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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