annex i list of the names, pharmaceutical forms, strengths ... · annex i list of the names,...

Annex I

List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, marketing

authorisation holders in the member states

1

Member State (in EEA)

Marketing Authorisation Holder

INN Invented name Strength Pharmaceutical form

Route of administration

Austria Janssen - Cilag Pharma GmbH Vorgartenstraße 206b A-1020 Wien Austria

Norgestimate Ethinylestradiol

Cileste - Tabletten 0,25 mg 0,035 mg

Tablet Oral use

Austria N.V. Organon Kloosterstraat 6 5349 AB, Oss The Netherlands

Desogestrel Ethinylestradiol

Gracial - Tabletten 0,03 mg/0,125 mg 0,04 mg/0,025 mg

Tablet Oral use

Austria Bayer Austria GmbH Herbststrasse 6-10 1160 Wien Austria

Estradiol valerate Dienogest

Qlaira Filmtabletten 3 mg 2 mg/2 mg 2 mg/3 mg 1 mg

Film-coated tablet Oral use

Austria Gynial GmbH Gablenzgasse 11/III 1150 Wien Austria

Chlormadinone Ethinylestradiol

Bilinda 0,03 mg/2 mg Filmtabletten

0,03 mg 2 mg


Austria Kwizda Pharma GmbH Effingergasse 21 1160 Wien Austria


Delia 0,03 mg/2 mg Filmtabletten

0,03 mg 2 mg


Austria Dermapharm GmbH Türkenstraße 25/12 1090 Wien Austria


Madinette 0,03 mg/2 mg Filmtabletten

0,03 mg 2 mg


Austria Teva Pharma BV Computerweg 10 3542 DR Utrecht The Netherlands


Mellow ratiopharm 0,03 mg/2 mg Filmtabletten

0,03 mg 2 mg


2





Austria Actavis Group PTC ehf Reykjavikurvegi 76-78 220 Hafnarfjordur Iceland


Angiletta 0,03 mg/2 mg Filmtabletten

0,03 mg 2 mg


Austria Gedeon Richter Plc. Gyömröí út 19-21 HU-1103 Budapest Hungary


Balanca 0,03 mg/2 mg - Filmtabletten

0,03 mg 2 mg


Austria Pfizer Corporation Austria GmbH Floridsdorfer Hauptstraße 1 1210 Wien Austria


Beatrice 0,03 mg/2 mg Filmtabletten

0,03 mg 2 mg




Belara 0,03 mg/2 mg - Filmtabletten

0,03 mg 2 mg


Austria Madaus GmbH Colonia Allee 15 51067 Köln Germany


Bellissima 0,03 mg/2 mg Filmtabletten

0,03 mg 2 mg


Austria Hexal GmbH Stella-Klein-Löw-Weg 17 1020 Wien Austria


Ethinylestradiol/Chlormadinon Hexal 0,03 mg/2 mg - Filmtabletten

0,03 mg 2 mg




Desofemine 20 Mikrogramm/150 Mikrogramm Filmtabletten

0,02 mg 0,15 mg


3







Desofemine 30 Mikrogramm/150 Mikrogramm Filmtabletten

0,03 mg 0,15 mg




Desorelle 30 Mikrogramm/150 Mikrogramm 21+7 Filmtabletten

0,03 mg 0,15 mg




Desorelle Mite 20 Mikrogramm/150 Mikrogramm 21+7 Filmtabletten

0,02 mg 0,15 mg




Liberel - Filmtabletten 0,03 mg 0,15 mg




Liberel mite - Filmtabletten

0,02 mg 0,15 mg




Marvelon - Tabletten 0,03 mg 0,15 mg

Tablet Oral use



Mercilon - Tabletten 0,02 mg 0,15 mg

Tablet Oral use

4






Dienogest Ethinylestradiol

Bonisara 0,03 mg/2 mg Filmtabletten

0,03 mg 2 mg


Austria Aristo Pharma GmbH Wallenroder Straße 8-10 13435 Berlin Germany


Cara 0,03 mg/2 mg Filmtabletten

0,03 mg 2 mg




Dienovel 0,03 mg/2,0 mg Filmtabletten

0,03 mg 2 mg


Austria Pelpharma Handels GmbH Stammhaustraße 1210 Wien Austria


Peliette 0,03 mg/2 mg Filmtabletten

0,03 mg 2 mg


Austria Helm AG Nordkanalstrasse 28 20097 Hamburg Germany


Kappanogest 0,03 mg/2 mg Filmtabletten

0,03 mg 2 mg


Austria Velvian Germany GmbH Carl-Zeiss-Ring 9 85737 Ismaning Germany


Dienorette 0,03 mg/2 mg Filmtabletten

0,03 mg 2 mg




Larissa 0,03 mg/2 mg Filmtabletten

0,03 mg 2 mg


5





Austria Madaus GmbH Colonia Allee 15 51067 Köln Germany


Mayra 0,03 mg/2 mg Filmtabletten

0,03 mg 2 mg


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


Motion ratiopharm 2 mg/0,03 mg Filmtabletten

0,03 mg 2 mg




Sibilla 0,03 mg/2 mg Filmtabletten

0,03 mg 2 mg


Austria Stada Arzneimittel GmbH Muthgasse 36/2 1190 Wien Austria


Stella 0,03 mg/2,0 mg Filmtabletten

0,03 mg 2 mg




Valette Dragees 0,03 mg 2 mg

Coated tablet Oral use



Viola 0,03 mg/2 mg Filmtabletten

0,03 mg 2 mg


6






Drospirenone Ethinylestradiol

Aliane 0,02 mg/3 mg Filmtabletten

0,02 mg 3 mg




Balancette 0,02 mg/3 mg Filmtabletten

0,02 mg 3 mg




Danselle 0,02 mg/3 mg 21 + 7 Filmtabletten

0,02 mg 3 mg




Danselle 0,02 mg/3 mg 21 Filmtabletten

0,02 mg 3 mg




Danseo 0,03 mg/3 mg 21 + 7 Filmtabletten

0,03 mg 3 mg


7







Danseo 0,03 mg/3 mg 21 Filmtabletten

0,03 mg 3 mg




Eloine 0,02 mg/3 mg Filmtabletten

0,02 mg 3 mg




Ethinylestradiol/Drospirenon Bayer 0,03 mg/3 mg Filmtabletten

0,03 mg 3 mg


Austria Sandoz GmbH Biochemiestrase 10 6250 Kundl Austria


Ethinylestradiol/Drospirenon Sandoz 0,02 mg/3 mg 21 Filmtabletten

0,02 mg 3 mg




Ethinylestradiol/Drospirenon Sandoz 0,02 mg/3 mg 21+7 Filmtabletten

0,02 mg 3 mg




Ethinylestradiol/Drospirenon Sandoz 0,03 mg/3 mg 21 Filmtabletten

0,03 mg 3 mg


8







Ethinylestradiol/Drospirenon Sandoz 0,03 mg/3 mg 21+7 Filmtabletten

0,03 mg 3 mg


Austria Laboratorios Leon Farma SA Calle La Vallina S/N Poligono Industrial Navatejera Navatejera, Leon E-24008 Spain


Etindros 0,02 mg/3 mg Filmtabletten

0,02 mg 3 mg




Etindros 0,03 mg/3 mg Filmtabletten

0,03 mg 3 mg




Flexyess 0,02 mg/3 mg Filmtabletten

0,02 mg 3 mg




Jangee 0,02 mg/3 mg Filmtabletten

0,02 mg 3 mg


9







Jangee 0,03 mg/3 mg Filmtabletten

0,03 mg 3 mg




Lamiva 0,02 mg/3 mg Filmtabletten

0,02 mg 3 mg




Naraya 0,02 mg/3 mg Filmtabletten

0,02 mg 3 mg




Naraya 0,03 mg/3 mg Filmtabletten

0,03 mg 3 mg




Volina 0,03 mg/3 mg Filmtabletten

0,03 mg 3 mg


10







Volina mite 0,02 mg/3 mg Filmtabletten

0,02 mg 3 mg




Yasmin 0,03 mg/3 mg - Filmtabletten

0,03 mg 3 mg




Yasminelle 0,02 mg/3 mg Filmtabletten

0,02 mg 3 mg




YAZ 0,02 mg/3 mg Filmtabletten

0,02 mg 3 mg




Yirala 0,03 mg/3 mg - Filmtabletten

0,03 mg 3 mg



Gestodene Ethinylestradiol

Annantah 15 Mikrogramm/60 Mikrogramm Filmtabletten

0,015 mg 0,06 mg


11







Flow 15 µg / 60 µg Filmtabletten

0,015 mg 0,06 mg




Gynovin - Dragees 0,03 mg 0,075 mg




Harmonette - Dragees

0,02 mg 0,075 mg




Jamyle 15 Mikrogramm/60 Mikrogramm Filmtabletten

0,015 mg 0,06 mg




Lenea 20 µg/75 µg überzogene Tabletten

0,02 mg 0,075 mg




Meliane - Dragees 0,02 mg 0,075 mg


12







Minesse 15 Mikrogramm/60 Mikrogramm Filmtabletten

0,015 mg 0,06 mg




Minulet - Dragees 0,03 mg 0,075 mg




Mirelle 15 Mikrogramm/60 Mikrogramm - Filmtabletten

0,015 mg 0,06 mg




Sylgestrel 75 Mikrogramm + 30 Mikrogramm Dragees

0,03 mg 0,075 mg




Sylgestrel mite 75 Mikrogramm + 20 Mikrogramm Dragees

0,02 mg 0,075 mg




Triodena - Dragees 0,03 mg /0,05 mg 0,04 mg /0,07 mg 0,03 mg /0,10 mg




Varianta 15 Mikrogramm/60 Mikrogramm Filmtabletten

0,015 mg 0,06 mg


13







Wave ratiopharm 75 Mikrogramm/20 Mikrogramm überzogene Tabletten

0,02 mg 0,075 mg




Yris - Dragees 0,03 mg 0,075 mg




Yris mite - Dragees 0,02 mg 0,075 mg



Etonogestrel Ethinylestradiol

Circlet 0,120 mg / 0,015 mg pro 24 Stunden - Vaginalring

11,7 mg 2,7 mg

Vaginal delivery system

Vaginal use



NuvaRing 0,120 mg/0,015 mg pro 24 Stunden - Vaginalring

11,7 mg 2,7 mg


Vaginal use



TriCilest- Tabletten 0,18 mg/0,215 mg/0,25 mg 0,035 mg/0,035 mg/0,035 mg

Tablet Oral use

14







Vivelle - Tabletten 0,18 mg/0,215 mg/0,25 mg 0,035 mg/0,035 mg/0,035 mg

Tablet Oral use



Denise 20 Mikrokramm/150 Mikrogramm Tabletten

0,02 mg 0,15 mg

Tablet Oral use



Laurine 0,02 mg/3 mg Filmtabletten

0,02 mg 3 mg




Laurine 0,03 mg/3 mg Filmtabletten

0,03 mg 3 mg




Ethinylestradio/Drospirenon 0,02 mg/3 mg Filmtabletten

0,02 mg 3 mg


Austria Ivowen Limited 3 Anglesa St Tipperary Clonmel Ireland


Liladros 0,02 mg/ 3 mg Filmtabletten

0,02 mg 3 mg


15





Austria Ivowen Limited 3 Anglesa St Tipperary Clonmel Ireland


Lilas 0,03 mg/ 3 mg Filmtabletten

0,03 mg 3 mg


Austria Famy Care Europe Ltd One Wood Street EC2V 7WS London United Kingdom


Ethinylestradiol/Dienogest Famy 0,03 mg/ 2 mg Filmtabletten

0,03 mg 2 mg

film-coated tablet Oral use

Belgium BAYER SA-NV J.E. Mommaertslaan 14 1831 Diegem Belgium


QLAIRA 3 mg 2 mg/2 mg 2 mg/3 mg 1 mg


Belgium Gedeon Richter Plc. Gyömröí út 19-21 HU-1103 Budapest Hungary


BELLINA 0.03 mg 2.00 mg


Belgium Mithra Pharmaceuticals S.A. Rue Saint Georges 5 4000 Liège Belgium


HELEN 0.03 mg 2.00 mg


Belgium mibe GmbH Arzneimittel Münchener Str. 15 06796 Brehna Germany


MADINELLE 0.03 mg 2.00 mg


Belgium Madaus GmbH Colonia Allee 15 51067 Köln Germany


ORCHIDEA 0.03 mg 2.00 mg


16







DESO 20 0.02 mg 0.15 mg




DESO 30 0.03 mg 0.15 mg


Belgium N.V. Organon Kloosterstraat 6 5349 AB, Oss The Netherlands


GRACIAL 0.040 mg/0.025 mg 0.03 mg/0.125 mg

Tablet Oral use



MARVELON 0.03 mg 0.15 mg

Tablet Oral use



MERCILON 0.020 mg 0.150 mg

Tablet Oral use

Belgium Mithra Pharmaceuticals S.A. Rue Saint Georges 5 4000 Liège Belgium


LOUISE 0.03 mg 2.00 mg


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


VEREZANA 0.03 mg 2.00 mg


17







ANNABELLE 0.02 mg 3.00 mg




ANNAIS 0.03 mg 3.00 mg


Belgium SANDOZ N.V. Telecom Gardens Medialaan 40 1800 Vilvoorde Belgium


ARMUNIA 20 0.02 mg 3.00 mg




ARMUNIA 30 0.03 mg 3.00 mg


Belgium EFFIK BENELUX Lenniksebaan 451 1070 Anderlecht Belgium


DROSPIBEL 20 0.02 mg 3.00 mg






18







RHONYA 20 0.02 mg 3.00 mg




RHONYA 30 0.03 mg 3.00 mg




YASMIN 0.03 mg 3.00 mg




YAZ 0.02 mg 3.00 mg




CIRCLET 2.70 mg 11.70 mg


Vaginal use



NUVARING 2.70 mg 11.70 mg


Vaginal use

19





Belgium MPCA BVBA Vrijestraat 28 9960 Assenede Belgium


CAOIMHE 0.02 mg 0.075 mg




ESTINETTE 20 0.02 mg 0.075 mg




ESTINETTE 30 0.030mg 0.075 mg




FEMODENE 0.030mg 0.075 mg


Belgium MYLAN BVBA/SPRL Terhulpsesteenweg 6A 1560 Hoeilaart Belgium


GESICAMYLAN 0.02 mg 0.075 mg




GESICAMYLAN 0.030mg 0.075 mg




GESTODELLE 20 0.02 mg 0.075 mg


20





Belgium L.F. WILL & CIE SA Rue du Manil 80 1301 Wavre Belgium


GESTODENOL 20 0.02 mg 0.075 mg


Belgium L.F. WILL & CIE SA Rue du Manil 80 1301 Wavre Belgium


GESTODENOL 30 0.030mg 0.075 mg




GESTOFEME 30 0.030mg 0.075 mg


Belgium MPCA BVBA Vrijestraat 28 9960 Assenede Belgium


GRAINNE 0.030mg 0.075 mg


Belgium PFIZER S.A. 17 Boulevard de la Plaine 1050 Brussels Belgium


HARMONET 0.02 mg 0.075 mg




LIOSANNE 20 0.02 mg 0.075 mg


21







LIOSANNE 30 0.030mg 0.075 mg




MELIANE 0.02 mg 0.075 mg




MINULET 0.03 mg 0.07 mg




MIRELLE 0.015 mg 0.06 mg




TRI- MINULET 0.03 mg 0.05 mg




TRIODENE 0.03 mg /0.05 mg 0.04 mg /0.07 mg 0.03 mg /0.10 mg


22







YVELLIS 0.015 mg 0.060mg


Belgium JANSSEN-CILAG N.V. Antwerpseweg 15-17 2340 Beerse Belgium


CILEST 0.035 mg 0.25 mg

Tablet Oral use



YASMINELLE 0.02 mg 3.00 mg




DENISE 20 0.02 mg 0.150 mg

Tablet Oral use



EMMAMYLAN 0.020 mg 0.0150 mg

Tablet Oral use



EMMAMYLAN 0.030 mg 0.150 mg

Tablet Oral use



TRENDESO 20 0.02 mg 0.15 mg


23







TRENDESO 30 0.03 mg 0.15 mg




BRADLEY 20 0.02 mg 3.00 mg




CORNELIA 0.03 mg 3.00 mg




DORINELLETEVA 0.02 mg 3.00 mg




DORINELLETEVA CONTINU

0.02 mg 3.00 mg




DORINTEVA 0.03 mg 3.00 mg


24







DORINTEVA CONTINU 0.03 mg 3.00 mg




DROSEFIKK 0.02 mg 3.00 mg




NAIWANEL 0.02 mg 3.00 mg




REZEDIA 0.02 mg 3.00 mg




YADERE 0.02 mg 3.00 mg




Yvidually 0,02 mg/3 mg, filmomhulde tabletten

0,02 mg 3 mg


Bulgaria N.V. Organon Kloosterstraat 6 5349 AB, Oss The Netherlands


Marvelon 0,15 mg 0,03 mg

Tablet Oral use

25





Bulgaria Gedeon Richter Plc. Gyömröí út 19-21 HU-1103 Budapest Hungary


Novynette 0,15 mg 0,02 mg




Regulon 0,15 mg 0,03 mg




Mercillon 0,02 mg 0,15 mg

Tablet Oral use



Novynette 28 0,15 mg 0,02 mg




Aneea 0,02 mg 3 mg




Belusha 0,02 mg 3 mg




Daylette 0,02 mg 3 mg


26





Bulgaria Bayer Pharma AG D-13342 Berlin Germany


Eloine 0,02 mg 3 mg




Flexyess 0,02 mg 3 mg


Bulgaria Medico Uno Pharma Kft. Viadukt u. 12 Biatorbágy 2051 Hungary


Jangee 0,02 mg 3 mg




Jangee 0,03 mg 3 mg


Bulgaria Laboratorios Leon Farma SA Poligono Industrial Navatejera, La Vallina s/n, 24008 Villaquilambre,Leon Spain


Jangee 28 0,02 mg 3 mg




Jangee 28 0,03 mg 3 mg


27







Drosetil 28 0,02 mg 3 mg




Midiana 0,03 mg 3 mg




Palandra 0,03 mg 3 mg


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


Sidretella 0,02 mg 3 mg








Teenia 0,02 mg 3 mg


28





Bulgaria Teva Pharmaceuticals Bulgaria EOOD Gogol 15 Sofia 1124 Bulgaria


Veyann 0,02 mg 3 mg




Yasmin 0,03 mg 3 mg




Yaz 0,02 mg 3 mg




Artizia 0,075 mg 0,02 mg


Bulgaria Bayer Pharma AG Muellerstr. 178 13353 Berlin Germany


Femoden 0,03 mg 0,075 mg




Gestodette 0,02 mg 0,075 mg


29







Kostya 0,02 mg 0,075 mg


Bulgaria Bayer Pharma AG Muellerstr. 178 13353 Berlin Germany


Logest 0,02 mg 0,075 mg




Milligest 0,03 mg/0,05 mg 0,04 mg/0,07 mg 0,03 mg/0,1 mg


Bulgaria Actavis Group PTC ehf Reykjavikurvegi 76-78 220 Hafnarfjordur Iceland


Sylgestrel 20 0,02 mg 0,075 mg


Bulgaria Actavis Group PTC ehf Reykjavikurvegi 76-78 220 Hafnarfjordur Iceland


Sylgestrel 30 0,03 mg 0,075 mg




Vendiol 0,015 mg 0,06 mg




Zulfija 0,03 mg 0,075 mg


30







Lindynette 20 0,075 mg 0,02 mg






Bulgaria Johnson & Johnson d.o.o. Šmartinska cesta 53 1000 Ljubljana Slovenija


Cilest 0,25 mg 0,035 mg

Tablet Oral use



Qlaira 3 mg 2 mg/2 mg 2 mg/3 mg 1 mg




NuvaRing 0,120 mg/0,015 mg per 24 hours, vaginal delivery system

11.7 mg 2.7 mg


Vaginal use



Estmar 20 0,02 mg 0,15 mg

Tablet Oral use

31







Estmar 30 0,03 mg 0,15 mg

Tablet Oral use



Bonadea 0,03 mg 2 mg


Bulgaria Ivowen Limited 3 Anglesa St Tipperary Clonmel Ireland


Lulina 0,03 mg 3 mg


Cyprus Janssen-Cilag International N.V. Turnhoutseweg 30 B 2340 Beerse Belgium


Cilest Tablets 0.25 mg 0.035 mg

Tablet Oral use

Cyprus N.V. Organon Kloosterstraat 6 5349 AB, Oss The Netherlands


Marvelon Tablets 0.15 mg 0.03 mg

Tablet Oral use

Cyprus BAYER HELLAS AG Sorou street 18-20 Maroussi Athens 15125 Greece


Yasminelle 0.02mg 3mg


32






Ethinylestradiol Drospirenone

Flexyess 0.02 mg 3 mg




Yaz 0.02mg 3mg




Mercilon tablets 0.15 mg 0.02 mg

Tablet Oral use



Gracial tablets 0,125 mg/0,030 mg 0,025 mg/0,040 mg

Tablet Oral use



Qlaira 3 mg 2 mg/2 mg 2 mg /3 mg 1 mg




Palandra 0.03mg 3mg


33







Nuvaring 0.120mg/0.015mg per 24 hours,vaginal delivery system

11.70 mg 2.70 mg


Vaginal use

Czech Republic

Gedeon Richter Plc. Gyömröí út 19-21 HU-1103 Budapest Hungary


BELARA 2 mg 0,03 mg


Czech Republic

Stada Arzneimittel Aktiengesellschaft Stadastrasse 2/18 61118 Bad Vilbel Germany


BONISSA 0,03 MG/2 MG POTAHOVANÉ TABLETY

2 mg 0,03 mg


Czech Republic

WH-Pharma s.r.o. Talafusova 970 28401 Kutná Hora Czech Republic


CLORMETIN 2 MG/0,03 MG

2 mg 0,03 mg


Czech Republic

Teva Pharmaceuticals CR, s.r.o. Radlická 3185/1c 150 00 Praha 5 Czech Republic


ESETE 2 MG/0,03 MG 2 mg 0,03 mg


Czech Republic

Heaton k.s. Na Pankráci 14 14000 Praha 4 Czech Republic


FLAYA 0,030 MG/2 MG POTAHOVANÉ TABLETY

2 mg 0,03 mg


34





Czech Republic

mibe GmbH Arzneimittel Münchener Str. 15 06796 Brehna Germany


MADINELLE 0,03 MG/2 MG

2 mg 0,03 mg


Czech Republic



ADELE 0,15 mg 0,03 mg

Tablet Oral use

Czech Republic



ARNETTE 0,15 MG/0,03 MG

0,15 mg 0,03 mg

Tablet Oral use

Czech Republic



GAIA 0,15 MG/0,02 MG

0,15 mg 0,02 mg

Tablet Oral use

Czech Republic

N.V. Organon Kloosterstraat 6 5349 AB, Oss The Netherlands


GRACIAL 0,04 mg/0,025 mg 0,03 mg/0,125 mg

Tablet Oral use

Czech Republic



LAURINA 0,03 mg/0,1 mg 0,03 mg/0,15 mg 0,035 mg/0,05 mg


Czech Republic



MARVELON 0,15 mg 0,03 mg

Tablet Oral use

35





Czech Republic



MERCILON 0,15 mg 0,02 mg

Tablet Oral use

Czech Republic



NATALYA 0,15 mg 0,02 mg

Tablet Oral use

Czech Republic



NOVYNETTE 150 MCG/20 MCG POTAHOVANÉ TABLETY

0,15 mg 0,02 mg


Czech Republic

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


REGISHA 0,150 MG/0,02 MG TABLETY

0,15 mg 0,02 mg

Tablet Oral use

Czech Republic



REGISHA 0,150 MG/0,03 MG TABLETY

0,15 mg 0,03 mg

Tablet Oral use

Czech Republic



REGULON 150 MCG/30 MCG POTAHOVANÉ TABLETY

0,15 mg 0,03 mg


36





Czech Republic

Bayer Pharma AG D-13342 Berlin Germany

Ethinylestradiol Gestodene



Czech Republic





Czech Republic

VIVAX EuroAsia s.r.o. Karloveske rameno 6 841 01 Bratislava Slovensko


AIDEE 2 MG/0,03 MG POTAHOVANÉ TABLETY

2 mg 0,03 mg


Czech Republic



AYREEN 2 mg 0,03 mg


Czech Republic



BONADEA 2 mg 0,03 mg


Czech Republic



JEANINE 2 mg 0,03 mg


Czech Republic



MISTRA 2 MG/0,03 MG POTAHOVANÉ TABLETY

2 mg 0,03 mg


37





Czech Republic



VEREZANA 0,03 MG/2 MG POTAHOVANÉ TABLETY

2 mg 0,03 mg


Czech Republic

STADA Arzneimittel AG Stadastrasse 2-18 D-61118 Bad Vilbel Germany


YANELA 2 mg 0,03 mg


Czech Republic

LadeePharma Kft Lajos utca 48-66 H-1036 Budapest Hungary


JANGEE 0,03 MG/3 MG 28 POTAHOVANÝCH TABLET

3mg 0,03mg


Czech Republic



MAITALON 3 MG/0,03 MG POTAHOVANÉ TABLETY

3mg 0,03mg


Czech Republic

Sandoz s.r.o. Nagano III, U Nákladového nádraží 10 13000 Praha - 3 Czech Republic


RHONYA 3 MG/30 MCG

3mg 0,03mg


Czech Republic



SIDRETA 0,03 MG/3 MG POTAHOVANÉ TABLETY

3mg 0,03mg


38





Czech Republic



SOFTINE 0,03 MG/3 MG POTAHOVANÉ TABLETY

3mg 0,03mg


Czech Republic



SYLVIANE 0,03 MG/3 MG POTAHOVANÉ TABLETY

3mg 0,03mg


Czech Republic

Ivowen Limited 3 Anglesa St Tipperary Clonmel Ireland


WERRCA 3 MG/0,03 MG POTAHOVANÉ TABLETY

3mg 0,03mg


Czech Republic



YADINE 3mg 0,03mg


Czech Republic



DIENILLE POTAHOVANÁ TABLETA

0,03 mg 2 mg


Czech Republic

Laboratorios Leon Farma SA Calle La Vallina S/N Poligono Industrial Navatejera Navatejera, Leon E-24008 Spain


FOXINETTE 2 MG/0,03 MG

0,03 mg 2 mg


39





Czech Republic



FOXINETTE NEO 0,03 mg 2 mg


Czech Republic



BELANETTE 0,02 MG/3 MG POTAHOVANÉ TABLETY

0,02 mg 3 mg


Czech Republic



ELOINE 0,02 MG/3 MG POTAHOVANÉ TABLETY

0,02 mg 3 mg


Czech Republic



FLEXYESS 0,02 MG/3 MG POTAHOVANÉ TABLETY

0,02 mg 3 mg


Czech Republic



MYWY 0,02 MG/3 MG 0,02 mg 3 mg


Czech Republic



NYSSIELA 3 MG/0,02 MG

0,02 mg 3 mg


40





Czech Republic



SIDRETELLA 0,02 MG/3 MG POTAHOVANÉ TABLETY

0,02 mg 3 mg


Czech Republic



SOFTINELLE 0,02 MG/3 MG POTAHOVANÉ TABLETY

0,02 mg 3 mg


Czech Republic



VELMARI 3 MG/0,02 MG

0,02 mg 3 mg


Czech Republic



VEYANNE 0,02 MG/3 MG

0,02 mg 3 mg


Czech Republic



YASMINELLE 0,02 MG/3 MG POTAHOVANÉ TABLETY

0,02 mg 3 mg


Czech Republic



YAZ 0,02 MG/3 MG POTAHOVANÉ TABLETY

0,02 mg 3 mg


Czech Republic



YOSEFINNE 0,02 mg 3 mg


41





Czech Republic



BELUSHA 3 MG/0,02 MG POTAHOVANÉ TABLETY

0,02 mg 3 mg


Czech Republic



DAYLETTE 3 MG/0,02 MG POTAHOVANÉ TABLETY

0,02 mg 3 mg


Czech Republic



DAYLLA 3 MG/0,02 MG POTAHOVANÉ TABLETY

0,02 mg 3 mg


Czech Republic



JANGEE 0,02 MG/3 MG 28 POTAHOVANÝCH TABLET

0,02 mg 3 mg


Czech Republic



KIRGA 3 MG/0,02 MG POTAHOVANÉ TABLETY

0,02 mg 3 mg


Czech Republic



RHONYA 3 MG/20 MCG

0,02 mg 3 mg


42





Czech Republic



ARTIZIA 0,075 MG/0,020 MG OBALENÉ TABLETY

0,075 mg 0,02 mg


Czech Republic

Pfizer, spol. s r.o. Stroupežnického 17 150 00 Praha 5 Czech Republic


HARMONET OBALENÉ TABLETY

0,075 mg 0,02 mg


Czech Republic



KATYA 0,075 mg 0,03 mg


Czech Republic



LINDYNETTE 20 0,075 mg 0,02 mg


Czech Republic



LOGEST 0,075 mg 0,02 mg


Czech Republic



LUNAFEM 0,075 mg 0,02 mg


Czech Republic



MILLIGEST OBALENÉ TABLETY

0.05 mg/0.03 mg 0.07 mg/ 0.04 mg 0.1 mg/ 0.03 mg


43





Czech Republic



MINESSE POTAHOVANÉ TABLETY

0,06 mg 0,015 mg


Czech Republic



MINULET OBALENÉ TABLETY

0,075 mg 0,03 mg


Czech Republic



MIRELLE 0,015 mg 0,06 mg


Czech Republic



NELYA 0,015 MG/0,06 MG

0,06 mg 0,015 mg


Czech Republic

Medico Uno Pharma Kft. Viadukt u. 12 Biatorbágy 2051 Hungary


STODETTE OBALENÉ TABLETY

0,075 mg 0,02 mg


Czech Republic



SUNYA 0,075 mg 0,02 mg


Czech Republic



TRI-MINULET OBALENÉ TABLETY

0,05 mg/ 0,03 mg 0,07 mg/ 0,04 mg 0,1 mg/ 0,03 mg


44





Czech Republic



VIOLETTA 60 MIKROGRAMŮ/15 MIKROGRAMŮ POTAHOVANÉ TABLETY

0,06 mg 0,015 mg


Czech Republic



VONILLE 0,060 MG/0,015 MG

0,06 mg 0,015 mg


Czech Republic



ZULFIJA 75 MIKROGRAMŮ/ 20 MIKROGRAMŮ OBALENÉ TABLETY

0,075 mg 0,02 mg


Czech Republic



ZULFIJA 75 MIKROGRAMŮ/ 30 MIKROGRAMŮ OBALENÉ TABLETY

0,075 mg 0,03 mg


Czech Republic

Janssen-Cilag s.r.o. Karla Engliše 3201/6 150 00 Praha 5 - Smíchov Czech Republic


PRAMINO 0.18 mg /0.035 mg 0.215 mg /0.035 mg 0.25 mg /0.035 mg

Tablet Oral use

45





Czech Republic



PRAMINO 28 0,18 mg/ 0,035 mg 0,215 mg/ 0,035 mg 0,25 mg/ 0,035 mg

Tablet Oral use

Czech Republic



CILEST 0,25 mg 0,035 mg

Tablet Oral use

Czech Republic



NUVARING 0,120 MG/0,015 MG ZA 24 HODIN, VAGINÁLNÍ INZERT

2,7 mg 11,7 mg


Vaginal use

Czech Republic



Circlet 2.7 mg 11.7 mg


Vaginal use

Czech Republic

Famy Care Europe Ltd. 1 Wood Street EC2V7WS London United Kingdom


NORGESTIMATE/ETHINYLESTRADIOL FAMYCARE 0,25 MG/0,035 MG TABLETY

0,25 mg 0,035 mg

Tablet Oral use

46





Czech Republic

Famy Care Europe Ltd. 1 Wood Street EC2V7WS London United Kingdom


DIENOGEST/ETHINYLESTRADIOL FAMYCARE 2,0 MG/0,03 MG POTAHOVANÉ TABLETY

2 mg 0,03 mg


Denmark Gedeon Richter Plc. Gyömröí út 19-21 HU-1103 Budapest Hungary


Asphalia 28 0,15 mg 0,02 mg


Denmark Stragen Nordic A/S, Helsingørgade 8C, DK-3400 Hillerød, Denmark


Daisynelle 0,15 mg 0,02 mg

Tablet Oral use



Daisynelle 0,15 mg 0,03 mg

Tablet Oral use

Denmark Actavis Group PTC ehf Reykjavikurvegi 76-78 220 Hafnarfjordur Iceland


Desogestrel/ethinylestradiol Actavis

0,15 mg 0,02 mg

Tablet Oral use



Desogestrel/ethinylestradiol Actavis

0,15 mg 0,03 mg

Tablet Oral use

47





Denmark Sandoz A/S Edward Thomsens Vej 14 DK-2300 København S Denmark


Desorelle 0,15 mg 0,03 mg


Denmark Stada Arzneimittel AG, Stadastrasse 2-8, DE-61118 Bad Vibel, Germany


Femistad 0,15 mg 0,03 mg

Tablet Oral use

Denmark Stada Arzneimittel AG, Stadastrasse 2-8, DE-61118 Bad Vibel, Germany



Tablet Oral use

Denmark Medimpex UK Ltd, 127 Shirland Road, London W9 2EP United Kingdom


Gedarel 0,15 mg 0,03 mg

Tablet Oral use

Denmark N.V. Organon Kloosterstraat 6 5349 AB, Oss The Netherlands


Gracial 0,03 mg/0,125 mg 0,04 mg/0,025 mg

Tablet Oral use



Hunogidon 0,15 mg 0,02 mg




Hunogidon 28 0,15 mg 0,03 mg


48







Hunogidon 28 0,15 mg 0,02 mg


Denmark Medimpex UK Ltd, 127 Shirland Road, London W9 2EP United Kingdom


Igixon 0,15 mg 0,02 mg

Tablet Oral use

Denmark Mylan AB, Postbox 23033, Ynglingagatan 14, SE-10435 Stockholm, Sweden


Lestramyl 0,15 mg 0,02 mg

Tablet Oral use

Denmark Mylan AB, Postbox 23033, Ynglingagatan 14, SE-10435 Stockholm, Sweden



Tablet Oral use



Leticia 0,15 mg 0,03 mg




Leticia 28 0,15 mg 0,03 mg


49







Letione 28 0,15 mg 0,03 mg





Tablet Oral use



Marvelon 28 0,15 mg 0,03 mg

Tablet Oral use



Mercilon 0,15 mg 0,02 mg

Tablet Oral use



Myrzi 0,15 mg 0,02 mg




Myrzi 28 0,15 mg 0,02 mg






50







Novypil 28 0,15 mg 0,02 mg




Rigetrux 0,15 mg 0,03 mg




Rigetrux 28 0,15 mg 0,03 mg




Vivides 28 0,15 mg 0,02 mg


Denmark Bayer AB Postbox 606 Gustav III's Boulevard 56 SE-16926 Solna Sweden




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


Dretine 3mg 0,03mg


51







Dretine 28 3mg 0,03mg


Denmark Laboratorios Leon Farma SA Poligono Industrial Navatejera, La Vallina s/n, 24008 Villaquilambre,Leon Spain


Estron 28 3mg 0,03mg




Finminette 3mg 0,03mg


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


Movinella 3mg 0,03mg




Movinella 28 3mg 0,03mg




Palandra 3mg 0,03mg


52







Rubira 3mg 0,03mg


Denmark Bayer Pharma AG D-13342 Berlin Germany


Yasmin 3mg 0,03mg




Yasmin 28 3mg 0,03mg




Dretine 0,02 mg 3 mg




Dretine 28 0,02 mg 3 mg




Denise 0.15 mg 0.02 mg




Denise 0.15 mg 0.03 mg


53







Drosinetta 0,02 mg 3 mg




Drosinetta 28 0,02 mg 3 mg




Midiana 0,03 mg 3 mg




Eloine 0,02 mg 3 mg


Denmark Laboratorios Leon Farma SA Poligono Industrial Navatejera, La Vallina s/n, 24008 Villaquilambre,Leon Spain


Estron 28 0,02 mg 3 mg




Finminette 0,02 mg 3 mg


54











Liofora 0,02 mg 3 mg




Movinella 0,02 mg 3 mg




Movinella 28 0,02 mg 3 mg




Perlkala 0,02 mg 3 mg




Rubira 0,02 mg 3 mg


55







Stefaminelle 0,02 mg 3 mg




Veyann 0,02 mg 3 mg




Yasminelle 0,02 mg 3 mg




Yasminelle 28 0,02 mg 3 mg




Yaz 0,02 mg 3 mg




NuvaRing 11,7mg 2,7 mg


Vaginal use



Celia 0,06 mg 0,015 mg


56







Dorinette 0,075 mg 0,03 mg




Edesia 0,075 mg 0,02 mg




Edesia 0,075 mg 0,03 mg




Estinette 0,075 mg 0,02 mg




Gestilla 0,075 mg 0,02 mg




Gestinyl 0,075 mg 0,02 mg




Gestinyl 0,075 mg 0,03 mg


57





Denmark Mylan S.A.S 117 Allée des Parcs FR-69800 Saint Priest France


Gestoden/ethinylestradiol 75/20 Mylan

0,075 mg 0,02 mg


Denmark Mylan S.A.S 117 Allée des Parcs FR-69800 Saint Priest France


Gestoden/ethinylestradiol 75/30 Mylan

0,075 mg 0,03 mg




Gestoden/ethinylestradiol Actavis

0,075 mg 0,03 mg




Gestoden/ethinylestradiol Actavis

0,075 mg 0,02 mg




Gestoden/ethinylestradiol Gedion Richter

0,06 mg 0,015 mg


Denmark Ratiopharm GmbH Graf-Arco-Strasse 3 DE-89079 Ulm Germany


Gestodilat 0,075 mg 0,02 mg


Denmark Ratiopharm GmbH Graf-Arco-Strasse 3 DE-89079 Ulm Germany


Gestodilat 0,075 mg 0,03 mg


58







Gestonette 0,075 mg 0,02 mg




Halogest 0,05 mg 0,03 mg


Denmark Pfizer ApS, Lautrupvang 8, DK-2750 Ballerup, Denmark


Harmonet 0,075 mg 0,02 mg




Lindynette 0,075 mg 0,03 mg




Mandolina 0,06 mg 0,015 mg




Melitta 0,075 mg 0,03 mg




Milligest 0,05 mg 0,03 mg


59







Milna 0,075 mg 0,03 mg




Milna 0,075 mg 0,02 mg




Milvane 0.05 mg/0.03 mg 0.07 mg/0.04 mg 0.10 mg/0.03 mg




Minero 0,075 mg 0,02 mg


Denmark Pfizer ApS, Lautrupvang 8, DK-2750 Ballerup, Denmark


Minulet 0,075 mg 0,03 mg




Modina 0,075 mg 0,03 mg


60







Varianta 0,06 mg 0,015 mg




Vellena 0,075 mg 0,02 mg




Vellena 0,075 mg 0,03 mg








Violetta 0,06 mg 0,015 mg










61





Denmark Janssen-Cilag A/S, Hammerbakken 19 DK-3460 Birkerød Denmark



Tablet Oral use



Circlet 11,7 mg 2,7 mg


Vaginal use

Estonia Gedeon Richter Plc. Gyömröí út 19-21 HU-1103 Budapest Hungary


BELARA 2 mg 0,03 mg


Estonia Ladee Pharma Baltics UAB Žemaitijos g.13/Šiaulių g.10, LT-01134 Vilnius Lithuania


CLORMETIN 2 MG/0,03 MG

2 mg 0,03 mg


Estonia N.V. Organon Kloosterstraat 6 P.O. Box 20 5340 BH, Oss The Netherlands



Tablet Oral use




Tablet Oral use

62








Tablet Oral use



Nuvaring 11,7mg 2,7mg


Vaginal use



NOVYNETTE 0,15 mg 0,02 mg




NOVYNETTE PLUS 0,15 mg 0,02 mg




REGULON 0,15 mg 0,03 mg


Estonia Bayer Pharma AG D-13342 Berlin Germany




63





Estonia Orivas UAB J.Jasinskio 16B LT-01112 Vilinius Lithuania


AMMILY 2 MG / 0,03 MG

2 mg 0,03 mg








SIBILLA 2 mg 0,03 mg




JANGEE 0,03 MG/3 MG

3mg 0,03mg


Estonia Laboratorios Leon Farma SA Poligono Industrial Navatejera, La Vallina s/n, 24008 Villaquilambre,Leon Spain


LLUVIEIGHT 0,03 MG/3 MG

3mg 0,03mg


Estonia Ivowen Limited 3 Anglesa St Tipperary Clonmel Ireland


LULINA 3mg 0,03mg




MIDIANA 3mg 0,03mg


64







MINAYEIGHT 0,03 MG/3 MG

3mg 0,03mg




YARINA 3mg 0,03mg




ANEEA 0,02 mg 3 mg




BELUSHA 0,02 mg 3 mg




DAYLETTE 0,02 mg 3 mg




JANGEE 0,02 MG/3 MG

0,02 mg 3 mg


65







LLUVIEIGHT 0,02 MG/3 MG

0,02 mg 3 mg


Estonia Sandoz d.d. Verovskova 57 SI-1000 Ljubljana Slovenia


MADELEINE 0,02 mg 3 mg




MADELEINE 3mg 0,03mg




MARIONELLE 3mg 0,03mg




MARIONELLE 0,02 mg 3 mg




MINAYEIGHT 0,02 MG/3 MG

0,02 mg 3 mg


66







TEENIA 0,02 mg 3 mg




VELGYN 0,02 mg 3 mg




YASMINELLE 0,02 mg 3 mg




YAZ 0,02 mg 3 mg




YVIDUALLY 0,02 mg 3 mg




EDESIA 0,075 mg 0,02 mg




FEMODEN 0,075 mg 0,03 mg


Estonia Ratiopharm GmbH Graf-Arco-Strasse 3 DE-89079 Ulm Germany


GESYTIL 75/20 MIKROGRAMMI

0,075 mg 0,02 mg


67





Estonia Ratiopharm GmbH Graf-Arco-Strasse 3 DE-89079 Ulm Germany


GESYTIL 75/30 MIKROGRAMMI

0,075 mg 0,03 mg


Estonia Pfizer Europe MA EEIG Ramsgate Road Sandwich Kent CT13 9NJ United Kingdom


HARMONET 0,075 mg 0,02 mg














Estonia Pfizer Europe MA EEIG Ramsgate Road Sandwich Kent CT13 9NJ United Kingdom


MINULET 0,075 mg 0,03 mg






68







VIOLETTA 0,06 mg 0,015 mg




VONILLE 0,06 mg 0,015 mg




ZULFIJA 0,075 mg 0,02 mg


Estonia UAB „Johnson & Johnson“ Geležinio Vilko g. 18A LT-08104 Vilnius Lithuania


Cilest 0,25mg 0,035mg

Tablet oral use

Estonia Teva Pharma BV Computerweg 10 3542 DR Utrecht The Netherlands


DESTELE 0,15 mg 0,02 mg

Tablet Oral use

Estonia Teva Pharma BV Computerweg 10 3542 DR Utrecht The Netherlands


DESTELE 0,15 mg 0,03 mg

Tablet Oral use

Finland Stragen Nordic A/S Hesselvej 41 Ganlose 3660 Stenlose Denmark


DAISYNELLE 0,15 mg 0,02 mg

Tablet Oral use

69





Finland Gedeon Richter Plc. Gyömröí út 19-21 HU-1103 Budapest Hungary


DESODIOLCONT 0,15 mg 0,02 mg

Tablet Oral use

Finland N.V. Organon Kloosterstraat 6 5349 AB, Oss The Netherlands


GRACIAL 0.03 mg/0.125 mg 0.04 mg/0.025 mg

Tablet Oral use



LAURINA 0.035 mg/0.05 mg 0.03 mg/0.1 mg 0.03 mg/0.15 mg




LAURINA 28 0.035 mg/0.05 mg 0.03 mg/0.1 mg 0.03 mg/0.15 mg




CIRCLET 11,7 mg 2,7 mg


Vaginal use

Finland Mylan AB Box 23033 10435 Stockholm Sweden


LESTRAMYL 0,15 mg 0,02 mg

Tablet Oral use

Finland Mylan AB Box 23033 10435 Stockholm Sweden


LESTRAMYL 0,15 mg 0,03 mg

Tablet Oral use

70








Tablet Oral use

Finland Organon (Ireland) Ltd, PO Box 2857, Drynam Road, Swords, Co.Dublin, Ireland



Tablet Oral use



NOVYNETTE (28) 0,15 mg 0,02 mg

Tablet Oral use



RIGETRUX (28) 0,15 mg 0,03 mg

Tablet Oral use



SABLONA (28) 0,15 mg 0,03 mg

Tablet Oral use

Finland BAYER OY Pansiontie 47 PL 415 20210 Turku Finland




71







FLEXYESS 0,02 mg 3 mg


Finland Teva Sweden AB Järnvägsgatan 11 Box 1070 25110 Helsingborg Sweden


DRETINE 3mg 0,03mg

Tablet Oral use

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


ETHINYLESTRADIOL/DROSPIRENON ORIFARM

3 mg 0.020 mg/0.030 mg

Tablet Oral use



MOVINELLA 3 mg/0.020 mg 3 mg/0.030 mg




ETHINYLESTRADIOL/DROSPIRENONE RICHTER

3mg 0,03mg

Tablet Oral use

72





Finland LEON FARMA C/ La Vallina s/n, Pol. Ind., Navatejera 24008 León Spain


LLUVIANE 3 mg 0.020 mg/0.030 mg

Tablet Oral use



PALANDRA 3mg 0,03mg




PERLITA 3mg 0,03mg

Tablet Oral use

Finland Sandoz A/S Edward Thomsens Vej 14 DK-2300 København S Denmark


RUBIRA 3mg 0,03mg

Tablet Oral use



TASMINETTA 3 mg 0.020 mg/0.030 mg

Tablet Oral use



YASMIN 3mg 0,03mg


73





Finland Orifarm Oy Metsänneidonkuja 10 02130 Espoo Finland


YASMIN 3mg 0,03mg

Tablet Oral use

Finland Orifarm Oy Metsänneidonkuja 10 02130 Espoo Finland


MERCILON 0,15 mg/0,02 mg Tablet Oral use

Finland Teva Sweden AB Järnvägsgatan 11 Box 1070 25110 Helsingborg Sweden


DRETINELLE 0,02 mg 3 mg

Tablet Oral use



DROSINETTE 0,02 mg 3 mg

Tablet Oral use



LINATERA 0,02 mg 3 mg




LIOFORA 0,02 mg 3 mg


74







RUBIRA 0,02 mg 3 mg

Tablet Oral use



STEFAMINELLE 0,02 mg 3 mg

Tablet Oral use

Finland Ratiopharm GmbH Graf-Arco-Strasse 3 DE-89079 Ulm Germany


VEYANN 0,02 mg 3 mg

Tablet Oral use



YASMINELLE 0,02 mg 3 mg




YAZ 0,02 mg 3 mg




NUVARING 11,7 mg 2,7 mg


Vaginal use

75









Finland Paranova Oy Rajatorpantie 41 C 01640 Vantaa Finland



Tablet Oral use




Tablet Oral use



YASMIN 3mg 0,03mg

Tablet Oral use



MELIANE 0,075 mg 0,02 mg





Tablet Oral use

76








Tablet Oral use





Finland Stragen Nordic A/S Hesselvej 41 Ganlose 3660 Stenlose Denmark


GESTINYL 0.075mg 0.020/0.030 mg

Tablet Oral use

Finland Actavis Group PTC ehf Reykjavikurvegi 76-78 220 Hafnarfjordur Iceland


GESTODEN/ETHINYLESTRADIOL ACTAVIS

0.075mg 0.020/0.030 mg

Tablet Oral use



GESTODILAT 0.075mg 0.020/0.030 mg

Tablet Oral use

Finland PFIZER Oy Tietokuja 4 00330 Helsinki Finland



Tablet Oral use

77











MINERO 0,075 mg 0,02 mg

Tablet Oral use

Finland PFIZER Oy Tietokuja 4 00330 Helsinki Finland



Tablet Oral use







MODINA 0,075 mg 0,03 mg

Tablet Oral use

78







TRI-FEMODEN 0,05 mg/0,07 mg/0,1 mg 0,03 mg/0.04 mg/0,03 mg


Finland JANSSEN-CILAG OY Vaisalantie 2 02130 Espoo Finland


CILEST, CILEST 28 0,25 mg 0,035 mg

Tablet Oral use



DENISE 0,15 mg/0,02 mg Tablet Oral use



BENIDETTE 0,15 mg 0,02 mg

Tablet Oral use



BENIFEMA 0,15 mg 0,03 mg

Tablet Oral use

France Gedeon Richter Plc. Gyömröí út 19-21 HU-1103 Budapest Hungary


Balanca 2 mg 0,03 mg


79







Balancacontinu 2 mg 0,03 mg




Belara 2 mg 0,03 mg




Belaracontinu 2 mg 0,03 mg


France Arrow génériques SAS 26 Avenue Tony Garnier 69007 Lyon France


Chlormadinone Ethinylestradiol Actavis 2 mg/0.03 mg

2 mg 0,03 mg


France IDD (International Drug Development) 5, rue Simonet 75013 Paris France


Desiol 20 0,15 mg 0,02 mg

Tablet Oral use



Desiol 30 0,15 mg 0,02 mg

Tablet Oral use

80





France EFFIK 9-11 rue Jeanne Braconnier Bâtiment « Le Newton » 92366 Meudon la Foret cedex France


Desobel 150/20 0,15 mg 0,02 mg

Tablet Oral use



Desobel 150/30 0,15 mg 0,03 mg

Tablet Oral use

France BIOGARAN 15 Bd Charles de Gaulle 92700 Colombes France


Desogestrel Ethinylestradiol BIOGARAN 150/20

0,15 mg 0,02 mg




Desogestrel Ethinylestradiol BIOGARAN 150/30

0,15 mg 0,03 mg




Desogestrel Ethinylestradiol IDD 150/20

0,15 mg 0,02 mg

Tablet Oral use



Desogestrel Ethinylestradiol IDD 150/30

0,15 mg 0,03 mg

Tablet Oral use

81







Desogestrel Ethinylestradiol IDETEC 150/20

0,15 mg 0,03 mg

Tablet Oral use



Desogestrel Ethinylestradiol IDETEC 150/30

0,15 mg 0,03 mg

Tablet Oral use



Desogestrel Ethinylestradiol Quill 150/20

0,15 mg 0,02 mg

Tablet Oral use



Desogestrel Ethinylestradiol Quill 150/30

0,15 mg 0,03 mg

Tablet Oral use

France TEVA SANTE 110 Esplanade du Général de Gaulle 92931 Paris la Defense Cedex France


Desogestrel Ethinylestradiol TEVA 150/20

0,15 mg 0,02 mg

Tablet Oral use

82







Desogestrel Ethinylestradiol TEVA 150/30

0,15 mg 0,03 mg

Tablet Oral use



Desogestrel Ethinylestradiol Turner 150/20

0,15 mg 0,02 mg

Tablet Oral use



Desogestrel Ethinylestradiol Turner 150/30

0,15 mg 0,03 mg

Tablet Oral use

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


Desogestrel Ethinylestradiol ZENTIVA 150/20

0,15 mg 0,02 mg

Tablet Oral use



Desogestrel Ethinylestradiol ZENTIVA 150/30

0,15 mg 0,03 mg

Tablet Oral use

France Laboratoires Majorelle 12 Rue de Berri F-75008 Paris France


Desopharm 150/20 0,15 mg 0,02 mg

Tablet Oral use

83







Desopharm 150/30 0,15 mg 0,03 mg

Tablet Oral use



Desyl 20 0,15 mg 0,02 mg

Tablet Oral use



Desyl 30 0,15 mg 0,03 mg

Tablet Oral use

France MSD France 34 avenue Léonard de Vinci 92418 Courbevoie Cedex France



Tablet Oral use



Mirtinu 150/30 0,15 mg 0,03 mg


France PFIZER HOLDING France 23-25 avenue du Docteur Lannelongue 75668 PARIS Cedex 14 France


Novantica 150/20 0,15 mg 0,02 mg


84





France PFIZER HOLDING France 23-25 avenue du Docteur Lannelongue 75668 PARIS Cedex 14 France


Novantica 150/30 0,15 mg 0,03 mg


France CHEMICAL FARMA 3, Quai Louis Blériot 75016 Paris France


Ovulasten 20 0,15 mg 0,02 mg

Tablet Oral use



Ovulasten 30 0,15 mg 0,03 mg

Tablet Oral use



varnoline 0,15 mg 0,03 mg

Tablet Oral use



varnoline continu 0,15 mg 0,03 mg


France Bayer Sante 220 avenue de la Recherche 59120 Loos France




85







Convuline 3mg 0,03mg




Drospibel 0,03mg/3mg

3mg 0,03mg




Drospirenone Ethinylestradiol BIOGARAN 3mg/30µg

3mg 0,03mg




Jasmine 3mg 0,03mg




Palandra 0,03mg/3mg 3mg 0,03mg


France Laboratorios Leon Farma SA Poligono Industrial Navatejera, La Vallina s/n, 24008 Villaquilambre,Leon Spain


Bellmunt 3mg 0,03mg


86





France SANDOZ 49 avenue Georges Pompidou 92593 Levellois-Perret Cedex France


Drospirenone Ethinylestradiol GNR 3mg/30µg

3mg 0,03mg


France SANDOZ 49 avenue Georges Pompidou 92593 Levellois-Perret Cedex France


Drospirenone Ethinylestradiol SANDOZ 3mg/30µg

3mg 0,03mg




Drospirenone Ethinylestradiol TEVA 3mg/20µg

3 mg 0,020 mg




Drospirenone Ethinylestradiol TEVA 3mg/30µg

3 mg 0,020 mg




Drospirenone Ethinylestradiol TEVA SANTE 3mg/20µg

3 mg 0,020 mg




Naiwanel 0,03mg/3mg

3mg 0,03mg


87







Belanette 0,02 mg 3 mg




Drospibel 0,02mg/3mg

0,02 mg 3 mg




Drospirenone Ethinylestradiol BIOGARAN 3mg/20µg

0,02 mg 3 mg




Drospirenone Ethinylestradiol BIOGARAN CONTINU 3mg/20µg

0,02 mg 3 mg


France SANDOZ 49 avenue Georges Pompidou 92593 Levallois-Perret Cedex France


Drospirenone Ethinylestradiol GNR 3mg/20µg

0,02 mg 3 mg




Drospirenone Ethinylestradiol SANDOZ 3mg/20µg

0,02 mg 3 mg


88







Iren 0,02 mg 3 mg




Jasminellecontinu 0,02 mg 3 mg




Jasminelle 0,02 mg 3 mg




Naiwanel 0,02mg/3mg

0,02 mg 3 mg




Rimendia 0,02 mg 3 mg




Vallclara 0,02 mg 3 mg


89







Yaz 0,02 mg 3 mg






Vaginal use



Nuvaring 11.70 mg 2.7 mg


Vaginal use



Carlin 60/15

0,06 mg 0,015 mg




Carlin 75/20 0,075 mg 0,02 mg




Carlin 75/30 0,075 mg 0,03 mg


90





France Mylan S.A.S 117 Allée des Parcs FR-69800 Saint Priest France


Edenelle 0,06 mg 0,015 mg




Efezial 75/20 0,075 mg 0,02 mg




Efezial 75/30 0,075 mg 0,03 mg




Elleogeste 60/15 0,06 mg 0,015 mg




Gespharm 75/20 0,075 mg 0,02 mg




Gespharm 75/30 0,075 mg 0,03 mg




Gestodene Ethinylestradiol 75/20

0,075 mg 0,02 mg


91







Gestodene Ethinylestradiol 75/30

0,075 mg 0,03 mg


France Arrow Generiques 26 avenue Tony Garnier 69007 Lyon France


Gestodene Ethinylestradiol ARROW 60/15

0,06 mg 0,015 mg





0,075 mg 0,02 mg





0,075 mg 0,03 mg




Gestodene Ethinylestradiol BIOGARAN 60/15

0,06 mg 0,015 mg





0,075 mg 0,02 mg





0,075 mg 0,03 mg


92







Gestodene Ethinylestradiol CHIMICAL FARMA 75/20

0,075 mg 0,02 mg




Gestodene Ethinylestradiol CHIMICAL FARMA 75/30

0,075 mg 0,03 mg


France LABORATOIRES CRISTERS 22, quai Galliéni 92150 Suresnes France


Gestodene Ethinylestradiol CRISTERS 60/15

0,06 mg 0,015 mg


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


Gestodene Ethinylestradiol EG 60/15

0,06 mg 0,015 mg





0,075 mg 0,02 mg


93








0,075 mg 0,03 mg




Gestodene Ethinylestradiol GNR 60/15

0,06 mg 0,015 mg




Gestodene Ethinylestradiol IDETECH 75/20

0,075 mg 0,02 mg




Gestodene Ethinylestradiol IDETECH 75/30

0,075 mg 0,03 mg


France RANBAXY PHARMACIE GENERIQUES 11-15 Quai Dion Bouton 92816 Puteaux Cedex France


Gestodene Ethinylestradiol RANBAXY 75/20

0,075 mg 0,02 mg


94





France RANBAXY PHARMACIE GENERIQUES 11-15 Quai Dion Bouton 92816 Puteaux Cedex France


Gestodene Ethinylestradiol RANBAXY 75/30

0,075 mg 0,03 mg




Gestodene Ethinylestradiol RATIOPHARM 75/20

0,075 mg 0,02 mg




Gestodene Ethinylestradiol RATIOPHARM 75/30

0,075 mg 0,03 mg




Gestodene Ethinylestradiol SANDOZ 60/15

0,06 mg 0,015 mg





0,075 mg 0,02 mg





0,075 mg 0,03 mg


95





France STRAGEN France SAS 52 rue de la République 69002 Lyon France


Gestodene Ethinylestradiol STRAGEN 60/15

0,06 mg 0,015 mg




Gestodene Ethinylestradiol TEVA 60/15

0,06 mg 0,015 mg





0,075 mg 0,02 mg





0,075 mg 0,03 mg




Gestodene Ethinylestradiol ZENTIVA 60/15

0,06 mg 0,015 mg





0,075 mg 0,02 mg


96








0,075 mg 0,03 mg


France ZYDUS FRANCE ZAC Les Hautes Patures 25 Rue des peuliers 92752 Nanterre Cedex France


Gestodene Ethinylestradiol ZYDUS 75/20

0,075 mg 0,02 mg


France ZYDUS FRANCE ZAC Les Hautes Patures 25 Rue des peuliers 92752 Nanterre Cedex France


Gestodene Ethinylestradiol ZYDUS 75/30

0,075 mg 0,03 mg


France PFIZER HOLDING France 23-25 avenue du Docteur Lannelongue 75668 Paris Cedex 14 France






Meliane 0,075 mg 0,02 mg




Melodia 0,06 mg 0,015 mg


97







Minesse 0,06 mg 0,015 mg








Moneva 0,075 mg 0,03 mg




Optinesse 60/15 0,06 mg 0,015 mg




Perleane 0.050 mg/0.030 mg 0.070 mg/0.040mg 0.100 mg/0.030 mg




Phaeva 0.050 mg/0.030 mg 0.070 mg/0.040mg 0.100 mg/0.030 mg


98







Sylviane 0,06 mg 0,015 mg




Triminulet 0.050 mg/0.030 mg 0.070 mg/0.040 g 0.100 mg/0.030 mg


France Janssen-Cilag 1 rue Camille Desmoulins TSA 91003 92787 Issy-les-Moulineaux cedex 9 France



Tablet Oral use



Effiprev 0,25 mg 0,035 mg

Tablet Oral use



Triafemi 0.18 mg /0.035 mg 0.215 mg /0.035 mg 0.25 mg /0.035 mg

Tablet Oral use

99





France Janssen-Cilag 1 rue Camille Desmoulins TSA 91003 92787 Issy-les-Moulineaux cedex 9 France


Tricilest 0.18 mg /0.035 mg 0.215 mg /0.035 mg 0.25 mg /0.035 mg

Tablet Oral use

Germany Jenapharm GmbH & Co. KG Otto-Schott-Straße 15 07745 Jena Germany


Qlaira Filmtabletten 3 mg 2 mg/2 mg 2 mg/3 mg 1 mg


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


Yvidually 0.02 mg 3 mg


Germany Aliud Pharma GmbH Gottlieb-Daimler-Str. 19 89150 Laichingen Germany


Bonita AL 0,03 mg/2 mg Filmtabletten

0,03 mg 2 mg


Germany Actavis Group PTC ehf Reykjavikurvegi 76-78 220 Hafnarfjordur Iceland


Angiletta 2 mg/0,03 mg Filmtabletten

0,03 mg 2 mg


Germany Gedeon Richter Plc. Gyömröí út 19-21 HU-1103 Budapest Hungary


Balanca 0,03 mg 2 mg


100





Germany Pfizer Pharma GmbH Linkstr. 10 10785 Berlin Germany


beatrice 0,03 mg/2 mg Filmtabletten

0,03 mg 2 mg




Belara 0,03 mg 2 mg




Belara 21+7 0,03 mg 2 mg


Germany Madaus GmbH Colonia Allee 15 51067 Köln Germany


Bellissima 0,03 mg 2 mg




Bellissima 0,03 mg/2 mg filmtabletten

0,03 mg 2 mg


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


Bilmon - 1 A Pharma 0,03 mg/2 mg Filmtabletten

0,03 mg 2 mg




Chantal 0,03 mg 2 mg


101







Chariva 0,03 mg 2 mg




Chariva 21+7 0,03 mg 2 mg


Germany Zentiva Pharma GmbH Industriepark Frankfurt-Höchst, Gebäude K703 65926 Frankfurt am Main Germany


Chloee 0,03 mg 2 mg



Chlormadinone acetate Ethinylestradiol

Enriqa 2.0 mg 0.03 mg


Germany Sandoz Pharmaceuticals GmbH Raiffeisenstr. 11 83607 Holzkirchen Germany


eufem 2 mg/0,03 mg Filmtabletten

0,03 mg 2 mg


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


LaBibiane 0,03 mg 2 mg


102





Germany Aristo Pharma GmbH Wallenroder Straße 8-10 13435 Berlin Germany


Lilia 0,03 mg/2 mg Filmtabletten

0,03 mg 2 mg




Lisa 0,03 mg 2 mg


Germany Mylan dura gmbH Wittstichstr. 6 64295 Darmstadt Germany


Lisette 0,03 mg/2 mg Filmtabletten

0,03 mg 2 mg


Germany mibe GmbH Arzneimittel Münchener Str. 15 06796 Brehna Germany


Madinette 30 0,03 mg 2 mg


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


Minette 2 mg/0,03 mg Filmtabletten

0,03 mg 2 mg


Germany Hexal Aktiengesellschaft Industriestr. 25 83607 Holzkirchen Germany


Mona HEXAL 2 mg/0,03 mg Filmtabletten

0,03 mg 2 mg


103







Neo-Eunomin 0,05 mg / 0,05 mg 1 mg / 2 mg


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


Pink Luna 0,03 mg/2 mg Filmtabletten

0,03 mg 2 mg


Germany Hormosan Pharma GmbH Wilhelmshoeher Str. 106 60389 Frankfurt Germany


Solera 2 mg/0,03 mg Filmtabletten

0,03 mg 2 mg




Bellissima 21+7 0,03 mg 2 mg


Germany Ratiopharm GmbH Graf-Arco-Strasse 3 DE-89079 Ulm Germany


Verana-ratiopharm 2 mg/0,03 mg Filmtabletten

0,03 mg 2 mg


Germany Mithra Pharmaceuticals S.A. Rue Saint Georges 5 4000 Liège Belgium


Zetdinone 0,03 mg 2 mg




Belara 0,03 mg 2 mg


104







Ametist Filmtabletten 0,035 mg / 0,03 mg / 0,03 mg 0,05 mg / 0,1 mg / 0,15 mg


Germany betapharm Arzneimittel GmbH Kobelweg 95 86156 Augsburg Germany


Aricia beta 0,02 mg 0,15 mg

Tablet Oral use



Belinda AL 0,15 mg/0,02 mg Tabletten

0,02 mg 0,15 mg

Tablet Oral use



Belinda AL 0,15 mg/0,03 mg Tabletten

0,03 mg 0,15 mg

Tablet Oral use

Germany MSD Sharp & Dohme Gesellschaft mit beschränkter Haftung Lindenplatz 1 85540 Haar Germany


Biviol 0,04 mg/0,025 mg 0,03 mg/0,125 mg

Tablet Oral use



Cedia 20 20 µg/150 µg Tabletten

0,02 mg 0,15 mg

Tablet Oral use

105







Cedia 30 30 µg/150 µg Tabletten

0,03 mg 0,15 mg

Tablet Oral use



Desmin 20 0,02 mg 0,15 mg




Desmin 30 0,03 mg 0,15 mg




Desofemine 20 Nova 0,02 mg 0,15 mg




Desofemine 30 0,03 mg 0,15 mg




Famina-ratiopharm 20 0,02 mg 0,15 mg

Tablet Oral use



Famina-ratiopharm 30 0,03 mg 0,15 mg

Tablet Oral use

106







Gabrielle-20 0,15 mg/0,02 mg Tabletten

0,02 mg 0,15 mg

Tablet Oral use



Gabrielle-30 0,15 mg/0,03 mg Tabletten

0,03 mg 0,15 mg

Tablet Oral use



Juliane 20 0,02 mg 0,15 mg

Tablet Oral use



Juliane 30 0,03 mg 0,15 mg

Tablet Oral use



Kosima STADA 0,15 mg/0,02 mg Tabletten

0,02 mg 0,15 mg

Tablet Oral use



Kosima STADA 0,15 mg/0,03 mg Tabletten

0,03 mg 0,15 mg

Tablet Oral use

107







Lamuna 20 0,02 mg 0,15 mg




Lamuna 30 0,03 mg 0,15 mg


Germany betapharm Arzneimittel GmbH Kobelweg 95 86156 Augsburg Germany


Lonicera beta 0,03 mg 0,15 mg

Tablet Oral use



Lovelle 0,02 mg 0,15 mg

Tablet Oral use





108







Novial 0,035 mg/0,05 mg 0,03 mg/0,1 mg 0,03 mg/0,15 mg


Germany UCB Pharma GmbH Alfred-Nobel-Str. 10 40789 Monheim Germany


previva sanol 20 Tabletten

0,02 mg 0,15 mg

Tablet Oral use



previva sanol 30 Tabletten

0,03 mg 0,15 mg

Tablet Oral use



Amelie - 1 A Pharma 0,03 mg/0,2 mg Filmtabletten

0,03 mg 2 mg




Aristelle 0,03 mg/2 mg Filmtabletten

0,03 mg 2 mg




BonaDea 0,03 mg 2 mg


109







Celimona 0,03 mg 2 mg


Germany Bayer Pharma AG D-13342 Berlin Germany


Celimone 0,03 mg 2 mg


Germany Helm AG Nordkanalstrasse 28 20097 Hamburg Germany


Deltanogest 0,03 mg/2 mg Filmtabletten

0,03 mg 2 mg


Germany Pharbil Waltrop GmbH Im Wirrigen 25 45731 Waltrop Germany


Diena Pharbil 0,03 mg 2 mg




Dienestra 0,03 mg/2 mg Filmtabletten

0,03 mg 2 mg




Dienovel 0,03 mg 2 mg


Germany Pharbil Waltrop GmbH Im Wirrigen 25 45731 Waltrop Germany


Ethinylestradiol/Dienogest Pharbil Waltrop 0,03/2,0mg Filmtabletten

0,03 mg 2 mg


110





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


Finic 0,03 mg 2 mg

Tablet Oral use



Gamonogest 0,03 mg/2 mg Filmtabletten

0,03 mg 2 mg




Kappanogest 0,03 mg/2 mg Filmtabletten

0,03 mg 2 mg




ladonna sanol 2 mg /0,03 mg Filmtabletten

0,03 mg 2 mg




Lamdanogest 0,03 mg/2 mg Filmtabletten

0,03 mg 2 mg




LaViola 0,03 mg/2 mg Filmtabletten

0,03 mg 2 mg


111







maxim 0,03 mg 2 mg




Mayra 0,03 mg/2 mg Filmtabletten

0,03 mg 2 mg




Sibilla 2 mg/0,03 mg Filmtabletten

0,02 mg 3 mg




Starletta HEXAL 2 mg/0,03 mg Filmtabletten

0,03 mg 2 mg




Stella STADA 0,03 mg/2,0 mg Filmtabletten

0,03 mg 2 mg




Susette AL 0,03 mg/2,0 mg Filmtabletten

0,03 mg 2 mg


112





Germany "ARAC" At Regulatory Affairs Consulting GmbH Kichengasse 48/3 1070 Wien Austria


Tessa 0,03 mg/2 mg Filmtabletten

0,03 mg 2 mg




Valette 0,03 mg 2 mg




vatrice 0,03 mg/2 mg Filmtabletten

0,03 mg 2 mg


Germany Velvian Germany GmbH Carl-Zeiss-Ring 9 85737 Ismaning Germany


Velafee 0,03 mg/2 mg Filmtabletten

0,03 mg 2 mg




Velvet-ratiopharm 0,03 mg/2 mg Filmtabletten

0,03 mg 2 mg




Violette 0,03 mg/2 mg Filmtabletten

0,03 mg 2 mg


113







aida 0,02 mg 3 mg




ARTADAL 0,03 mg/3 mg Filmtablette

0,03 mg 3 mg




BERTELLE unterbrechungsfreie Einnahme 3 mg/0,03 mg Filmtabletten

0,03 mg 3 mg




Daylette 0,02 mg/3 mg

0,02 mg 3 mg




Eliza HEXAL 0,02 mg 3 mg




Eloine 0,02 mg/3 mg Filmtabletten

0,02 mg 3 mg


114







Sidretella 20 0,02 mg/3 mg Filmtabletten

0,02 mg 3 mg




ESLARILA 0,02 mg/3 mg Filmtabletten

0,02 mg 3 mg




ESLARILA unterbrechungsfreie Einnahme 0,02 mg/3 mg Filmtabletten

0,02 mg 3 mg




Georgette-20 3mg/0,02mg Filmtabletten

0,02 mg 3 mg


Germany Laboratorios Leon Farma SA Poligono Industrial Navatejera, La Vallina s/n, 24008 Villaquilambre,Leon Spain


Iren 28 0,02 mg/3 mg Filmtabletten

0,02 mg 3 mg


Germany Ivowen Limited 3 Anglesa St Tipperary Clonmel Ireland


KYLNETTA 0,03 mg/3 mg Filmtablette

0,03 mg 3 mg


115







LaYaisa 0,02 mg 3 mg




LaYanina 0,03 mg 3 mg




LaYnes 0,02 mg 3 mg




LaYanina 28 0,03 mg 3 mg




LILADROS 0,02 mg/3 mg Filmtabletten

0,02 mg 3 mg




LILADROS unterbrechungsfreie Einnnahme 0,02 mg/3 mg Filmtabletten

0,02 mg 3 mg






116







MAITALON 20 0,02 mg/3 mg Filmtabletten

0,02 mg 3 mg




MAITALON 20/21+7 0,02 mg/3 mg Filmtabletten

0,02 mg 3 mg




MAITALON 30 0,03 mg/3 mg Filmtabletten

0,03 mg 3 mg




MAITALON 30/21+7 0,03 mg/3 mg Filmtabletten

0,03 mg 3 mg




MESILARA 0,02 mg/3 mg Filmtabletten

0,02 mg 3 mg




Sidretella 30 0,03 mg/3 mg Filmtabletten

0,03 mg 3 mg


117











Petibelle 0,03 mg/3 mg Filmtabletten

0,03 mg 3 mg




Georgette-30 3 mg/0,03 mg Filmtabletten

0,03 mg 3 mg


Germany Laboratorios Leon Farma SA Poligono Industrial Navatejera, La Vallina s/n, 24008 Villaquilambre,Leon Spain


Rosal 28 0,03 mg/3 mg Filmtabletten

0,03 mg 3 mg




SELIKYNE 0,02 mg/3 mg Filmtabletten

0,02 mg 3 mg




YARA HEXAL 20 0,02 mg 3 mg


118







YARA HEXAL 20 und Placebo

0,02 mg 3 mg




YARA HEXAL 30 0,03 mg 3 mg




YARA HEXAL 30 und Placebo

0,03 mg 3 mg




Yasmin 0,03 mg/3 mg Filmtabletten

0,03 mg 3 mg




Yasminelle 0,02 mg/3 mg Filmtabletten

0,02 mg 3 mg




YAZ 0,02 mg/3 mg Filmtabletten

0,02 mg 3 mg




Alessia HEXAL 0,06 mg/ 0,015 mg Filmtabletten

0,015 mg 0,06 mg


119







Femovan 0,03 mg/0,075 mg überzogene Tabletten

0,03 mg 0,075 mg


Germany Velvian Germany GmbH Carl-Zeiss-Ring 9 85737 Ismaning Germany


Jamyle 0,060 mg / 0,015 mg Filmtabletten

0,015 mg 0,06 mg




Lenisagyn - 1 A Pharma

0,015 mg 0,06 mg






Germany Janssen-Cilag GmbH Johnson & Johnson Platz 1 41470 Neuss Germany



Tablet Oral use

Germany Janssen-Cilag GmbH Johnson & Johnson Platz 1 41470 Neuss Germany


Pramino 0,035 mg /0,035 mg / 0,035 mg 0,18 mg / 0,215 mg / 0,25 mg

Tablet Oral use

120







NuvaRing vaginales Freisetzungssystem

2,7 mg 11,7 mg


Vaginal use

Germany Varipharm Arzneimittel GmbH Lindenplatz 1 85540 Haar Germany


Circlet 0,120 mg/0,015 mg pro 24 Stunden vaginales Freisetzungssystem

2,7 mg 11,7 mg


Vaginal use

Greece N.V. Organon Kloosterstraat 6 5349 AB, Oss The Netherlands



Tablet Oral use





Greece Teva Pharma BV Computerweg 10 3542 DR Utrecht The Netherlands


GISSELINA 3 mg 0,02mg




GISSELINA 28 3 mg 0.02mg


121







GISSELLE 3mg 0,03mg




GISSELLE 28 3 mg 0.02mg




MERCILON 0,02 mg 0.15 mg

Tablet Oral use

Greece Gedeon Richter Plc. Gyömröí út 19-21 HU-1103 Budapest Hungary


VILUZOR 3 mg/0.3 mg Film-coated tablet Oral use



TREMOSAN 3 mg 0.02 mg




TREMOSAN EDT 3 mg 0.02 mg




CHIFLATON 3 mg 0.02 mg


122





Greece BAYER HELLAS AG Sorou street 18-20 Maroussi Athens 15125 Greece


YASMIN 3mg 0.03mg




YASMINELLE 3mg 0.02mg








HUNOGIDON 0,02 mg 0.15 mg




YAZ 0.02mg 3mg




NUVARING 11,7 mg 2,7 mg


Vaginal use

123





Hungary Gedeon Richter Plc. Gyömröí út 19-21 HU-1103 Budapest Hungary


AMETIST 0,05 mg/0,035 mg 0,10 mg/0,03 mg 0,15 mg/0,03 mg




CARICIA 0,05 mg/0,035 mg 0,1 mg/0,03 mg 0,15 mg/0,03 mg


Hungary Stragen Nordic A/S, Helsingørgade 8C, DK-3400 Hillerød, Denmark


CONTROVUL 0,15 mg 0,02 mg


Hungary Stragen Nordic A/S, Helsingørgade 8C, DK-3400 Hillerød, Denmark


CONTROVUL 0,15 mg 0,03 mg


Hungary N.V. Organon P.O. Box 20 5340 BH, Oss The Netherlands


GRACIAL 0.04 mg/0,025 mg 0,03 mg/0,125 mg

Tablet Oral use








Tablet Oral use

124











NOVYNETTE CONTINUOUS

0,15 mg 0,02 mg








SAMBA 0,05 mg/0,035 mg 0,1 mg/0,03 mg 0,15 mg/0,03 mg


Hungary Bayer Hungaria ltd Alkotás street 50. Budapest 1123 Hungary


ALIANE 3 mg 0,02 mg




AMAROSA 3 mg 0,02 mg




AMAROSA CONTINUOUS

3 mg 0,02 mg


125





Hungary Bayer Hungaria ltd Alkotás street 50. Budapest 1123 Hungary


ANAESTELL 3mg 0,03mg




ANEEA 3 mg 0,02 mg




ARANKA 3mg 0,03mg




BELUSHA 3 mg 0,02 mg




BERTELLE 3mg 0,03mg


Hungary Teva Hungary PLC Pallagi street 13., Debrecen 4042 Hungary


CORENELLE 3 mg 0,02 mg




CORENELLE 3mg 0,03mg


126






desogestrel ethinylestradiol

Sensilon 0,15 mg 0,02 mg



desogestrel ethinylestradiol

Sensilon 0,15 mg 0,03 mg


Hungary Sandoz Hungary LTD Bartók Béla street 43-47. Budapest 1114 Hungary


DECIORA 3 mg 0,02 mg




DECIORA 3mg 0,03mg




DEREN 3mg 0,03mg




MISTRAL Continuous 2mg 0,03mg


127







DEREN CONTINUOUS 3mg 0,03mg




DROSINETTA 3 mg 0,02 mg




DROSINETTA CONTINUOUS

3 mg 0,02 mg




DROSPIRENONE/ETHINYLESTRADIOL RICHTER

3mg 0,03mg




ESLARILA 3 mg 0,02 mg




ESLARILA CONTINUOUS

3 mg 0,02 mg




EVERISSA 3 mg 0,02 mg


128







FEDERIA 3 mg 0,02 mg




FEDERIA CONTINUOUS

3 mg 0,02 mg


Hungary Laboratorios Leon Farma SA Calle La Vallina S/N Poligono Industrial Navatejera Navatejera, Leon E-24008 Spain


FERRANELLES 3 mg 0,02 mg




GYNDORA 3 mg 0,02 mg




GYNDORA CONTINUOUS

3 mg 0,02 mg




INKODESS 3 mg 0,02 mg


129







INKODESS CONTINUOUS

3 mg 0,02 mg


Hungary LadeePharma Kft Lajos utca 48-66 H-1036 Budapest Hungary


JANGEE 3 mg/0.02 mg

3 mg 0,02 mg




JANGEE 3 mg/0.03 mg

3mg 0,03mg




JANGEE NAPONTA 3 mg/0.02 mg

3 mg 0,02 mg




JANGEE NAPONTA 3 mg/0.03 mg

3mg 0,03mg




KATUL 3mg 0,03mg


130







KATUL CONTINUOUS 3mg 0,03mg




KLEODINA 3mg 0,03mg




KYLIXA 3 mg 0,02 mg




KYLNETTA 3mg 0,03mg




KYLNETTA CONTINUOUS

3mg 0,03mg




LILAS 3mg 0,03mg




LULINA 3mg 0,03mg


131







MINKIAN 3 mg 0,02 mg




PERLITA 3 mg 0,02 mg




PYRLA 3 mg 0,02 mg




PYRLA CONTINUOUS 3 mg 0,02 mg




REZIA 3 mg 0,02 mg




SEELAR 3mg 0,03mg




SELIKYNE 3 mg 0,02 mg


132







SVELTA 3 mg 0,02 mg




SYMICIA 3 mg 0,02 mg




TENTACIA 3 mg 0.02mg




TOLUKIM 3 mg 0,02 mg




VELGYN 3 mg 0,02 mg




VESPIREA 3mg 0,03mg




VIVIENNE 3mg 0,03mg


133







VOLINA 3mg 0,03mg




XINDEA 3 mg 0,02 mg


Hungary Bayer Pharma AG D-13342 Berlin Germany


YADINE 3mg 0,03mg




YASMINELLE 3 mg 0,02 mg




ZEELAR CONTINUOUS 3mg 0,03mg




ZEPHIRENE 3mg 0,03mg




ZOA 3mg 0,03mg


134





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

gestodene ethinylestradiol

DALIA 0,075 mg 0,02 mg



drospirenone ethinylestradiol

Sidretella 3mg 0,02mg



drospirenone ethinylestradiol







Hungary Aramis Pharma Kft. Mester u. 28B III/5 1095 Budapest Hungary


GESTOMIX 0,075 mg 0,02 mg




Gefemin 0.06 mg 0.015 mg


135





Hungary Aramis Pharma Kft. Mester u. 28B III/5 1095 Budapest Hungary


GESTOMIX 0,075 mg 0,03 mg


Hungary Wyeth LTD. Alkotás u. 53 Budapest 1123 Hungary






IAMNA 0,075 mg 0,02 mg




IAMNA 0,075 mg 0,03 mg




LINDYNETTE 0,075 mg 0,02 mg




LINDYNETTE 0,075 mg 0,03 mg


136











MILLIGEST 0,05 mg/0,03 mg 0,07 mg/0,04 mg 0,01 mg/0,03 mg


Hungary Pfizer Hungary LTD. Alkotás street 53 Budapest 1123 Hunagry




Hungary Q Pharma Kft. Veres Pálné u. 4-6. Budapest 1053 Hungary


MIRABELLA 0,075 mg 0,02 mg


Hungary Q Pharma Kft. Veres Pálné u. 4-6. Budapest 1053 Hungary


MIRABELLA 0,075 mg 0,03 mg


Hungary Ratiopharm GmbH Graf-Arco-Strasse 3 DE-89079 Ulm Germany


SENSONETTE 0,075 mg 0,02 mg




SENSONETTE 0,075 mg 0,03 mg


137







SOLDANELLE 0,06 mg 0,015 mg


Hungary Medico Uno Pharma Kft. Viadukt u. 12 Biatorbágy 2051 Hungary


STODETTE 0,075 mg 0,02 mg




TRIODENA 0,05 mg/0,03 mg 0,07 mg/0,04 mg 0,1 mg/0,03 mg












MISTRAL 2mg 0,03mg




DIENILLE 2mg 0,03mg


138







BONADEA 2mg 0,03mg








NUVARING 11.7 mg 2.7 mg


Vaginal use



CIRCLET 11.7 mg 2.7 mg


Vaginal use



Estmar 0.15 mg 0.02 mg

Tablet Oral use



Estmar 0.15 mg 0.03 mg

Tablet Oral use

139







Marvelon 0.15 mg 0.03 mg

Tablet Oral use



Angeliq 3mg 0,02mg




Drosetil NAPONTA 3 mg / 0,02mg filmtabletta

3mg 0,02mg




Drosetil NAPONTA 3 mg / 0,03 mg filmtabletta

3mg 0,03mg


Hungary Bayer Pharma AG Müllerstrasse 170-178. 13342 Berlin Germany


Flexyess 3mg 0,02mg




Belara 0,03 mg 2 mg


140







Claranette-ratiopharm 2mg 0.03mg




Clormetin 2mg 0.03mg


Iceland ratiopharm GmbH Graf-Arco Strasse 3 89079 ULM Germany


Denise 0,15 mg 0,02 mg

Tablet Oral use

Iceland Bayer Pharma AG Müllerstrasse 178 D-13342 Berlin Germany




Iceland Bayer AB Postbox 606 Gustav III's Boulevard 56 SE-16926 Solna Sweden


YAZ 0,02 mg 3 mg


Iceland N.V. Organon Kloosterstraat 6 5349 AB, Oss The Netherlands


Gracial 0.04 mg/0.25 mg 0.03 mg/0.125 mg

Tablet Oral use

141








Tablet Oral use



Mercilon 0.02 mg 0.15 mg

Tablet Oral use



Eloine 0,02 mg 3 mg








Yasmin 0,03 mg 3 mg




Yasmin 28 0,03 mg 3 mg


142





Iceland Pfizer ApS, Lautrupvang 8, DK-2750 Ballerup, Denmark


Harmonet 0.020mg + 0.075 mg

Tablet Oral use

Iceland Actavis Group PTC ehf Reykjavikurvegi 76-78 220 Hafnarfjordur Iceland


Benidette 0,15 mg 0,02 mg

Tablet Oral use

Iceland Actavis Group PTC ehf Reykjavikurvegi 76-78 220 Hafnarfjordur Iceland


Benifema 0,15 mg 0,03 mg

Tablet Oral use



Flexyess 3mg 0,02 mg




NuvaRing 11,7 mg 2,7 mg


Vaginal use





143





Ireland Organon (Ireland) Ltd, PO Box 2857, Drynam Road, Swords, Co.Dublin, Ireland

Desogestrel/ Ethinylestradiol

Gracial 0.025 mg/0.04 mg 0.125 mg/0.03 mg

Tablet Oral use

Ireland Gedeon Richter Plc. Gyömröí út 19-21 HU-1103 Budapest Hungary


Leticia 0.15 mg 0.03 mg




Marviol 0.15 mg/ 0.03 mg

Tablet Oral use



Mercilon 0.15 mg/ 0.02 mg

Tablet Oral use



Vivides 0.15 mg 0.02 mg


144





Ireland Bayer Limited The Atrium, Blackthorn Road, Dublin 18, Ireland




Ireland Teva Pharma BV Computerweg 10 3542 DR Utrecht The Netherlands


Dretine 0.3mg 3mg




Yaz 0.02mg 3mg




Dretinelle 0.02mg 3mg




Enador 0.02mg 3mg




Enador&Placebo 0.02mg 3mg


145





Ireland Laboratorios Leon Farma SA Calle La Vallina S/N Poligono Industrial Navatejera Navatejera, Leon E-24008 Spain


Ethinylestradiol / Drospirenone Leon Farma

0.02mg 3mg




Ethinylestradiol / Drospirenone Leon Farma & Placebo

0.02mg 3mg





0.03mg 3mg





0.03mg 3mg




Ethinylestradiol/Drospirenone Gedeon Richter

0.03mg 3mg


146





Ireland Rowex Ltd Bantry Co. Cork Ireland


Freedo 0.03mg 3mg




Freedo&Placebo 0.03mg 3.0mg




Freedonel 0.02mg 3mg




Freedonel&Placebo 0.02mg 3.0mg




Palandra 0.03mg 3mg




Svelta 0.02mg 3mg


147







Veyann 0.02mg 3mg




Yasmin 0.03mg 3mg




Yasminelle 0.02mg 3mg




Liofora 0.02mg 3mg




Flexyess 0.02mg 3mg


148







Circlet 11.7mg 2.7mg


Vaginal use



Nuvaring 11.7mg 2.7mg


Vaginal use

Ireland Pfizer Healthcare Ireland 9 Riverwalk National Digital Park Citywest Business Campus Dublin 24 Ireland


Tri-minulet 0.050mg/0.070mg/0.100mg 0.030mg/0.040mg/0.030mg


Ireland Clonmel Healthcare Ltd Waterford Road Clonmel Co Tipperary Ireland


Estelle 0.075mg 0.030mg




Carmen 0.03mg 3mg


149







Carmenelle 0.02mg 3mg




Harmonet 0.075mg 0.020mg




Minesse 0.060mg 0.015mg




Minulet 0.075mg 0.030mg


150





Ireland Janssen-Cilag Limited 50-100 Holmers Farm Way High Wycombe Buckinghamshire HP12 4EG United Kingdom


Cilest 0.25 mg 0.035 mg

Tablet Oral use

Ireland Laboratorios Leon Farma SA C/Roa de la Vega 15 1-24008 Leon Spain


Ethinylestradiol / Drospirenone Leon Farma

0.03mg 3mg


Italy Teva Italia S.r.l. via Messina 38 20154 Milano Italy


DENISELLE 0,15 mg 0,02 mg

Tablet Oral use

Italy MYLAN S.P.A. Viale dell'Innovazione, 3, 20125 Milano Italy


DESOGESTREL E ETINILESTRADIOLO MYLAN GENERICS

0,15 mg 0,02 mg

Tablet Oral use

Italy MYLAN S.P.A. Viale dell'Innovazione, 3, 20125 Milano Italy



0,15 mg 0,03 mg

Tablet Oral use

Italy A. Menarini Industrie Farmaceutiche Riunite s.r.l., via Sette Santi, 3 - 50131 Florence Italy


DUEVA 0,04 mg/0,025 mg 0,03 mg/0,125 mg

Tablet Oral use

151





Italy Farmitalia Industrie Chimico Farmaceutiche Via Alcide De Gasperi, 165 B 95127 Catania Italy


ANTELA 0,02 mg 0,15 mg

Tablet Oral use

Italy Farmitalia Industrie Chimico Farmaceutiche Via Alcide De Gasperi, 165 B 95127 Catania Italy


ANTELA 0,03 mg 0,15 mg

Tablet Oral use

Italy N.V. Organon Kloosterstraat 6 5349 AB, Oss The Netherlands


GRACIAL 0,025 mg/ 0,04 mg 0,125 mg/ 0,03 mg

Tablet Oral use



LUCILLE 0,035 mg/0,05 mg 0,03 mg/0,1 mg 0,03 mg/0,15 mg





Tablet Oral use

Italy Farmitalia Industria chimico farmaceutica S.R.L Via Alcide De Gasperi 165/B - 95100 Catania Italy




152







PLANUM 0,15 mg 0,03 mg

Tablet Oral use



PRACTIL 0,15 mg 0,03 mg

Tablet Oral use



SECURGIN 0,15 mg 0,02 mg

Tablet Oral use

Italy EG S.p.A. Via D. Scarlatti, 31 20124 Milano Italy


ZAKIRA 0,15 mg 0,02 mg

Tablet Oral use



ZAKIRA 0,15 mg 0,03 mg

Tablet Oral use

Italy Effik Italia S.p.A. Via Lincoln 7/A, 20092 Cinisello Balsamo (MI) Italy


EFFIPREV 2 mg 0,003 mg


153





Italy Gedeon Richter Plc. Gyömröí út 19-21 HU-1103 Budapest Hungary




Italy Bayer S.p.A. Viale Certosa, 130 - 20156 Milano (MI) Italy


ALIANE 3 mg 0,02 mg




Yvidually 3 mg 0,02 mg


Italy Sandoz Spa Largo U. Boccioni, 1 21040 Origgio (VA) Italy


CALINDIR 3mg 0,03mg




CREDIGYNE 3mg 0,03mg




CREDIGYNETTE 3 mg 0,02 mg




DAYLETTE 3mg 0,03mg


154





Italy Doc Generici S.R.L. Via Manuzio 7 20124 - Milano Italy


DOCGYN 3 mg 0,02 mg




DOCTYNE 3mg 0,03mg




DROSPIL 3mg 0,03mg




DROSURE 3mg 0,03mg




DROSURELLE 3 mg 0,02 mg




ELOINE 3 mg 0,02 mg




ETINILESTRADIOLO E DROSPIRENONE DOC

3 mg 0,02 mg


155







ETINILESTRADIOLO E DROSPIRENONE DOC GENERICI

3 mg 0,02 mg




ETINILESTRADIOLO E DROSPIRENONE DOCGEN

3mg 0,03mg




LERNA 3 mg 0,02 mg




LILADROS 3 mg 0,02 mg




LUSINE 3mg 0,03mg




LUSINELLE 3 mg 0,02 mg


156







MIDIANA 3mg 0,03mg




RUBIRA 3 mg 0,02 mg




YASMIN 3mg 0,03mg




YASMINELLE 3 mg 0,02 mg




YAZ 3 mg 0,02 mg




ALCMENA 0,06 mg 0,015 mg


157







ARIANNA 0,06 mg 0,015 mg












ESTINETTE 0,075 mg 0,02 mg


Italy Mylan S.p.A. Via Vittor Pisani 20 20124 Milano Italy



0,15 mg 0,02 mg

Tablet Oral use




0,15 mg 0,03 mg

Tablet Oral use



ETINILESTRADIOLO E GESTODENE MYLAN GENERICS

0,075 mg 0,02 mg


158







ETINILESTRADIOLO E GESTODENE MYLAN GENERICS

0,075 mg 0,03 mg




FEDRA 0,075 mg 0,02 mg




GESTODIOL 0,075 mg 0,02 mg




GESTODIOL 0,075 mg 0,03 mg




GINODEN 0,075 mg 0,03 mg


Italy WYETH MEDICA IRELAND Little Connell Newbridge County Kildare Ireland




159







KIPLING 0,075 mg 0,03 mg




LIUDA 0,075 mg 0,02 mg




LIUDA 0,075 mg 0,03 mg




MILVANE 0,05 mg/0,03 mg 0,07 mg/0,04 mg 0,1 mg/0,03 mg


Italy Pfizer Italia S.r.l., via Isonzo, 71 04100 Latina Italy


MINESSE 0,06 mg 0,015 mg






160







TRIMINULET 0,05 mg/0,03 mg 0,07 mg/0,04 mg 0,1 mg/0,03 mg




YVETTE 0,06 mg 0,015 mg


Italy Actavis Group PTC ehf Reykjavikurvegi 76-78 220 Hafnarfjordur Iceland


ZOE 0,075 mg 0,02 mg


Italy Actavis Group PTC ehf Reykjavikurvegi 76-78 220 Hafnarfjordur Iceland


ZOE 0,075 mg 0,03 mg




NUVARING 0,120 mg/ 0,015 mg/24 hours


Vaginal use



CIRCLET 0,120 mg/ 0,015 mg/24 hours


Vaginal use

161







KLAIRA 3 mg 2 mg/2 mg 2 mg/3 mg 1 mg




LUTIZ 3 mg 0,02mg




YARINA 3mg 0,03mg




TYARENA 2 mg 0,03 mg




BELARA 2 mg 0,03 mg




EVE 2 mg 0,03 mg


162





Italy Ratiopharm GmbH Graf-Arco-Strasse 3 DE-89079 Ulm Germany


CLORETINYL 2 mg 0,03 mg




CLORMADINONE ETINILESTRADIOLO MYLAN

2 mg 0,03 mg




NAVEEN 2 mg 0,03 mg


Latvia UAB „Ladee Pharma Baltics“ Zemaitijos g.13/Siauliu g.10 Vilnius LT-01134 Lithuania


Clormetin 2 mg/0,03 mg film-coated tablets

2 mg 0,03 mg


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


Estmar 150/20 micrograms tablets

0,15 mg 0,02 mg

Tablet Oral use



Estmar 150/30 micrograms tablets

0,15 mg 0,03 mg

Tablet Oral use

163





Latvia N.V. Organon P.O. Box 20 Kloosterstraat 6 5340 BH, Oss The Netherlands


Gracial tablets 0.125 mg/0.030 mg 0.025 mg/0.040 mg

Tablet Oral use



Marvelon 150/30 micrograms tablets

0,15 mg 0,03 mg

Tablet Oral use

Latvia Organon (Ireland) Ltd, PO Box 2857, Drynam Road, Swords, Co.Dublin, Ireland


Mercilon 150/20 micrograms tablets

0,15 mg 0,02 mg

Tablet Oral use

Latvia Gedeon Richter Plc. Gyömröí út 19-21 HU-1103 Budapest Hungary


Novynette 150/20 microgram film-coated tablets

0,15 mg 0,02 mg




Novynette Plus 150 micrograms/ 20 micrograms film-coated tablets

0,15 mg 0,02 mg


164







Regulon 150/30 micrograms film-coated tablets

0,15 mg 0,03 mg


Latvia Orivas UAB J.Jasinskio 16B LT-01112 Vilinius Lithuania


Ammily 2 mg/0,03 mg film-coated tablets

2 mg 0,03 mg


Latvia Bayer Pharma AG D-13342 Berlin Germany


Jeanine 2000/30 micrograms film-coated tablets

2 mg 0,03 mg




Sibilla 2 mg/0,03 mg film-coated tablets

2 mg 0,03 mg




Zenadea 2 mg/0,03 mg film-coated tablets

2 mg 0,03 mg


Latvia Ivowen Limited 3 Anglesa St Tipperary Clonmel Ireland


Lulina 3 mg/0,03 mg film-coated tablets

3mg 0,03mg




Midiana 3mg/0,03 mg film-coated tablets

3mg 0,03mg


165







Yarina 3000/30 micrograms film-coated tablets

3mg 0,03mg



Dienogest Estradiol

Qlaira film-coated tablets

3 mg 2 mg/2 mg 2 mg /3 mg 1 mg




Belara 0,03 mg/2 mg film-coated tablets

0,03 mg 2 mg




Aneea 3 mg/0,02 mg film-coated tablets

3 mg 0,02 mg




Belusha 3 mg/0,02 mg film-coated tablets

3 mg 0,02 mg




Daylette 3 mg/0,02 mg film-coated tablets

3 mg 0,02 mg




Etindros 0,02 mg/3 mg film-coated tablets

0,02 mg 3 mg


166







Etindros 0,03 mg/3 mg film-coated tablets

0,03 mg 3 mg




LETHE 0,02 mg/3 mg film-coated tablets

0,02 mg 3 mg




Sidretella 0,02 mg/3 mg film-coated tablets

0,02 mg 3 mg




Sidretella 0,03 mg/3 mg film-coated tablets

0,03 mg 3 mg




Teenia 3 mg/0,02 mg film-coated tablets

3 mg 0,02 mg




Velgyn 0,02 mg/3 mg film-coated tablets

0,02 mg 3 mg


167







Yasminelle 0,02 mg/3 mg film-coated tablets

0,02 mg 3 mg




YAZ 0,02 mg/3 mg film-coated tablets

0,02 mg 3 mg




Yvidually 0,02 mg/3 mg film-coated tablets

0,02 mg 3 mg




NuvaRing 120/15 micrograms/24 hours vaginal delivery system

11.7 mg 2.7 mg


Vaginal use



ARTIZIA 75 micrograms/20 micrograms coated tablets

0,075 mg 0,02 mg




Edesia 75 micrograms/20 micrograms coated tablets

0,075 mg 0,02 mg




Femoden 75/30 micrograms film-coated tablets

0,075 mg 0,03 mg


168





Latvia Ratiopharm GmbH Graf-Arco-Strasse 3 DE-89079 Ulm Germany


Gesytil 75/20 micrograms coated tablets

0,075 mg 0,02 mg


Latvia Ratiopharm GmbH Graf-Arco-Strasse 3 DE-89079 Ulm Germany


Gesytil 75/30 micrograms coated tablets

0,075 mg 0,03 mg


Latvia Pfizer Europe MA EEIG Ramsgate Road Sandwich Kent CT13 9NJ United Kingdom


Harmonet 75 micrograms/20 micrograms film-coated tablets

0,075 mg 0,02 mg




Lindynette 75/20 micrograms coated tablets

0,075 mg 0,02 mg




Lindynette 75/30 micrograms coated tablets

0,075 mg 0,03 mg




Logest 75 micrograms/20 micrograms film-coated tablets

0,075 mg 0,02 mg


169





Latvia Pfizer Europe MA EEIG Ramsgate Road Sandwich Kent CT13 9NJ United Kingdom


Minulet 75 micrograms/30 micrograms coated tablets

0,075 mg 0,03 mg




Mirelle 60/15 micrograms film-coated tablets

0,06 mg 0,015 mg




Violetta 60 micrograms/15 micrograms film-coated tablets

0,06 mg 0,015 mg




VONILLE 60 micrograms/15 micrograms film-coated tablets

0,06 mg 0,015 mg




Zulfija 75 micrograms/30 micrograms coated tablets

0,075 mg 0,03 mg


Latvia UAB „Johnson & Johnson“ Geležinio Vilko g. 18A LT-08104 Vilnius Lithuania


Cilest 250/35 micrograms tablets

0,25 mg 0,035 mg

Tablet Oral use

Lithuania UAB Orivas J.Jasinskio 16B, LT-01112 Vilnius Lithuania


Ammily 2 mg 0,03 mg


170





Lithuania Bayer Pharma AG D-13342 Berlin Germany


Jeanine 2 mg 0,03 mg


Lithuania Gedeon Richter Plc. Gyömröí út 19-21 HU-1103 Budapest Hungary




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


Zenadea 2 mg 0,03 mg


Lithuania Laboratorios Leon Farma SA Poligono Industrial Navatejera, La Vallina s/n, 24008 Villaquilambre,Leon Spain


Espirol 3mg 0,03mg


Lithuania Ivowen Limited 3 Anglesa St Tipperary Clonmel Ireland


LULINA 3mg 0,03mg




MIDIANA 3mg 0,03mg


171







Pirestrol 3mg 0,03mg




Zenadea 2 mg 0,03 mg








Yarina 3mg 0,03mg




Yvidually 0.02 mg 3 mg




Qlaira 3 mg 2 mg/2 mg 2 mg /3 mg 1 mg


172







Belara 0,03 mg 2 mg




ANEEA 0,02 mg 3 mg












Espirol 0,02 mg 3 mg


Lithuania UAB „Ladee Pharma Baltics“ Zemaitijos g.13/Siauliu g.10 Vilnius LT-01134 Lithuania


Etindros 0,02 mg 3 mg


173







Etindros 0,03 mg 3 mg




LETHE 0,02 mg 3 mg




Pirestrol 0,02 mg 3 mg








TEENIA 0,02 mg 3 mg




Velgyn 0,02 mg 3 mg


174











YAZ 0,02 mg 3 mg


Lithuania Pfizer Europe MA EEIG Ramsgate Road Sandwich Kent CT13 9NJ United Kingdom




Lithuania Pfizer Europe MA EEIG Ramsgate Road Sandwich Kent CT13 9NJ United Kingdom


Minulet 0.03 mg 0.075 mg




ARTIZIA 0,075 mg 0,02 mg






Lithuania Ratiopharm GmbH Graf-Arco-Strasse 3 DE-89079 Ulm Germany


Gesytil 0,075 mg 0,03 mg


175





Lithuania Ratiopharm GmbH Graf-Arco-Strasse 3 DE-89079 Ulm Germany


Gesytil 0,075 mg 0,02 mg
















Mirelle 0,06 mg 0,015 mg




VIOLETTA 0,06 mg 0,015 mg




VONILLE 0,06 mg 0,015 mg


176













Lithuania UAB „Johnson & Johnson“ Geležinio Vilko g. 18A LT-08104 Vilnius Lithuania



Tablet Oral use



ESTMAR 0,15 mg 0,02 mg

Tablet Oral use



ESTMAR 0,15 mg 0,03 mg

Tablet Oral use

Lithuania N.V. Organon P.O.Box 20 5340 BH Oss The Netherlands



Tablet Oral use

177








Tablet Oral use




Tablet Oral use











NOVYNETTE CONTINUOUS

0,15 mg 0,02 mg




NuvaRing 11.7 mg 2.7 mg


Vaginal use

Lithuania UAB „Johnson & Johnson“ Geležinio Vilko g. 18A LT-08104 Vilnius Lithuania


Cilest 0,25mg 0,035mg

Tablet Oral use

178





Lithuania Teva Pharma B.V. Computerweg 10 3542 DR Utrecht The Netherlands


Destele 0,15 mg 0,03 mg

Tablet Oral use

Lithuania Teva Pharma B.V. Computerweg 10 3542 DR Utrecht The Netherlands


Destele 0,15 mg 0,02 mg

Tablet Oral use

Luxembourg BAYER SA-NV J.E. Mommaertslaan 14 1831 Diegem Belgium




Luxembourg Gedeon Richter Plc. Gyömröí út 19-21 HU-1103 Budapest Hungary


Bellina 0,03 mg 2 mg


Luxembourg Madaus GmbH Colonia Allee 15 51067 Köln Germany


Bellissima 0,03 mg 2 mg


Luxembourg Mithra Pharmaceuticals S.A. Rue Saint Georges 5 4000 Liège Belgium


Helen 0,03 mg 2 mg


179





Luxembourg Ratiopharm GmbH Graf-Arco-Strasse 3 DE-89079 Ulm Germany


Verana-ratiopharm 0,03 mg 2 mg




Deso 20 0,02 mg 0,15 mg


Luxembourg N.V. Organon Kloosterstraat 6 5349 AB, Oss The Netherlands


Gracial 0.04 mg /0,025 mg 0.03 mg /0,125 mg

Tablet Oral use




Tablet Oral use




Tablet Oral use





Luxembourg Mithra Pharmaceuticals S.A. Rue Saint Georges 5 4000 Liège Belgium


Louise 0,03 mg 2 mg


180







Annabelle 0,02 mg 3 mg




Annais 0,03 mg 3 mg


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


LaYaisa 0,02 mg 3 mg




LaYanina 0,03 mg 3 mg




LaYnes 0,02 mg 3 mg




LaYva 0,03 mg 3 mg




Yasmin 0,03 mg 3 mg


181











Yaz 0,02 mg 3 mg






Vaginal use





Vaginal use



Femodene 0,03 mg 0,075 mg


Luxembourg Gedeon Richter France SARL 1-3 rue Caumartin 75009 Paris France


Gestodelle 20 0,02 mg 0,075 mg

Coated tablet oral use

Luxembourg Gedeon Richter France SARL 1-3 rue Caumartin 75009 Paris France


Gestofeme 30 0,03 mg / 0,075 mg

Coated tablet oral use

182





Luxembourg PFIZER S.A. 17 Boulevard de la Plaine 1050 Brussels Belgium


















Tri-Minulet 0,03 mg / 0,05 mg 0,04 mg / 0,07 mg 0,03 mg / 0,1 mg




Triodene 0,03 mg /0,05 mg 0,04 mg / 0,07 mg 0,03 mg / 0,1 mg


Luxembourg JANSSEN-CILAG N.V. Antwerpseweg 15-17 2340 Beerse Belgium



Tablet Oral use

183





Luxembourg Helm AG Nordkanalstrasse 28 20097 Hamburg Germany


Deltanogest 0,03 mg/2 mg Filmtabletten

0,03 mg 2 mg




Gamanogest 0,03 mg/2 mg Filmtabletten

0,03 mg 2 mg




Ema 0,03 mg/3 mg Filmtabletten

0,03 mg 3 mg




Emalia 0,02 mg/3 mg Filmtabletten

0,02 mg 3 mg




Emanuela 0,0 mg/3 mg Filmtabletten

0,02 mg 3 mg




Nanami 0,02 mg 3 mg




Nanette 0,02 mg 3 mg


184







Nannina 0,03 mg 3 mg




Pea 0,03 mg 3 mg




Pearline 0,02 mg 3 mg




Pearly 0,03 mg 3 mg


Luxembourg EFFIK BENELUX Lenniksebaan 451 1070 Anderlecht Belgium


CORNELIA 0.03 mg 3.00 mg




DROSEFIKK 0.02 mg 3.00 mg






185















NAIWANEL 0.02 mg 3.00 mg


Luxembourg Ratiopharm GmbH Graf-Arco-Strasse 3 DE-89079 Ulm Germany


Velvet-ratiopharm 0,03 mg/2 mg Filmtabletten

0,03 mg 2 mg


Malta Organon Laboratories Limited, Cambridge Science Park, Milton Road, Cambridge CB4 0FL, United Kingdom



Tablet Oral use

Malta Bayer PLC Bayer House Strawberry Hill Newbury Berkshire RG14 1JA United Kingdom

Dienogest Estradiol

Qlaira, film-coated tablets

3 mg 2 mg/2 mg 2 mg /3 mg 1 mg


186







ELOINE 0.02 mg / 3 mg film coated tablets

0.02 mg 3 mg




Palandra 0.03 mg / 3 mg film-coated tablets

0.03 mg 3mg




Yasmin film-coated tablets 0.03 mg/3 mg

0.03 mg 3mg




Yaz 0.02mg/3mg film-coated tablets

0.02 mg 3 mg


187





Malta Bayer Limited The Atrium, Blackthorn Road, Dublin 18, Ireland


Aliane 0.02 mg / 3 mg film-coated tablets

0.02 mg 3mg


Malta Bayer Limited The Atrium, Blackthorn Road, Dublin 18, Ireland


Yasminelle 0.02 mg/3 mg film-coated tablets

0.02 mg 3mg


Malta Pfizer Hellas S.A. 243 Messoghion Avenue, 154 51 N. Psychiko, Greece


Minesse 0.06 mg 0.015 mg


Malta Janssen-Cilag International N.V. Turnhoutseweg 30 B 2340 Beerse Belgium


CILEST 250/35 microgram Oral Contraceptive Tablets

0.25 mg 0.035 mg

Tablet Oral use

Malta Stragen UK Limited, Castle Court, 41 London Road, Reigate, Surrey RH2 9RJ United Kingdom


Sunya 20/75 0.02 mg 0.075 mg


188





Malta Stragen UK Limited, Castle Court, 41 London Road, Reigate, Surrey RH2 9RJ United Kingdom


Katya 30/75 0.03 mg 0.075 mg


Malta Organon Laboratories Limited, Cambridge Science Park, Milton Road, Cambridge CB4 0FL, United Kingdom



Tablet Oral use

Malta N.V. Organon Kloosterstraat 6 5349 AB, Oss The Netherlands




Vaginal use



Flexyess 0.02mg/3mg film-coated tablets

0.02 mg 3mg


Malta Actavis Group PTC ehf Reykjavikurvegi 76-78 220 Hafnarfjordur Iceland


Benifema 150micrograms/30micrograms film-coated tablets

0.15mg 0.03 mg


189





Norway Gedeon Richter Plc. Gyömröí út 19-21 HU-1103 Budapest Hungary


Desodiolcont 0,02 mg 0,15 mg


Norway Medimpex UK Ltd, 127 Shirland Road, London W9 2EP United Kingdom


Igixon 0,02 mg 0,15 mg


Norway Mylan AB, Postbox 23033, Ynglingagatan 14, SE-10435 Stockholm, Sweden



Tablet Oral use

Norway Mylan AB, Postbox 23033, Ynglingagatan 14, SE-10435 Stockholm, Sweden


Lestramyl 0.03 mg 0.15 mg

Tablet Oral use

Norway N.V. Organon Kloosterstraat 6 5349 AB, Oss The Netherlands



Tablet Oral use



Marvelon 28 0.15 mg 0.03 mg

Tablet Oral use

190







Mercilon 28 0,15 mg 0,02 mg

Tablet Oral use

Norway Medimpex UK Ltd, 127 Shirland Road, London W9 2EP United Kingdom


Regulon 0.03 mg 0.15 mg


Norway Bayer AB Postbox 606 Gustav III's Boulevard 56 SE-16926 Solna Sweden




Norway Laboratorios Leon Farma SA Poligono Industrial Navatejera, La Vallina s/n, 24008 Villaquilambre,Leon Spain


Calima 0,02 mg 3 mg




Calima 28 0,02 mg 3 mg


Norway Teva Sweden AB Järnvägsgatan 11 Box 1070 25110 Helsingborg Sweden




191











Dretinelle 0,02 mg 3 mg




Dretinelle 28 0,02 mg 3 mg










192







Drosinetta 0,02 mg 3 mg




Drosinetta 28 0,02 mg 3 mg




Drospirenone/Ethinylestradiol Richter

0,03 mg 3 mg




Eloine 0,02 mg 3 mg


Norway Sandoz A/S Edward Thomsens Vej 14 DK-2300 København S Denmark


Elyra 0,03 mg 3 mg




Elyra 28 0,03 mg 3 mg


193





Norway Ratiopharm GmbH Graf-Arco-Strasse 3 DE-89079 Ulm Germany


Estez 0,02 mg 3 mg












Iradier 0,02 mg 3 mg




Iren 0,02 mg 3 mg




Iren 28 0,02 mg 3 mg


194





Norway Bayer Pharma AG D-13342 Berlin Germany






Liofora 28 0,02 mg 3 mg


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
















195







Naiwanel 0,02 mg 3 mg




Naiwanel 28 0,02 mg 3 mg




Ospen 0,03 mg 3 mg




Ospen 28 0,03 mg 3 mg






196







Perlita 0,02 mg 3 mg




Rosal 0,03 mg 3 mg




Rosal 28 0,03 mg 3 mg




Rubira 0,02 mg 3 mg




Rubira 0,03 mg 3 mg


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


Sidreta 0,03 mg 3 mg


197





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






Varena 0,03 mg 3 mg




Varena 28 0,03 mg 3 mg




Varenelle 0,02 mg 3 mg




Varenelle 28 0,02 mg 3 mg


198







Yalisca 0,02 mg 3 mg




Yasmin 0,03 mg 3 mg
















Yaz 0,02 mg 3 mg




Nuvaring 0,120 mg/0,015 mg/ 24 timer, vaginalinlegg

0.12 mg/0.015 mg Vaginal delivery system

Vaginal use

199





Norway Janssen-Cilag AS Drammensveien 288 0283 Oslo Norway



Tablet Oral use

Poland N.V. Organon Kloosterstraat 6 5349 AB, Oss The Netherlands



Tablet Oral use





Vaginal use





Vaginal use

Poland Organon (Ireland) Ltd, PO Box 2857, Drynam Road, Swords, Co.Dublin, Ireland



Tablet Oral use

Poland Gedeon Richter Plc. Gyömröí út 19-21 HU-1103 Budapest Hungary




200





Poland Pabianickie Zakłady Farmaceutyczne Polfa S.A. ul. Marszałka J. Piłsudskiego 5 95-200 Pabianice Poland


Ovulastan 0,15 mg 0,02 mg

Tablet Oral use



Ovulastan Forte 0,15 mg 0,03 mg

Tablet Oral use

Poland Gedeon Richter Polska Sp. z o.o. 5 Ks. J. Poniatowskiego Street 05-825 Grodzisk Mazowiecki Poland


Samba tabletka powlekana

0,05 mg/0,035 mg 0,1 mg/0,03 mg 0,15 mg/0,03 mg


Poland Temapharm Sp. z o.o. ul. Żwirki i Wigury 81 02-091 Warszawa Poland


Asubtela 3mg 0,03mg


Poland Teva Pharmaceuticals Polska Sp. z o.o. ul. Emilii Plater 53 00-113 Warszawa Poland


Cortelle 3mg 0,03mg


201







Lesine 3mg 0,03mg


Poland Ivowen Limited 3 Anglesa St Tipperary Clonmel Ireland


Lulina 3mg 0,03mg


Poland Gedeon Richter Polska Sp. z o.o. 5 Ks. J. Poniatowskiego Street 05-825 Grodzisk Mazowiecki Poland


Midiana 3mg 0,03mg


Poland Bayer Pharma AG D-13342 Berlin Germany


Palandra 3mg 0,03mg




Flexyess 0.02 mg 3 mg


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


Sidretella 30 3mg 0,03mg


202





Poland Zakłady Farmaceutyczne POLPHARMA S.A. ul. Pelplińska 19 83-200 Starogard Gdański Poland


Vibin 3mg 0,03mg






Poland Sun-Farm Sp. z o.o. Człekówka 75 05-340 Kołbiel, Poland


Madinette 0,03 mg 2 mg




Dessette 0.02 mg 0.15 mg

Film-coated tablet oral use



Dessette Forte 0.03 mg 0.15 mg

Film-coated tablet oral use





203





Poland Cyndea Pharma S.L. Polígono Industrial Emiliano Revilla Sanz Av. De Ágreda 31 42110 Ólvega (Soria) Spain


Aidee 0,03 mg 2 mg




Atywia 0,03 mg 2 mg




Bonadea 0,03 mg 2 mg


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


Dionelle 0,03 mg 2 mg

Tablet Oral use



Dorin 0,03 mg 2 mg


Poland Pharbil Waltrop GmbH Im Wirrigen 25 45731 Waltrop Germany


Ethinylestradiol/Dienogest Pharbil

0,03 mg 2 mg


204







Jeanine 0,03 mg 2 mg




Aliane 0,02 mg 3 mg


Poland Gedeon Richter Polska Sp. z o.o. ul.Graniczna 35 05-825 Grodzisk Mazowiecki Poland


Sibilla 0,03 mg 2 mg




Aneea 0,02 mg 3 mg




Belusha 0,02 mg 3 mg




Daylette 0,02 mg 3 mg


205







Lesinelle 0,02 mg 3 mg




Linatera 0,02 mg 3 mg




Naraya 0,02 mg 3 mg




Naraya Plus 0,02 mg 3 mg




Sidretella 20 0,02 mg 3 mg




Teenia 0,02 mg 3 mg


206







Varenelle 0,02 mg 3 mg




Lesiplus 0,02 mg 3 mg


Poland Zakłady Farmaceutyczne POLPHARMA S.A. ul. Pelplińska 19 83-200 Starogard Gdański Poland


Vibin mini 0,02 mg 3 mg




Yasmin 0,03 mg 3 mg








Yaz 0,02 mg 3 mg


207







Femipol 0,03 mg 0,075 mg




Femoden 0.075 mg 0.03 mg


Poland Pfizer Europe MA EEIG Ramsgate Road Sandwich Kent CT13 9NJ United Kingdom






Kontracept 0,02 mg 0,075 mg


Poland SymPhar Sp. z o.o. ul. Włoska 1 00-777 Warszawa Poland


Sylvie 20 0,02 mg 0,075 mg


Poland SymPhar Sp. z o.o. ul. Włoska 1 00-777 Warszawa Poland


Sylvie 30 0.03 mg 0.075 mg


208







Artilla 0,075 mg 0,02 mg




Gefemin 0,06 mg 0,015 mg


Poland Actavis Group PTC ehf Reykjavikurvegi 76-78 220 Hafnarfjordur Iceland


Gestodene/Ethinylestradiol Actavis

0,075 mg 0,02 mg




Angiletta 2 mg 0,03 mg




Gestodene/Ethinylestradiol Actavis

0,075 mg 0,03 mg




Kostya 0,075 mg 0,02 mg


209















Milvane 0,05 mg/0,03 mg 0,07 mg/ 0,04 mg 0,10 mg /0,03 mg


Poland Pfizer Europe MA EEIG Ramsgate Road Sandwich Kent CT13 9NJ United Kingdom












210





Poland Janssen-Cilag International N.V. Turnhoutseweg 30 B 2340 Beerse Belgium



Tablet Oral use



Estmar 0,15 mg 0,02 mg

Tablet Oral use



Estmar 0,15 mg 0,03 mg

Tablet Oral use

Portugal Gedeon Richter Plc. Gyömröí út 19-21 HU-1103 Budapest Hungary


Belara 2 mg 0.03 mg


Portugal Laboratorios Leon Farma SA Poligono Industrial Navatejera, La Vallina s/n, 24008 Villaquilambre,Leon Spain


Bonae 2 mg 0.03 mg


211





Portugal Italfarmaco - Produtos Farmacêuticos, Lda. Rua Consiglieri Pedroso, 123 - Queluz de Baixo 2730-056 Barcarena Portugal


Clarissa 2 mg 0.03 mg


Portugal Actavis Group PTC ehf Reykjavikurvegi 76-78 220 Hafnarfjordur Iceland


Jeniasta 2 mg 0.03 mg




Libeli 2 mg 0.03 mg


Portugal Merck Sharp & Dohme, Lda. Quinta da Fonte 19 Edificio Vasco da Gama 2770-192 Paço d' Arcos Portugal



Tablet Oral use



Benidette 0.15 mg 0.02 mg

Tablet Oral use



Benifema 0.15 mg 0.03 mg

Tablet Oral use

212





Portugal Stragen Nordic A/S, Helsingørgade 8C, DK-3400 Hillerød, Denmark


Desogestrel + Etinilestradiol Generis

0.15 mg 0.02 mg

Tablet Oral use



Desogestrel + Etinilestradiol Generis

0.15 mg 0.03 mg

Tablet Oral use

Portugal Mylan, Lda. Rua Doutor António Loureiro Borges, Edificio Arquiparque 1, R/C Esq 1499-016 Algés Portugal


Desogestrel + Etinilestradiol Mylan

0.15 mg 0.02 mg

Tablet Oral use

Portugal Mylan, Lda. Rua Doutor António Loureiro Borges, Edificio Arquiparque 1, R/C Esq 1499-016 Algés Portugal


Desogestrel + Etinilestradiol Mylan

0.15 mg 0.03 mg

Tablet Oral use



Laurina 0,035 mg/0,05mg 0,03 mg/0,10 mg 0,03 mg/0,15 mg


213







Laurina 28 0,035 mg/0,05mg 0,03 mg/0,10 mg 0,03 mg/0,15 mg





Tablet Oral use




Tablet Oral use



Novynette 0.15 mg 0.02 mg




Regulon 0.15 mg 0.03 mg




Ydeza 0.15 mg 0.02 mg

Tablet Oral use

214







Ydeza 0.15 mg 0.03 mg

Tablet Oral use

Portugal Berlifarma, Especialidades Farmacêuticas, Lda. Rua Quinta Pinheiro, 5 2794-003 Carnaxide Portugal




Portugal Laboratórios EFFIK, Sociedade Unipessoal, Lda. Rua Consiglieri Pedroso, 123 2730-056 Barcarena Portugal


Denille 2 mg 0.03 mg




Sibilla 2 mg 0.03 mg




Valette 2 mg 0.03 mg


Portugal Lusal, Produção Químico Farmacêutica Luso Alemã, Lda. Rua Quinta do Pinheiro, 5 2794-003 Carnaxide Portugal


Aliane 3 mg 0.02 mg


215







Aranka 3 mg 0.03 mg




Arankelle 3 mg 0.02 mg




Arankitelle 3 mg 0.02 mg




Daylette 3 mg 0.02 mg


Portugal Sandoz Farmaceutica, Lda. Alameda da Beloura Edificio 1, 2º Escritorio 15 2710-693 Sintra Portugal


Dioz 3 mg 0.02 mg




Drosianne 3 mg 0,03 mg


216





Portugal Teva Pharma - Produtos Farmaceuticos, Lda Edifício Cyprium, Av. 25 de Abril, 15, 2º F 2795-195 Linda-a-Velha Portugal


Dretine 3 mg 0.03 mg


Portugal Teva Pharma - Produtos Farmaceuticos, Lda Edifício Cyprium, Av. 25 de Abril, 15, 2º F 2795-195 Linda-a-Velha Portugal


Dretinelle 3 mg 0.02 mg




Droseffik 3 mg 0.02 mg




Drosianelle 3 mg 0.02 mg




Drosurall 3 mg 0.02 mg


217







Drosure 3 mg 0.03 mg




Liladros 3 mg 0.02 mg




Linatera 3 mg 0.02 mg




Nelecta 3 mg 0.02 mg




Palandra 3 mg 0.03 mg


218







Petibelle 3 mg 0.03 mg


Portugal Sanofi - Produtos Farmaceuticos, Lda. Empreendimento Lagoas Park, Edifício 7 - 3º Piso - Porto Salvo 2740-244 Portugal


Sidreta 3 mg 0.03 mg


Portugal Sanofi - Produtos Farmaceuticos, Lda. Empreendimento Lagoas Park, Edifício 7 - 3º Piso - Porto Salvo 2740-244 Portugal


Sidretella 3 mg 0.02 mg




Tunile 3 mg 0.03 mg


Portugal Bayer Portugal, S.A. Rua Quinta do Pinheiro 5 2794-003 Carnaxide Portugal


Yasmin 3 mg 0.03 mg


219





Portugal Berlex Especialidades Farmacêuticas Lda. Rua Quinta do Pinheiro, 5 2794-003 Carnaxide Portugal


Yasminelle 3 mg 0.02 mg




Flexyess 3 mg 0.02 mg




Yaz 3 mg 0.02 mg




Effiplen 0.03 mg 0.075 mg




Estinette 0.02 mg 0.075 mg


220







Sofiperla 0.03 mg 0.075 mg




Juliperla 0.02 mg 0.075 mg


Portugal Medimpex France, S.A 1-3, Rue Caumartin F-75009 Paris France


Etinilestradiol + Gestodeno Dorinette

0.03 mg 0.075 mg


Portugal Generis Farmacêutica, S.A. Rua João de Deus, 19 2700-487 Amadora Portugal


Etinilestradiol + Gestodeno Generis

0.03 mg 0.075 mg


Portugal Generis Farmacêutica, S.A. Rua João de Deus, 19 2700-487 Amadora Portugal


Etinilestradiol + Gestodeno Generis

0.02 mg 0.075 mg


Portugal Medimpex France, S.A 1-3, Rue Caumartin F-75009 Paris France


Etinilestradiol + Gestodeno Gestilla

0.02 mg 0.075 mg




Etinilestradiol + Gestodeno Phagecon

0.015 mg 0.06 mg


221







Gynera 0.075 mg 0.03 mg


Portugal Laboratórios Pfizer, Lda. Lagoas Park, Edificio 10 2740-271 Porto Salvo Portugal


Harmonet 0.02 mg 0.075 mg




Microgeste 0.06 mg 0.015 mg




Minesse 0.015 mg 0.06 mg




Minigeste 0.075 mg 0.02 mg




Minulet 0.03 mg 0.075 mg


222







Tri-Gynera 0.050 mg/0.030 mg 0.070 mg/0.040 mg 0.100 mg/0.030 mg




Tri-Minulet 0,03 mg / 0,05 mg 0,04 mg / 0,07 mg 0,03 mg / 0,1 mg




Varianta 0.015 mg 0.06 mg






Vaginal use





Vaginal use

Romania Gedeon Richter România S.A. Str. Cuza-Vodă, nr. 99-105 540306 Târgu Mureş România


BELARA 2 mg 0,03 mg


223







NOVYNETTE CONTINUU

0,15 mg 0,02 mg


Romania Gedeon Richter Plc. Gyömröí út 19-21 HU-1103 Budapest Hungary


SAMBA 0,05 mg/0,035 mg 0,1 mg/0,03 mg 0,15 mg/0,03 mg






Romania LadeePharma Kft Lajos utca 48-66 H-1036 Budapest Hungary


DIENILLE 2 mg 0,03 mg


Romania Jenapharm GmbH & Co. KG Otto-Schott-Straße 15 07745 Jena Germany




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


ZENADEA 2 mg 0,03 mg


224





Romania Medico Uno Pharma Kft. Viadukt u. 12 Biatorbágy 2051 Hungary


JOLINA 3mg 0,03mg


Romania Ivowen Limited 3 Anglesa St Tipperary Clonmel Ireland


LULINA 3mg 0,03mg




MIDIANA 3mg 0,03mg


Romania Bayer Pharma AG Muellerstr. 178 D-13353 Berlin Germany


YASMIN 0,03 mg/ 3 mg comprimate filmate

3mg 0,03mg


Romania Bayer Pharma AG Muellerstrasse 170-178 D-13353 Berlin Germany


QLAIRA, comprimate filmate

3 mg 2 mg/2 mg 2 mg/3 mg 1 mg




ANEEA 0,02 mg 3 mg






225









Romania Laboratorios Leon Farma SA Poligono Industrial Navatejera, La Vallina s/n, 24008 Villaquilambre,Leon Spain


DROSETIL 0,02 mg 3 mg


Romania Teva Pharmaceuticals S.R.L. Str. Domniţa Ruxandra nr. 12, parter, Sector 2 Bucureşti România


DROSPIR 0,03 mg/3 mg Film-coated tablet Oral use

Romania S.C. SANDOZ S.R.L. Str. Livezeni nr. 7A, 540472 Târgu Mureş, România.


FELICITY 0,03 mg/3 mg Film-coated tablet Oral use



JANGEE 0,02 mg 3 mg




MYWY 0,02 mg 3 mg


226







PALANDRA 0,03 mg/ 3 mg comprimate filmate

0,03 mg 3 mg




SIDRETELLA 0,03 mg 3 mg




TAISA 0,02 mg 3 mg


Romania LadeePharma Kft Lajos utca 48-66 H-1036 Budapest Hungary


VELGYN 0,02 mg 3 mg




YAZ 0,02 mg/ 3 mg comprimate filmate

0,02 mg 3 mg


Romania N.V. Organon Kloosterstraat 6 5349 AB, Oss The Netherlands


CIRCLET0,120 mg/0,015 mg per 24 ore sistem cu cedare vaginală

0,12 mg 0,015 mg


Vaginal use

227







NUVARING 0,120 mg/0,015 mg per 24 ore sistem cu cedare vaginală

0,12 mg 0,015 mg


Vaginal use



MARVELON 21, comprimate

0,15 mg 0,03 mg

Tablet Oral use


Desogestrel/ Etinylestradiol

LAURINA comprimate filmate

0,05mg/0,035mg 0,035 mg/0,05mg 0,10mg/0,03mg




MARVELON 28 FAMILY PLANNINGS, comprimate

0,15mg 0,03mg

Tablet Oral use



MERCILON, comprimate

0,15 mg 0,02 mg

Tablet Oral use



ARTIZIA 0,075 mg 0,02 mg


228







STODETTE 0,075 mg 0,02 mg


Romania Pfizer Europe MA EEIG Ramsgate Road Sandwich Kent CT13 9NJ United Kingdom






KARISSA 0,075 mg 0,02 mg




KOSTYA 0,075 mg 0,02 mg


Romania Bayer Pharma AG D-13342 Berlin Germany






MILLIGEST 0,03 mg/0,05 mg 0,04 mg/0,07 mg 0,03 mg/0,1 mg




VENDIOL 0,06 mg 0,015 mg


229









Romania Johnson & Johnson d.o.o. Šmartinska cesta 53 1000 Ljubljana Slovenija


CILEST 0,25 mg 0,035 mg

Tablet Oral use



VEYANN 3 mg/0,02 mg

3 mg 0,02 mg


Romania Famy Care Europe Ltd. One Wood Street EC2V 7WS London United Kingdom


NORGESTIMAT/ETINILESTRADIOL FAMY CARE 250 micrograme/35 micrograme

0,25 mg 0,035 mg

Tablet Oral use

Romania Bayer Pharma AG Muellerstrasse 170-178 Berlin D-13353 Germany


YVIDUALLY 0,02 mg/3 mg comprimate filmate

0,02 mg 3 mg




TYARENA 200 micrograme/30 microgrmae

0,2 mg 0,03 mg


230







JULIANE 0,15 mg 0,03 mg

Tablet Oral use



JULIANE 0,15 mg 0,02 mg

Tablet Oral use

Slovak Republic

Actavis Group PTC ehf Reykjavikurvegi 76-78 220 Hafnarfjordur Iceland


Angiletta 2 mg / 0,03 mg

2 mg 0,03 mg


Slovak Republic



Belara 2 mg 0,03 mg


Slovak Republic

Stada Arzneimittel AG, Stadastrasse 2-8, DE-61118 Bad Vibel, Germany


Belissa 2 mg 0,03 mg


Slovak Republic

Ratiopharm GmbH Graf-Arco-Strasse 3 DE-89079 Ulm Germany


Egretta 2 mg/0,03 mg 2 mg 0,03 mg


231





Slovak Republic

mibe GmbH Arzneimittel Münchener Str. 15 06796 Brehna Germany


Etinylestradiol 0,03 mg/ Chlormadinoniumacetat 2 mg mibe filmom obalene tablety

2 mg 0,03 mg


Slovak Republic

Heaton a.s. Na Pankráci 14 14000 Praha 4 Czech Republic


Adele 0,15 mg 0,03 mg

Tablet Oral use

Slovak Republic



Laurina 0.035 mg/0,05 mg 0,03 mg/0,1 mg 0,03 mg / 0,15 mg


Slovak Republic




Tablet Oral use

Slovak Republic




Tablet Oral use

Slovak Republic



Natalya 0,15 mg 0,02 mg

Tablet Oral use

232





Slovak Republic





Slovak Republic



Regisha 0,150 mg/0,02 mg

0,15 mg 0,02 mg

Tablet Oral use

Slovak Republic



Regisha 0,150 mg/0,03 mg

0,15 mg 0,03 mg

Tablet Oral use

Slovak Republic





Slovak Republic

VIVAX EuroAsia s.r.o. Karloveske rameno 6 841 01 Bratislava Slovensko


AIDEE 2 mg/0,03 mg filmom obalene tablety

2 mg 0,03 mg


Slovak Republic

LADEEPHARMA Slovakia s.r.o. Prievozská 4D 82109 Bratislava Slovak Republic


Dienorette filmom obalene tablety

2 mg 0,03 mg


233





Slovak Republic



Jeanine 2 mg 0,03 mg


Slovak Republic



Mistra 2 mg 0,03 mg


Slovak Republic

Sandoz Pharmaceuticals d.d. Verovškova 57 1000 Ľubľana Slovenia


SEEGEE 2 mg/0,03 mg

2 mg 0,03 mg


Slovak Republic



ZENADEA 2 mg 0,03 mg


Slovak Republic



KarHla 3mg 0,03mg


Slovak Republic



KarHleight 3mg 0,03mg


Slovak Republic



MAITALON 3 mg/ 0,03 mg filmom obalene tablety

3mg 0,03mg


234





Slovak Republic



Narayeight 3mg 0,03mg


Slovak Republic

Bayer, spol. s r.o. Digital Park II Einsteinova 25 851 01 Bratislava Slovak republic


Palandra 3mg 0,03mg


Slovak Republic



Flexyess 0,02 mg/3 mg filmom obalené tablety

3 mg 0.02 mg


Slovak Republic



Phaenya 21 3mg 0,03mg


Slovak Republic



Phaenya 28 3mg 0,03mg


Slovak Republic



Sidreta 3mg 0,03mg


235





Slovak Republic

Teva Pharmaceuticals Slovakia s.r.o. Teslova 26 821 02 Bratislava Slovak republic


Softine 0,03 mg/3 mg filmom obalené tablety

3mg 0,03mg


Slovak Republic

Ivowen Limited 3 Anglesa St Tipperary Clonmel Ireland


WERRCA 3mg 0,03mg


Slovak Republic



Yadine 3mg 0,03mg


Slovak Republic





Slovak Republic



Aliane 0,02 mg 3 mg


Slovak Republic





Slovak Republic





236





Slovak Republic



DAYLLA 0,02 mg 3 mg


Slovak Republic



KIRGA 0,02 mg 3 mg


Slovak Republic



Linatera 0,02 mg 3 mg


Slovak Republic

Laboratorios Leon Farma SA Poligono Industrial Navatejera, La Vallina s/n, 24008 Villaquilambre,Leon Spain


LluviEight 0,02 mg 3 mg


Slovak Republic



Lunytta 0,02 mg 3 mg


Slovak Republic



Lunytteight 0,02 mg 3 mg


237





Slovak Republic



Phaenyela 21 0,02 mg 3 mg


Slovak Republic



Phaenyela 28 0,02 mg 3 mg


Slovak Republic





Slovak Republic

Teva Pharmaceuticals Slovakia s.r.o. Teslova 26 821 02 Bratislava Slovak republic


Softinelle 0,02 mg/3 mg filmom obalené tablety

0,02 mg 3 mg


Slovak Republic





Slovak Republic



YAZ 0,02 mg 3 mg


238





Slovak Republic





Vaginal use

Slovak Republic





Vaginal use

Slovak Republic



ARTIZIA 0,075 mg/ 0,020 mg obalene tablety

0,075 mg 0,02 mg


Slovak Republic





Slovak Republic



Gefemin 0,060 mg/0,015 mg

0,06 mg 0,015 mg


Slovak Republic

Medico Uno Pharma Kft. Viadukt u. 12 Biatorbágy 2051 Hungary


Gestodette 0,075 mg 0,02 mg


Slovak Republic



Katya 0,075 mg 0,03 mg


239





Slovak Republic



KOSTYA 0,02 mg/0,075 mg obalene tablety

0,075 mg 0,02 mg


Slovak Republic





Slovak Republic





Slovak Republic





Slovak Republic





Slovak Republic



Sunya 0,075 mg 0,02 mg


Slovak Republic



Violetta 0,06 mg 0,015 mg


240





Slovak Republic



ZULFIJA 0,03 mg/0,075 mg obalené tablety

0,075 mg 0,03 mg


Slovak Republic

Johnson & Johnson, s. r. o. Karadžičova 12 821 08 Bratislava Slovak republic



Tablet Oral use

Slovenia Gedeon Richter Plc. Gyömröí út 19-21 HU-1103 Budapest Hungary


Belara 0,03 mg/2 mg filmsko obložene tablete

0,03 mg 2 mg


Slovenia Bayer d.o.o., Bravničarjeva 13, Ljubljana, Slovenia


Linatera 0,02 mg/3 mg filmsko obložene tablete

0,02 mg 3 mg




Qlaira filmsko obložene tablete



Slovenia Bayer Pharma AG D-13342 Berlin Germany


Liofora 0,02 mg/3 mg filmsko obložene tablete

0,02 mg 3 mg




Yarina 0,03 mg/3 mg filmsko obložene tablete

0,03 mg 3 mg


241







Yasminelle 0,02 mg/3 mg filmsko obložene tablete

0,02 mg 3 mg




YAZ 0,02 mg/3 mg filmsko obložene tablete

0,02 mg 3 mg


Slovenia N.V. Organon Kloosterstraat 6 5349 AB, Oss The Netherlands


NuvaRing 0,120 mg/0,015 mg na 24 ur vaginalni dostavni sistem

0.12 mg 0.015 mg


Vaginal use

Slovenia N.V. Organon Kloosterstraat 6 5349 AB, Oss The Netherlands


Circlet 0,120 mg/0,015 mg na 24 ur vaginalni dostavni sistem

0.12 mg 0.015 mg


Vaginal use



Femoden 0,03 mg/0,075 mg obložene tablete

0,075 mg 0,03 mg


Slovenia Pfizer Europe MA EEIG Ramsgate Road Sandwich Kent CT13 9NJ United Kingdom


Harmonet 75 mikrogramov/20 mikrogramov obložene tablete

0,075 mg 0,02 mg


Slovenia Chemical Works of Gedeon Richter Plc., Gyömrői ut 19-21, H-1103 Budapest, Hungary


LINDYNETTE 0,075 mg/0,02 mg obložene tablete

0,075 mg 0,02 mg


242





Slovenia Chemical Works of Gedeon Richter Plc., Gyömrői ut 19-21, H-1103 Budapest, Hungary


LINDYNETTE 0,075 mg/0,03 mg obložene tablete

0,075 mg 0,03 mg




Logest 0,02 mg/0,075 mg obložene tablete

0,075 mg 0,02 mg


Slovenia Pfizer Europe MA EEIG Ramsgate Road Sandwich Kent CT13 9NJ United Kingdom


MINULET 75 mikrogramov/30 mikrogramov obložene tablete

0,075 mg 0,03 mg


Slovenia Johnson & Johnson d.o.o. Šmartinska cesta 53 1000 Ljubljana Slovenija


Cilest 0,25 mg/0,035 mg tablete

0,25 mg 0,035 mg

Tablet Oral use



Leticia 150 mikrogramov/20 mikrogramov filmsko obložene tablete

0,15 mg 0,02 mg




Rozetta 150 mikrogramov/30 mikrogramov filmsko obložene tablete

0,15 mg 0,03 mg


243







Kostya 75 mikrogramov/20 mikrogramov obložene tablete

0,075 mg 0,02 mg




Zulfija 75 mikrogramov/30 mikrogramov obložene tablete

0,075 mg 0,03 mg




Aneea 3 mg/0,02 mg filmsko obložene tablete

3 mg 0,02 mg




Daylette 3 mg/0,02 mg filmsko obložene tablete

3 mg 0,02 mg




Daylla 3 mg/0,02 mg filmsko obložene tablete

3 mg 0,02 mg




Flexyess 0,02 mg/3 mg filmsko obložene tablete

0,02 mg 3 mg




Hedfor 3 mg/0,02 mg filmsko obložene tablete

3 mg 0,02 mg


244





Slovenia Laboratorios Leon Farma SA Poligono Industrial Navatejera, La Vallina s/n, 24008 Villaquilambre,Leon Spain


MYWY 3 mg/0,02 mg filmsko obložene tablete

3 mg 0,02 mg




Palandra 0,03 mg/3 mg filmsko obložene tablete

0,03 mg 3 mg


Slovenia sanofi-aventis d.o.o. Dunajska cesta 151 1000 Ljubljana Slovenia


Sidretella 0,02 mg/3 mg filmsko obložene tablete

3 mg 0,02 mg


Slovenia sanofi-aventis d.o.o. Dunajska cesta 151 1000 Ljubljana Slovenia


Sidretella 0,03 mg/3 mg filmsko obložene tablete

3 mg 0,03 mg


Slovenia LadeePharma Kft Lajos utca 48-66 H-1036 Budapest Hungary


Velgyn 3 mg/0,02 mg filmsko obložene tablete

3 mg 0,02 mg


Slovenia Ivowen Limited 3 Anglesa St Tipperary Clonmel Ireland


Werrca 3 mg/0,03 mg filmsko obložene tablete

3 mg 0,03 mg


245





Slovenia LadeePharma Kft Lajos utca 48-66 H-1036 Budapest Hungary


Dienille 2 mg/0,03 mg filmsko obložene tablete

2 mg 0,03 mg


Spain Actavis Group PTC ehf Reykjavikurvegi 76-78 220 Hafnarfjordur Iceland


ANGILETTA 0,03 mg /2 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG

2 mg 0,03 mg


Spain FAES FARMA, S.A. Maximo Aguirre, 14. 48940 Lamiaco-Lejona (Vizcaya) Spain


BALIANCA 0,03 mg/2mg COMPRIMIDOS RECUBIERTOS CON PELICULA

2 mg 0,03 mg


Spain FAES FARMA, S.A. Maximo Aguirre, 14. 48940 Lamiaco-Lejona (Vizcaya) Spain


BALIANCA DIARIO 0,03 mg/2 mg COMPRIMIDOS RECUBIERTOS CON PELICULA

2 mg 0,03 mg


Spain Gedeon Richter Plc. Gyömröí út 19-21 HU-1103 Budapest Hungary


BELARA 0,03 mg/2 mg COMPRIMIDOS RECUBIERTOS CON PELICULA

2 mg 0,03 mg




BELARA DIARIO 0,03 mg/2 mg COMPRIMIDOS RECUBIERTOS CON PELICULA

2 mg 0,03 mg


246





Spain BRILL PHARMA, S.L. Mandri 66 Escalera A despacho 2 08022 Barcelona Spain


ELYNOR 0.03 mg/2 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG

2 mg 0,03 mg


Spain Pharmacia Grupo Pfizer S.L. Avda. de Europa 20 B Parque Empresarial la Moraleja 28108 Alcobendas (Madrid) Spain


TEYDA 0,03 mg/ 2 mg comprimidos recubiertos con película EFG

2 mg 0,03 mg


Spain LABORATORIO STADA, S.L. Frederic Mompou, 5 08960 Sant Just Desvern Barcelona Spain


ETINILESTRADIOL/CLORMADINONA STADA 0,03 mg/2 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG

2 mg 0,03 mg


Spain TEVA PHARMA S.L.U. C/ Anabel Segura, 11 Edificio Albatros B 1ª planta 28108 Alcobendas Madrid Spain


TYARENA 0,03 mg/2 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG

2 mg 0,03 mg


247





Spain Merck Sharp and Dohme de España, S.A c/ Josefa Valcárcel, 38 28027 Madrid España (Spain)

Ethinylestradiol Desogestrel

GRACIAL comprimidos 0,03 mg/0,125 mg 0,04 mg/0,025 mg

Tablet Oral use

Spain GYNEA LABORATORIOS, S.L. Colón, 5 08184 Palau-Solitá i Plegamans Barcelona Spain


BEMASIVE 150 microgramos/20 microgramos comprimidos recubiertos

0,15 mg 0,02 mg




BENIDETTE 0,15 mg/0,02 mg comprimidos EFG

0,15 mg 0,02 mg

Tablet Oral use



BENIFEMA 0,15 mg/0,03 mg comprimidos EFG

0,15 mg 0,03 mg

Tablet Oral use

Spain Famy Care Europe Ltd. One Wood Street EC2V 7WS London United Kingdom


DESOGESTREL/ETINILESTRADIOL FAMYCARE 0,15 mg/0,02 mg comprimidos EFG

0,15 mg 0,02 mg

Tablet Oral use

Spain Famy Care Europe Ltd. One Wood Street EC2V 7WS London United Kingdom


DESOGESTREL/ETINILESTRADIOL FAMYCARE 0,15 mg/0,03 mg comprimidos EFG

0,15 mg 0,03 mg

Tablet Oral use

248





Spain MYLAN PHARMACEUTICALS S.L. Plom, 2-4, 5ª planta 08038 Barcelona Spain


DESOGESTREL/ETINILESTRADIOL MYLAN 0,15 mg/0,02 mg comprimidos EFG

0,15 mg 0,02 mg

Tablet Oral use



DESOGESTREL/ETINILESTRADIOL MYLAN 0,15 mg/0,03 mg comprimidos EFG

0,15 mg 0,03 mg

Tablet Oral use



MICRODIOL comprimidos

0,15 mg 0,03 mg

Tablet Oral use



REGULON 150 microgramos/30 microgramos comprimidos recubiertos

0,15 mg 0,03 mg




SUAVURET comprimidos

0,15 mg 0,02 mg

Tablet Oral use

Spain BAYER HISPANIA, S.L Avda. Baix Llobregat 3 y 5 08970 Sant Joan Despi Barcelona Spain


Qlaira comprimidos recubiertos con película



249





Spain BIAL INDUSTRIAL FARMACEUTICA, S.A. Parque Científico y Tecnológico de Bizkaia, Edificio 401 48170 Zamudio (Vizcaya) Spain


AILYN 2 mg/0,03 mg comprimidos recubiertos con película EFG

2 mg 0,03 mg


Spain GYNEA LABORATORIOS, S.L. Colón, 5 08184 Palau-Solitá i Plegamans Barcelona Spain


DANIELLE 2 mg/0,03 mg comprimidos recubiertos con película

2 mg 0,03 mg


Spain LABORATORIOS EFFIK, S.A. San Rafael, 3 28108 Alcobendas Madrid Spain


DONABEL comprimidos recubiertos con película

2 mg 0,03 mg


Spain KERN PHARMA, S.L. Venus, 72 Polígono Industrial Colón II 08228 Tarrasa Barcelona Spain


ANTIN 0,03 mg/3 mg comprimidos con película EFG

3mg 0,03mg


250







ANTIN DIARIO 0,03 mg/3 mg comprimidos con película EFG

3mg 0,03mg




ARANKA 0,03 mg/3 mg comprimidos recubiertos con película EFG

3mg 0,03mg




DRETINE 0,03 mg/3 mg comprimidos recubiertos con película EFG

3mg 0,03mg




DRETINE 0,03 mg/3 mg 28 comprimidos recubiertos con película EFG

3mg 0,03mg


251





Spain LABORATORIOS CINFA, S.A. Olaz-Chipi, 10 Polígon Industrial Areta 31620 Huarte-Pamplona (Navarra) Spain


ETINILESTRADIOL/DROSPIRENONA DIARIO CINFA 0,03 mg/3 mg comprimidos recubiertos con película EFG

3mg 0,03mg


Spain LABORATORIOS CINFA, S.A. Olaz-Chipi, 10 Polígono Industrial Areta 31620 Huarte-Pamplona (Navarra) Spain


ETINILESTRADIOL/CLORMADINONA CINFA 0,03 mg/2 mg comprimidos recubiertos con película EFG

2 mg 0,03 mg




DESOGESTREL/ETINILESTRADIOL CINFA 0,15 mg/0,02 mg comprimidos EFG

0,15 mg 0,02 mg

Tablet Oral use



ESTINILESTRADIOL/DROSPIRENONA CINFA 0,03 mg/3 mg comprimidos recubiertos con película EFG

3mg 0,03mg


252







ETINILESTRADIOL/DROSPIRENONA CINFA 0,02 mg/3 mg comprimidos recubiertos con película EFG

3 mg 0,02 mg




ETINILESTRADIOL/DROSPIRENONA CINFA 0,02 mg/3 mg comprimidos recubiertos con película EFG

3 mg 0,02 mg


Spain SANDOZ FARMACEUTICA, S.A. Avda. Osa Mayor, 4 28023 Aravaca Madrid Spain


DROSIANELLE 0,03 mg/3 mg comprimido recubiertos con película EFG

3 mg 0,03 mg




DROSIANE DIARIO 0,03 mg/3 mg comprimidos recubiertos con película EFG

3mg 0,03mg




DROSURE 0,03 mg/3 mg comprimidos recubiertos con película EFG

3mg 0,03mg


253







DROSURE DIARIO 0,03 mg/3 mg comprimidos recubiertos con película EFG

3mg 0,03mg


Spain ACTAVIS SPAIN, S.A. Avda. de Burgos, 16-D 28036 Madrid Spain


CLEOSENSA DIARIO 0,03 mg/3 mg comprimidos recubiertos con película EFG

3mg 0,03mg




CLEOSENSA 0,03 mg/3 mg comprimidos recubiertos con película EFG

3mg 0,03mg




ESTINILESTRADIOL/DROSPIRENONA DIARIO STADA 0,03 mg/3 mg comprimidos recubiertos con película EFG

3mg 0,03mg




ESTINILESTRADIOL/DROSPIRENONA STADA 0,03 mg/3 mg comprimidos recubiertos con película EFG

3mg 0,03mg


254





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


ESTINILESTRADIOL/DROSPIRENONA ZENTIVA 0,03 mg/3 mg comprimidos recubiertos con película EFG

3mg 0,03mg




Palandra 0,03 mg/3 mg comprimidos recubiertos con película

0,03mg 3mg




Flexyess 0,02 mg/3 mg comprimidos recubiertos con película

0,02 mg 3 mg




Yasmin 0,03 mg/3 mg comprimidos recubiertos con película

0,03 mg 3 mg




Yasmin Diario 0,03 mg/3 mg comprimidos recubiertos con película

0,03 mg 3 mg


255







Yira 0,03 mg/3 mg comprimidos recubiertos con película

0,03 mg 3 mg




ANTINELLE 0,02 mg/3 mg comprimidos recubiertos con película EFG

0,02 mg 3 mg




ANTINELLE DIARIO 0,02 mg/3 mg comprimidos recubiertos con película EFG

0,02 mg 3 mg




ARANKELLE 0,02 mg/3 mg comprimidos recubiertos con película EFG

0,02 mg 3 mg




ARANKELLE DIARIO 0,02 mg/3 mg comprimidos recubiertos con película EFG

0,02 mg 3 mg


256







DAYLETTE 0,02 mg/3 mg comprimidos recubiertos con película EFG

0,02 mg 3 mg




DRELLE 0,02 mg/3 mg comprimidos recubiertos con película EFG

0,02 mg 3 mg




DRETINELLE 0,02 mg/3 mg 28 comprimidos recubiertos con película EFG

0,02 mg 3 mg




DRETINELLE 0,02 mg/3 mg comprimidos recubiertos con película EFG

0,02 mg 3 mg


257





Spain LABORATORIOS CINFA, S.A. Olaz-Chipi, 10 Polígon Industrial Areta 31620 Huarte-Pamplona (Navarra) Spain


ETINILESTRADIOL/DROSPIRENONA DIARIO CINFA 0,02 mg/3 mg comprimidos recubiertos con película EFG

0,02 mg 3 mg




DROSIANELLE 0,02 mg/3 mg comprimidos recubiertos con película EFG

0,02 mg 3 mg




DROSIANELLE DIARIO 0,02 mg/3 mg comprimido recubiertos con película EFG

0,02 mg 3 mg




DROSPIL 0,02 mg/3 mg comprimidos recubiertos con película EFG

0,02 mg 3 mg




DROSURELLE 0,02 mg/3 mg comprimido recubiertos con película EFG

0,02 mg 3 mg


258







DROSURELLE DIARIO 0,02 mg/3 mg comprimidos recubiertos con película EFG

0,02 mg 3 mg




Eloine 0,02 mg/3 mg comprimidos recubiertos con película

0,02 mg 3 mg




CLEODETTE DIARIO 0,02 mg/3 mg comprimidos recubiertos con película EFG

3 mg 0,02 mg




CLEODETTE 0,02 mg/3 mg comprimidos recubiertos con película EFG

3 mg 0,02 mg


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


ESTINILESTRADIOL/DROSPERINONA ZENTIVA 0,02 mg/3 mg comprimidos recubiertos con película EFG

3 mg 0,02 mg


259







ESTINILESTRADIOL/DROSPIRENONA DIARIO STADA 0,02 mg/3 mg comprimidos recubiertos con película EFG

0,02 mg 3 mg




ESTINILESTRADIOL/DROSPIRENONA STADA 0,02 mg/3 mg comprimidos recubiertos con película EFG

0,02 mg 3 mg




Liofora 0,02 mg/3 mg comprimidos recubiertos con película

0,02 mg 3 mg




Liofora Diario 0,02 mg/3 mg comprimidos recubiertos con película

0,02 mg 3 mg




Yasminelle 0,02 mg/3 mg comprimidos recubiertos con película

0,02 mg 3 mg


260







Yasminelle Diario 0,02 mg/3 mg comprimidos recubiertos con película

0,02 mg 3 mg




YAZ 0,02 mg/3 mg comprimidos recubiertos con película

0,02 mg 3 mg


Spain Schering – Plough S.A. c/ Josefa Valcárcel, 38 28027 Madrid España (Spain)


CIRCLET 0,120 mg/0,015 mg CADA 24 HORAS, SISTEMA DE LIBERACION VAGINAL

11,7 mg 2,7 mg


Vaginal use



NUVARING 0,120 mg/0,015 mg CADA 24 HORAS, SISTEMA DE LIBERACION VAGINAL

11,7 mg 2,7 mg


Vaginal use



ETINILESTRADIOL/G ESTODENO SANDOZ 0,02 mg/0,075 mg comprimidos recubiertos

0,075 mg 0,02 mg


261







GESTINYL 20/75 microgramos comprimidos recubiertos

0,075 mg 0,02 mg




Gynovin 0,075 mg 0,03 mg


Spain WYETH FARMA, S.A. Ctra. de Burgos, Km 23. Desvio Algete, Km. 1 28700 San Sebastián de los Reyes - Madrid Spain


HARMONET 75/20 microgramos comprimidos recubiertos

0,075 mg 0,02 mg




JULIPERLA 0,02 mg/0,075 mg comprimidos recubiertos con película

0,075 mg 0,02 mg






262







Meliane Diario 0,075 mg 0,02 mg




Melodene-15 0,06 mg /0,015 mg comprimidos recubiertos con película

0,06 mg 0,015 mg




MELTEVA 0,02 mg/0,075 mg comprimidos recubiertos con película

0,075 mg 0,02 mg




MINESSE 60 microgramos/15 microgramos comprimidos recubiertos

0,0618 mg 0,0154 mg


263







MINULET 75/30 microgramos comprimidos recubiertos

0,075 mg 0,03 mg




SOFIPERLA 0,03 mg/0,075 mg comprimidos recubiertos con película

0,075 mg 0,03 mg




TEVALET 0,03 mg/0,075 mg comprimidos recubiertos

0,075 mg 0,02 mg




Trigynovin comprimidos recubiertos

0,05 mg/0,03 mg 0,07 mg/ 0,04 mg 0,10 mg/0,03 mg


264







TRI-MINULET comprimidos recubiertos

0,05 mg/0,03 mg 0,07 mg/0,04 mg 0,10 mg/0,03 mg




VARIANTA 60 microgramos/15 microgramos comprimidos recubiertos con película

0,06 mg 0,015 mg




EDELSIN comprimidos 0,25 mg 0,035 mg

Tablet Oral use

Spain MADAUS GmbH Colonia Allee 15 51101 Colonia Germany


ETINILESTRADIOL/CLORMADINONA MADAUS 0,03 mg/2 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG

2 mg 0,03 mg


Spain SANDOZ FARMACÉUTICA, S.A. Avda. Osa Mayor, 4 28023 Aravaca (Madrid) Spain


DESOGESTREL/ETINILESTRADIOL SANDOZ 0,15 mg/0,02 mg comprimidos EFG

0,15 mg 0,02 mg

Tablet Oral use

265





Spain SANDOZ FARMACÉUTICA, S.A. Avda. Osa Mayor, 4 28023 Aravaca (Madrid) Spain


DESOGESTREL/ETINILESTRADIOL SANDOZ 0,15 mg/0,03 mg comprimidos EFG

0,15 mg 0,03 mg

Tablet Oral use

Spain BIAL INDUSTRIAL FARMACEUTICA, S.A. Parque Científico y Tecnológico de Bizkaia, Edificio 401 48170 Zamudio (Vizcaya) Spain


AILYN 2 DIARIO 2 mg/0,03 mg comprimidos recubiertos con película EFG

2 mg 0,03 mg


Spain GEDEON RICHTER, PLC Gyömroi ut 19-21 H-1103 Budapest Hungary


SIBILLA 2 mg/0,03 mg comprimidos recubiertos con película

2 mg 0,03 mg




ESTINILESTRADIOL/DROSPIRENONA MYLAN PHARMACEUTICALS 0,03 mg/3 mg comprimidos recubiertos con película

0,03 mg 3 mg


266







ESTINILESTRADIOL/DROSPIRENONA DIARIO MYLAN PHARMACEUTICALS 0,03 mg/3 mg comprimidos recubiertos con película EFG

0,03 mg 3 mg


Spain QUALITEC EUROPA, S.L Paseo Pintor Rosales, 42 28008 Madrid Spain


ESTINILESTRADIOL/DROSPIRENONA DIARIO QUALITEC 0,03 mg/3 mg comprimidos recubiertos con película

3 mg 0,03 mg




ESTINILESTRADIOL/DROSPIRENONA DIARIO QUALITEC 0,03 mg/3 mg comprimidos recubiertos con película EFG

3 mg 0,03 mg


267







ESTINILESTRADIOL/DROSPIRENONA DIARIO QUASSET 0,03 mg/3 mg comprimidos recubiertos con película EFG

3 mg 0,03 mg




DRAZ 0,02 mg/3 mg 28 comprimidos recubiertos con película EFG

0,02 mg 3 mg




ESTINILESTRADIOL/DROSPIRENONA DIARIO QUALITEC 0,02 mg/3 mg comprimidos recubiertos con película EFG

3 mg 0,02 mg




ESTINILESTRADIOL/DROSPIRENONA QUALITEC 0,02 mg/3 mg comprimidos recubiertos con película

3 mg 0,02 mg


268







ESTINILESTRADIOL/DROSPIRENONA DIARIO QUASSET 0,02 mg/3 mg comprimidos recubiertos con película EFG

3 mg 0,02 mg




ESTINILESTRADIOL/DROSPIRENONA MYLAN PHARMACEUTICALS 0,02 mg/3 mg comprimidos recubiertos con película EFG

0,02 mg 3 mg




ESTINILESTRADIOL/DROSPIRENONA DIARIO MYLAN PHARMACEUTICALS 0,02 mg/3 mg comprimidos recubiertos con película EFG

0,02 mg 3 mg




ESTINILESTRADIOL/DROSPIRENONA STADA 0,02 mg/3 mg comprimidos recubiertos con película (24+4) EFG

3 mg 0,02 mg


269





Sweden Bayer AB Postbox 606 Gustav III's Boulevard 56 SE-16926 Solna Sweden




Sweden Gedeon Richter Plc. Gyömröí út 19-21 HU-1103 Budapest Hungary


Aroletta 28 0,03 mg 0,15 mg




Asphalia 0,03 mg 0,15 mg




Caricia 0,03 mg 0,15 mg




Desodiol 0,02 mg 0,15 mg




Desodiolcont 0,02 mg 0,15 mg


270





Sweden N.V. Organon Kloosterstraat 6 5349 AB, Oss The Netherlands


Desolett 0,03 mg 0,15 mg

Tablet Oral use



Desolett 28 0,03 mg 0,15 mg

Tablet Oral use



Docrelen 28 0,02 mg 0,15 mg


Sweden Stada Arzneimittel AG, Stadastrasse 2-8, DE-61118 Bad Vibel, Germany



Tablet Oral use

Sweden Stada Arzneimittel AG, Stadastrasse 2-8, DE-61118 Bad Vibel, Germany



Tablet Oral use

Sweden Mylan AB, Postbox 23033, Ynglingagatan 14, SE-10435 Stockholm, Sweden



Tablet Oral use

271







Mercilon 28 0,02 mg 0,15 mg

Tablet Oral use



Sablona 28 0,03 mg 0,15 mg


Sweden Ivowen Limited 3 Anglesa St Tipperary Clonmel Ireland


Artadal 0,03 mg 3 mg




Artadal 28 0,03 mg 3 mg


Sweden Teva Sweden AB Järnvägsgatan 11 Box 1070 25110 Helsingborg Sweden








272







Dretinelle 0,02 mg 3 mg




Dretinelle 28 0,02 mg 3 mg




Eloine 0,02 mg 3 mg




Ethinylestradiol / Drospirenone Teva

0,02 mg 3 mg






273





Sweden Laboratorios Leon Farma SA Poligono Industrial Navatejera, La Vallina s/n, 24008 Villaquilambre,Leon Spain


Iradier 0,02 mg 3 mg


Sweden Bayer Pharma AG D-13342 Berlin Germany






Mesilara 0,02 mg 3 mg






Sweden Sandoz A/S Edward Thomsens Vej 14 DK-2300 København S Denmark


Stefaminelle 0,02 mg 3 mg




Valdorin 0,02 mg 3 mg


274







Valdorin 28 0,02 mg 3 mg




Yasmin 0,03 mg 3 mg
















Yaz 0,02 mg 3 mg






Vaginal use

275





Sweden Janssen-Cilag AB, Box 7073, 192 07 Sollentuna, Sweden


Cilest® 0,035 mg 0,25 mg

Tablet Oral use

Sweden Janssen-Cilag AB, Box 7073, 192 07 Sollentuna, Sweden


Cilest® 28 0,035 mg 0,25 mg

Tablet Oral use

The Netherlands

betapharm Arzneimittel GmbH Kobelweg 95 86156 Augsburg Germany


Desogestrel 150 microgram en Ethinylestradiol 20 microgram betapharm tabletten

0,15 mg 0,02 mg

Tablet Oral use

The Netherlands



Desogestrel/Ethinylestradiol Actavis 150/20 microgram tabletten

0,15 mg 0,02 mg

Tablet Oral use

The Netherlands



Desogestrel/Ethinylestradiol Actavis 150/30 microgram tabletten

0,15 mg 0,03 mg

Tablet Oral use

The Netherlands

Centrafarm B.V. Nieuwe Donk 3 4879 AC Etten-Leur The Netherlands


Desogestrel/Ethinylestradiol CF 0,15/0,02 mg, tabletten

0,15 mg 0,02 mg

Tablet Oral use

276





The Netherlands



Desogestrel/Ethinylestradiol CF 0,15/0,03 mg, tabletten

0,15 mg 0,03 mg

Tablet Oral use

The Netherlands



Desogestrel/Ethinylestradiol STADA 0,15/0,02 mg, tabletten

0,15 mg 0,02 mg

Tablet Oral use

The Netherlands



Desogestrel/Ethinylestradiol STADA 0,15/0,03 mg, tabletten

0,15 mg 0,03 mg

Tablet Oral use

The Netherlands

Teva Nederland B.V. Swensweg 5 2031 GA Haarlem The Netherlands


Ethinylestradiol/Desogestrel 0,02/0,15 mg Teva, tabletten

0,15 mg 0,02 mg

Tablet Oral use

The Netherlands

WeCare, Lagedijk 1-3; 1541 KA Koog aan de Zaan, The Netherlands


Ethinylestradiol/desogestrel 0,020 mg/0,150 mg WEC tabletten

0,15 mg 0,02 mg

Tablet Oral use

The Netherlands



Ethinylestradiol/Desogestrel 0,03/0,15 mg Teva, tabletten

0,15 mg 0,03 mg

Tablet Oral use

The Netherlands

WeCare, Lagedijk 1-3; 1541 KA Koog aan de Zaan, The Netherlands


Ethinylestradiol/desogestrel 0,030 mg/0,150 mg WEC tabletten

0,15 mg 0,03 mg

Tablet Oral use

277





The Netherlands

Mylan B.V. Dieselweg 25 3752 LB BUNSCHOTEN The Netherlands


Ethinylestradiol/Desogestrel Mylan 0,02/0,15 mg, tabletten

0,15 mg 0,02 mg

Tablet Oral use

The Netherlands



Ethinylestradiol/Desogestrel Mylan 0,03/0,15 mg, tabletten

0,15 mg 0,03 mg

Tablet Oral use

The Netherlands



Ethinylestradiol/desogestrel Richter 0,02 mg/0,15 mg filmomhulde tabletten

0,15 mg 0,02 mg


The Netherlands



Ethinylestradiol/desogestrel Richter 0,03 mg/0,15 mg filmomhulde tabletten

0,15 mg 0,03 mg


The Netherlands



Ethinylestradiol/Desogestrel Richter 0.02 mg/0.15mg -28 filmomhulde tabletten

0,15 mg 0,02 mg


The Netherlands



Ethinylestradiol/Desogestrel Richter 150 microgram/30 microgram -28 filmomhulde tabletten

0,15 mg 0,03 mg


278





The Netherlands



Juliane 150/20 microgram tabletten

0,15 mg 0,02 mg

Tablet Oral use

The Netherlands



Juliane 150/30 microgram tabletten

0,15 mg 0,03 mg

Tablet Oral use

The Netherlands



Laurina, tabletten 0,035 mg/0,05 mg 0,03 mg/0,1 mg 0,03 mg/0,15 mg


The Netherlands



Gracial, tabletten 0,03 mg/0,125 mg 0,04 mg/0,025 mg

Tablet Oral use

The Netherlands

betapharm Arzneimittel GmbH Kobelweg 95 86156 Augsburg Germany


Lonicera 150/30 microgram tabletten

0,15 mg 0,03 mg

Tablet Oral use

The Netherlands



Marvelon, tabletten 0,15 mg 0,03 mg

Tablet Oral use

279





The Netherlands



Mercilon, tabletten 0,15 mg 0,02 mg

Tablet Oral use

The Netherlands

Sandoz B.V. Veluwezoom 22 1327 AH Almere The Netherlands


Armarrok 28, filmomhulde tabletten 0,03 mg/3 mg

3mg 0,03mg


The Netherlands

Berlipharm B.V. Energieweg 1 3641 RT Mijdrecht The Netherlands


Ethinylestradiol/ Drospirenon 0,03 mg/ 3 mg Berlipharm, filmomhulde tabletten 0,03/3 mg

3mg 0,03mg


The Netherlands



Ethinylestradiol/Drospirenon 0,03 mg/3 mg Teva, filmomhulde tabletten

3mg 0,03mg


The Netherlands



Ethinylestradiol/Drospirenon Richter 0,03 mg/3 mg filmomhulde tabletten 28x

3mg 0,03mg


The Netherlands



Ethinylestradiol/Drospirenon Sandoz 0,03/3 mg, filmomhulde tabletten

3mg 0,03mg


280





The Netherlands

Bayer B.V. Pharmaceuticals Energieweg 1 3641 RT Mijdrecht The Netherlands


Palandra, filmomhulde tabletten 0,03 mg/3 mg

3mg 0,03mg


The Netherlands



Rosal 0,03 mg/3 mg, filmomhulde tabletten

3mg 0,03mg


The Netherlands



Rosal 28, filmomhulde tabletten

3mg 0,03mg


The Netherlands



Volina 0,03 mg / 3 mg filmomhulde tabletten

3mg 0,03mg


The Netherlands



Yasmin 28, filmomhulde tabletten 0,03/3 mg

3mg 0,03mg


The Netherlands



Yasmin, omhulde tabletten 0,03/3 mg

3mg 0,03mg


281





The Netherlands


Dienogest Estradiol

Qlaira filmomhulde tabletten



The Netherlands



Armunia 28, filmomhulde tabletten 0,02 mg/3 mg

0,02 mg 3 mg


The Netherlands



Armunia, filmomhulde tabletten 0,02 mg/3 mg

0,02 mg 3 mg


The Netherlands



Belanette 28, filmomhulde tabletten 0,02 mg/3 mg

0,02 mg 3 mg


The Netherlands



Belanette, filmomhulde tabletten 0,02 mg/3 mg

0,02 mg 3 mg


The Netherlands

Berlipharm B.V. Energieweg 1 3641 RT Mijdrecht The Netherlands


Ethinylestradiol/Drospirenon 24+4 0,02 mg/3 mg Berlipharm filmomhulde tabletten

0,02 mg 3 mg


282





The Netherlands



Daylette 0,02 mg/3 mg filmomhulde tabletten 24 + 4

0,02 mg 3 mg


The Netherlands



Liofora, filmomhulde tabletten 0,02 mg/3 mg

0,02 mg 3 mg


The Netherlands



Vallclara 0,02 mg/3 mg, filmomhulde tabletten

0,02 mg 3 mg


The Netherlands



Vallclara 28 0,02 mg/3 mg, filmomhulde tabletten

0,02 mg 3 mg


The Netherlands



Volina 0,02 mg/3 mg filmomhulde tabletten

0,02 mg 3 mg


The Netherlands



Yasminelle 28, filmomhulde tabletten 0,02 mg/3 mg

0,02 mg 3 mg


283





The Netherlands



Yasminelle, filmomhulde tabletten 0,02 mg/3 mg

0,02 mg 3 mg


The Netherlands



Yaz 24+4 0,02 mg/3 mg filmomhulde tabletten

0,02 mg 3 mg


The Netherlands



Yvidually 0,02 mg/3 mg, filmomhulde tabletten

0,02 mg 3 mg


The Netherlands



Annantah 0,060 mg/0,015 mg, filmomhulde tabletten

0,015 mg 0,06 mg


The Netherlands

Apothecon B.V. Nijverheidsweg 3 3771 ME Barneveld The Netherlands


Ethinylestradiol/gestodeen 0,015/0,060 A filmomhulde tabletten 0,015/0,060 mg

0,015 mg 0,06 mg


The Netherlands



Ethinylestradiol/gestodeen 0,02/0,075 A, omhulde tabletten 0,02 mg/0,075 mg

0,02 mg 0,075 mg


284





The Netherlands



Ethinylestradiol/gestodeen 0,03/0,075 A, omhulde tabletten 0,03 mg/0,075 mg

0,03 mg 0,075 mg


The Netherlands



Ethinylestradiol/Gestodeen Mylan 0,02/0,075 mg, omhulde tabletten

0,02 mg 0,075 mg


The Netherlands



Ethinylestradiol/Gestodeen Mylan 0,03/0,075 mg, omhulde tabletten

0,03 mg 0,075 mg


The Netherlands



Ethinylestradiol/Gestodeen Sandoz 0,020/0,075 mg, omhulde tabletten

0,02 mg 0,075 mg


The Netherlands



Ethinylestradiol/Gestodeen Sandoz 0,030/0,075 mg, omhulde tabletten

0,03 mg 0,075 mg


The Netherlands



Femodeen 0,075 mg / 0,030 mg omhulde tabletten

0,03 mg 0,075 mg


285





The Netherlands

Pharmachemie B.V. Swensweg 5 2031 GA Haarlem The Netherlands


Gestodeen/Ethinylestradiol 0,075 mg/0,020 mg PCH, omhulde tabletten

0,02 mg 0,075 mg


The Netherlands

Pharmachemie B.V. Swensweg 5 2031 GA Haarlem The Netherlands


Gestodeen/Ethinylestradiol 0,075 mg/0,030 mg PCH, omhulde tabletten

0,03 mg 0,075 mg


The Netherlands

Velvian Germany GmbH Carl-Zeiss-Ring 9 85737 Ismaning Germany


Jamyle 0,060 mg / 0,015 mg, filmomhulde tabletten

0,015 mg 0,06 mg


The Netherlands

Pfizer B.V. Rivium Westlaan 142 2909 LD Capelle a/d IJssel The Netherlands


Minulet, dragees 0,03 mg 0,075 mg


The Netherlands



Circlet 0,120 mg/0,015 mg per 24 uur, hulpmiddel voor vaginaal gebruik

11,7 mg 2,7 mg


Vaginal use

The Netherlands



NuvaRing 0,120 mg/0,015 mg per 24 uur, hulpmiddel voor vaginaal gebruik

11,7 mg 2,7 mg


Vaginal use

286





The Netherlands



Bryoronna 150/30 microgram, filmomhulde tabletten

0,15 mg 0,03 mg


The Netherlands



Bryoronna 28 150/30 microgram, filmomhulde tabletten

0,15 mg 0,03 mg


The Netherlands



Ethinylestradiol/Desogestrel 0,02 mg/0,15 mg Teva, tabletten

0,15 mg 0,02 mg

Tablet Oral use

The Netherlands



Gestodeen/ethinylestradiol Actavis 0,060 mg/0,015 mg, filmomhulde tabletten

0,06 mg 0,015 mg


The Netherlands

LadeePharma Kft Lajos u 48-66 1036 Budapest Hungary


Drospirenon/Ethinylestradiol 3/0,02 mg 24+4 Ladee, filmomhulde tabletten

0,02 mg 3 mg


The Netherlands

EFFIK Bâtument le Newton 9-11, rue Jeanne Braconnier 92366 Meudon la Forêt Frankrijk


Drospirenon/Ethinylestradiol 3/0,02 mg 24+4 Effik, filmomhulde tabletten

0,02 mg 3 mg


287





The Netherlands



Drospirenon/Ethinylestradiol 3/0,02 mg 24+4 Sandoz, filmomhulde tabletten

0,02 mg 3 mg


The Netherlands



Drosperinon/Ethinylestradiol 3/0,02 mg 24+4 Teva, filmomhulde tabletten

0,02 mg 3 mg


The Netherlands



MYWY 0,02 mg / 3 mg, filmomhulde tabletten

0,02 mg 3 mg


The Netherlands



Iradier 3 mg/0,02 mg, filmomhulde tabletten

0,02 mg 3 mg


The Netherlands

DOC Generici Srl Via Turati 40 20121 Milano Italy


Drospirenon/Ethinylestradiol 3/0,02 mg 24+4 DOC Generici, filmomhulde tabletten

0,02 mg 3 mg


The Netherlands



Ethinylestradiol/Drospirenon CF 0,02 mg/3 mg, 24+4 filmomhulde tabletten

0,02 mg 3 mg


288





The Netherlands



Ethinylestradiol/Drospirenon CF 0,02 mg/3 mg, 24+4 filmomhulde tabletten

0,02 mg 3 mg


The Netherlands



Ethinylestradiol/Drospirenon STADA 0,02 mg/3 mg, 24+4 filmomhulde tabletten

0,02 mg 3 mg


The Netherlands



Ethinylestradiol/Drospirenon Mylan 24+4 0,02/3 mg, filmomhulde tabletten

0,02 mg 3 mg


The Netherlands

Janssen-Cilag B.V. Dr. Paul Janssenweg 150 5026 RH Tilburg The Netherlands


Cilest, tabletten 0,25 mg 0,035 mg

Tablet Oral use

United Kingdom



Gedarel 150/20 Micrograms Film-Coated Tablets

0,15 mg 0,02 mg


United Kingdom



Gedarel 150/30 Micrograms Film-Coated Tablets

0,15 mg 0,03 mg


United Kingdom



Gedarel ED 20 micrograms/150 micrograms

0,15 mg 0,02 mg


289





United Kingdom



Gedarel ED 30 micrograms/150 micrograms

0,15 mg 0,03 mg


United Kingdom

Bayer PLC Bayer House Strawberry Hill Newbury Berkshire RG14 1JA United Kingdom

Dienogest Estradiol

Qlaira, film-coated tablets



United Kingdom

Merck Sharp & Dohme Limited, Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom




Vaginal use

United Kingdom

Morningside Healthcare Limited, 115 Narborough Road, Leicester LE3 0PA United Kingdom


Cimizt Tablets 150 mg/30 mg

0,03 mg 0,15 mg

Tablet Oral use

United Kingdom

Generics (UK) Limited Station Close, Potters Bar Hertfordshire EN6 1TL United Kingdom


Lestramyl Tablets 150 microgram/20 microgram

0,02 mg 0,15 mg

Tablet Oral use

United Kingdom

Generics (UK) Limited Station Close, Potters Bar Hertfordshire EN6 1TL United Kingdom


Lestramyl Tablets 150 microgram/30 microgram

0,03 mg 0,15 mg

Tablet Oral use

290





United Kingdom



Marvelon 150/30 Tablets

0,03 mg 0,15 mg

Tablet Oral use

United Kingdom



Mercilon Tablets 0.02 mg 0.15 mg

Tablet Oral use

United Kingdom



Armentinar Tablets 0.02 mg/3 mg

0,02 mg 3 mg


United Kingdom



Bellmunt 28 Film-coated Tablets 0.03 mg/3 mg

0,03 mg 3 mg


United Kingdom



Bellmunt Film-coated Tablets 0.03 mg/3 mg

0,03 mg 3 mg


291





United Kingdom



Daylette film-coated tablets 0.02mg/3mg

0,02 mg 3 mg


United Kingdom

Teva UK Limited, Brampton Road, Hampden Park, Eastbourne, East Sussex BN22 9AG, United Kingdom


Dretine 28 Tablets 0.03mg/3.0mg

0,03 mg 3 mg


United Kingdom

Teva UK Limited, Brampton Road, Hampden Park, Eastbourne, East Sussex BN22 9AG, United Kingdom


Dretine Tablets 0.03mg/3.0mg

0,03 mg 3 mg


United Kingdom



ELOINE 0.02 mg / 3 mg film coated tablets

0,02 mg 3 mg


United Kingdom



Eslarilla ED Film-coated tablets 0.02mg/3mg

0,02 mg 3 mg


292





United Kingdom



Eslarilla Film-coated tablets 0.02mg/3mg

0,02 mg 3 mg


United Kingdom



Flexyess 0.02 mg / 3 mg film-coated tablets

0,02 mg 3 mg


United Kingdom



Kylnetta ED film-coated tablets 0.03mg/3mg

0,03 mg 3 mg


United Kingdom



Kylnetta film-coated tablets 0.03mg/3mg

0,03 mg 3 mg


United Kingdom



Lovette ED film-coated tablets 0.02mg/3mg

0,02 mg 3 mg


United Kingdom



Lovette film-coated tablets 0.02mg/3mg

0,02 mg 3 mg


293





United Kingdom



Lucette ED film-coated tablets 0.03mg/3mg

0,03 mg 3 mg


United Kingdom



Lucette Film-coated tablets 0.03mg/3mg

0,03 mg 3 mg


United Kingdom



Minkian film-coated tablets 0.02mg/3mg

0,02 mg 3 mg


United Kingdom



Palandra 0.03 mg / 3 mg film-coated tablets

0,03 mg 3 mg


United Kingdom



Vallclara 28 Film-coated Tablets 0.02 mg/3 mg

0,02 mg 3 mg


United Kingdom



Vallclara Film-coated Tablets 0.02 mg/3 mg

0,02 mg 3 mg


294





United Kingdom



Yasmin ED, film-coated tablets, 0.03 mg / 3 mg

0,03 mg 3 mg


United Kingdom



Yasmin, film-coated tablets, 0.03 mg / 3 mg

0,03 mg 3 mg


United Kingdom



Yasminelle 0.02 mg / 3 mg film-coated tablets

0,02 mg 3 mg


United Kingdom



Yaz 0.02 mg / 3 mg film coated tablets

0,02 mg 3 mg


United Kingdom



Edesia Coated Tablets 75 micrograms / 20 micrograms

0,02 mg 0,075 mg


295





United Kingdom



Edesia Coated Tablets 75 micrograms / 30 micrograms

0.03 mg 0.075 mg


United Kingdom



Femodene ED Tablets 0.03 mg 0.075 mg

Sugar-coated tablet Oral use

United Kingdom



Femodene Tablets 0.03 mg 0.075 mg


United Kingdom



Femodette 0,02 mg 0,075 mg


United Kingdom

Gedeon Richter France, 1-3 Ruse Caumartin, Paris 75009, France


Gestilla Coated Tablets 75 micrograms / 30 micrograms

0.03 mg 0.075 mg


296





United Kingdom

Stragen UK Limited, Castle Court, 41 London Road, Reigate, Surrey RH2 9RJ United Kingdom


Katya Coated Tablets 30/75

0.03 mg 0.075 mg


United Kingdom

Gedeon Richter France, 1-3 Ruse Caumartin, Paris 75009, France


Millinette Coated Tablets 75 micrograms / 30 micrograms

0.03 mg 0.075 mg


United Kingdom



Millinette ED Micrograms Film-Coated Tablets 15 / 60

0,015 mg 0,06 mg


United Kingdom

Stragen UK Limited, Castle Court, 41 London Road, Reigate, Surrey RH2 9RJ United Kingdom


Sunya 20/75 Coated Tablets

0,02 mg 0,075 mg


United Kingdom



Triadene 0,03 mg / 0,05 mg 0,04 mg / 0,07 mg 0,03 mg / 0,1 mg


297





United Kingdom

Morningside Healthcare Limited, 115 Narborough Road, Leicester LE3 0PA United Kingdom


Lizinna Tablets 250/35mcg

0.035 mg 0,25 mg

Tablet Oral use

United Kingdom

Janssen-Cilag Limited 50-100 Holmers Farm Way High Wycombe Buckinghamshire HP12 4EG United Kingdom


Cilest Tablets 0,25 mg 0,035 mg

Tablet Oral use

298

Annex II

Scientific conclusions and grounds for the variation to the terms of the marketing authorisations, and detailed explanation for the differences

from the PRAC recommendation

299

Scientific conclusions and grounds for the conclusions The CHMP considered the below PRAC recommendation dated 10 October 2013 with regards to combined hormonal contraceptives containing chlormadinone, desogestrel, dienogest, drospirenone, etonogestrel, gestodene, norelgestromin, norgestimate or nomegestrol.

1 – Overall summary of the scientific evaluation Medicinal products containing chlormadinone, desogestrel, dienogest, drospirenone, etonogestrel, gestodene, norelgestromin, norgestimate or nomegestrol are authorised in the European Union as combined hormonal contraceptives (CHCs). These are combined with varying doses of ethinylestradiol (EE) or with estradiol (E2).

In February 2013, the French medicines agency (ANSM) initiated a referral procedure under Article 31 of Directive 2001/83/EC on the basis that the benefit-risk balance of these combined hormonal contraceptives had become unfavourable in the currently authorised indication of contraception due to the increased risk of thromboembolism (TE) and therefore it was in the interest of the Union to refer the matter to the PRAC. The PRAC was requested to give a recommendation on whether the indication of medicinal products containing chlormadinone, desogestrel, dienogest, drospirenone, etonogestrel, gestodene, norelgestromin, norgestimate or nomegestrol combined with an oestrogen (ethinylestradiol or estradiol) should be restricted and/or any other regulatory measure(s) taken.

The PRAC reviewed all available data from clinical studies, pharmacoepidemiological studies, published literature, post-marketing experience, including responses submitted by the marketing authorisation holders (MAHs) in writing and at oral explanations, as well as the views of an ad hoc expert meeting on the efficacy and safety of the CHCs, in particular in relation to the risk of thromboembolism.

Thromboembolic events are adverse events which usually occur in a vein of the leg (deep vein thrombosis, DVT). When diagnosis is not made and no treatment is started, or when clear symptoms of thrombosis are not identifiable, the clot can move upwards to the lung (pulmonary embolism, PE) or the brain (cerebral embolism, CE). Misdiagnosis is possible, since TE presents with diffuse symptoms and is a rare event in a population of healthy young women. Overall, venous thromboembolic events (VTE) could be fatal in 1-2% of the cases. Known risk factors for VTE include history of VTE, pregnancy, trauma, surgery, immobilisation (e.g. after surgery or long flights), obesity and smoking (i.e. all situations of a pro-thrombotic state). Also there are certain hereditary thrombophilic defects that increase the risk. Checking personal and family history of VTE before prescribing combined CHC medicinal products is, therefore, recommended in the product information of the products.

Many studies have evaluated the risk of VTE and its complications (deep vein thrombosis, pulmonary embolism) among users of different CHCs. The current review confirmed the previous understanding that the level of VTE risk with CHCs containing low dose of ethinylestradiol (ethinylestradiol <50µg) is small, but differences in the VTE risk were observed between most products depending on the type of progestogen they contain. Based on the totality of the available data the PRAC concluded that the risk of VTE differs between products - with the lower risk products being those containing the progestogens levonorgestrel, norethisterone and norgestimate. For some products (i.e. chlormadinone, dienogest, nomegestrol) there are currently insufficient data to establish the risk compares with the lower risk products. For chlormadinone this will be investigated through a post-authorisation safety study, which is further discussed below. For dienogest and nomegestrol studies are on going and results will be submitted when available.

300

The risk of VTE with CHCs differs among products depending on the type of progestogen they contain. Having assessed all the available data, the PRAC concluded that:

• The estimated incidence of risk is lowest with the CHCs containing the progestogens levonorgestrel, norgestimate and norethisterone: it is estimated that each year there will be between 5 and 7 cases of VTE per 10,000 women who use these medicines.

• The estimated incidence of risk is higher with the progestogens etonogestrel and norelgestromin, with between 6 and 12 cases yearly per 10,000 women.

• The estimated incidence of risk is also higher with the progestogens gestodene, desogestrel, drospirenone, with between 9 and 12 cases yearly per 10,000 women.

• For CHCs containing chlormadinone, dienogest and nomegestrol, the available data are insufficient to know how the risk compares with the other CHCs.

For comparison, in women who are not using CHCs (no-users) and who are not pregnant, there will be around 2 cases of VTE each year per 10,000 women.

It has been shown that risk of VTE is highest during the first year a woman starts hormonal contraceptives or when she re-starts after a period of non-use of at least one month (Dinger et al,. 2007, Sidney et al., 2013). After an initially higher risk during the first year of use, the risk decreases to a constant lower level. The risk of VTE is also higher in the presence of intrinsic risk factors. Considering that risk factors for VTE change over time the PRAC noted that an individual’s risk should be re-evaluated periodically.

It is known that the risk of arterial thromboembolism (ATE) (myocardial infarction, cerebrovascular accident) is also increased with use of CHCs, however there was no evidence for differences between CHCs in their relative risk of ATE.

Therefore, on the basis of the available evidence, the PRAC acknowledged that the benefits associated with using a CHC far outweigh the risk of serious adverse events in most women. There was no evidence for differences between these medicinal products in terms of beneficial effects. However, the PRAC recommended routine risk minimisation measures, including a strengthening of the wording of the product information to reflect the current knowledge of risks (incidence rate) as well as symptoms for VTE and ATE and clarifying the situations for which these products are contraindicated. In particular, these medicinal products should be contraindicated in patients with multiple risk factors, in patients after major surgery with prolonged immobilisation, patients who smoke and patients with history or hereditary predisposition of thromboembolism. Furthermore, proactive information to communicate the outcome of the present review and to highlight the risk of the thromboembolic events through a direct healthcare professional communication (DHPC) was recommended.

In addition the PRAC imposed a post-authorisation safety study in order to better characterise the relative risk of thromboembolic events due to chlormadinone compared to the levonorgestrel-containing medicinal products.

Benefit –risk balance

Having considered all the above, the PRAC concluded that the benefit-risk balance of the medicinal products identified in Annex I in the indication of contraception remains favourable, subject to the inclusion of the restrictions, warnings and other changes to the product information agreed. In addition the marketing authorisation holders of chlormadinone should perform a post-authorisation safety study.

301

Grounds for the variation to the terms of the marketing authorisations

Whereas

• The PRAC considered the procedure under Article 31 of Directive 2001/83/EC for the combined hormonal contraceptives containing medicinal products.

• The PRAC reviewed all available data from clinical studies, pharmacoepidemiological studies, published literature, post-marketing experience, including responses submitted by the marketing authorisation holders (MAHs) in writing and at oral explanations, on the efficacy and safety of the combined hormonal contraceptive containing medicinal products, in particular with regards to the risk of thromboembolism. The PRAC confirmed the known risk of thromboembolism of combined hormonal contraceptive containing medicinal products, and recommended clear labelling of symptoms of thromboembolic events, as well as the risk factors for thromboembolic events.

• The PRAC considered that in view of the currently available safety data, the benefit-risk balance of combined hormonal contraceptives is favourable, subject to restrictions, warnings and other changes to the product information. In particular, these medicinal products should be contraindicated in patients with multiple risk factors (overweight, smoking, hypertension, increasing age etc.), in patients after major surgery with prolonged immobilisation and patients with history or hereditary predisposition of venous thrombosis. Further changes to the product information will contribute to better inform the healthcare professionals and women on the risk of thromboembolism.

• The PRAC is of the opinion that the benefits of combined hormonal contraceptive containing medicinal products continue to outweigh the risks in the indication of contraception.

• The PRAC considered that further data are required for the combined hormonal contraceptives containing chlormadinone and imposed the conduct of a post authorisation safety study (PASS) to evaluate the relative risk of thromboembolic events due to these products compared to the ones containing levonorgestrel.

The PRAC, as a consequence, concluded that the benefit-risk balance of the medicinal products identified in Annex I in the indication of contraception remains favourable, subject to the agreed conditions, restrictions, warnings, other changes to the product information and additional risk minimisation measures.

2 – Detailed explanation for the differences from the PRAC recommendation Having reviewed the PRAC recommendation, the CHMP agreed with the overall scientific conclusions and grounds for recommendation. However, the CHMP considered that the section on Fertility, pregnancy and lactation of the SmPC should be amended to reflect the increased risk of VTE in the post-partum period, to ensure consistency with the warning section of the SmPC.

The following sentence was therefore inserted in the Pregnancy section of the SmPC:

“The increased risk of VTE during the postpartum period should be considered when re-starting [invented name] (see section 4.2 and 4.4).”

No further amendments were considered necessary.

302

CHMP opinion The CHMP, having considered the PRAC recommendation dated 10 October 2013 pursuant to Article 107k(3) of Directive 2001/83/EC, is of the opinion that the marketing authorisations for combined hormonal contraceptives containing chlormadinone, desogestrel, dienogest, drospirenone, etonogestrel, gestodene, norgestimate should be varied. The amendments to the relevant sections of the Summary of Product Characteristics and package leaflet are set out in Annex III.

The marketing authorisations for chlormadinone containing combined hormonal contraceptives are subject to the conditions set out in Annex IV.

303

Annex III

Amendments to relevant sections of the summary of product characteristics and package leaflets

Note:

The relevant sections of the Summary of Product Characteristics and package leaflet are the outcome of the referral procedure.

The product information shall be subsequently updated by the Member State competent authorities and in liaison with the Reference Member State for medicinal product(s) authorised under Chapter 4 of Title III of Directive 2001/83/EC.

304

ANNEX III.A - chlormadinone containing combined hormonal contraceptives

305

[For all chlormadinone containing combined hormonal contraceptives listed in Annex I, the existing product information shall be amended (insertion, replacement or deletion of the text as appropriate) to reflect the agreed wording as provided below]

I. Summary of Product Characteristics

[The folllowing text should be included at the top of the SmPC]

This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions.

Section 4.1 - Therapeutic indications [The wording below should be inserted at the end of this section] [...] The decision to prescribe [invented name] should take into consideration the individual woman’s current risk factors, particularly those for venous thromboembolism (VTE), and how the risk of VTE with [invented name] compares with other CHCs (see sections 4.3 and 4.4).

Section 4.3 - Contraindications [This section should be amended to include the following contraindications]

Combined hormonal contraceptives (CHCs) should not be used in the following conditions: [...] • Presence or risk of venous thromboembolism (VTE)

o Venous thromboembolism – current VTE (on anticoagulants) or history of (e.g. deep venous thrombosis [DVT] or pulmonary embolism [PE])

o Known hereditary or acquired predisposition for venous thromboembolism, such as APC-resistance, (including Factor V Leiden), antithrombin-III-deficiency, protein C deficiency, protein S deficiency

o Major surgery with prolonged immobilisation (see section 4.4)

o A high risk of venous thromboembolism due to the presence of multiple risk factors (see section 4.4)

• Presence or risk of arterial thromboembolism (ATE)

o Arterial thromboembolism – current arterial thromboembolism, history of arterial thromboembolism (e.g. myocardial infarction) or prodromal condition (e.g. angina pectoris)

o Cerebrovascular disease – current stroke, history of stroke or prodromal condition (e.g. transient ischaemic attack, TIA)

o Known hereditary or acquired predisposition for arterial thromboembolism, such as hyperhomocysteinaemia and antiphospholipid-antibodies (anticardiolipin-antibodies, lupus anticoagulant).

306

o History of migraine with focal neurological symptoms.

o A high risk of arterial thromboembolism due to multiple risk factors (see section 4.4) or to the presence of one serious risk factor such as:

• diabetes mellitus with vascular symptoms

• severe hypertension

• severe dyslipoproteinaemia [...]

Section 4.4 - Special warnings and precautions for use [This section should be amended to reflect the following wording]

Warnings

[...]

If any of the conditions or risk factors mentioned below is present, the suitability of [invented name] should be discussed with the woman.

In the event of aggravation, or first appearance of any of these conditions or risk factors, the woman should be advised to contact her doctor to determine whether the use of [Invented name] should be discontinued.

Risk of venous thromboembolism (VTE) [The wording below should be inserted at the top of this section]

The use of any combined hormonal contraceptive (CHC) increases the risk of venous thromboembolism (VTE) compared with no use. Products that contain levonorgestrel, norgestimate or norethisterone are associated with the lowest risk of VTE. It is not yet known how the risk with [invented name] compares with these lower risk products. The decision to use any product other than one known to have the lowest VTE risk should be taken only after a discussion with the woman to ensure she understands the risk of VTE with CHCs, how her current risk factors influence this risk, and that her VTE risk is highest in the first ever year of use. There is also some evidence that the risk is increased when a CHC is re-started after a break in use of 4 weeks or more.

[The wording below should also be inserted in this section]

In women who do not use a CHC and are not pregnant about 2 out of 10,000 will develop a VTE over the period of one year. However, in any individual woman the risk may be far higher, depending on her underlying risk factors (see below).

Epidemiological studies in women who use low dose combined oral contraceptives (<50 μg ethinylestradiol) have found that out of 10,000 women between about 6 and 12 will develop a VTE in one year.

Out of 10,000 women who use a levonorgestrel-containing CHC about 61 will develop a VTE in one year.

It is not yet known how the risk with chlormadinone-containing CHCs compares with the risk with levonorgestrel-containing CHCs.

1 Mid-point of range of 5-7 per 10,000 WY, based on a relative risk for CHCs containing levonorgestrel versus non-use of approximately 2.3 to 3.6

307

The number of VTEs per year with low dose CHCs is fewer than the number expected in women during pregnancy or in the postpartum period.

VTE may be fatal in 1-2% of cases.

[The following wording to be kept/added, as appropriate] Extremely rarely, thrombosis has been reported to occur in CHC users in other blood vessels, e.g. hepatic, mesenteric, renal or retinal veins and arteries. [The following should be deleted (where applicable)] There is no consensus as to whether the occurrence of these events is associated with the use of CHCs. [This following wording should be inserted in this section]

Risk factors for VTE

The risk for venous thromboembolic complications in CHC users may increase substantially in a woman with additional risk factors, particularly if there are multiple risk factors (see table).

[Invented name] is contraindicated if a woman has multiple risk factors that put her at high risk of venous thrombosis (see section 4.3). If a woman has more than one risk factor, it is possible that the increase in risk is greater than the sum of the individual factors – in this case her total risk of VTE should be considered. If the balance of benefits and risks is considered to be negative a CHC should not be prescribed (see section 4.3).

Table: Risk factors for VTE

Risk factor Comment

Obesity (body mass index over 30 kg/m²)

Risk increases substantially as BMI rises.

Particularly important to consider if other risk factors also present.

Prolonged immobilisation, major surgery, any surgery to the legs or pelvis, neurosurgery, or major trauma

Note: temporary immobilisation including air travel >4 hours can also be a risk factor for VTE, particularly in women with other risk factors

In these situations it is advisable to discontinue use of the patch/pill/ring (in the case of elective surgery at least four weeks in advance) and not resume until two weeks after complete remobilisation. Another method of contraception should be used to avoid unintentional pregnancy.

Antithrombotic treatment should be considered if [invented name] has not been discontinued in advance.

Positive family history (venous thromboembolism ever in a sibling or parent especially at a relatively early age e.g. before 50).

If a hereditary predisposition is suspected, the woman should be referred to a specialist for advice before deciding about any CHC use.

308

Other medical conditions associated with VTE

Cancer, systemic lupus erythematosus, haemolytic uraemic syndrome, chronic inflammatory bowel disease (Crohn’s disease or ulcerative colitis) and sickle cell disease

Increasing age Particularly above 35 years

There is no consensus about the possible role of varicose veins and superficial thrombophlebitis in the onset or progression of venous thrombosis.

The increased risk of thromboembolism in pregnancy, and particularly the 6 week period of the puerperium, must be considered (for information on “Pregnancy and lactation” see section 4.6).

Symptoms of VTE (deep vein thrombosis and pulmonary embolism)

In the event of symptoms women should be advised to seek urgent medical attention and to inform the healthcare professional that she is taking a CHC.

Symptoms of deep vein thrombosis (DVT) can include:

- unilateral swelling of the leg and/or foot or along a vein in the leg;

- pain or tenderness in the leg which may be felt only when standing or

walking,

- increased warmth in the affected leg; red or discoloured skin on the leg.

Symptoms of pulmonary embolism (PE) can include:

- sudden onset of unexplained shortness of breath or rapid breathing;

- sudden coughing which may be associated with haemoptysis;

- sharp chest pain;

- severe light headedness or dizziness;

- rapid or irregular heartbeat.

Some of these symptoms (e.g. “shortness of breath”, “coughing”) are non-specific and might be misinterpreted as more common or less severe events (e.g. respiratory tract infections).

Other signs of vascular occlusion can include: sudden pain, swelling and slight blue discoloration of an extremity.

If the occlusion occurs in the eye symptoms can range from painless blurring of vision which can progress to loss of vision. Sometimes loss of vision can occur almost immediately.

Risk of arterial thromboembolism (ATE)

Epidemiological studies have associated the use of CHCs with an increased risk for arterial thromboembolism (myocardial infarction) or for cerebrovascular accident (e.g. transient ischaemic attack, stroke). Arterial thromboembolic events may be fatal.

Risk factors for ATE

The risk of arterial thromboembolic complications or of a cerebrovascular accident in CHC users increases in women with risk factors (see table). [Invented name] is contraindicated if a woman has one serious or multiple risk factors for ATE that puts her at high risk of arterial thrombosis (see section 4.3). If a woman has more than one risk factor, it is possible that the increase in risk is

309

greater than the sum of the individual factors - in this case her total risk should be considered. If the balance of benefits and risks is considered to be negative a CHC should not be prescribed (see section 4.3). Table: Risk factors for ATE

Risk factor Comment


Smoking Women should be advised not to smoke if they wish to use a CHC. Women over 35 who continue to smoke should be strongly advised to use a different method of contraception.

Hypertension

Obesity (body mass index over 30 kg/m2)

Risk increases substantially as BMI increases.

Particularly important in women with additional risk factors

Positive family history (arterial thromboembolism ever in a sibling or parent especially at relatively early age e.g. below 50).

If a hereditary predisposition is suspected, the woman should be referred to a specialist for advice before deciding about any CHC use

Migraine An increase in frequency or severity of migraine during CHC use (which may be prodromal of a cerebrovascular event) may be a reason for immediate discontinuation

Other medical conditions associated with adverse vascular events

Diabetes mellitus, hyperhomocysteinaemia, valvular heart disease and atrial fibrillation, dyslipoproteinaemia and systemic lupus erythematosus.

Symptoms of ATE


Symptoms of a cerebrovascular accident can include:

- sudden numbness or weakness of the face, arm or leg, especially on one side of the body;

- sudden trouble walking, dizziness, loss of balance or coordination;

- sudden confusion, trouble speaking or understanding;

- sudden trouble seeing in one or both eyes;

- sudden, severe or prolonged headache with no known cause;

- loss of consciousness or fainting with or without seizure.

Temporary symptoms suggest the event is a transient ischaemic attack (TIA).

310

Symptoms of myocardial infarction (MI) can include:

- pain, discomfort, pressure, heaviness, sensation of squeezing or fullness in the chest, arm, or below the breastbone;

- discomfort radiating to the back, jaw, throat, arm, stomach;

- feeling of being full, having indigestion or choking;

- sweating, nausea, vomiting or dizziness;

- extreme weakness, anxiety, or shortness of breath;

- rapid or irregular heartbeats.

[…]

Medical examination/consultation

Prior to the initiation or reinstitution of [invented name] a complete medical history (including family history) should be taken and pregnancy must be ruled out. Blood pressure should be measured and a physical examination should be performed, guided by the contra-indications (see section 4.3) and warnings (see section 4.4). It is important to draw a woman’s attention to the information on venous and arterial thrombosis, including the risk of [invented name] compared with other CHCs, the symptoms of VTE and ATE, the known risk factors and what to do in the event of a suspected thrombosis.

The woman should also be instructed to carefully read the user leaflet and to adhere to the advice given. The frequency and nature of examinations should be based on established practice guidelines and be adapted to the individual woman.

Women should be advised that hormonal contraceptives do not protect against HIV infections (AIDS) and other sexually transmitted diseases.

[...]

Section 4.6 - Fertility, pregnancy and lactation

Pregnancy

[The following wording should be added to this section] The increased risk of VTE during the postpartum period should be considered when re-starting [invented name] (see section 4.2 and 4.4).

Section 4.8 – Undesirable effects [This following wording should be reflected in this section] […] Description of selected adverse reactions An increased risk of arterial and venous thrombotic and thrombo-embolic events, including myocardial infarction, stroke, transient ischemic attacks, venous thrombosis and pulmonary embolism has been observed in women using CHCs, which are discussed in more detail in section 4.4. […]

311

[VTE or ATE should be listed in the adverse events table, under the frequency “Rare”.]

[The folllowing text should be included as these products will be in the Additional monitoring list]

Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V*. [*For the printed material, please refer to the guidance of the annotated QRD template.]

312

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc

II. Package Leaflet


This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.

[The wording below should be inserted at the top of the package leaflet]

Important things to know about combined hormonal contraceptives (CHCs):

• They are one of the most reliable reversible methods of contraception if used correctly • They slightly increase the risk of having a blood clot in the veins and arteries, especially in

the first year or when restarting a combined hormonal contraceptive following a break of 4 or more weeks

• Please be alert and see your doctor if you think you may have symptoms of a blood clot (see section 2 “Blood clots”)

[…]

Section 2. What you need to know before you use [Invented name]

[The wording below should be inserted at the top of this section]

General notes

Before you start using [invented name] you should read the information on blood clots in section 2. It is particularly important to read the symptoms of a blood clot – see Section 2 “Blood clots”).

[…]

When you should not use [Invented name]

[This section should be amended to include the below wording]

You should not use [Invented name] if you have any of the conditions listed below. If you do have any of the conditions listed below, you must tell your doctor. Your doctor will discuss with you what other form of birth control would be more appropriate.

• if you have (or have ever had) a blood clot in a blood vessel of your legs (deep vein thrombosis, DVT), your lungs (pulmonary embolus, PE) or other organs;

• if you know you have a disorder affecting your blood clotting – for instance, protein C deficiency, protein S deficiency, antithrombin-III deficiency, Factor V Leiden or antiphospholipid antibodies;

• if you need an operation or if you are off your feet for a long time (see section ‘Blood clots’);

• if you have ever had a heart attack or a stroke;

• if you have (or have ever had) angina pectoris (a condition that causes severe chest pain and may be a first sign of a heart attack) or transient ischaemic attack (TIA – temporary stroke symptoms);

313

• if you have any of the following diseases that may increase your risk of a clot in the arteries:

– severe diabetes with blood vessel damage

– very high blood pressure

– a very high level of fat in the blood (cholesterol or triglycerides)

– a condition known as hyperhomocysteinaemia

• if you have (or have ever had) a type of migraine called ‘migraine with aura’;

[…]

When to take special care with [Invented name]

[The below wording should be inserted in this section]

When should you contact your doctor?

Seek urgent medical attention

- if you notice possible signs of a blood clot that may mean you are suffering from a blood clot in the leg (i.e. deep vein thrombosis), a blood clot in the lung (i.e. pulmonary embolism), a heart attack or a stroke (see ‘Blood clot’ (thrombosis) section below.

For a description of the symptoms of these serious side effects please go to “How to recognise a blood clot”.

[...] Tell your doctor if any of the following conditions apply to you. If the condition develops, or gets worse while you are using [invented name], you should also tell your doctor.

[...]

• if you have Crohn’s disease or ulcerative colitis (chronic inflammatory bowel disease);

• if you have systemic lupus erythematosus (SLE –; a disease affecting your natural defence system);

• if you have haemolytic uraemic syndrome (HUS - a disorder of blood clotting causing failure of the kidneys);

• if you have sickle cell anaemia (an inherited disease of the red blood cells);

• if you have elevated levels of fat in the blood (hypertriglyceridaemia) or a positive family history for this condition. Hypertriglyceridaemia has been associated with an increased risk of developing pancreatitis (inflammation of the pancreas);

• if you need an operation, or you are off your feet for a long time (see in section 2 ‘Blood clots’);

• if you have just given birth you are at an increased risk of blood clots. You should ask your doctor how soon after delivery you can start taking [invented name];

• If you have an inflammation in the veins under the skin (superficial thrombophlebitis);

• If you have varicose veins.

314

BLOOD CLOTS

Using a combined hormonal contraceptive such as [invented name] increases your risk of developing a blood clot compared with not using one. In rare cases a blood clot can block blood vessels and cause serious problems.

Blood clots can develop

in veins (referred to as a ‘venous thrombosis’, ‘venous thromboembolism’ or VTE)

in the arteries (referred to as an ‘arterial thrombosis’, ‘arterial thromboembolism’ or ATE).

Recovery from blood clots is not always complete. Rarely, there may be serious lasting effects or, very rarely, they may be fatal.

It is important to remember that the overall risk of a harmful blood clot due to [invented name] is small.

HOW TO RECOGNISE A BLOOD CLOT

Seek urgent medical attention if you notice any of the following signs or symptoms.

Are you experiencing any of these signs? What are you possibly suffering from?

• swelling of one leg or along a vein in the leg or foot especially when accompanied by:

• pain or tenderness in the leg which may be felt only when standing or walking

• increased warmth in the affected leg

• change in colour of the skin on the leg e.g. turning pale, red or blue

Deep vein thrombosis

• sudden unexplained breathlessness or rapid breathing;

• sudden cough without an obvious cause, which may bring up blood;

• sharp chest pain which may increase with deep breathing;

• severe light headedness or dizziness;

• rapid or irregular heartbeat

• severe pain in your stomach;

If you are unsure, talk to a doctor as some of these symptoms such as coughing or being short of breath may be mistaken for a milder condition such as a respiratory tract infection (e.g. a ‘common cold’).

Pulmonary embolism

Symptoms most commonly occur in one eye:

• immediate loss of vision or

• painless blurring of vision which can progress to loss of

Retinal vein thrombosis (blood clot in the eye)

315

vision

• chest pain, discomfort, pressure, heaviness

• sensation of squeezing or fullness in the chest, arm or below the breastbone;

• fullness, indigestion or choking feeling;

• upper body discomfort radiating to the back, jaw, throat, arm and stomach;

• sweating, nausea, vomiting or dizziness;

• extreme weakness, anxiety, or shortness of breath;

• rapid or irregular heartbeats

Heart attack

• sudden weakness or numbness of the face, arm or leg, especially on one side of the body;

• sudden confusion, trouble speaking or understanding;

• sudden trouble seeing in one or both eyes;

• sudden trouble walking, dizziness, loss of balance or coordination;

• sudden, severe or prolonged headache with no known cause;

• loss of consciousness or fainting with or without seizure. Sometimes the symptoms of stroke can be brief with an almost immediate and full recovery, but you should still seek urgent medical attention as you may be at risk of another stroke.

Stroke

• swelling and slight blue discolouration of an extremity;

• severe pain in your stomach (acute abdomen) Blood clots blocking other blood vessels

BLOOD CLOTS IN A VEIN What can happen if a blood clot forms in a vein?

• The use of combined hormonal contraceptives has been connected with an increase in the risk of blood clots in the vein (venous thrombosis). However, these side effects are rare. Most frequently, they occur in the first year of use of a combined hormonal contraceptive.

• If a blood clot forms in a vein in the leg or foot it can cause a deep vein thrombosis (DVT).

• If a blood clot travels from the leg and lodges in the lung it can cause a pulmonary embolism.

• Very rarely a clot may form in a vein in another organ such as the eye (retinal vein thrombosis). When is the risk of developing a blood clot in a vein highest?

The risk of developing a blood clot in a vein is highest during the first year of taking a combined hormonal contraceptive for the first time. The risk may also be higher if you restart taking a

316

combined hormonal contraceptive (the same product or a different product) after a break of 4 weeks or more

After the first year, the risk gets smaller but is always slightly higher than if you were not using a combined hormonal contraceptive.

When you stop [invented name] your risk of a blood clot returns to normal within a few weeks. What is the risk of developing a blood clot?

The risk depends on your natural risk of VTE and the type of combined hormonal contraceptive you are taking.

The overall risk of a blood clot in the leg or lung (DVT or PE) with [invented name] is small.


- […] - Out of 10,000 women who are not using any combined hormonal contraceptive and are not

pregnant, about 2 will develop a blood clot in a year.

- Out of 10,000 women who are using a combined hormonal contraceptive that contains levonorgestrel, norethisterone, or norgestimate about 5-7 will develop a blood clot in a year.

- It is not yet known how the risk of a blood clot with [invented name] compares to the risk with a combined hormonal contraceptive that contains levonorgestrel.

- The risk of having a blood clot will vary according to your personal medical history (see “Factors that increase your risk of a blood clot” below)

- […].

Risk of developing a blood clot in a year

Women who are not using a combined hormonal pill/patch/ring and are not pregnant

About 2 out of 10,000 women

Women using a combined hormonal contraceptive pill containing levonorgestrel, norethisterone or norgestimate

About 5-7 out of 10,000 women

Women using [Invented name] Not yet known.

Factors that increase your risk of a blood clot in a vein

The risk of a blood clot with [invented name] is small but some conditions will increase the risk. Your risk is higher:

• if you are very overweight (body mass index or BMI over 30kg/m2);

• if one of your immediate family has had a blood clot in the leg, lung or other organ at a young age (e.g. below the age of about 50). In this case you could have a hereditary blood clotting disorder;

• if you need to have an operation, or if you are off your feet for a long time because of an injury or illness, or you have your leg in a cast. The use of [invented name] may need to be stopped

317

several weeks before surgery or while you are less mobile. If you need to stop [invented name] ask your doctor when you can start using it again.

• as you get older (particularly above about 35 years);

• if you gave birth less than a few weeks ago

The risk of developing a blood clot increases the more conditions you have.

Air travel (>4 hours) may temporarily increase your risk of a blood clot, particularly if you have some of the other factors listed.

It is important to tell your doctor if any of these conditions apply to you, even if you are unsure. Your doctor may decide that [invented name] needs to be stopped.

If any of the above conditions change while you are using [invented name], for example a close family member experiences a thrombosis for no known reason; or you gain a lot of weight, tell your doctor.

BLOOD CLOTS IN AN ARTERY

What can happen if a blood clot forms in an artery?

Like a blood clot in a vein, a clot in an artery can cause serious problems. For example, it can cause a heart attack or a stroke.

Factors that increase your risk of a blood clot in an artery

It is important to note that the risk of a heart attack or stroke from using [invented name] is very small but can increase:

• with increasing age (beyond about 35 years);

• if you smoke. When using a combined hormonal contraceptive like [invented name] you are advised to stop smoking. If you are unable to stop smoking and are older than 35 your doctor may advise you to use a different type of contraceptive;

• if you are overweight;

• if you have high blood pressure;

• if a member of your immediate family has had a heart attack or stroke at a young age (less then about 50). In this case you could also have a higher risk of having a heart attack or stroke;

• if you, or someone in your immediate family, have a high level of fat in the blood (cholesterol or triglycerides);

• if you get migraines, especially migraines with aura;

• if you have a problem with your heart (valve disorder, disturbance of the rhythm called atrial fibrillation)

• if you have diabetes.

If you have more than one of these conditions or if any of them are particularly severe the risk of developing a blood clot may be increased even more.

If any of the above conditions change while you are using [invented name], for example you start smoking, a close family member experiences a thrombosis for no known reason; or you gain a lot of weight, tell your doctor.

318

[…]

Section 4. Possible side effects [The following text should be inserted in this section]

Like all medicines, [Invented name] can cause side effects, although not everybody gets them. If you get any side effect, particularly if severe and persistent, or have any change to your health that you think may be due to [invented name], please talk to your doctor.

An increased risk of blood clots in your veins (venous thromboembolism (VTE)) or blood clots in your arteries (arterial thromboembolism (ATE)) is present for all women taking combined hormonal contraceptives. For more detailed information on the different risks from taking combined hormonal contraceptives please see section 2 “What you need to know before you use [invented name]”.

[The below wording should be added and the frequency of the adverse events should be aligned to that of the SmPC]

• Harmful blood clots in a vein or artery for example:

o in a leg or foot (i.e. DVT)

o in a lung (i.e. PE)

o heart attack

o stroke

o mini-stroke or temporary stroke-like symptoms, known as a transient ischaemic attack (TIA)

o blood clots in the liver, stomach/intestine, kidneys or eye.

The chance of having a blood clot may be higher if you have any other conditions that increase this risk (See section 2 for more information on the conditions that increase risk for blood clots and the symptoms of a blood clot)

[…]


Reporting of side effects If you get any side effects, talk to your <doctor> <or> <,> <pharmacist> <or nurse>. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V*. By reporting side effects you can help provide more information on the safety of this medicine. [*For the printed material, please refer to the guidance of the annotated QRD template.]

319

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc

ANNEX III.B - desogestrel containing combined hormonal contraceptives

320

[For all desogestrel-containing products listed in Annex I, the existing product information shall be amended (insertion, replacement or deletion of the text as appropriate) to reflect the agreed wording as provided below]




Combined hormonal contraceptives (CHCs) should not be used in the following conditions. [...] • Presence or risk of venous thromboembolism (VTE)













• severe dyslipoproteinaemia

321

[...]

Section 4.4 - Special warnings and precautions for use

[This section should be amended to reflect the following wording]

Warnings [...]




The use of any combined hormonal contraceptive (CHC) increases the risk of venous thromboembolism (VTE) compared with no use. Products that contain levonorgestrel, norgestimate or norethisterone are associated with the lowest risk of VTE. Other products such as [invented name] may have up to twice this level of risk. The decision to use any product other than one with the lowest VTE risk should be taken only after a discussion with the woman to ensure she understands the risk of VTE with [invented name], how her current risk factors influence this risk, and that her VTE risk is highest in the first ever year of use. There is also some evidence that the risk is increased when a CHC is re-started after a break in use of 4 weeks or more.

[The wording below should be inserted in this section]


It is estimated2 that out of 10,000 women who use a CHC containing desogestrel between 9 and 12 women will develop a VTE in one year; this compares with about 63 in women who use a levonorgestrel-containing CHC.

2 These incidences were estimated from the totality of the epidemiological study data, using relative risks for the different products compared with levonorgestrel-containing CHCs. 3 Mid-point of range of 5-7 per 10,000 WY, based on a relative risk for CHCs containing levonorgestrel versus non-use of approximately 2.3 to 3.6

322




















walking,




324


- sharp chest pain;









The risk of arterial thromboembolic complications or of a cerebrovascular accident in CHC users increases in women with risk factors (see table). [Invented name] is contraindicated if a woman has one serious or multiple risk factors for ATE that puts her at high risk of arterial thrombosis (see section 4.3). If a woman has more than one risk factor, it is possible that the increase in risk is greater than the sum of the individual factors - in this case her total risk should be considered. If the balance of benefits and risks is considered to be negative a CHC should not be prescribed (see section 4.3).

Table: Risk factors for ATE

Risk factor Comment



Hypertension






Migraine An increase in frequency or severity of migraine during CHC use (which may be prodromal of a

325

cerebrovascular event) may be a reason for immediate discontinuation



Symptoms of ATE

















[…]




326


[...]


Pregnancy [The following wording should be added to this section] The increased risk of VTE during the postpartum period should be considered when re-starting [invented name] (see section 4.2 and 4.4).

Section 4.8 – Undesirable effects [This following wording should be reflected in this section] […] Description of selected adverse reactions An increased risk of arterial and venous thrombotic and thrombo-embolic events, including myocardial infarction, stroke, transient ischemic attacks, venous thrombosis and pulmonary embolism has been observed in women using CHCs, which are discussed in more detail in section 4.4. […] [VTE or ATE should be listed in the adverse events table, under the frequency “Rare”.]

327

II. Package Leaflet



• They are one of the most reliable reversible methods of contraception if used correctly • They slightly increase the risk of having a blood clot in the veins and arteries, especially in the

first year or when restarting a combined hormonal contraceptive following a break of 4 or more weeks

• Please be alert and see your doctor if you think you may have symptoms of a blood clot (see section 2 “Blood clots”) […]



General notes


[…]













328



[…]








[...]






• if you need an operation, or you are off your feet for a long time (see in section 2 ‘Blood clots’).

• if you have just given birth you are at an increased risk of blood clots. You should ask your doctor how soon after delivery you can start taking [invented name].

• If you have an inflammation in the veins under the skin (superficial thrombophlebitis).


BLOOD CLOTS

329






















Pulmonary embolism



• painless blurring of vision which can progress to loss of vision


330








Heart attack







Stroke








The risk of developing a blood clot in a vein is highest during the first year of taking a combined hormonal contraceptive for the first time. The risk may also be higher if you restart taking a combined hormonal contraceptive (the same product or a different product) after a break of 4 weeks or more

331









- Out of 10,000 women who are using a combined hormonal contraceptive that contains desogestrel, such as [invented name], between about 9 and 12 women will develop a blood clot in a year.


- […].






Women using [Invented name] About 9-12 out of 10,000 women





• if you need to have an operation, or if you are off your feet for a long time because of an injury or illness, or you have your leg in a cast. The use of [invented name] may need to be stopped several

332

weeks before surgery or while you are less mobile. If you need to stop [invented name] ask your doctor when you can start using it again.






















333


[…]

Section 4. Possible side effects

[The following text should be inserted in this section]




• harmful blood clots in a vein or artery for example:



o heart attack

o stroke




[…]

334

ANNEX III.C – dienogest containing combined hormonal contraceptives

335

[For all dienogest-containing products listed in Annex I, the existing product information shall be amended (insertion, replacement or deletion of the text as appropriate) to reflect the agreed wording as provided below]

















336



Warnings

[...]




The use of any combined hormonal contraceptive (CHC) increases the risk of venous thromboembolism (VTE) compared with no use. Products that contain levonorgestrel, norgestimate or norethisterone are associated with the lowest risk of VTE. It is not yet known how the risk with [invented name] compares with these lower risk products. The decision to use any product other than one known to have the lowest VTE risk should be taken only after a discussion with the woman to ensure she understands the risk of VTE with CHCs, how her current risk factors influence this risk, and that her VTE risk is highest in the first ever year of use. There is also some evidence that the risk is increased when a CHC is re-started after a break in use of 4 weeks or more.

[For dienogest containing products in combination with low dose (<50μg) ethinylestradiol] [The wording below should be inserted in this section]


Epidemiological studies in women who use low dose combined oral contraceptives (<50 μg ethinylestradiol) have found that out of 10,000 women between about 6 to 12 will develop a VTE in one year.

It is estimated that out of 10,000 women who use a levonorgestrel-containing CHC about 61 will develop a VTE in one year.

Limited epidemiological data suggest that the risk of VTE with dienogest-containing CHCs may be similar to the risk with levonorgestrel-containing CHCs.

This number of VTEs per year is fewer than the number expected in women during pregnancy or in the postpartum period.



337

[For dienogest containing products in combination with estradiol valerate] [The wording below should be inserted in this section]


Epidemiological studies in women who use low dose (<50 μg ethinylestradiol) combined hormonal contraceptives have found that out of 10,000 women between about 6 and 12 will develop a VTE in one year

It is estimated that out of 10,000 women who use a levonorgestrel-containing CHC about 61 will develop a VTE in one year.

It is not yet known how the risk of VTE with CHCs that contain [progestogen] in combination with estradiol compares with the risk with low dose levonorgestrel-containing CHCs.

The number of VTEs per year with low dose CHCs is fewer than the number expected in women during pregnancy or in the postpartum period.


[For all dienogest containing products listed in Annex I]

[The following wording to be kept/added (as appropriate)] Extremely rarely, thrombosis has been reported to occur in CHC users in other blood vessels, e.g. hepatic, mesenteric, renal or retinal veins and arteries. [The following should be deleted (where applicable)] There is no consensus as to whether the occurrence of these events is associated with the use of CHCs. [This following wording should be inserted in this section]





Risk factor Comment

Obesity (body mass index over 30 Risk increases substantially as BMI rises.


338

kg/m²) Particularly important to consider if other risk factors also present.

















walking,





339

- sharp chest pain;











Risk factor Comment



Hypertension






Migraine An increase in frequency or severity of migraine during CHC use (which may be prodromal of a cerebrovascular event) may be a reason for

340

immediate discontinuation



Symptoms of ATE

















[…]



341



[...]




342

II. Package Leaflet








General notes


[…]













343



[…]








[...]










BLOOD CLOTS

344






















Pulmonary embolism





345








Heart attack







Stroke









346









- It is not yet known how the risk of a blood clot with [invented name] compares to the risk with a combined hormonal contraceptive that contains levonorgestrel.


- […].






Women using [Invented name] Not yet known.





• if you need to have an operation, or if you are off your feet for a long time because of an injury or illness, or you have your leg in a cast. The use of [invented name] may need to be stopped several weeks before surgery or while you are less mobile. If you need to stop [invented name] ask your doctor when you can start using it again.

347























348

[…]









o heart attack

o stroke




[…]

349

ANNEX III.D – drospirenone containing combined hormonal contraceptives

350

[For all drospirenone containing products listed in Annex I, the existing product information shall be amended (insertion, replacement or deletion of the text as appropriate) to reflect the agreed wording as provided below]



Section 4.3 - Contraindications

[This section should be amended to include the following contraindications]














351



Warnings

[...]




The use of any combined hormonal contraceptive (CHC) increases the risk of venous thromboembolism (VTE) compared with no use. Products that contain levonorgestrel, norgestimate or norethisterone are associated with the lowest risk of VTE. Other products such as [invented name] may have up to twice this level of risk. The decision to use any product other than one with the lowest VTE risk should be taken only after a discussion with the woman to ensure she understands the risk of VTE with [invented name], how her current risk factors influence this risk, and that her VTE risk is highest in the first ever year of use. There is also some evidence that the risk is increased when a CHC is re-started after a break in use of 4 weeks or more. [The wording below should be inserted in this section]


It is estimated1 that out of 10,000 women who use a CHC containing drospirenone, between 9 and 12 women will develop a VTE in one year; this compares with about 62 in women who use a levonorgestrel-containing CHC.

In both cases, the number of VTEs per year is fewer than the number expected during pregnancy or in the postpartum period.



352

[The following graph should be inserted here.]

Number of VTE events per 10,000 women in one year






Risk factor Comment




353

















walking,





- sharp chest pain;


354










Risk factor Comment



Hypertension







Other medical conditions associated Diabetes mellitus, hyperhomocysteinaemia, valvular

355

with adverse vascular events heart disease and atrial fibrillation, dyslipoproteinaemia and systemic lupus erythematosus.

Symptoms of ATE

















[…]




356


[...]




357

II. Package Leaflet








General notes


[…]













358



[…]








[...]










BLOOD CLOTS

359






















Pulmonary embolism





360








Heart attack







Stroke









361









- Out of 10,000 women who are using a combined hormonal contraceptive that contains drospirenone, such as [invented name], between about 9 and 12 women will develop a blood clot in a year.

- The risk of having a blood clot will vary according to your personal medical history (see “Factors that increase your risk of a blood clot” below).

- […].












362























363


[…]









o heart attack

o stroke




[…]

364

ANNEX III.E – etonogestrel containing combined hormonal contraceptives

365

[For all etonogestrel containing products listed in Annex I, the existing product information shall be amended (insertion, replacement or deletion of the text as appropriate) to reflect the agreed wording as provided below]


















366

[...]


Warnings

[...]






It is estimated that out of 10,000 women who use a low dose CHC that contains levonorgestrel, about 61 will develop a VTE in one year.

Inconsistent results on the risk of VTE with [Invented name] compared with CHCs that contain levonorgestrel have been found (with relative risk estimates ranging from no increase, RR=0.96, to an almost 2 fold increase, RR=1.90). This corresponds to between about 6 and 12 VTEs in a year out of 10,000 women who use [Invented name].

In both cases, the number of VTEs per year is fewer than the number expected in women during pregnancy or in the postpartum period.



367

















walking,





- sharp chest pain;


369










Risk factor Comment



Hypertension








370


Symptoms of ATE

















[…]




371


[...]




372

II. Package Leaflet








General notes


[…]













373



[…]








[...]







• if you have just given birth you are at an increased risk of blood clots. You should ask your doctor how soon after delivery you can start using [invented name];



BLOOD CLOTS

374






















Pulmonary embolism





375








Heart attack







Stroke









376









- Out of 10,000 women who are using a combined hormonal contraceptive that contains etonogestrel or norelgestromin such as [invented name] between about 6 and 12 women will develop a blood clot in a year.


- […]












377























378


[…]









o heart attack

o stroke




[…]

379

ANNEX III.F – gestodene containing combined hormonal contraceptives

380

[For all gestodene containing products listed in Annex I, the existing product information shall be amended (insertion, replacement or deletion of the text as appropriate) to reflect the agreed wording as provided below]


















381

[...]


Warnings

[...]






It is estimated1 that out of 10,000 women who use a CHC containing gestodene between 9 and 12 women will develop a VTE in one year; this compares with about 62 in women who use a levonorgestrel-containing CHC.

In both cases, the number of VTEs per year is fewer than the number expected during pregnancy or in the postpartum period.



382

[The following graph should be inserted here.]







Risk factor Comment




Prolonged immobilisation, major surgery, any surgery to the legs or

In these situations it is advisable to discontinue use of the patch/pill/ring (in the case of elective surgery at

383

pelvis, neurosurgery, or major trauma


least four weeks in advance) and not resume until two weeks after complete remobilisation. Another method of contraception should be used to avoid unintentional pregnancy.














walking,





- sharp chest pain;



384









Risk factor Comment



Hypertension








Diabetes mellitus, hyperhomocysteinaemia, valvular heart disease and atrial fibrillation,

385

dyslipoproteinaemia and systemic lupus erythematosus.

Symptoms of ATE

















[…]





[...]

386




387

II. Package Leaflet








General notes


[…]














388


[…]








[...]






• if you need an operation, or you are off your feet for a long time (see in section 2 ‘Blood clots ’);




BLOOD CLOTS


389





















Pulmonary embolism







Heart attack

390











• loss of consciousness or fainting with or without seizure. Sometimes the symptoms of stroke can be brief with an almost immediate and full recovery, but you should still seek urgent medical attention as you may be at risk of another stroke..

Stroke










When you stop [invented name] your risk of a blood clot returns to normal within a few weeks.

391

What is the risk of developing a blood clot?







- Out of 10,000 women who are using a combined hormonal contraceptive that contains gestodene such as [invented name] between about 9 and 12 women will develop a blood clot in a year.


- […].














392





















[…]


393








o heart attack

o stroke




[…]

394

ANNEX III.G – norgestimate containing combined hormonal contraceptives

395

[For all norgestimate containing products listed in Annex I, the existing product information shall be amended (insertion, replacement or deletion of the text as appropriate) to reflect the agreed wording as provided below]


















396

[...]


Warnings

[...]




The use of any combined hormonal contraceptive (CHC) increases the risk of venous thromboembolism (VTE) compared with no use. Products that contain levonorgestrel, norgestimate (including [invented name]) or norethisterone are associated with the lowest risk of VTE. The decision to use [invented name] should be taken after a discussion with the woman to ensure she understands the risk of VTE with [invented name], how her current risk factors influence this risk, and that her VTE risk is highest in the first ever year of use. There is also some evidence that the risk is increased when a CHC is re-started after a break in use of 4 weeks or more. [The wording below should be inserted in this section]


It is estimated that out of 10,000 women who use a CHC that contains levonorgestrel, about 61 will develop a VTE in a year.

Current evidence suggests that the risk of VTE with use of norgestimate-containing CHCs is similar to the risk with levonorgestrel-containing CHCs.

This number of VTEs per year is fewer than the number expected in women during pregnancy or in the postpartum period.



397

[The following graph should be inserted here]







Risk factor Comment




398

















walking,





- sharp chest pain;


399










Risk factor Comment



Hypertension








400


Symptoms of ATE

















[…]





401

[...]




402

II. Package Leaflet








General notes


[…]













403



[…]








[...]










BLOOD CLOTS

404






















Pulmonary embolism





405








Heart attack






• loss of consciousness or fainting with or without seizure. Sometimes the symptoms of stroke can be brief with an almost immediate and full recovery, but you should still seek urgent medical attention as you may be at risk of another stroke..

Stroke









406






- Out of 10,000 women who are not using any combined hormonal contraceptive and are not pregnant, about 2 will develop a blood clot in a year.

- Out of 10,000 women who are using a combined hormonal contraceptive that contains levonorgestrel or norethisterone, or norgestimate such as [Invented name], about 5-7 will develop a blood clot in a year.
















407




















408

[…]









o heart attack

o stroke




[…]

409

Annex IV

Conditions to the marketing authorisations

410

Conditions to the marketing authorisations

National Competent Authorities of Member States or Reference Member States, if applicable, shall ensure that the following conditions are fulfilled by the MAHs:

Conditions

Date

For chlormadinone-containing combined hormonal contraceptives

The MAHs for chlormadinone containing CHCs should carry out a post-authorisation safety study to compare the risk of VTE with chlormadinone/ethinyestradiol versus levonorgestrel/ethinyestradiol.

The protocol of this study should be submitted to the PRAC within 6 months after notification of the EC Decision.

The final study report should be submitted by:

End of December 2018

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annex i list of the names, pharmaceutical forms, strengths ... · annex i list of the names,...

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