft House Wellcroft Road Slough, SL1 4AQ United Kingdom

LEMSIP MAX ALL NIGHT COLD & FLU TABLETS

Ibuprofen 200 mg Tablet Oral use

United Kingdom

Reckitt Benckiser Healthcare (UK) Ltd Regulatory Department Wellcroft House Wellcroft Road Slough, SL1 4AQ United Kingdom

IBUPROFEN AND PARACETAMOL 200MG/500MG TABLETS

Ibuprofen 200 mg Film-coated tablet Oral use

United Kingdom

Reckitt Benckiser Healthcare (UK) Ltd Regulatory Department Wellcroft House Wellcroft Road Slough, SL1 4AQ United Kingdom

NUROFEN EXPRESS SOLUBLE ORAL POWDER 400MG

IBUPROFEN LYSINATE

683,34 mg Powder for oral solution

Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 352/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

United Kingdom

Reckitt Benckiser Healthcare (UK) Ltd Regulatory Department Wellcroft House Wellcroft Road Slough, SL1 4AQ United Kingdom

NUROFEN CAPSULE 400 MG

Ibuprofen 400 mg Capsule, soft Oral use

United Kingdom

Reckitt Benckiser Healthcare (UK) Ltd Regulatory Department Wellcroft House Wellcroft Road Slough, SL1 4AQ United Kingdom

NUROFEN EXPRESS ORAL POWDER 400MG

IBUPROFEN LYSINATE

683,34 mg Powder for oral solution

Oral use

United Kingdom

Reckitt Benckiser Healthcare (UK) Ltd Regulatory Department Wellcroft House Wellcroft Road Slough, SL1 4AQ United Kingdom

NUROFEN EXPRESS PERIOD PAIN CAPSULES 200MG

Ibuprofen 200 mg Capsule, soft Oral use

United Kingdom

Reckitt Benckiser Healthcare (UK) Ltd Regulatory Department Wellcroft House Wellcroft Road Slough, SL1 4AQ United Kingdom

RECKITT BENCKISER HEALTHCARE UK IBUPROFEN LIQUICAPS 200MG

Ibuprofen 200 mg Capsule, soft Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 353/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

United Kingdom

Reckitt Benckiser Healthcare (UK) Ltd Regulatory Department Wellcroft House Wellcroft Road Slough, SL1 4AQ United Kingdom

NUROMOL 200MG/500MG TABLETS

Ibuprofen 200 mg Film-coated tablet Oral use

United Kingdom

Reckitt Benckiser Healthcare (UK) Ltd Regulatory Department Wellcroft House Wellcroft Road Slough, SL1 4AQ United Kingdom

RECKITT BENCKISER IBUPROFEN CAPSULES 200MG

Ibuprofen 200 mg Capsule, soft Oral use

United Kingdom

Reckitt Benckiser Healthcare (UK) Ltd Regulatory Department Wellcroft House Wellcroft Road Slough, SL1 4AQ United Kingdom

NUROFEN EXPRESS LIQUID CAPSULES 400MG

Ibuprofen 400 mg Capsule, soft Oral use

United Kingdom

Reckitt Benckiser Healthcare (UK) Ltd Regulatory Department Wellcroft House Wellcroft Road Slough, SL1 4AQ United Kingdom

NUROFEN 200MG LIQUICAPS PHARMACY ONLY

Ibuprofen 200 mg Capsule, soft Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 354/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

United Kingdom

Reckitt Benckiser Healthcare (UK) Ltd Regulatory Department Wellcroft House Wellcroft Road Slough, SL1 4AQ United Kingdom

NUROFEN EXPRESS 256 MG TABLETS

Ibuprofen sodium 256 mg Tablet Oral use

United Kingdom

Reckitt Benckiser Healthcare (UK) Ltd Regulatory Department Wellcroft House Wellcroft Road Slough, SL1 4AQ United Kingdom

NUROFEN EXPRESS CAPLETS 256MG

Ibuprofen sodium 256 mg Tablet Oral use

United Kingdom

Reckitt Benckiser Healthcare (UK) Ltd Regulatory Department Wellcroft House Wellcroft Road Slough, SL1 4AQ United Kingdom

NUROFEN EXPRESS TABLETS 512MG

Ibuprofen sodium 512 mg Tablet Oral use

United Kingdom

Relonchem Limited Cheshire House Gorsey Lane Widnes WA8 0RP United Kingdom

RELONCHEM IBUPROFEN TABLETS 400MG

Ibuprofen 400 mg Film-coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 355/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

United Kingdom

Relonchem Limited Cheshire House Gorsey Lane Widnes WA8 0RP United Kingdom

RELONCHEM LIMITED IBUPROFEN TABLETS 200MG

Ibuprofen 200 mg Coated tablet Oral use

United Kingdom

Remedica Ltd. P.O. Box 51706 CY-3508 Limassol Cyprus

REMEDICA IBUPROFEN TABLETS 200MG

Ibuprofen 200 mg Coated tablet Oral use

United Kingdom

Remedica Ltd. P.O. Box 51706 CY-3508 Limassol Cyprus

REMEDICA IBUPROFEN TABLETS 400MG

Ibuprofen 400 mg Coated tablet Oral use

United Kingdom

Remedica Ltd. P.O. Box 51706 CY-3508 Limassol Cyprus

REMEDICA IBUPROFEN TABLETS 400MG

Ibuprofen 400 mg Coated tablet Oral use

United Kingdom

Smithkline Beecham (SWG) Limited Beecham Group PLC 980 Great West Road Brentford Middlesex TW8 9GS United Kingdom

IBUPROFEN 200 MG FILM-COATED TABLETS

Ibuprofen 200 mg Coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 356/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

United Kingdom

Special Concept Development (UK) Ltd Unit 1-7 Colonial Way Watford Hertfordshire WD24 4YR United Kingdom

SPECIAL CONCEPT IBUPROFEN TABLETS BP 400MG

Ibuprofen 400 mg Coated tablet Oral use

United Kingdom

Special Concept Development (UK) Ltd Unit 1-7 Colonial Way Watford Hertfordshire WD24 4YR United Kingdom

SPECIAL CONCEPT IBUPROFEN TABLETS 200MG

Ibuprofen 200 mg Coated tablet Oral use

United Kingdom

Special Concept Development (UK) Ltd Unit 1-7 Colonial Way Watford Hertfordshire WD24 4YR United Kingdom

SPECIAL CONCEPT IBUPROFEN TABLETS 200MG

Ibuprofen 200 mg Coated tablet Oral use

United Kingdom

SSL International plc Wellcroft House Wellcroft Road Slough, Berkshire SL1 4AQ United Kingdom

IBUPROFEN & CODEINE TABLETS 200MG/12.8MG

Ibuprofen 200 mg Tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 357/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

United Kingdom

Teva UK Limited Field House Station Approach, Harlow Essex CM20 2FB United Kingdom

GALPHARM IBUPROFEN TABLETS BP 200MG

Ibuprofen 200 mg Coated tablet Oral use

United Kingdom

Teva UK Limited Field House Station Approach, Harlow Essex CM20 2FB United Kingdom

IBUPROFEN TABLETS BP 400MG (APSIFEN-F)

Ibuprofen 400 mg Coated tablet Oral use

United Kingdom

Teva UK Limited Field House Station Approach, Harlow Essex CM20 2FB United Kingdom

TEVA UK IBUPROFEN TABLETS BP 400MG

Ibuprofen 400 mg Coated tablet Oral use

United Kingdom

Teva UK Limited Field House Station Approach, Harlow Essex CM20 2FB United Kingdom

TEVA UK IBUPROFEN TABLETS 600MG

Ibuprofen 600 mg Film-coated tablet Oral use

United Kingdom

The Boots Company PLC Nottingham Support Office D90 West First 17 Thane Road Nottingham NG90 5EF United Kingdom

BOOTS IBUPROFEN CAPLETS 200 MG

Ibuprofen 200 mg Tablet Oral use

United Kingdom

The Boots Company PLC Nottingham Support Office D90 West First 17 Thane Road Nottingham NG90 5EF United Kingdom

BOOTS IBUPROFEN CAPLETS 400MG

Ibuprofen 400 mg Tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 358/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

United Kingdom

The Boots Company PLC Nottingham Support Office D90 West First 17 Thane Road Nottingham NG90 5EF United Kingdom

BOOTS COLD & FLU RELIEF WITH IBUPROFEN TABLETS

Ibuprofen 200 mg Tablet Oral use

United Kingdom

The Boots Company PLC Nottingham Support Office D90 West First 17 Thane Road Nottingham NG90 5EF United Kingdom

BOOTS IBUPROFEN AND CODEINE TABLETS

Ibuprofen 200 mg Film-coated tablet Oral use

United Kingdom

Thornton & Ross Ltd Linthwaite, Huddersfield HD7 5QH United Kingdom

CARE IBUPROFEN ORAL SUSPENSION

Ibuprofen 100 mg Oral suspension Oral use

United Kingdom

Vitabiotics Limited, 1 Apsley Way London NW2 7HF United Kingdom

VITABIOTICS IBUPROFEN TABLETS 400MG

Ibuprofen 400 mg Coated tablet Oral use

United Kingdom

Vitabiotics Limited, 1 Apsley Way London NW2 7HF United Kingdom

VITABIOTICS IBUPROFEN TABLETS 400MG

Ibuprofen 400 mg Coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 359/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

United Kingdom

Waymade Plc Sovereign House Miles Gray Road Basildon, Essex SS14 3FR United Kingdom

WAYMADE IBUPROFEN TABLETS 200MG

Ibuprofen 200 mg Coated tablet Oral use

United Kingdom

Waymade Plc Sovereign House Miles Gray Road Basildon, Essex SS14 3FR United Kingdom

WAYMADE IBUPROFEN TABLETS 400MG

Ibuprofen 400 mg Coated tablet Oral use

United Kingdom

Waymade Plc Sovereign House Miles Gray Road Basildon, Essex SS14 3FR United Kingdom

WAYMADE IBUPROFEN TABLETS 600MG

Ibuprofen 600 mg Film-coated tablet Oral use

United Kingdom

Waymade Plc Sovereign House Miles Gray Road Basildon, Essex SS14 3FR United Kingdom

WAYMADE IBUPROFEN TABLETS BP 200MG

Ibuprofen 200 mg Coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 360/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

United Kingdom

Waymade Plc Sovereign House Miles Gray Road Basildon, Essex SS14 3FR United Kingdom

WAYMADE IBUPROFEN TABLETS BP 400MG

Ibuprofen 400 mg Coated tablet Oral use

United Kingdom

Waymade Plc Sovereign House Miles Gray Road Basildon, Essex SS14 3FR United Kingdom

WAYMADE IBUPROFEN TABLETS BP 600MG

Ibuprofen 600 mg Coated tablet Oral use

United Kingdom

Winthrop Pharmaceuticals Uk Limited One Onslow Street Guildford, Surrey GU1 4YS United Kingdom

IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE TABLETS 200 MG/5 MG

Ibuprofen 200 mg Film-coated tablet Oral use

United Kingdom

Wockhardt UK Limited Ash Road North Wrexham Industrial Estate Wrexham, LL13 9UF United Kingdom

WOCKHARDT UK IBUPROFEN TABLETS 200MG

Ibuprofen 200 mg Coated tablet Oral use

United Kingdom

Wockhardt UK Limited Ash Road North Wrexham Industrial Estate Wrexham, LL13 9UF United Kingdom

WOCKHARDT UK MAXIMUM STRENGTH IBUPROFEN TABLETS 400MG

Ibuprofen 400 mg Coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 361/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

United Kingdom

Wockhardt UK Limited Ash Road North Wrexham Industrial Estate Wrexham, LL13 9UF United Kingdom

WOCKHARDT UK IBUPROFEN CAPLETS 200MG

Ibuprofen 200 mg Coated tablet Oral use

United Kingdom

Wockhardt UK Limited Ash Road North Wrexham Industrial Estate Wrexham, LL13 9UF United Kingdom

WOCKHARDT UK EXTRA STRENGTH IBUPROFEN CAPLETS 400MG

Ibuprofen 400 mg Coated tablet Oral use

United Kingdom

Wockhardt UK Limited Ash Road North Wrexham Industrial Estate Wrexham, LL13 9UF United Kingdom

WOCKHARDT UK IBUPROFEN TABLETS 200MG

Ibuprofen 200 mg Coated tablet Oral use

United Kingdom

Wockhardt UK Limited Ash Road North Wrexham Industrial Estate Wrexham, LL13 9UF United Kingdom

WOCKHARDT UK IBUPROFEN TABLETS 200MG

Ibuprofen 200 mg Coated tablet Oral use

United Kingdom

Wockhardt UK Limited Ash Road North Wrexham Industrial Estate Wrexham, LL13 9UF United Kingdom

WOCKHARDT UK EXTRA STRENGTH IBUPROFEN TABLETS 400MG

Ibuprofen 400 mg Coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 362/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

United Kingdom

Wockhardt UK Limited Ash Road North Wrexham Industrial Estate Wrexham, LL13 9UF United Kingdom

WOCKHARDT UK IBUPROFEN CAPLETS 200MG

Ibuprofen 200 mg Coated tablet Oral use

United Kingdom

Wrafton Laboratories Limited Exeter Road Wrafton, Braunton Devon EX33 2DL United Kingdom

WRAFTON LABS MIGRAINE RELIEF TABLETS 342MG

Ibuprofen lysine 342 mg Tablet Oral use

United Kingdom

Wrafton Laboratories Limited Exeter Road Wrafton, Braunton Devon EX33 2DL United Kingdom

WRAFTON LABS IBUPROFEN PERRIGO FILM-COATED TABLETS 200MG

Ibuprofen lysine 342 mg Film-coated tablet Oral use

United Kingdom

Wrafton Laboratories Limited Exeter Road Wrafton, Braunton Devon EX33 2DL United Kingdom

WRAFTON LABS IBUPROFEN PERRIGO TABLETS 400 MG

Ibuprofen lysine 684 mg Film-coated tablet Oral use

United Kingdom

Zanza Laboratories (Holdings) Limited Unit 2A Sefton Business Park Aintree, Liverpool L30 1RD United Kingdom

ZANZA LABS HOLDINGS IBUPROFEN TABLETS 200MG

Ibuprofen 200 mg Coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 363/364

Member State in EEA

Marketing authorisaton holder

Product name INN Strength Pharmaceutical form Route of administration

United Kingdom

Zanza Laboratories (Holdings) Limited Unit 2A Sefton Business Park Aintree, Liverpool L30 1RD United Kingdom

ZANZA LABS HOLDINGS IBUPROFEN TABLETS 400MG

Ibuprofen 400 mg Coated tablet Oral use

United Kingdom

Gebro Pharma GmbH A- 6391 Fieberbrunn Austria

SERACTIL TABLETS 300MG

Dexibuprofen 300 mg Film-coated tablet Oral use

United Kingdom

Gebro Pharma GmbH A- 6391 Fieberbrunn Austria

SERACTIL TABLETS 400MG

Dexibuprofen 400 mg Film-coated tablet Oral use

Annex I - List of the medicines affected by the referral EMA/713187/20124 Page 364/364