Annex I List of the Names, Pharmaceutical Forms, Strengths Of

Annex I

List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, marketing authorisation holders in the member states

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Austria Janssen - Cilag Pharma GmbH Norgestimate Cileste - Tabletten 0,25 mg Tablet Oral use Vorgartenstraße 206b Ethinylestradiol 0,035 mg A-1020 Wien Austria Austria N.V. Organon Desogestrel Gracial - Tabletten 0,03 mg/0,125 mg Tablet Oral use Kloosterstraat 6 Ethinylestradiol 0,04 mg/0,025 mg 5349 AB, Oss The Netherlands Austria Bayer Austria GmbH Estradiol valerate Qlaira Filmtabletten 3 mg Film-coated tablet Oral use Herbststrasse 6-10 Dienogest 2 mg/2 mg 1160 Wien 2 mg/3 mg Austria 1 mg Austria Gynial GmbH Chlormadinone Bilinda 0,03 mg/2 mg 0,03 mg Film-coated tablet Oral use Gablenzgasse 11/III Ethinylestradiol Filmtabletten 2 mg 1150 Wien Austria Austria Kwizda Pharma GmbH Chlormadinone Delia 0,03 mg/2 mg 0,03 mg Film-coated tablet Oral use Effingergasse 21 Ethinylestradiol Filmtabletten 2 mg 1160 Wien Austria Austria Dermapharm GmbH Chlormadinone Madinette 0,03 mg/2 0,03 mg Film-coated tablet Oral use Türkenstraße 25/12 Ethinylestradiol mg Filmtabletten 2 mg 1090 Wien Austria Austria Teva Pharma BV Chlormadinone Mellow ratiopharm 0,03 mg Film-coated tablet Oral use Computerweg 10 Ethinylestradiol 0,03 mg/2 mg 2 mg 3542 DR Utrecht Filmtabletten The Netherlands

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Austria Actavis Group PTC ehf Chlormadinone Angiletta 0,03 mg/2 0,03 mg Film-coated tablet Oral use Reykjavikurvegi 76-78 Ethinylestradiol mg Filmtabletten 2 mg 220 Hafnarfjordur Iceland Austria Gedeon Richter Plc. Chlormadinone Balanca 0,03 mg/2 0,03 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol mg - Filmtabletten 2 mg HU-1103 Budapest Hungary Austria Pfizer Corporation Austria GmbH Chlormadinone Beatrice 0,03 mg/2 0,03 mg Film-coated tablet Oral use Floridsdorfer Hauptstraße 1 Ethinylestradiol mg Filmtabletten 2 mg 1210 Wien Austria Austria Gedeon Richter Plc. Chlormadinone Belara 0,03 mg/2 mg 0,03 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol - Filmtabletten 2 mg HU-1103 Budapest Hungary Austria Madaus GmbH Chlormadinone Bellissima 0,03 mg/2 0,03 mg Film-coated tablet Oral use Colonia Allee 15 Ethinylestradiol mg Filmtabletten 2 mg 51067 Köln Germany Austria Hexal GmbH Chlormadinone Ethinylestradiol/Chlor 0,03 mg Film-coated tablet Oral use Stella-Klein-Löw-Weg 17 Ethinylestradiol madinon Hexal 0,03 2 mg 1020 Wien mg/2 mg - Austria Filmtabletten Austria Dermapharm GmbH Desogestrel Desofemine 20 0,02 mg Film-coated tablet Oral use Türkenstraße 25/12 Ethinylestradiol Mikrogramm/150 0,15 mg 1090 Wien Mikrogramm Austria Filmtabletten

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Austria Dermapharm GmbH Desogestrel Desofemine 30 0,03 mg Film-coated tablet Oral use Türkenstraße 25/12 Ethinylestradiol Mikrogramm/150 0,15 mg 1090 Wien Mikrogramm Austria Filmtabletten Austria Gedeon Richter Plc. Desogestrel Desorelle 30 0,03 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol Mikrogramm/150 0,15 mg HU-1103 Budapest Mikrogramm 21+7 Hungary Filmtabletten Austria Gedeon Richter Plc. Desogestrel Desorelle Mite 20 0,02 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol Mikrogramm/150 0,15 mg HU-1103 Budapest Mikrogramm 21+7 Hungary Filmtabletten Austria Kwizda Pharma GmbH Desogestrel Liberel - Filmtabletten 0,03 mg Film-coated tablet Oral use Effingergasse 21 Ethinylestradiol 0,15 mg 1160 Wien Austria Austria Kwizda Pharma GmbH Desogestrel Liberel mite - 0,02 mg Film-coated tablet Oral use Effingergasse 21 Ethinylestradiol Filmtabletten 0,15 mg 1160 Wien Austria Austria N.V. Organon Desogestrel Marvelon - Tabletten 0,03 mg Tablet Oral use Kloosterstraat 6 Ethinylestradiol 0,15 mg 5349 AB, Oss The Netherlands Austria N.V. Organon Desogestrel Mercilon - Tabletten 0,02 mg Tablet Oral use Kloosterstraat 6 Ethinylestradiol 0,15 mg 5349 AB, Oss The Netherlands

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Austria Pfizer Corporation Austria GmbH Dienogest Bonisara 0,03 mg/2 0,03 mg Film-coated tablet Oral use Floridsdorfer Hauptstraße 1 Ethinylestradiol mg Filmtabletten 2 mg 1210 Wien Austria Austria Aristo Pharma GmbH Dienogest Cara 0,03 mg/2 mg 0,03 mg Film-coated tablet Oral use Wallenroder Straße 8-10 Ethinylestradiol Filmtabletten 2 mg 13435 Berlin Germany Austria Dermapharm GmbH Dienogest Dienovel 0,03 mg/2,0 0,03 mg Film-coated tablet Oral use Türkenstraße 25/12 Ethinylestradiol mg Filmtabletten 2 mg 1090 Wien Austria Austria Pelpharma Handels GmbH Dienogest Peliette 0,03 mg/2 mg 0,03 mg Film-coated tablet Oral use Stammhaustraße Ethinylestradiol Filmtabletten 2 mg 1210 Wien Austria Austria Helm AG Dienogest Kappanogest 0,03 0,03 mg Film-coated tablet Oral use Nordkanalstrasse 28 Ethinylestradiol mg/2 mg 2 mg 20097 Hamburg Filmtabletten Germany Austria Velvian Germany GmbH Dienogest Dienorette 0,03 mg/2 0,03 mg Film-coated tablet Oral use Carl-Zeiss-Ring 9 Ethinylestradiol mg Filmtabletten 2 mg 85737 Ismaning Germany Austria Gynial GmbH Dienogest Larissa 0,03 mg/2 mg 0,03 mg Film-coated tablet Oral use Gablenzgasse 11/III Ethinylestradiol Filmtabletten 2 mg 1150 Wien Austria

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Austria Madaus GmbH Dienogest Mayra 0,03 mg/2 mg 0,03 mg Film-coated tablet Oral use Colonia Allee 15 Ethinylestradiol Filmtabletten 2 mg 51067 Köln Germany Austria Ratiopharm Arzneimittel Dienogest Motion ratiopharm 2 0,03 mg Film-coated tablet Oral use Vertriebs-GmbH Ethinylestradiol mg/0,03 mg 2 mg Albert-Schweitzer-Gasse 3 Filmtabletten 1140 Wien Austria Austria Gedeon Richter Plc. Dienogest Sibilla 0,03 mg/2 mg 0,03 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol Filmtabletten 2 mg HU-1103 Budapest Hungary Austria Stada Arzneimittel GmbH Dienogest Stella 0,03 mg/2,0 0,03 mg Film-coated tablet Oral use Muthgasse 36/2 Ethinylestradiol mg Filmtabletten 2 mg 1190 Wien Austria Austria Bayer Austria GmbH Dienogest Valette Dragees 0,03 mg Coated tablet Oral use Herbststrasse 6-10 Ethinylestradiol 2 mg 1160 Wien Austria Austria Velvian Germany GmbH Dienogest Viola 0,03 mg/2 mg 0,03 mg Film-coated tablet Oral use Carl-Zeiss-Ring 9 Ethinylestradiol Filmtabletten 2 mg 85737 Ismaning Germany

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Austria Bayer Austria GmbH Drospirenone Aliane 0,02 mg/3 mg 0,02 mg Film-coated tablet Oral use Herbststrasse 6-10 Ethinylestradiol Filmtabletten 3 mg 1160 Wien Austria Austria Ratiopharm Arzneimittel Drospirenone Balancette 0,02 mg/3 0,02 mg Film-coated tablet Oral use Vertriebs-GmbH Ethinylestradiol mg Filmtabletten 3 mg Albert-Schweitzer-Gasse 3 1140 Wien Austria Austria Ratiopharm Arzneimittel Drospirenone Danselle 0,02 mg/3 0,02 mg Film-coated tablet Oral use Vertriebs-GmbH Ethinylestradiol mg 21 + 7 3 mg Albert-Schweitzer-Gasse 3 Filmtabletten 1140 Wien Austria Austria Ratiopharm Arzneimittel Drospirenone Danselle 0,02 mg/3 0,02 mg Film-coated tablet Oral use Vertriebs-GmbH Ethinylestradiol mg 21 Filmtabletten 3 mg Albert-Schweitzer-Gasse 3 1140 Wien Austria Austria Ratiopharm Arzneimittel Drospirenone Danseo 0,03 mg/3 mg 0,03 mg Film-coated tablet Oral use Vertriebs-GmbH Ethinylestradiol 21 + 7 Filmtabletten 3 mg Albert-Schweitzer-Gasse 3 1140 Wien Austria

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Austria Ratiopharm Arzneimittel Drospirenone Danseo 0,03 mg/3 mg 0,03 mg Film-coated tablet Oral use Vertriebs-GmbH Ethinylestradiol 21 Filmtabletten 3 mg Albert-Schweitzer-Gasse 3 1140 Wien Austria Austria Bayer Austria GmbH Drospirenone Eloine 0,02 mg/3 mg 0,02 mg Film-coated tablet Oral use Herbststrasse 6-10 Ethinylestradiol Filmtabletten 3 mg 1160 Wien Austria Austria Bayer Austria GmbH Drospirenone Ethinylestradiol/Drospi 0,03 mg Film-coated tablet Oral use Herbststrasse 6-10 Ethinylestradiol renon Bayer 0,03 3 mg 1160 Wien mg/3 mg Austria Filmtabletten Austria Sandoz GmbH Drospirenone Ethinylestradiol/Drospi 0,02 mg Film-coated tablet Oral use Biochemiestrase 10 Ethinylestradiol renon Sandoz 0,02 3 mg 6250 Kundl mg/3 mg 21 Austria Filmtabletten Austria Sandoz GmbH Drospirenone Ethinylestradiol/Drospi 0,02 mg Film-coated tablet Oral use Biochemiestrase 10 Ethinylestradiol renon Sandoz 0,02 3 mg 6250 Kundl mg/3 mg 21+7 Austria Filmtabletten Austria Sandoz GmbH Drospirenone Ethinylestradiol/Drospi 0,03 mg Film-coated tablet Oral use Biochemiestrase 10 Ethinylestradiol renon Sandoz 0,03 3 mg 6250 Kundl mg/3 mg 21 Austria Filmtabletten

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Austria Sandoz GmbH Drospirenone Ethinylestradiol/Drospi 0,03 mg Film-coated tablet Oral use Biochemiestrase 10 Ethinylestradiol renon Sandoz 0,03 3 mg 6250 Kundl mg/3 mg 21+7 Austria Filmtabletten Austria Laboratorios Leon Farma SA Drospirenone Etindros 0,02 mg/3 0,02 mg Film-coated tablet Oral use Calle La Vallina S/N Ethinylestradiol mg Filmtabletten 3 mg Poligono Industrial Navatejera Navatejera, Leon E-24008 Spain Austria Laboratorios Leon Farma SA Drospirenone Etindros 0,03 mg/3 0,03 mg Film-coated tablet Oral use Calle La Vallina S/N Ethinylestradiol mg Filmtabletten 3 mg Poligono Industrial Navatejera Navatejera, Leon E-24008 Spain Austria Bayer Austria GmbH Drospirenone Flexyess 0,02 mg/3 0,02 mg Film-coated tablet Oral use Herbststrasse 6-10 Ethinylestradiol mg Filmtabletten 3 mg 1160 Wien Austria Austria Laboratorios Leon Farma SA Drospirenone Jangee 0,02 mg/3 mg 0,02 mg Film-coated tablet Oral use Calle La Vallina S/N Ethinylestradiol Filmtabletten 3 mg Poligono Industrial Navatejera Navatejera, Leon E-24008 Spain

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Austria Laboratorios Leon Farma SA Drospirenone Jangee 0,03 mg/3 mg 0,03 mg Film-coated tablet Oral use Calle La Vallina S/N Ethinylestradiol Filmtabletten 3 mg Poligono Industrial Navatejera Navatejera, Leon E-24008 Spain Austria Velvian Germany GmbH Drospirenone Lamiva 0,02 mg/3 mg 0,02 mg Film-coated tablet Oral use Carl-Zeiss-Ring 9 Ethinylestradiol Filmtabletten 3 mg 85737 Ismaning Germany Austria Laboratorios Leon Farma SA Drospirenone Naraya 0,02 mg/3 mg 0,02 mg Film-coated tablet Oral use Calle La Vallina S/N Ethinylestradiol Filmtabletten 3 mg Poligono Industrial Navatejera Navatejera, Leon E-24008 Spain Austria Laboratorios Leon Farma SA Drospirenone Naraya 0,03 mg/3 mg 0,03 mg Film-coated tablet Oral use Calle La Vallina S/N Ethinylestradiol Filmtabletten 3 mg Poligono Industrial Navatejera Navatejera, Leon E-24008 Spain Austria Gedeon Richter Plc. Drospirenone Volina 0,03 mg/3 mg 0,03 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol Filmtabletten 3 mg HU-1103 Budapest Hungary

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Austria Gedeon Richter Plc. Drospirenone Volina mite 0,02 mg/3 0,02 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol mg Filmtabletten 3 mg HU-1103 Budapest Hungary Austria Bayer Austria GmbH Drospirenone Yasmin 0,03 mg/3 mg 0,03 mg Film-coated tablet Oral use Herbststrasse 6-10 Ethinylestradiol - Filmtabletten 3 mg 1160 Wien Austria Austria Bayer Austria GmbH Drospirenone Yasminelle 0,02 mg/3 0,02 mg Film-coated tablet Oral use Herbststrasse 6-10 Ethinylestradiol mg Filmtabletten 3 mg 1160 Wien Austria Austria Bayer Austria GmbH Drospirenone YAZ 0,02 mg/3 mg 0,02 mg Film-coated tablet Oral use Herbststrasse 6-10 Ethinylestradiol Filmtabletten 3 mg 1160 Wien Austria Austria Bayer Austria GmbH Drospirenone Yirala 0,03 mg/3 mg - 0,03 mg Film-coated tablet Oral use Herbststrasse 6-10 Ethinylestradiol Filmtabletten 3 mg 1160 Wien Austria Austria Laboratorios Leon Farma SA Gestodene Annantah 15 0,015 mg Film-coated tablet Oral use Calle La Vallina S/N Ethinylestradiol Mikrogramm/60 0,06 mg Poligono Industrial Navatejera Mikrogramm Navatejera, Filmtabletten Leon E-24008 Spain

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Austria Ratiopharm Arzneimittel Gestodene Flow 15 µg / 60 µg 0,015 mg Film-coated tablet Oral use Vertriebs-GmbH Ethinylestradiol Filmtabletten 0,06 mg Albert-Schweitzer-Gasse 3 1140 Wien Austria Austria Bayer Austria GmbH Gestodene Gynovin - Dragees 0,03 mg Coated tablet Oral use Herbststrasse 6-10 Ethinylestradiol 0,075 mg 1160 Wien Austria Austria Pfizer Corporation Austria GmbH Gestodene Harmonette - 0,02 mg Coated tablet Oral use Floridsdorfer Hauptstraße 1 Ethinylestradiol Dragees 0,075 mg 1210 Wien Austria Austria Velvian Germany GmbH Gestodene Jamyle 15 0,015 mg Film-coated tablet Oral use Carl-Zeiss-Ring 9 Ethinylestradiol Mikrogramm/60 0,06 mg 85737 Ismaning Mikrogramm Germany Filmtabletten Austria Gynial GmbH Gestodene Lenea 20 µg/75 µg 0,02 mg Coated tablet Oral use Gablenzgasse 11/III Ethinylestradiol überzogene Tabletten 0,075 mg 1150 Wien Austria Austria Bayer Austria GmbH Gestodene Meliane - Dragees 0,02 mg Coated tablet Oral use Herbststrasse 6-10 Ethinylestradiol 0,075 mg 1160 Wien Austria

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Austria Pfizer Corporation Austria GmbH Gestodene Minesse 15 0,015 mg Film-coated tablet Oral use Floridsdorfer Hauptstraße 1 Ethinylestradiol Mikrogramm/60 0,06 mg 1210 Wien Mikrogramm Austria Filmtabletten Austria Pfizer Corporation Austria GmbH Gestodene Minulet - Dragees 0,03 mg Coated tablet Oral use Floridsdorfer Hauptstraße 1 Ethinylestradiol 0,075 mg 1210 Wien Austria Austria Bayer Austria GmbH Gestodene Mirelle 15 0,015 mg Film-coated tablet Oral use Herbststrasse 6-10 Ethinylestradiol Mikrogramm/60 0,06 mg 1160 Wien Mikrogramm - Austria Filmtabletten Austria Actavis Group PTC ehf Gestodene Sylgestrel 75 0,03 mg Coated tablet Oral use Reykjavikurvegi 76-78 Ethinylestradiol Mikrogramm + 30 0,075 mg 220 Hafnarfjordur Mikrogramm Dragees Iceland Austria Actavis Group PTC ehf Gestodene Sylgestrel mite 75 0,02 mg Coated tablet Oral use Reykjavikurvegi 76-78 Ethinylestradiol Mikrogramm + 20 0,075 mg 220 Hafnarfjordur Mikrogramm Dragees Iceland Austria Bayer Austria GmbH Gestodene Triodena - Dragees 0,03 mg /0,05 mg Coated tablet Oral use Herbststrasse 6-10 Ethinylestradiol 0,04 mg /0,07 mg 1160 Wien 0,03 mg /0,10 mg Austria Austria Gedeon Richter Plc. Gestodene Varianta 15 0,015 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol Mikrogramm/60 0,06 mg HU-1103 Budapest Mikrogramm Hungary Filmtabletten

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Austria Ratiopharm Arzneimittel Gestodene Wave ratiopharm 75 0,02 mg Coated tablet Oral use Vertriebs-GmbH Ethinylestradiol Mikrogramm/20 0,075 mg Albert-Schweitzer-Gasse 3 Mikrogramm 1140 Wien überzogene Tabletten Austria Austria Kwizda Pharma GmbH Gestodene Yris - Dragees 0,03 mg Coated tablet Oral use Effingergasse 21 Ethinylestradiol 0,075 mg 1160 Wien Austria Austria Kwizda Pharma GmbH Gestodene Yris mite - Dragees 0,02 mg Coated tablet Oral use Effingergasse 21 Ethinylestradiol 0,075 mg 1160 Wien Austria Austria N.V. Organon Etonogestrel Circlet 0,120 mg / 11,7 mg Vaginal delivery Vaginal use Kloosterstraat 6 Ethinylestradiol 0,015 mg pro 24 2,7 mg system 5349 AB, Oss Stunden - Vaginalring The Netherlands Austria N.V. Organon Etonogestrel NuvaRing 0,120 11,7 mg Vaginal delivery Vaginal use Kloosterstraat 6 Ethinylestradiol mg/0,015 mg pro 24 2,7 mg system 5349 AB, Oss Stunden - Vaginalring The Netherlands Austria Janssen - Cilag Pharma GmbH Norgestimate TriCilest- Tabletten 0,18 mg/0,215 Tablet Oral use Vorgartenstraße 206b Ethinylestradiol mg/0,25 mg A-1020 Wien 0,035 mg/0,035 Austria mg/0,035 mg

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Austria Janssen - Cilag Pharma GmbH Norgestimate Vivelle - Tabletten 0,18 mg/0,215 Tablet Oral use Vorgartenstraße 206b Ethinylestradiol mg/0,25 mg A-1020 Wien 0,035 mg/0,035 Austria mg/0,035 mg Austria Ratiopharm Arzneimittel Desogestrel Denise 20 0,02 mg Tablet Oral use Vertriebs-GmbH Ethinylestradiol Mikrokramm/150 0,15 mg Albert-Schweitzer-Gasse 3 Mikrogramm Tabletten 1140 Wien Austria Austria Stada Arzneimittel GmbH Drospirenone Laurine 0,02 mg/3 mg 0,02 mg Film-coated tablet Oral use Muthgasse 36/2 Ethinylestradiol Filmtabletten 3 mg 1190 Wien Austria Austria Stada Arzneimittel GmbH Drospirenone Laurine 0,03 mg/3 mg 0,03 mg Film-coated tablet Oral use Muthgasse 36/2 Ethinylestradiol Filmtabletten 3 mg 1190 Wien Austria Austria Stada Arzneimittel GmbH Drospirenone Ethinylestradio/Drospi 0,02 mg Film-coated tablet Oral use Muthgasse 36/2 Ethinylestradiol renon 0,02 mg/3 mg 3 mg 1190 Wien Filmtabletten Austria Austria Ivowen Limited Drospirenone Liladros 0,02 mg/ 3 0,02 mg Film-coated tablet Oral use 3 Anglesa St Ethinylestradiol mg Filmtabletten 3 mg Tipperary Clonmel Ireland

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Austria Ivowen Limited Drospirenone Lilas 0,03 mg/ 3 mg 0,03 mg Film-coated tablet Oral use 3 Anglesa St Ethinylestradiol Filmtabletten 3 mg Tipperary Clonmel Ireland Austria Famy Care Europe Ltd Dienogest Ethinylestradiol/Dieno 0,03 mg film-coated tablet Oral use One Wood Street Ethinylestradiol gest Famy 0,03 mg/ 2 2 mg EC2V 7WS London mg Filmtabletten United Kingdom Belgium BAYER SA-NV Estradiol valerate QLAIRA 3 mg Film-coated tablet Oral use J.E. Mommaertslaan 14 Dienogest 2 mg/2 mg 1831 Diegem 2 mg/3 mg Belgium 1 mg Belgium Gedeon Richter Plc. Chlormadinone BELLINA 0.03 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 2.00 mg HU-1103 Budapest Hungary Belgium Mithra Pharmaceuticals S.A. Chlormadinone HELEN 0.03 mg Film-coated tablet Oral use Rue Saint Georges 5 Ethinylestradiol 2.00 mg 4000 Liège Belgium Belgium mibe GmbH Arzneimittel Chlormadinone MADINELLE 0.03 mg Film-coated tablet Oral use Münchener Str. 15 Ethinylestradiol 2.00 mg 06796 Brehna Germany Belgium Madaus GmbH Chlormadinone ORCHIDEA 0.03 mg Film-coated tablet Oral use Colonia Allee 15 Ethinylestradiol 2.00 mg 51067 Köln Germany

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Belgium Gedeon Richter Plc. Desogestrel DESO 20 0.02 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 0.15 mg HU-1103 Budapest Hungary Belgium Gedeon Richter Plc. Desogestrel DESO 30 0.03 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 0.15 mg HU-1103 Budapest Hungary Belgium N.V. Organon Desogestrel GRACIAL 0.040 mg/0.025 Tablet Oral use Kloosterstraat 6 Ethinylestradiol mg 5349 AB, Oss 0.03 mg/0.125 mg The Netherlands Belgium N.V. Organon Desogestrel MARVELON 0.03 mg Tablet Oral use Kloosterstraat 6 Ethinylestradiol 0.15 mg 5349 AB, Oss The Netherlands Belgium N.V. Organon Desogestrel MERCILON 0.020 mg Tablet Oral use Kloosterstraat 6 Ethinylestradiol 0.150 mg 5349 AB, Oss The Netherlands Belgium Mithra Pharmaceuticals S.A. Dienogest LOUISE 0.03 mg Film-coated tablet Oral use Rue Saint Georges 5 Ethinylestradiol 2.00 mg 4000 Liège Belgium Belgium Teva Pharma Belgium N.V. Dienogest VEREZANA 0.03 mg Film-coated tablet Oral use Laarstraat 16 Ethinylestradiol 2.00 mg 2610 Wilrijk Belgium

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Belgium Gedeon Richter Plc. Drospirenone ANNABELLE 0.02 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 3.00 mg HU-1103 Budapest Hungary Belgium Gedeon Richter Plc. Drospirenone ANNAIS 0.03 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 3.00 mg HU-1103 Budapest Hungary Belgium SANDOZ N.V. Drospirenone ARMUNIA 20 0.02 mg Film-coated tablet Oral use Telecom Gardens Ethinylestradiol 3.00 mg Medialaan 40 1800 Vilvoorde Belgium Belgium SANDOZ N.V. Drospirenone ARMUNIA 30 0.03 mg Film-coated tablet Oral use Telecom Gardens Ethinylestradiol 3.00 mg Medialaan 40 1800 Vilvoorde Belgium Belgium EFFIK BENELUX Drospirenone DROSPIBEL 20 0.02 mg Film-coated tablet Oral use Lenniksebaan 451 Ethinylestradiol 3.00 mg 1070 Anderlecht Belgium Belgium EFFIK BENELUX Drospirenone DROSPIBEL 30 0.03 mg Film-coated tablet Oral use Lenniksebaan 451 Ethinylestradiol 3.00 mg 1070 Anderlecht Belgium

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Belgium SANDOZ N.V. Drospirenone RHONYA 20 0.02 mg Film-coated tablet Oral use Telecom Gardens Ethinylestradiol 3.00 mg Medialaan 40 1800 Vilvoorde Belgium Belgium SANDOZ N.V. Drospirenone RHONYA 30 0.03 mg Film-coated tablet Oral use Telecom Gardens Ethinylestradiol 3.00 mg Medialaan 40 1800 Vilvoorde Belgium Belgium BAYER SA-NV Drospirenone YASMIN 0.03 mg Film-coated tablet Oral use J.E. Mommaertslaan 14 Ethinylestradiol 3.00 mg 1831 Diegem Belgium Belgium BAYER SA-NV Drospirenone YAZ 0.02 mg Film-coated tablet Oral use J.E. Mommaertslaan 14 Ethinylestradiol 3.00 mg 1831 Diegem Belgium Belgium N.V. Organon Etonogestrel CIRCLET 2.70 mg Vaginal delivery Vaginal use Kloosterstraat 6 Ethinylestradiol 11.70 mg system 5349 AB, Oss The Netherlands Belgium N.V. Organon Etonogestrel NUVARING 2.70 mg Vaginal delivery Vaginal use Kloosterstraat 6 Ethinylestradiol 11.70 mg system 5349 AB, Oss The Netherlands

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Belgium MPCA BVBA Gestodene CAOIMHE 0.02 mg Coated tablet Oral use Vrijestraat 28 Ethinylestradiol 0.075 mg 9960 Assenede Belgium Belgium EFFIK BENELUX Gestodene ESTINETTE 20 0.02 mg Coated tablet Oral use Lenniksebaan 451 Ethinylestradiol 0.075 mg 1070 Anderlecht Belgium Belgium EFFIK BENELUX Gestodene ESTINETTE 30 0.030mg Coated tablet Oral use Lenniksebaan 451 Ethinylestradiol 0.075 mg 1070 Anderlecht Belgium Belgium BAYER SA-NV Gestodene FEMODENE 0.030mg Coated tablet Oral use J.E. Mommaertslaan 14 Ethinylestradiol 0.075 mg 1831 Diegem Belgium Belgium MYLAN BVBA/SPRL Gestodene GESICAMYLAN 0.02 mg Coated tablet Oral use Terhulpsesteenweg 6A Ethinylestradiol 0.075 mg 1560 Hoeilaart Belgium Belgium MYLAN BVBA/SPRL Gestodene GESICAMYLAN 0.030mg Coated tablet Oral use Terhulpsesteenweg 6A Ethinylestradiol 0.075 mg 1560 Hoeilaart Belgium Belgium Gedeon Richter Plc. Gestodene GESTODELLE 20 0.02 mg Coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 0.075 mg HU-1103 Budapest Hungary

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Belgium L.F. WILL & CIE SA Gestodene GESTODENOL 20 0.02 mg Coated tablet Oral use Rue du Manil 80 Ethinylestradiol 0.075 mg 1301 Wavre Belgium Belgium L.F. WILL & CIE SA Gestodene GESTODENOL 30 0.030mg Coated tablet Oral use Rue du Manil 80 Ethinylestradiol 0.075 mg 1301 Wavre Belgium Belgium Gedeon Richter Plc. Gestodene GESTOFEME 30 0.030mg Coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 0.075 mg HU-1103 Budapest Hungary Belgium MPCA BVBA Gestodene GRAINNE 0.030mg Coated tablet Oral use Vrijestraat 28 Ethinylestradiol 0.075 mg 9960 Assenede Belgium Belgium PFIZER S.A. Gestodene HARMONET 0.02 mg Coated tablet Oral use 17 Boulevard de la Plaine Ethinylestradiol 0.075 mg 1050 Brussels Belgium Belgium SANDOZ N.V. Gestodene LIOSANNE 20 0.02 mg Coated tablet Oral use Telecom Gardens Ethinylestradiol 0.075 mg Medialaan 40 1800 Vilvoorde Belgium

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Belgium SANDOZ N.V. Gestodene LIOSANNE 30 0.030mg Coated tablet Oral use Telecom Gardens Ethinylestradiol 0.075 mg Medialaan 40 1800 Vilvoorde Belgium Belgium BAYER SA-NV Gestodene MELIANE 0.02 mg Coated tablet Oral use J.E. Mommaertslaan 14 Ethinylestradiol 0.075 mg 1831 Diegem Belgium Belgium PFIZER S.A. Gestodene MINULET 0.03 mg Coated tablet Oral use 17 Boulevard de la Plaine Ethinylestradiol 0.07 mg 1050 Brussels Belgium Belgium BAYER SA-NV Gestodene MIRELLE 0.015 mg Film-coated tablet Oral use J.E. Mommaertslaan 14 Ethinylestradiol 0.06 mg 1831 Diegem Belgium Belgium PFIZER S.A. Gestodene TRI- MINULET 0.03 mg Coated tablet Oral use 17 Boulevard de la Plaine Ethinylestradiol 0.05 mg 1050 Brussels Belgium Belgium BAYER SA-NV Gestodene TRIODENE 0.03 mg /0.05 mg Coated tablet Oral use J.E. Mommaertslaan 14 Ethinylestradiol 0.04 mg /0.07 mg 1831 Diegem 0.03 mg /0.10 mg Belgium

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Belgium Gedeon Richter Plc. Gestodene YVELLIS 0.015 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 0.060mg HU-1103 Budapest Hungary Belgium JANSSEN-CILAG N.V. Norgestimate CILEST 0.035 mg Tablet Oral use Antwerpseweg 15-17 Ethinylestradiol 0.25 mg 2340 Beerse Belgium Belgium BAYER SA-NV Drospirenone YASMINELLE 0.02 mg Film-coated tablet Oral use J.E. Mommaertslaan 14 Ethinylestradiol 3.00 mg 1831 Diegem Belgium Belgium Teva Pharma Belgium N.V. Desogestrel DENISE 20 0.02 mg Tablet Oral use Laarstraat 16 Ethinylestradiol 0.150 mg 2610 Wilrijk Belgium Belgium MYLAN BVBA/SPRL Desogestrel EMMAMYLAN 0.020 mg Tablet Oral use Terhulpsesteenweg 6A Ethinylestradiol 0.0150 mg 1560 Hoeilaart Belgium Belgium MYLAN BVBA/SPRL Desogestrel EMMAMYLAN 0.030 mg Tablet Oral use Terhulpsesteenweg 6A Ethinylestradiol 0.150 mg 1560 Hoeilaart Belgium Belgium Gedeon Richter Plc. Desogestrel TRENDESO 20 0.02 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 0.15 mg HU-1103 Budapest Hungary

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Belgium Gedeon Richter Plc. Desogestrel TRENDESO 30 0.03 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 0.15 mg HU-1103 Budapest Hungary Belgium SANDOZ N.V. Drospirenone BRADLEY 20 0.02 mg Film-coated tablet Oral use Telecom Gardens Ethinylestradiol 3.00 mg Medialaan 40 1800 Vilvoorde Belgium Belgium EFFIK BENELUX Drospirenone CORNELIA 0.03 mg Film-coated tablet Oral use Lenniksebaan 451 Ethinylestradiol 3.00 mg 1070 Anderlecht Belgium Belgium Teva Pharma Belgium N.V. Drospirenone DORINELLETEVA 0.02 mg Film-coated tablet Oral use Laarstraat 16 Ethinylestradiol 3.00 mg 2610 Wilrijk Belgium Belgium Teva Pharma Belgium N.V. Drospirenone DORINELLETEVA 0.02 mg Film-coated tablet Oral use Laarstraat 16 Ethinylestradiol CONTINU 3.00 mg 2610 Wilrijk Belgium Belgium Teva Pharma Belgium N.V. Drospirenone DORINTEVA 0.03 mg Film-coated tablet Oral use Laarstraat 16 Ethinylestradiol 3.00 mg 2610 Wilrijk Belgium

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Belgium Teva Pharma Belgium N.V. Drospirenone DORINTEVA CONTINU 0.03 mg Film-coated tablet Oral use Laarstraat 16 Ethinylestradiol 3.00 mg 2610 Wilrijk Belgium Belgium EFFIK BENELUX Drospirenone DROSEFIKK 0.02 mg Film-coated tablet Oral use Lenniksebaan 451 Ethinylestradiol 3.00 mg 1070 Anderlecht Belgium Belgium EFFIK BENELUX Drospirenone NAIWANEL 0.02 mg Film-coated tablet Oral use Lenniksebaan 451 Ethinylestradiol 3.00 mg 1070 Anderlecht Belgium Belgium Gedeon Richter Plc. Drospirenone REZEDIA 0.02 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 3.00 mg HU-1103 Budapest Hungary Belgium Teva Pharma Belgium N.V. Drospirenone YADERE 0.02 mg Film-coated tablet Oral use Laarstraat 16 Ethinylestradiol 3.00 mg 2610 Wilrijk Belgium Belgium BAYER SA-NV Drospirenone Yvidually 0,02 mg/3 0,02 mg Film-coated tablet Oral use J.E. Mommaertslaan 14 Ethinylestradiol mg, filmomhulde 3 mg 1831 Diegem tabletten Belgium Bulgaria N.V. Organon Desogestrel Marvelon 0,15 mg Tablet Oral use Kloosterstraat 6 Ethinylestradiol 0,03 mg 5349 AB, Oss The Netherlands

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Bulgaria Gedeon Richter Plc. Desogestrel Novynette 0,15 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 0,02 mg HU-1103 Budapest Hungary Bulgaria Gedeon Richter Plc. Desogestrel Regulon 0,15 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 0,03 mg HU-1103 Budapest Hungary Bulgaria N.V. Organon Desogestrel Mercillon 0,02 mg Tablet Oral use Kloosterstraat 6 Ethinylestradiol 0,15 mg 5349 AB, Oss The Netherlands Bulgaria Gedeon Richter Plc. Desogestrel Novynette 28 0,15 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 0,02 mg HU-1103 Budapest Hungary Bulgaria Gedeon Richter Plc. Drospirenone Aneea 0,02 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 3 mg HU-1103 Budapest Hungary Bulgaria Gedeon Richter Plc. Drospirenone Belusha 0,02 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 3 mg HU-1103 Budapest Hungary Bulgaria Gedeon Richter Plc. Drospirenone Daylette 0,02 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 3 mg HU-1103 Budapest Hungary

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Bulgaria Bayer Pharma AG Drospirenone Eloine 0,02 mg Film-coated tablet Oral use D-13342 Berlin Ethinylestradiol 3 mg Germany Bulgaria Bayer Pharma AG Drospirenone Flexyess 0,02 mg Film-coated tablet Oral use D-13342 Berlin Ethinylestradiol 3 mg Germany Bulgaria Medico Uno Pharma Kft. Drospirenone Jangee 0,02 mg Film-coated tablet Oral use Viadukt u. 12 Ethinylestradiol 3 mg Biatorbágy 2051 Hungary Bulgaria Medico Uno Pharma Kft. Drospirenone Jangee 0,03 mg Film-coated tablet Oral use Viadukt u. 12 Ethinylestradiol 3 mg Biatorbágy 2051 Hungary Bulgaria Laboratorios Leon Farma SA Drospirenone Jangee 28 0,02 mg Film-coated tablet Oral use Poligono Industrial Navatejera, Ethinylestradiol 3 mg La Vallina s/n, 24008 Villaquilambre,Leon Spain Bulgaria Laboratorios Leon Farma SA Drospirenone Jangee 28 0,03 mg Film-coated tablet Oral use Poligono Industrial Navatejera, Ethinylestradiol 3 mg La Vallina s/n, 24008 Villaquilambre,Leon Spain

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Bulgaria Laboratorios Leon Farma SA Drospirenone Drosetil 28 0,02 mg Film-coated tablet Oral use Poligono Industrial Navatejera, Ethinylestradiol 3 mg La Vallina s/n, 24008 Villaquilambre,Leon Spain Bulgaria Gedeon Richter Plc. Drospirenone Midiana 0,03 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 3 mg HU-1103 Budapest Hungary Bulgaria Bayer Pharma AG Drospirenone Palandra 0,03 mg Film-coated tablet Oral use D-13342 Berlin Ethinylestradiol 3 mg Germany Bulgaria Zentiva, k.s. Drospirenone Sidretella 0,02 mg Film-coated tablet Oral use U kabelovny 130 Ethinylestradiol 3 mg 102 37 Praha 10 Dolní Měcholupy Czech Republic Bulgaria Zentiva, k.s. Drospirenone Sidretella 0,03 mg Film-coated tablet Oral use U kabelovny 130 Ethinylestradiol 3 mg 102 37 Praha 10 Dolní Měcholupy Czech Republic Bulgaria Gedeon Richter Plc. Drospirenone Teenia 0,02 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 3 mg HU-1103 Budapest Hungary

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Bulgaria Teva Pharmaceuticals Bulgaria Drospirenone Veyann 0,02 mg Film-coated tablet Oral use EOOD Ethinylestradiol 3 mg Gogol 15 Sofia 1124 Bulgaria Bulgaria Bayer Pharma AG Drospirenone Yasmin 0,03 mg Film-coated tablet Oral use D-13342 Berlin Ethinylestradiol 3 mg Germany Bulgaria Bayer Pharma AG Drospirenone Yaz 0,02 mg Film-coated tablet Oral use D-13342 Berlin Ethinylestradiol 3 mg Germany Bulgaria Zentiva, k.s. Gestodene Artizia 0,075 mg Coated tablet Oral use U kabelovny 130 Ethinylestradiol 0,02 mg 102 37 Praha 10 Dolní Měcholupy Czech Republic Bulgaria Bayer Pharma AG Gestodene Femoden 0,03 mg Coated tablet Oral use Muellerstr. 178 Ethinylestradiol 0,075 mg 13353 Berlin Germany Bulgaria Medico Uno Pharma Kft. Gestodene Gestodette 0,02 mg Coated tablet Oral use Viadukt u. 12 Ethinylestradiol 0,075 mg Biatorbágy 2051 Hungary

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Bulgaria Gedeon Richter Plc. Gestodene Kostya 0,02 mg Coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 0,075 mg HU-1103 Budapest Hungary Bulgaria Bayer Pharma AG Gestodene Logest 0,02 mg Coated tablet Oral use Muellerstr. 178 Ethinylestradiol 0,075 mg 13353 Berlin Germany Bulgaria Gedeon Richter Plc. Gestodene Milligest 0,03 mg/0,05 mg Coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 0,04 mg/0,07 mg HU-1103 Budapest 0,03 mg/0,1 mg Hungary Bulgaria Actavis Group PTC ehf Gestodene Sylgestrel 20 0,02 mg Coated tablet Oral use Reykjavikurvegi 76-78 Ethinylestradiol 0,075 mg 220 Hafnarfjordur Iceland Bulgaria Actavis Group PTC ehf Gestodene Sylgestrel 30 0,03 mg Coated tablet Oral use Reykjavikurvegi 76-78 Ethinylestradiol 0,075 mg 220 Hafnarfjordur Iceland Bulgaria Gedeon Richter Plc. Gestodene Vendiol 0,015 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 0,06 mg HU-1103 Budapest Hungary Bulgaria Gedeon Richter Plc. Gestodene Zulfija 0,03 mg Coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 0,075 mg HU-1103 Budapest Hungary

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Bulgaria Gedeon Richter Plc. Gestodene Lindynette 20 0,075 mg Coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 0,02 mg HU-1103 Budapest Hungary Bulgaria Gedeon Richter Plc. Gestodene Lindynette 30 0,075 mg Coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 0,03 mg HU-1103 Budapest Hungary Bulgaria Johnson & Johnson d.o.o. Norgestimate Cilest 0,25 mg Tablet Oral use Šmartinska cesta 53 Ethinylestradiol 0,035 mg 1000 Ljubljana Slovenija Bulgaria Bayer Pharma AG Estradiol valerate Qlaira 3 mg Film-coated tablet Oral use D-13342 Berlin Dienogest 2 mg/2 mg Germany 2 mg/3 mg 1 mg Bulgaria N.V. Organon Etonogestrel NuvaRing 0,120 11.7 mg Vaginal delivery Vaginal use Kloosterstraat 6 Ethinylestradiol mg/0,015 mg per 24 2.7 mg system 5349 AB, Oss hours, vaginal The Netherlands delivery system Bulgaria Zentiva, k.s. Desogestrel Estmar 20 0,02 mg Tablet Oral use U kabelovny 130 Ethinylestradiol 0,15 mg 102 37 Praha 10 Dolní Měcholupy Czech Republic

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Bulgaria Zentiva, k.s. Desogestrel Estmar 30 0,03 mg Tablet Oral use U kabelovny 130 Ethinylestradiol 0,15 mg 102 37 Praha 10 Dolní Měcholupy Czech Republic Bulgaria Zentiva, k.s. Dienogest Bonadea 0,03 mg Film-coated tablet Oral use U kabelovny 130 Ethinylestradiol 2 mg 102 37 Praha 10 Dolní Měcholupy Czech Republic Bulgaria Ivowen Limited Drospirenone Lulina 0,03 mg Film-coated tablet Oral use 3 Anglesa St Ethinylestradiol 3 mg Tipperary Clonmel Ireland Cyprus Janssen-Cilag International N.V. Norgestimate Cilest Tablets 0.25 mg Tablet Oral use Turnhoutseweg 30 Ethinylestradiol 0.035 mg B 2340 Beerse Belgium Cyprus N.V. Organon Desogestrel Marvelon Tablets 0.15 mg Tablet Oral use Kloosterstraat 6 Ethinylestradiol 0.03 mg 5349 AB, Oss The Netherlands Cyprus BAYER HELLAS AG Drospirenone Yasminelle 0.02mg Film-coated tablet Oral use Sorou street 18-20 Ethinylestradiol 3mg Maroussi Athens 15125 Greece

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Cyprus BAYER HELLAS AG Ethinylestradiol Flexyess 0.02 mg Film-coated tablet Oral use Sorou street 18-20 Drospirenone 3 mg Maroussi Athens 15125 Greece Cyprus BAYER HELLAS AG Drospirenone Yaz 0.02mg Film-coated tablet Oral use Sorou street 18-20 Ethinylestradiol 3mg Maroussi Athens 15125 Greece Cyprus N.V. Organon Desogestrel Mercilon tablets 0.15 mg Tablet Oral use Kloosterstraat 6 Ethinylestradiol 0.02 mg 5349 AB, Oss The Netherlands Cyprus N.V. Organon Desogestrel Gracial tablets 0,125 mg/0,030 Tablet Oral use Kloosterstraat 6 Ethinylestradiol mg 5349 AB, Oss 0,025 mg/0,040 The Netherlands mg Cyprus BAYER HELLAS AG Estradiol valerate Qlaira 3 mg Film-coated tablet Oral use Sorou street 18-20 Dienogest 2 mg/2 mg Maroussi 2 mg /3 mg Athens 15125 1 mg Greece Cyprus BAYER HELLAS AG Drospirenone Palandra 0.03mg Film-coated tablet Oral use Sorou street 18-20 Ethinylestradiol 3mg Maroussi Athens 15125 Greece

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Cyprus N.V. Organon Etonogestrel Nuvaring 11.70 mg Vaginal delivery Vaginal use Kloosterstraat 6 Ethinylestradiol 0.120mg/0.015mg 2.70 mg system 5349 AB, Oss per 24 hours,vaginal The Netherlands delivery system Czech Gedeon Richter Plc. Chlormadinone BELARA 2 mg Film-coated tablet Oral use Republic Gyömröí út 19-21 Ethinylestradiol 0,03 mg HU-1103 Budapest Hungary Czech Stada Arzneimittel Chlormadinone BONISSA 0,03 MG/2 2 mg Film-coated tablet Oral use Republic Aktiengesellschaft Ethinylestradiol MG POTAHOVANÉ 0,03 mg Stadastrasse 2/18 TABLETY 61118 Bad Vilbel Germany Czech WH-Pharma s.r.o. Chlormadinone CLORMETIN 2 2 mg Film-coated tablet Oral use Republic Talafusova 970 Ethinylestradiol MG/0,03 MG 0,03 mg 28401 Kutná Hora Czech Republic Czech Teva Pharmaceuticals CR, s.r.o. Chlormadinone ESETE 2 MG/0,03 MG 2 mg Film-coated tablet Oral use Republic Radlická 3185/1c Ethinylestradiol 0,03 mg 150 00 Praha 5 Czech Republic Czech Heaton k.s. Chlormadinone FLAYA 0,030 MG/2 MG 2 mg Film-coated tablet Oral use Republic Na Pankráci 14 Ethinylestradiol POTAHOVANÉ 0,03 mg 14000 Praha 4 TABLETY Czech Republic

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Czech mibe GmbH Arzneimittel Chlormadinone MADINELLE 0,03 2 mg Film-coated tablet Oral use Republic Münchener Str. 15 Ethinylestradiol MG/2 MG 0,03 mg 06796 Brehna Germany Czech Heaton k.s. Desogestrel ADELE 0,15 mg Tablet Oral use Republic Na Pankráci 14 Ethinylestradiol 0,03 mg 14000 Praha 4 Czech Republic Czech Teva Pharmaceuticals CR, s.r.o. Desogestrel ARNETTE 0,15 0,15 mg Tablet Oral use Republic Radlická 3185/1c Ethinylestradiol MG/0,03 MG 0,03 mg 150 00 Praha 5 Czech Republic Czech Teva Pharmaceuticals CR, s.r.o. Desogestrel GAIA 0,15 MG/0,02 0,15 mg Tablet Oral use Republic Radlická 3185/1c Ethinylestradiol MG 0,02 mg 150 00 Praha 5 Czech Republic Czech N.V. Organon Desogestrel GRACIAL 0,04 mg/0,025 mg Tablet Oral use Republic Kloosterstraat 6 Ethinylestradiol 0,03 mg/0,125 mg 5349 AB, Oss The Netherlands Czech N.V. Organon Desogestrel LAURINA 0,03 mg/0,1 mg Film-coated tablet Oral use Republic Kloosterstraat 6 Ethinylestradiol 0,03 mg/0,15 mg 5349 AB, Oss 0,035 mg/0,05 mg The Netherlands Czech N.V. Organon Desogestrel MARVELON 0,15 mg Tablet Oral use Republic Kloosterstraat 6 Ethinylestradiol 0,03 mg 5349 AB, Oss The Netherlands

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Czech N.V. Organon Desogestrel MERCILON 0,15 mg Tablet Oral use Republic Kloosterstraat 6 Ethinylestradiol 0,02 mg 5349 AB, Oss The Netherlands Czech Heaton k.s. Desogestrel NATALYA 0,15 mg Tablet Oral use Republic Na Pankráci 14 Ethinylestradiol 0,02 mg 14000 Praha 4 Czech Republic Czech Gedeon Richter Plc. Desogestrel NOVYNETTE 150 0,15 mg Film-coated tablet Oral use Republic Gyömröí út 19-21 Ethinylestradiol MCG/20 MCG 0,02 mg HU-1103 Budapest POTAHOVANÉ Hungary TABLETY Czech Zentiva, k.s. Desogestrel REGISHA 0,150 0,15 mg Tablet Oral use Republic U kabelovny 130 Ethinylestradiol MG/0,02 MG TABLETY 0,02 mg 102 37 Praha 10 Dolní Měcholupy Czech Republic Czech Zentiva, k.s. Desogestrel REGISHA 0,150 0,15 mg Tablet Oral use Republic U kabelovny 130 Ethinylestradiol MG/0,03 MG TABLETY 0,03 mg 102 37 Praha 10 Dolní Měcholupy Czech Republic Czech Gedeon Richter Plc. Desogestrel REGULON 150 0,15 mg Film-coated tablet Oral use Republic Gyömröí út 19-21 Ethinylestradiol MCG/30 MCG 0,03 mg HU-1103 Budapest POTAHOVANÉ Hungary TABLETY

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Czech Bayer Pharma AG Ethinylestradiol Femoden 0,03 mg Coated tablet Oral use Republic D-13342 Berlin Gestodene 0,075 mg Germany Czech Bayer Pharma AG Estradiol valerate QLAIRA 3 mg Film-coated tablet Oral use Republic D-13342 Berlin Dienogest 2 mg/2 mg Germany 2 mg/3 mg 1 mg Czech VIVAX EuroAsia s.r.o. Dienogest AIDEE 2 MG/0,03 MG 2 mg Film-coated tablet Oral use Republic Karloveske rameno 6 Ethinylestradiol POTAHOVANÉ 0,03 mg 841 01 Bratislava TABLETY Slovensko Czech WH-Pharma s.r.o. Dienogest AYREEN 2 mg Film-coated tablet Oral use Republic Talafusova 970 Ethinylestradiol 0,03 mg 28401 Kutná Hora Czech Republic Czech Zentiva, k.s. Dienogest BONADEA 2 mg Film-coated tablet Oral use Republic U kabelovny 130 Ethinylestradiol 0,03 mg 102 37 Praha 10 Dolní Měcholupy Czech Republic Czech Bayer Pharma AG Dienogest JEANINE 2 mg Coated tablet Oral use Republic D-13342 Berlin Ethinylestradiol 0,03 mg Germany Czech Gedeon Richter Plc. Dienogest MISTRA 2 MG/0,03 2 mg Film-coated tablet Oral use Republic Gyömröí út 19-21 Ethinylestradiol MG POTAHOVANÉ 0,03 mg HU-1103 Budapest TABLETY Hungary

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Czech Teva Pharmaceuticals CR, s.r.o. Dienogest VEREZANA 0,03 MG/2 2 mg Film-coated tablet Oral use Republic Radlická 3185/1c Ethinylestradiol MG POTAHOVANÉ 0,03 mg 150 00 Praha 5 TABLETY Czech Republic Czech STADA Arzneimittel AG Dienogest YANELA 2 mg Film-coated tablet Oral use Republic Stadastrasse 2-18 Ethinylestradiol 0,03 mg D-61118 Bad Vilbel Germany Czech LadeePharma Kft Drospirenone JANGEE 0,03 MG/3 3mg Film-coated tablet Oral use Republic Lajos utca 48-66 Ethinylestradiol MG 28 0,03mg H-1036 Budapest POTAHOVANÝCH Hungary TABLET Czech Gedeon Richter Plc. Drospirenone MAITALON 3 MG/0,03 3mg Film-coated tablet Oral use Republic Gyömröí út 19-21 Ethinylestradiol MG POTAHOVANÉ 0,03mg HU-1103 Budapest TABLETY Hungary Czech Sandoz s.r.o. Drospirenone RHONYA 3 MG/30 3mg Film-coated tablet Oral use Republic Nagano III, Ethinylestradiol MCG 0,03mg U Nákladového nádraží 10 13000 Praha - 3 Czech Republic Czech Zentiva, k.s. Drospirenone SIDRETA 0,03 MG/3 3mg Film-coated tablet Oral use Republic U kabelovny 130 Ethinylestradiol MG POTAHOVANÉ 0,03mg 102 37 Praha 10 TABLETY Dolní Měcholupy Czech Republic

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Czech Teva Pharmaceuticals CR, s.r.o. Drospirenone SOFTINE 0,03 MG/3 3mg Film-coated tablet Oral use Republic Radlická 3185/1c Ethinylestradiol MG POTAHOVANÉ 0,03mg 150 00 Praha 5 TABLETY Czech Republic Czech Bayer Pharma AG Drospirenone SYLVIANE 0,03 MG/3 3mg Film-coated tablet Oral use Republic D-13342 Berlin Ethinylestradiol MG POTAHOVANÉ 0,03mg Germany TABLETY Czech Ivowen Limited Drospirenone WERRCA 3 MG/0,03 3mg Film-coated tablet Oral use Republic 3 Anglesa St Ethinylestradiol MG POTAHOVANÉ 0,03mg Tipperary Clonmel TABLETY Ireland Czech Bayer Pharma AG Drospirenone YADINE 3mg Film-coated tablet Oral use Republic D-13342 Berlin Ethinylestradiol 0,03mg Germany Czech LadeePharma Kft Dienogest DIENILLE 0,03 mg Film-coated tablet Oral use Republic Lajos utca 48-66 Ethinylestradiol POTAHOVANÁ 2 mg H-1036 Budapest TABLETA Hungary Czech Laboratorios Leon Farma SA Dienogest FOXINETTE 2 MG/0,03 0,03 mg Film-coated tablet Oral use Republic Calle La Vallina S/N Ethinylestradiol MG 2 mg Poligono Industrial Navatejera Navatejera, Leon E-24008 Spain

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Czech Sandoz s.r.o. Dienogest FOXINETTE NEO 0,03 mg Film-coated tablet Oral use Republic Nagano III, Ethinylestradiol 2 mg U Nákladového nádraží 10 13000 Praha - 3 Czech Republic Czech Bayer Pharma AG Drospirenone BELANETTE 0,02 0,02 mg Film-coated tablet Oral use Republic D-13342 Berlin Ethinylestradiol MG/3 MG 3 mg Germany POTAHOVANÉ TABLETY Czech Bayer Pharma AG Drospirenone ELOINE 0,02 MG/3 0,02 mg Film-coated tablet Oral use Republic D-13342 Berlin Ethinylestradiol MG POTAHOVANÉ 3 mg Germany TABLETY Czech Bayer Pharma AG Drospirenone FLEXYESS 0,02 MG/3 0,02 mg Film-coated tablet Oral use Republic D-13342 Berlin Ethinylestradiol MG POTAHOVANÉ 3 mg Germany TABLETY Czech Zentiva, k.s. Drospirenone MYWY 0,02 MG/3 MG 0,02 mg Film-coated tablet Oral use Republic U kabelovny 130 Ethinylestradiol 3 mg 102 37 Praha 10 Dolní Měcholupy Czech Republic Czech Sandoz s.r.o. Drospirenone NYSSIELA 3 MG/0,02 0,02 mg Film-coated tablet Oral use Republic Nagano III, Ethinylestradiol MG 3 mg U Nákladového nádraží 10 13000 Praha - 3 Czech Republic

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Czech Zentiva, k.s. Drospirenone SIDRETELLA 0,02 0,02 mg Film-coated tablet Oral use Republic U kabelovny 130 Ethinylestradiol MG/3 MG 3 mg 102 37 Praha 10 POTAHOVANÉ Dolní Měcholupy TABLETY Czech Republic Czech Teva Pharmaceuticals CR, s.r.o. Drospirenone SOFTINELLE 0,02 0,02 mg Film-coated tablet Oral use Republic Radlická 3185/1c Ethinylestradiol MG/3 MG 3 mg 150 00 Praha 5 POTAHOVANÉ Czech Republic TABLETY Czech LadeePharma Kft Drospirenone VELMARI 3 MG/0,02 0,02 mg Film-coated tablet Oral use Republic Lajos utca 48-66 Ethinylestradiol MG 3 mg H-1036 Budapest Hungary Czech Teva Pharmaceuticals CR, s.r.o. Drospirenone VEYANNE 0,02 MG/3 0,02 mg Film-coated tablet Oral use Republic Radlická 3185/1c Ethinylestradiol MG 3 mg 150 00 Praha 5 Czech Republic Czech Bayer Pharma AG Drospirenone YASMINELLE 0,02 0,02 mg Film-coated tablet Oral use Republic D-13342 Berlin Ethinylestradiol MG/3 MG 3 mg Germany POTAHOVANÉ TABLETY Czech Bayer Pharma AG Drospirenone YAZ 0,02 MG/3 MG 0,02 mg Film-coated tablet Oral use Republic D-13342 Berlin Ethinylestradiol POTAHOVANÉ 3 mg Germany TABLETY Czech WH-Pharma s.r.o. Drospirenone YOSEFINNE 0,02 mg Film-coated tablet Oral use Republic Talafusova 970 Ethinylestradiol 3 mg 28401 Kutná Hora Czech Republic

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Czech Gedeon Richter Plc. Drospirenone BELUSHA 3 MG/0,02 0,02 mg Film-coated tablet Oral use Republic Gyömröí út 19-21 Ethinylestradiol MG POTAHOVANÉ 3 mg HU-1103 Budapest TABLETY Hungary Czech Gedeon Richter Plc. Drospirenone DAYLETTE 3 MG/0,02 0,02 mg Film-coated tablet Oral use Republic Gyömröí út 19-21 Ethinylestradiol MG POTAHOVANÉ 3 mg HU-1103 Budapest TABLETY Hungary Czech Gedeon Richter Plc. Drospirenone DAYLLA 3 MG/0,02 0,02 mg Film-coated tablet Oral use Republic Gyömröí út 19-21 Ethinylestradiol MG POTAHOVANÉ 3 mg HU-1103 Budapest TABLETY Hungary Czech LadeePharma Kft Drospirenone JANGEE 0,02 MG/3 0,02 mg Film-coated tablet Oral use Republic Lajos utca 48-66 Ethinylestradiol MG 28 3 mg H-1036 Budapest POTAHOVANÝCH Hungary TABLET Czech Gedeon Richter Plc. Drospirenone KIRGA 3 MG/0,02 MG 0,02 mg Film-coated tablet Oral use Republic Gyömröí út 19-21 Ethinylestradiol POTAHOVANÉ 3 mg HU-1103 Budapest TABLETY Hungary Czech Sandoz s.r.o. Drospirenone RHONYA 3 MG/20 0,02 mg Film-coated tablet Oral use Republic Nagano III, Ethinylestradiol MCG 3 mg U Nákladového nádraží 10 13000 Praha - 3 Czech Republic

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Czech Zentiva, k.s. Gestodene ARTIZIA 0,075 0,075 mg Coated tablet Oral use Republic U kabelovny 130 Ethinylestradiol MG/0,020 MG 0,02 mg 102 37 Praha 10 OBALENÉ TABLETY Dolní Měcholupy Czech Republic Czech Pfizer, spol. s r.o. Gestodene HARMONET OBALENÉ 0,075 mg Coated tablet Oral use Republic Stroupežnického 17 Ethinylestradiol TABLETY 0,02 mg 150 00 Praha 5 Czech Republic Czech Heaton k.s. Gestodene KATYA 0,075 mg Coated tablet Oral use Republic Na Pankráci 14 Ethinylestradiol 0,03 mg 14000 Praha 4 Czech Republic Czech Gedeon Richter Plc. Gestodene LINDYNETTE 20 0,075 mg Coated tablet Oral use Republic Gyömröí út 19-21 Ethinylestradiol 0,02 mg HU-1103 Budapest Hungary Czech Bayer Pharma AG Gestodene LOGEST 0,075 mg Coated tablet Oral use Republic D-13342 Berlin Ethinylestradiol 0,02 mg Germany Czech Bayer Pharma AG Gestodene LUNAFEM 0,075 mg Coated tablet Oral use Republic D-13342 Berlin Ethinylestradiol 0,02 mg Germany Czech Gedeon Richter Plc. Gestodene MILLIGEST OBALENÉ 0.05 mg/0.03 mg Coated tablet Oral use Republic Gyömröí út 19-21 Ethinylestradiol TABLETY 0.07 mg/ 0.04 mg HU-1103 Budapest 0.1 mg/ 0.03 mg Hungary

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Czech Pfizer, spol. s r.o. Gestodene MINESSE 0,06 mg Film-coated tablet Oral use Republic Stroupežnického 17 Ethinylestradiol POTAHOVANÉ 0,015 mg 150 00 Praha 5 TABLETY Czech Republic Czech Pfizer, spol. s r.o. Gestodene MINULET OBALENÉ 0,075 mg Coated tablet Oral use Republic Stroupežnického 17 Ethinylestradiol TABLETY 0,03 mg 150 00 Praha 5 Czech Republic Czech Bayer Pharma AG Gestodene MIRELLE 0,015 mg Film-coated tablet Oral use Republic D-13342 Berlin Ethinylestradiol 0,06 mg Germany Czech Heaton k.s. Gestodene NELYA 0,015 MG/0,06 0,06 mg Film-coated tablet Oral use Republic Na Pankráci 14 Ethinylestradiol MG 0,015 mg 14000 Praha 4 Czech Republic Czech Medico Uno Pharma Kft. Gestodene STODETTE OBALENÉ 0,075 mg Coated tablet Oral use Republic Viadukt u. 12 Ethinylestradiol TABLETY 0,02 mg Biatorbágy 2051 Hungary Czech Heaton k.s. Gestodene SUNYA 0,075 mg Coated tablet Oral use Republic Na Pankráci 14 Ethinylestradiol 0,02 mg 14000 Praha 4 Czech Republic Czech Pfizer, spol. s r.o. Gestodene TRI-MINULET 0,05 mg/ 0,03 mg Coated tablet Oral use Republic Stroupežnického 17 Ethinylestradiol OBALENÉ TABLETY 0,07 mg/ 0,04 mg 150 00 Praha 5 0,1 mg/ 0,03 mg Czech Republic

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Czech Gedeon Richter Plc. Gestodene VIOLETTA 60 0,06 mg Film-coated tablet Oral use Republic Gyömröí út 19-21 Ethinylestradiol MIKROGRAMŮ/15 0,015 mg HU-1103 Budapest MIKROGRAMŮ Hungary POTAHOVANÉ TABLETY Czech LadeePharma Kft Gestodene VONILLE 0,060 0,06 mg Film-coated tablet Oral use Republic Lajos utca 48-66 Ethinylestradiol MG/0,015 MG 0,015 mg H-1036 Budapest Hungary Czech Gedeon Richter Plc. Gestodene ZULFIJA 75 0,075 mg Coated tablet Oral use Republic Gyömröí út 19-21 Ethinylestradiol MIKROGRAMŮ/ 20 0,02 mg HU-1103 Budapest MIKROGRAMŮ Hungary OBALENÉ TABLETY Czech Gedeon Richter Plc. Gestodene ZULFIJA 75 0,075 mg Coated tablet Oral use Republic Gyömröí út 19-21 Ethinylestradiol MIKROGRAMŮ/ 30 0,03 mg HU-1103 Budapest MIKROGRAMŮ Hungary OBALENÉ TABLETY Czech Janssen-Cilag s.r.o. Norgestimate PRAMINO 0.18 mg /0.035 Tablet Oral use Republic Karla Engliše 3201/6 Ethinylestradiol mg 150 00 Praha 5 - Smíchov 0.215 mg /0.035 Czech Republic mg 0.25 mg /0.035 mg

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Czech Janssen-Cilag s.r.o. Norgestimate PRAMINO 28 0,18 mg/ 0,035 Tablet Oral use Republic Karla Engliše 3201/6 Ethinylestradiol mg 150 00 Praha 5 - Smíchov 0,215 mg/ 0,035 Czech Republic mg 0,25 mg/ 0,035 mg Czech Janssen-Cilag s.r.o. Norgestimate CILEST 0,25 mg Tablet Oral use Republic Karla Engliše 3201/6 Ethinylestradiol 0,035 mg 150 00 Praha 5 - Smíchov Czech Republic Czech N.V. Organon Etonogestrel NUVARING 0,120 2,7 mg Vaginal delivery Vaginal use Republic Kloosterstraat 6 Ethinylestradiol MG/0,015 MG ZA 24 11,7 mg system 5349 AB, Oss HODIN, VAGINÁLNÍ The Netherlands INZERT Czech N.V. Organon Etonogestrel Circlet 2.7 mg Vaginal delivery Vaginal use Republic Kloosterstraat 6 Ethinylestradiol 11.7 mg system 5349 AB, Oss The Netherlands Czech Famy Care Europe Ltd. Norgestimate NORGESTIMATE/ETHI 0,25 mg Tablet Oral use Republic 1 Wood Street Ethinylestradiol NYLESTRADIOL 0,035 mg EC2V7WS London FAMYCARE 0,25 United Kingdom MG/0,035 MG TABLETY

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Czech Famy Care Europe Ltd. Dienogest DIENOGEST/ETHINYL 2 mg Film-coated tablet Oral use Republic 1 Wood Street Ethinylestradiol ESTRADIOL 0,03 mg EC2V7WS London FAMYCARE 2,0 United Kingdom MG/0,03 MG POTAHOVANÉ TABLETY Denmark Gedeon Richter Plc. Desogestrel Asphalia 28 0,15 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 0,02 mg HU-1103 Budapest Hungary Denmark Stragen Nordic A/S, Desogestrel Daisynelle 0,15 mg Tablet Oral use Helsingørgade 8C, Ethinylestradiol 0,02 mg DK-3400 Hillerød, Denmark Denmark Stragen Nordic A/S, Desogestrel Daisynelle 0,15 mg Tablet Oral use Helsingørgade 8C, Ethinylestradiol 0,03 mg DK-3400 Hillerød, Denmark Denmark Actavis Group PTC ehf Desogestrel Desogestrel/ethinylest 0,15 mg Tablet Oral use Reykjavikurvegi 76-78 Ethinylestradiol radiol Actavis 0,02 mg 220 Hafnarfjordur Iceland Denmark Actavis Group PTC ehf Desogestrel Desogestrel/ethinylest 0,15 mg Tablet Oral use Reykjavikurvegi 76-78 Ethinylestradiol radiol Actavis 0,03 mg 220 Hafnarfjordur Iceland

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Denmark Sandoz A/S Desogestrel Desorelle 0,15 mg Film-coated tablet Oral use Edward Thomsens Vej 14 Ethinylestradiol 0,03 mg DK-2300 København S Denmark Denmark Stada Arzneimittel AG, Desogestrel Femistad 0,15 mg Tablet Oral use Stadastrasse 2-8, Ethinylestradiol 0,03 mg DE-61118 Bad Vibel, Germany Denmark Stada Arzneimittel AG, Desogestrel Femistad 0,15 mg Tablet Oral use Stadastrasse 2-8, Ethinylestradiol 0,02 mg DE-61118 Bad Vibel, Germany Denmark Medimpex UK Ltd, Desogestrel Gedarel 0,15 mg Tablet Oral use 127 Shirland Road, Ethinylestradiol 0,03 mg London W9 2EP United Kingdom Denmark N.V. Organon Desogestrel Gracial 0,03 mg/0,125 mg Tablet Oral use Kloosterstraat 6 Ethinylestradiol 0,04 mg/0,025 mg 5349 AB, Oss The Netherlands Denmark Gedeon Richter Plc. Desogestrel Hunogidon 0,15 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 0,02 mg HU-1103 Budapest Hungary Denmark Gedeon Richter Plc. Desogestrel Hunogidon 28 0,15 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 0,03 mg HU-1103 Budapest Hungary

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Denmark Gedeon Richter Plc. Desogestrel Hunogidon 28 0,15 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 0,02 mg HU-1103 Budapest Hungary Denmark Medimpex UK Ltd, Desogestrel Igixon 0,15 mg Tablet Oral use 127 Shirland Road, Ethinylestradiol 0,02 mg London W9 2EP United Kingdom Denmark Mylan AB, Desogestrel Lestramyl 0,15 mg Tablet Oral use Postbox 23033, Ethinylestradiol 0,02 mg Ynglingagatan 14, SE-10435 Stockholm, Sweden Denmark Mylan AB, Desogestrel Lestramyl 0,15 mg Tablet Oral use Postbox 23033, Ethinylestradiol 0,03 mg Ynglingagatan 14, SE-10435 Stockholm, Sweden Denmark Gedeon Richter Plc. Desogestrel Leticia 0,15 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 0,03 mg HU-1103 Budapest Hungary Denmark Gedeon Richter Plc. Desogestrel Leticia 28 0,15 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 0,03 mg HU-1103 Budapest Hungary

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Denmark Gedeon Richter Plc. Desogestrel Letione 28 0,15 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 0,03 mg HU-1103 Budapest Hungary Denmark N.V. Organon Desogestrel Marvelon 0,15 mg Tablet Oral use Kloosterstraat 6 Ethinylestradiol 0,03 mg 5349 AB, Oss The Netherlands Denmark N.V. Organon Desogestrel Marvelon 28 0,15 mg Tablet Oral use Kloosterstraat 6 Ethinylestradiol 0,03 mg 5349 AB, Oss The Netherlands Denmark N.V. Organon Desogestrel Mercilon 0,15 mg Tablet Oral use Kloosterstraat 6 Ethinylestradiol 0,02 mg 5349 AB, Oss The Netherlands Denmark Gedeon Richter Plc. Desogestrel Myrzi 0,15 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 0,02 mg HU-1103 Budapest Hungary Denmark Gedeon Richter Plc. Desogestrel Myrzi 28 0,15 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 0,02 mg HU-1103 Budapest Hungary Denmark Sandoz A/S Desogestrel Novynette 0,15 mg Film-coated tablet Oral use Edward Thomsens Vej 14 Ethinylestradiol 0,02 mg DK-2300 København S Denmark

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Denmark Gedeon Richter Plc. Desogestrel Novypil 28 0,15 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 0,02 mg HU-1103 Budapest Hungary Denmark Gedeon Richter Plc. Desogestrel Rigetrux 0,15 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 0,03 mg HU-1103 Budapest Hungary Denmark Gedeon Richter Plc. Desogestrel Rigetrux 28 0,15 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 0,03 mg HU-1103 Budapest Hungary Denmark Gedeon Richter Plc. Desogestrel Vivides 28 0,15 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 0,02 mg HU-1103 Budapest Hungary Denmark Bayer AB Estradiol valerate Qlaira 3 mg Film-coated tablet Oral use Postbox 606 Dienogest 2 mg/2 mg Gustav III's Boulevard 56 2 mg/3 mg SE-16926 Solna 1 mg Sweden Denmark Teva Danmark A/S, Drospirenone Dretine 3mg Film-coated tablet Oral use Parallelvej 10-12, Ethinylestradiol 0,03mg DK-2800 Kongens Lyngby, Denmark

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Denmark Teva Danmark A/S, Drospirenone Dretine 28 3mg Film-coated tablet Oral use Parallelvej 10-12, Ethinylestradiol 0,03mg DK-2800 Kongens Lyngby, Denmark Denmark Laboratorios Leon Farma SA Drospirenone Estron 28 3mg Film-coated tablet Oral use Poligono Industrial Navatejera, Ethinylestradiol 0,03mg La Vallina s/n, 24008 Villaquilambre,Leon Spain Denmark Sandoz A/S Drospirenone Finminette 3mg Film-coated tablet Oral use Edward Thomsens Vej 14 Ethinylestradiol 0,03mg DK-2300 København S Denmark Denmark Orifarm Generics A/S Drospirenone Movinella 3mg Film-coated tablet Oral use Postbox 69 Ethinylestradiol 0,03mg Energivej 15 DK-5260 Odense S Denmark Denmark Orifarm Generics A/S Drospirenone Movinella 28 3mg Film-coated tablet Oral use Postbox 69 Ethinylestradiol 0,03mg Energivej 15 DK-5260 Odense S Denmark Denmark Bayer AB Drospirenone Palandra 3mg Film-coated tablet Oral use Postbox 606 Ethinylestradiol 0,03mg Gustav III's Boulevard 56 SE-16926 Solna Sweden

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Denmark Sandoz A/S Drospirenone Rubira 3mg Film-coated tablet Oral use Edward Thomsens Vej 14 Ethinylestradiol 0,03mg DK-2300 København S Denmark Denmark Bayer Pharma AG Drospirenone Yasmin 3mg Film-coated tablet Oral use D-13342 Berlin Ethinylestradiol 0,03mg Germany Denmark Bayer Pharma AG Drospirenone Yasmin 28 3mg Film-coated tablet Oral use D-13342 Berlin Ethinylestradiol 0,03mg Germany Denmark Teva Danmark A/S, Drospirenone Dretine 0,02 mg Film-coated tablet Oral use Parallelvej 10-12, Ethinylestradiol 3 mg DK-2800 Kongens Lyngby, Denmark Denmark Teva Danmark A/S, Drospirenone Dretine 28 0,02 mg Film-coated tablet Oral use Parallelvej 10-12, Ethinylestradiol 3 mg DK-2800 Kongens Lyngby, Denmark Denmark Teva Danmark A/S, Desogestrel Denise 0.15 mg Film-coated tablet Oral use Parallelvej 10-12, Ethinylestradiol 0.02 mg DK-2800 Kongens Lyngby, Denmark Denmark Teva Danmark A/S, Desogestrel Denise 0.15 mg Film-coated tablet Oral use Parallelvej 10-12, Ethinylestradiol 0.03 mg DK-2800 Kongens Lyngby, Denmark

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Denmark Gedeon Richter Plc. Drospirenone Drosinetta 0,02 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 3 mg HU-1103 Budapest Hungary Denmark Gedeon Richter Plc. Drospirenone Drosinetta 28 0,02 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 3 mg HU-1103 Budapest Hungary Denmark Gedeon Richter Plc. Drospirenone Midiana 0,03 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 3 mg HU-1103 Budapest Hungary Denmark Bayer AB Drospirenone Eloine 0,02 mg Film-coated tablet Oral use Postbox 606 Ethinylestradiol 3 mg Gustav III's Boulevard 56 SE-16926 Solna Sweden Denmark Laboratorios Leon Farma SA Drospirenone Estron 28 0,02 mg Film-coated tablet Oral use Poligono Industrial Navatejera, Ethinylestradiol 3 mg La Vallina s/n, 24008 Villaquilambre,Leon Spain Denmark Sandoz A/S Drospirenone Finminette 0,02 mg Film-coated tablet Oral use Edward Thomsens Vej 14 Ethinylestradiol 3 mg DK-2300 København S Denmark

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Denmark Bayer AB Drospirenone Flexyess 0,02 mg Film-coated tablet Oral use Postbox 606 Ethinylestradiol 3 mg Gustav III's Boulevard 56 SE-16926 Solna Sweden Denmark Bayer Pharma AG Drospirenone Liofora 0,02 mg Film-coated tablet Oral use D-13342 Berlin Ethinylestradiol 3 mg Germany Denmark Orifarm Generics A/S Drospirenone Movinella 0,02 mg Film-coated tablet Oral use Postbox 69 Ethinylestradiol 3 mg Energivej 15 DK-5260 Odense S Denmark Denmark Orifarm Generics A/S Drospirenone Movinella 28 0,02 mg Film-coated tablet Oral use Postbox 69 Ethinylestradiol 3 mg Energivej 15 DK-5260 Odense S Denmark Denmark Gedeon Richter Plc. Drospirenone Perlkala 0,02 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 3 mg HU-1103 Budapest Hungary Denmark Sandoz A/S Drospirenone Rubira 0,02 mg Film-coated tablet Oral use Edward Thomsens Vej 14 Ethinylestradiol 3 mg DK-2300 København S Denmark

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Denmark Sandoz A/S Drospirenone Stefaminelle 0,02 mg Film-coated tablet Oral use Edward Thomsens Vej 14 Ethinylestradiol 3 mg DK-2300 København S Denmark Denmark Teva Danmark A/S, Drospirenone Veyann 0,02 mg Film-coated tablet Oral use Parallelvej 10-12, Ethinylestradiol 3 mg DK-2800 Kongens Lyngby, Denmark Denmark Bayer Pharma AG Drospirenone Yasminelle 0,02 mg Film-coated tablet Oral use D-13342 Berlin Ethinylestradiol 3 mg Germany Denmark Bayer Pharma AG Drospirenone Yasminelle 28 0,02 mg Film-coated tablet Oral use D-13342 Berlin Ethinylestradiol 3 mg Germany Denmark Bayer AB Drospirenone Yaz 0,02 mg Film-coated tablet Oral use Postbox 606 Ethinylestradiol 3 mg Gustav III's Boulevard 56 SE-16926 Solna Sweden Denmark N.V. Organon Etonogestrel NuvaRing 11,7mg Vaginal delivery Vaginal use Kloosterstraat 6 Ethinylestradiol 2,7 mg system 5349 AB, Oss The Netherlands Denmark Gedeon Richter Plc. Gestodene Celia 0,06 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 0,015 mg HU-1103 Budapest Hungary

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Denmark Gedeon Richter Plc. Gestodene Dorinette 0,075 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 0,03 mg HU-1103 Budapest Hungary Denmark Gedeon Richter Plc. Gestodene Edesia 0,075 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 0,02 mg HU-1103 Budapest Hungary Denmark Gedeon Richter Plc. Gestodene Edesia 0,075 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 0,03 mg HU-1103 Budapest Hungary Denmark Gedeon Richter Plc. Gestodene Estinette 0,075 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 0,02 mg HU-1103 Budapest Hungary Denmark Gedeon Richter Plc. Gestodene Gestilla 0,075 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 0,02 mg HU-1103 Budapest Hungary Denmark Stragen Nordic A/S, Gestodene Gestinyl 0,075 mg Film-coated tablet Oral use Helsingørgade 8C, Ethinylestradiol 0,02 mg DK-3400 Hillerød, Denmark Denmark Stragen Nordic A/S, Gestodene Gestinyl 0,075 mg Film-coated tablet Oral use Helsingørgade 8C, Ethinylestradiol 0,03 mg DK-3400 Hillerød, Denmark

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Denmark Mylan S.A.S Gestodene Gestoden/ethinylestra 0,075 mg Film-coated tablet Oral use 117 Allée des Parcs Ethinylestradiol diol 75/20 Mylan 0,02 mg FR-69800 Saint Priest France Denmark Mylan S.A.S Gestodene Gestoden/ethinylestra 0,075 mg Film-coated tablet Oral use 117 Allée des Parcs Ethinylestradiol diol 75/30 Mylan 0,03 mg FR-69800 Saint Priest France Denmark Actavis Group PTC ehf Gestodene Gestoden/ethinylestra 0,075 mg Film-coated tablet Oral use Reykjavikurvegi 76-78 Ethinylestradiol diol Actavis 0,03 mg 220 Hafnarfjordur Iceland Denmark Actavis Group PTC ehf Gestodene Gestoden/ethinylestra 0,075 mg Film-coated tablet Oral use Reykjavikurvegi 76-78 Ethinylestradiol diol Actavis 0,02 mg 220 Hafnarfjordur Iceland Denmark Gedeon Richter Plc. Gestodene Gestoden/ethinylestra 0,06 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol diol Gedion Richter 0,015 mg HU-1103 Budapest Hungary Denmark Ratiopharm GmbH Gestodene Gestodilat 0,075 mg Film-coated tablet Oral use Graf-Arco-Strasse 3 Ethinylestradiol 0,02 mg DE-89079 Ulm Germany Denmark Ratiopharm GmbH Gestodene Gestodilat 0,075 mg Film-coated tablet Oral use Graf-Arco-Strasse 3 Ethinylestradiol 0,03 mg DE-89079 Ulm Germany

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Denmark Sandoz A/S Gestodene Gestonette 0,075 mg Film-coated tablet Oral use Edward Thomsens Vej 14 Ethinylestradiol 0,02 mg DK-2300 København S Denmark Denmark Gedeon Richter Plc. Gestodene Halogest 0,05 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 0,03 mg HU-1103 Budapest Hungary Denmark Pfizer ApS, Gestodene Harmonet 0,075 mg Film-coated tablet Oral use Lautrupvang 8, Ethinylestradiol 0,02 mg DK-2750 Ballerup, Denmark Denmark Sandoz A/S Gestodene Lindynette 0,075 mg Film-coated tablet Oral use Edward Thomsens Vej 14 Ethinylestradiol 0,03 mg DK-2300 København S Denmark Denmark Gedeon Richter Plc. Gestodene Mandolina 0,06 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 0,015 mg HU-1103 Budapest Hungary Denmark Gedeon Richter Plc. Gestodene Melitta 0,075 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 0,03 mg HU-1103 Budapest Hungary Denmark Sandoz A/S Gestodene Milligest 0,05 mg Film-coated tablet Oral use Edward Thomsens Vej 14 Ethinylestradiol 0,03 mg DK-2300 København S Denmark

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Denmark Stragen Nordic A/S, Gestodene Milna 0,075 mg Film-coated tablet Oral use Helsingørgade 8C, Ethinylestradiol 0,03 mg DK-3400 Hillerød, Denmark Denmark Stragen Nordic A/S, Gestodene Milna 0,075 mg Film-coated tablet Oral use Helsingørgade 8C, Ethinylestradiol 0,02 mg DK-3400 Hillerød, Denmark Denmark Bayer Pharma AG Gestodene Milvane 0.05 mg/0.03 mg Film-coated tablet Oral use D-13342 Berlin Ethinylestradiol 0.07 mg/0.04 mg Germany 0.10 mg/0.03 mg Denmark Orifarm Generics A/S Gestodene Minero 0,075 mg Film-coated tablet Oral use Postbox 69 Ethinylestradiol 0,02 mg Energivej 15 DK-5260 Odense S Denmark Denmark Pfizer ApS, Gestodene Minulet 0,075 mg Film-coated tablet Oral use Lautrupvang 8, Ethinylestradiol 0,03 mg DK-2750 Ballerup, Denmark Denmark Orifarm Generics A/S Gestodene Modina 0,075 mg Film-coated tablet Oral use Postbox 69 Ethinylestradiol 0,03 mg Energivej 15 DK-5260 Odense S Denmark

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Denmark Gedeon Richter Plc. Gestodene Varianta 0,06 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 0,015 mg HU-1103 Budapest Hungary Denmark Actavis Group PTC ehf Gestodene Vellena 0,075 mg Film-coated tablet Oral use Reykjavikurvegi 76-78 Ethinylestradiol 0,02 mg 220 Hafnarfjordur Iceland Denmark Actavis Group PTC ehf Gestodene Vellena 0,075 mg Film-coated tablet Oral use Reykjavikurvegi 76-78 Ethinylestradiol 0,03 mg 220 Hafnarfjordur Iceland Denmark Gedeon Richter Plc. Gestodene Vendiol 0,06 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 0,015 mg HU-1103 Budapest Hungary Denmark Gedeon Richter Plc. Gestodene Violetta 0,06 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 0,015 mg HU-1103 Budapest Hungary Denmark Gedeon Richter Plc. Gestodene Zulfija 0,075 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 0,02 mg HU-1103 Budapest Hungary Denmark Gedeon Richter Plc. Gestodene Zulfija 0,075 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 0,03 mg HU-1103 Budapest Hungary

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Denmark Janssen-Cilag A/S, Norgestimate Cilest 0,25 mg Tablet Oral use Hammerbakken 19 Ethinylestradiol 0,035 mg DK-3460 Birkerød Denmark Denmark N.V. Organon Etonogestrel Circlet 11,7 mg Vaginal delivery Vaginal use Kloosterstraat 6 Ethinylestradiol 2,7 mg system 5349 AB, Oss The Netherlands Estonia Gedeon Richter Plc. Chlormadinone BELARA 2 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 0,03 mg HU-1103 Budapest Hungary Estonia Ladee Pharma Baltics UAB Chlormadinone CLORMETIN 2 2 mg Film-coated tablet Oral use Žemaitijos g.13/Šiaulių g.10, Ethinylestradiol MG/0,03 MG 0,03 mg LT-01134 Vilnius Lithuania Estonia N.V. Organon Desogestrel GRACIAL 0,125 mg/0,030 Tablet Oral use Kloosterstraat 6 Ethinylestradiol mg P.O. Box 20 0,025 mg/0,040 5340 BH, Oss mg The Netherlands Estonia N.V. Organon Desogestrel MARVELON 0,15 mg Tablet Oral use Kloosterstraat 6 Ethinylestradiol 0,03 mg P.O. Box 20 5340 BH, Oss The Netherlands

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Estonia N.V. Organon Desogestrel MERCILON 0,15 mg Tablet Oral use Kloosterstraat 6 Ethinylestradiol 0,02 mg P.O. Box 20 5340 BH, Oss The Netherlands Estonia N.V. Organon Etonogestrel Nuvaring 11,7mg Vaginal delivery Vaginal use Kloosterstraat 6 Ethinylestradiol 2,7mg system P.O. Box 20 5340 BH, Oss The Netherlands Estonia Gedeon Richter Plc. Desogestrel NOVYNETTE 0,15 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 0,02 mg HU-1103 Budapest Hungary Estonia Gedeon Richter Plc. Desogestrel NOVYNETTE PLUS 0,15 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 0,02 mg HU-1103 Budapest Hungary Estonia Gedeon Richter Plc. Desogestrel REGULON 0,15 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 0,03 mg HU-1103 Budapest Hungary Estonia Bayer Pharma AG Estradiol valerate QLAIRA 3 mg Film-coated tablet Oral use D-13342 Berlin Dienogest 2 mg/2 mg Germany 2 mg/3 mg 1 mg

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Estonia Orivas UAB Dienogest AMMILY 2 MG / 0,03 2 mg Film-coated tablet Oral use J.Jasinskio 16B Ethinylestradiol MG 0,03 mg LT-01112 Vilinius Lithuania Estonia Bayer Pharma AG Dienogest JEANINE 2 mg Coated tablet Oral use D-13342 Berlin Ethinylestradiol 0,03 mg Germany Estonia Gedeon Richter Plc. Dienogest SIBILLA 2 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 0,03 mg HU-1103 Budapest Hungary Estonia Ladee Pharma Baltics UAB Drospirenone JANGEE 0,03 MG/3 3mg Film-coated tablet Oral use Žemaitijos g.13/Šiaulių g.10, Ethinylestradiol MG 0,03mg LT-01134 Vilnius Lithuania Estonia Laboratorios Leon Farma SA Drospirenone LLUVIEIGHT 0,03 3mg Film-coated tablet Oral use Poligono Industrial Navatejera, Ethinylestradiol MG/3 MG 0,03mg La Vallina s/n, 24008 Villaquilambre,Leon Spain Estonia Ivowen Limited Drospirenone LULINA 3mg Film-coated tablet Oral use 3 Anglesa St Ethinylestradiol 0,03mg Tipperary Clonmel Ireland Estonia Gedeon Richter Plc. Drospirenone MIDIANA 3mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 0,03mg HU-1103 Budapest Hungary

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Estonia Laboratorios Leon Farma SA Drospirenone MINAYEIGHT 0,03 3mg Film-coated tablet Oral use Poligono Industrial Navatejera, Ethinylestradiol MG/3 MG 0,03mg La Vallina s/n, 24008 Villaquilambre,Leon Spain Estonia Bayer Pharma AG Drospirenone YARINA 3mg Film-coated tablet Oral use D-13342 Berlin Ethinylestradiol 0,03mg Germany Estonia Gedeon Richter Plc. Drospirenone ANEEA 0,02 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 3 mg HU-1103 Budapest Hungary Estonia Gedeon Richter Plc. Drospirenone BELUSHA 0,02 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 3 mg HU-1103 Budapest Hungary Estonia Gedeon Richter Plc. Drospirenone DAYLETTE 0,02 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 3 mg HU-1103 Budapest Hungary Estonia Ladee Pharma Baltics UAB Drospirenone JANGEE 0,02 MG/3 0,02 mg Film-coated tablet Oral use Žemaitijos g.13/Šiaulių g.10, Ethinylestradiol MG 3 mg LT-01134 Vilnius Lithuania

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Estonia Laboratorios Leon Farma SA Drospirenone LLUVIEIGHT 0,02 0,02 mg Film-coated tablet Oral use Poligono Industrial Navatejera, Ethinylestradiol MG/3 MG 3 mg La Vallina s/n, 24008 Villaquilambre,Leon Spain Estonia Sandoz d.d. Drospirenone MADELEINE 0,02 mg Film-coated tablet Oral use Verovskova 57 Ethinylestradiol 3 mg SI-1000 Ljubljana Slovenia Estonia Sandoz d.d. Drospirenone MADELEINE 3mg Film-coated tablet Oral use Verovskova 57 Ethinylestradiol 0,03mg SI-1000 Ljubljana Slovenia Estonia Sandoz d.d. Drospirenone MARIONELLE 3mg Film-coated tablet Oral use Verovskova 57 Ethinylestradiol 0,03mg SI-1000 Ljubljana Slovenia Estonia Sandoz d.d. Drospirenone MARIONELLE 0,02 mg Film-coated tablet Oral use Verovskova 57 Ethinylestradiol 3 mg SI-1000 Ljubljana Slovenia Estonia Laboratorios Leon Farma SA Drospirenone MINAYEIGHT 0,02 0,02 mg Film-coated tablet Oral use Poligono Industrial Navatejera, Ethinylestradiol MG/3 MG 3 mg La Vallina s/n, 24008 Villaquilambre,Leon Spain

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Estonia Gedeon Richter Plc. Drospirenone TEENIA 0,02 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 3 mg HU-1103 Budapest Hungary Estonia Ladee Pharma Baltics UAB Drospirenone VELGYN 0,02 mg Film-coated tablet Oral use Žemaitijos g.13/Šiaulių g.10, Ethinylestradiol 3 mg LT-01134 Vilnius Lithuania Estonia Bayer Pharma AG Drospirenone YASMINELLE 0,02 mg Film-coated tablet Oral use D-13342 Berlin Ethinylestradiol 3 mg Germany Estonia Bayer Pharma AG Drospirenone YAZ 0,02 mg Film-coated tablet Oral use D-13342 Berlin Ethinylestradiol 3 mg Germany Estonia Bayer Pharma AG Drospirenone YVIDUALLY 0,02 mg Film-coated tablet Oral use D-13342 Berlin Ethinylestradiol 3 mg Germany Estonia Gedeon Richter Plc. Gestodene EDESIA 0,075 mg Coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 0,02 mg HU-1103 Budapest Hungary Estonia Bayer Pharma AG Gestodene FEMODEN 0,075 mg Coated tablet Oral use D-13342 Berlin Ethinylestradiol 0,03 mg Germany Estonia Ratiopharm GmbH Gestodene GESYTIL 75/20 0,075 mg Coated tablet Oral use Graf-Arco-Strasse 3 Ethinylestradiol MIKROGRAMMI 0,02 mg DE-89079 Ulm Germany

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Estonia Ratiopharm GmbH Gestodene GESYTIL 75/30 0,075 mg Coated tablet Oral use Graf-Arco-Strasse 3 Ethinylestradiol MIKROGRAMMI 0,03 mg DE-89079 Ulm Germany Estonia Pfizer Europe MA EEIG Gestodene HARMONET 0,075 mg Coated tablet Oral use Ramsgate Road Ethinylestradiol 0,02 mg Sandwich Kent CT13 9NJ United Kingdom Estonia Gedeon Richter Plc. Gestodene LINDYNETTE 20 0,075 mg Coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 0,02 mg HU-1103 Budapest Hungary Estonia Gedeon Richter Plc. Gestodene LINDYNETTE 30 0,075 mg Coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 0,03 mg HU-1103 Budapest Hungary Estonia Bayer Pharma AG Gestodene LOGEST 0,075 mg Coated tablet Oral use D-13342 Berlin Ethinylestradiol 0,02 mg Germany Estonia Pfizer Europe MA EEIG Gestodene MINULET 0,075 mg Coated tablet Oral use Ramsgate Road Ethinylestradiol 0,03 mg Sandwich Kent CT13 9NJ United Kingdom Estonia Bayer Pharma AG Gestodene MIRELLE 0,06 mg Film-coated tablet Oral use D-13342 Berlin Ethinylestradiol 0,015 mg Germany

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Estonia Gedeon Richter Plc. Gestodene VIOLETTA 0,06 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 0,015 mg HU-1103 Budapest Hungary Estonia Ladee Pharma Baltics UAB Gestodene VONILLE 0,06 mg Film-coated tablet Oral use Žemaitijos g.13/Šiaulių g.10, Ethinylestradiol 0,015 mg LT-01134 Vilnius Lithuania Estonia Gedeon Richter Plc. Gestodene ZULFIJA 0,075 mg Coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 0,02 mg HU-1103 Budapest Hungary Estonia UAB „Johnson & Johnson“ Norgestimate Cilest 0,25mg Tablet oral use Geležinio Vilko g. 18A Ethinylestradiol 0,035mg LT-08104 Vilnius Lithuania Estonia Teva Pharma BV Desogestrel DESTELE 0,15 mg Tablet Oral use Computerweg 10 Ethinylestradiol 0,02 mg 3542 DR Utrecht The Netherlands Estonia Teva Pharma BV Desogestrel DESTELE 0,15 mg Tablet Oral use Computerweg 10 Ethinylestradiol 0,03 mg 3542 DR Utrecht The Netherlands Finland Stragen Nordic A/S Desogestrel DAISYNELLE 0,15 mg Tablet Oral use Hesselvej 41 Ganlose Ethinylestradiol 0,02 mg 3660 Stenlose Denmark

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Finland Gedeon Richter Plc. Desogestrel DESODIOLCONT 0,15 mg Tablet Oral use Gyömröí út 19-21 Ethinylestradiol 0,02 mg HU-1103 Budapest Hungary Finland N.V. Organon Desogestrel GRACIAL 0.03 mg/0.125 mg Tablet Oral use Kloosterstraat 6 Ethinylestradiol 0.04 mg/0.025 mg 5349 AB, Oss The Netherlands Finland N.V. Organon Desogestrel LAURINA 0.035 mg/0.05 mg Film-coated tablet Oral use Kloosterstraat 6 Ethinylestradiol 0.03 mg/0.1 mg 5349 AB, Oss 0.03 mg/0.15 mg The Netherlands Finland N.V. Organon Desogestrel LAURINA 28 0.035 mg/0.05 mg Film-coated tablet Oral use Kloosterstraat 6 Ethinylestradiol 0.03 mg/0.1 mg 5349 AB, Oss 0.03 mg/0.15 mg The Netherlands Finland N.V. Organon Etonogestrel CIRCLET 11,7 mg Vaginal delivery Vaginal use Kloosterstraat 6 Ethinylestradiol 2,7 mg system 5349 AB, Oss The Netherlands Finland Mylan AB Desogestrel LESTRAMYL 0,15 mg Tablet Oral use Box 23033 Ethinylestradiol 0,02 mg 10435 Stockholm Sweden Finland Mylan AB Desogestrel LESTRAMYL 0,15 mg Tablet Oral use Box 23033 Ethinylestradiol 0,03 mg 10435 Stockholm Sweden

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Finland N.V. Organon Desogestrel MARVELON 0,15 mg Tablet Oral use Kloosterstraat 6 Ethinylestradiol 0,03 mg 5349 AB, Oss The Netherlands Finland Organon (Ireland) Ltd, Desogestrel MERCILON 0,15 mg Tablet Oral use PO Box 2857, Ethinylestradiol 0,02 mg Drynam Road, Swords, Co.Dublin, Ireland Finland Gedeon Richter Plc. Desogestrel NOVYNETTE (28) 0,15 mg Tablet Oral use Gyömröí út 19-21 Ethinylestradiol 0,02 mg HU-1103 Budapest Hungary Finland Gedeon Richter Plc. Desogestrel RIGETRUX (28) 0,15 mg Tablet Oral use Gyömröí út 19-21 Ethinylestradiol 0,03 mg HU-1103 Budapest Hungary Finland Gedeon Richter Plc. Desogestrel SABLONA (28) 0,15 mg Tablet Oral use Gyömröí út 19-21 Ethinylestradiol 0,03 mg HU-1103 Budapest Hungary Finland BAYER OY Estradiol valerate QLAIRA 3 mg Film-coated tablet Oral use Pansiontie 47 Dienogest 2 mg/2 mg PL 415 2 mg/3 mg 20210 Turku 1 mg Finland

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Finland BAYER OY Drospirenone FLEXYESS 0,02 mg Film-coated tablet Oral use Pansiontie 47 Ethinylestradiol 3 mg PL 415 20210 Turku Finland Finland Teva Sweden AB Drospirenone DRETINE 3mg Tablet Oral use Järnvägsgatan 11 Ethinylestradiol 0,03mg Box 1070 25110 Helsingborg Sweden Finland Orifarm Generics A/S Drospirenone ETHINYLESTRADIOL/D 3 mg Tablet Oral use Postbox 69 Ethinylestradiol ROSPIRENON 0.020 mg/0.030 Energivej 15 ORIFARM mg DK-5260 Odense S Denmark Finland Orifarm Generics A/S Drospirenone MOVINELLA 3 mg/0.020 mg Film-coated tablet Oral use Postbox 69 Ethinylestradiol 3 mg/0.030 mg Energivej 15 DK-5260 Odense S Denmark Finland Gedeon Richter Plc. Drospirenone ETHINYLESTRADIOL/D 3mg Tablet Oral use Gyömröí út 19-21 Ethinylestradiol ROSPIRENONE 0,03mg HU-1103 Budapest RICHTER Hungary

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Finland LEON FARMA Drospirenone LLUVIANE 3 mg Tablet Oral use C/ La Vallina s/n, Pol. Ind., Ethinylestradiol 0.020 mg/0.030 Navatejera mg 24008 León Spain Finland BAYER OY Drospirenone PALANDRA 3mg Film-coated tablet Oral use Pansiontie 47 Ethinylestradiol 0,03mg PL 415 20210 Turku Finland Finland Gedeon Richter Plc. Drospirenone PERLITA 3mg Tablet Oral use Gyömröí út 19-21 Ethinylestradiol 0,03mg HU-1103 Budapest Hungary Finland Sandoz A/S Drospirenone RUBIRA 3mg Tablet Oral use Edward Thomsens Vej 14 Ethinylestradiol 0,03mg DK-2300 København S Denmark Finland Sandoz A/S Drospirenone TASMINETTA 3 mg Tablet Oral use Edward Thomsens Vej 14 Ethinylestradiol 0.020 mg/0.030 DK-2300 København S mg Denmark Finland BAYER OY Drospirenone YASMIN 3mg Film-coated tablet Oral use Pansiontie 47 Ethinylestradiol 0,03mg PL 415 20210 Turku Finland

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Finland Orifarm Oy Drospirenone YASMIN 3mg Tablet Oral use Metsänneidonkuja 10 Ethinylestradiol 0,03mg 02130 Espoo Finland Finland Orifarm Oy Desogestrel MERCILON 0,15 mg/0,02 mg Tablet Oral use Metsänneidonkuja 10 Ethinylestradiol 02130 Espoo Finland Finland Teva Sweden AB Drospirenone DRETINELLE 0,02 mg Tablet Oral use Järnvägsgatan 11 Ethinylestradiol 3 mg Box 1070 25110 Helsingborg Sweden Finland Gedeon Richter Plc. Drospirenone DROSINETTE 0,02 mg Tablet Oral use Gyömröí út 19-21 Ethinylestradiol 3 mg HU-1103 Budapest Hungary Finland BAYER OY Drospirenone LINATERA 0,02 mg Film-coated tablet Oral use Pansiontie 47 Ethinylestradiol 3 mg PL 415 20210 Turku Finland Finland BAYER OY Drospirenone LIOFORA 0,02 mg Film-coated tablet Oral use Pansiontie 47 Ethinylestradiol 3 mg PL 415 20210 Turku Finland

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Finland Sandoz A/S Drospirenone RUBIRA 0,02 mg Tablet Oral use Edward Thomsens Vej 14 Ethinylestradiol 3 mg DK-2300 København S Denmark Finland Sandoz A/S Drospirenone STEFAMINELLE 0,02 mg Tablet Oral use Edward Thomsens Vej 14 Ethinylestradiol 3 mg DK-2300 København S Denmark Finland Ratiopharm GmbH Drospirenone VEYANN 0,02 mg Tablet Oral use Graf-Arco-Strasse 3 Ethinylestradiol 3 mg DE-89079 Ulm Germany Finland BAYER OY Drospirenone YASMINELLE 0,02 mg Film-coated tablet Oral use Pansiontie 47 Ethinylestradiol 3 mg PL 415 20210 Turku Finland Finland BAYER OY Drospirenone YAZ 0,02 mg Film-coated tablet Oral use Pansiontie 47 Ethinylestradiol 3 mg PL 415 20210 Turku Finland Finland N.V. Organon Etonogestrel NUVARING 11,7 mg Vaginal delivery Vaginal use Kloosterstraat 6 Ethinylestradiol 2,7 mg system 5349 AB, Oss The Netherlands

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Finland BAYER OY Gestodene FEMODEN 0,075 mg Coated tablet Oral use Pansiontie 47 Ethinylestradiol 0,03 mg PL 415 20210 Turku Finland Finland Paranova Oy Desogestrel MARVELON 0,15 mg Tablet Oral use Rajatorpantie 41 C Ethinylestradiol 0,03 mg 01640 Vantaa Finland Finland Paranova Oy Desogestrel MERCILON 0,15 mg Tablet Oral use Rajatorpantie 41 C Ethinylestradiol 0,02 mg 01640 Vantaa Finland Finland Paranova Oy Drospirenone YASMIN 3mg Tablet Oral use Rajatorpantie 41 C Ethinylestradiol 0,03mg 01640 Vantaa Finland Finland Paranova Oy Gestodene MELIANE 0,075 mg Coated tablet Oral use Rajatorpantie 41 C Ethinylestradiol 0,02 mg 01640 Vantaa Finland Finland Paranova Oy Gestodene MINULET 0,075 mg Tablet Oral use Rajatorpantie 41 C Ethinylestradiol 0,03 mg 01640 Vantaa Finland

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Finland Paranova Oy Gestodene HARMONET 0,075 mg Tablet Oral use Rajatorpantie 41 C Ethinylestradiol 0,02 mg 01640 Vantaa Finland Finland Paranova Oy Gestodene FEMODEN 0,075 mg Coated tablet Oral use Rajatorpantie 41 C Ethinylestradiol 0,03 mg 01640 Vantaa Finland Finland Stragen Nordic A/S Gestodene GESTINYL 0.075mg Tablet Oral use Hesselvej 41 Ganlose Ethinylestradiol 0.020/0.030 mg 3660 Stenlose Denmark Finland Actavis Group PTC ehf Gestodene GESTODEN/ETHINYLE 0.075mg Tablet Oral use Reykjavikurvegi 76-78 Ethinylestradiol STRADIOL ACTAVIS 0.020/0.030 mg 220 Hafnarfjordur Iceland Finland Ratiopharm GmbH Gestodene GESTODILAT 0.075mg Tablet Oral use Graf-Arco-Strasse 3 Ethinylestradiol 0.020/0.030 mg DE-89079 Ulm Germany Finland PFIZER Oy Gestodene HARMONET 0,075 mg Tablet Oral use Tietokuja 4 Ethinylestradiol 0,02 mg 00330 Helsinki Finland

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Finland BAYER OY Gestodene MELIANE 0,075 mg Coated tablet Oral use Pansiontie 47 Ethinylestradiol 0,02 mg PL 415 20210 Turku Finland Finland Orifarm Generics A/S Gestodene MINERO 0,075 mg Tablet Oral use Postbox 69 Ethinylestradiol 0,02 mg Energivej 15 DK-5260 Odense S Denmark Finland PFIZER Oy Gestodene MINULET 0,075 mg Tablet Oral use Tietokuja 4 Ethinylestradiol 0,03 mg 00330 Helsinki Finland Finland BAYER OY Gestodene MIRELLE 0,06 mg Film-coated tablet Oral use Pansiontie 47 Ethinylestradiol 0,015 mg PL 415 20210 Turku Finland Finland Orifarm Generics A/S Gestodene MODINA 0,075 mg Tablet Oral use Postbox 69 Ethinylestradiol 0,03 mg Energivej 15 DK-5260 Odense S Denmark

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Finland BAYER OY Gestodene TRI-FEMODEN 0,05 mg/0,07 Coated tablet Oral use Pansiontie 47 Ethinylestradiol mg/0,1 mg PL 415 0,03 mg/0.04 20210 Turku mg/0,03 mg Finland Finland JANSSEN-CILAG OY Norgestimate CILEST, CILEST 28 0,25 mg Tablet Oral use Vaisalantie 2 Ethinylestradiol 0,035 mg 02130 Espoo Finland Finland Ratiopharm GmbH Desogestrel DENISE 0,15 mg/0,02 mg Tablet Oral use Graf-Arco-Strasse 3 Ethinylestradiol DE-89079 Ulm Germany Finland Actavis Group PTC ehf Desogestrel BENIDETTE 0,15 mg Tablet Oral use Reykjavikurvegi 76-78 Ethinylestradiol 0,02 mg 220 Hafnarfjordur Iceland Finland Actavis Group PTC ehf Desogestrel BENIFEMA 0,15 mg Tablet Oral use Reykjavikurvegi 76-78 Ethinylestradiol 0,03 mg 220 Hafnarfjordur Iceland France Gedeon Richter Plc. Chlormadinone Balanca 2 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 0,03 mg HU-1103 Budapest Hungary

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

France Gedeon Richter Plc. Chlormadinone Balancacontinu 2 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 0,03 mg HU-1103 Budapest Hungary France Gedeon Richter Plc. Chlormadinone Belara 2 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 0,03 mg HU-1103 Budapest Hungary France Gedeon Richter Plc. Chlormadinone Belaracontinu 2 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 0,03 mg HU-1103 Budapest Hungary France Arrow génériques SAS Chlormadinone Chlormadinone 2 mg Film-coated tablet Oral use 26 Avenue Tony Garnier Ethinylestradiol Ethinylestradiol 0,03 mg 69007 Lyon Actavis 2 mg/0.03 mg France France IDD (International Drug Desogestrel Desiol 20 0,15 mg Tablet Oral use Development) Ethinylestradiol 0,02 mg 5, rue Simonet 75013 Paris France France IDD (International Drug Desogestrel Desiol 30 0,15 mg Tablet Oral use Development) Ethinylestradiol 0,02 mg 5, rue Simonet 75013 Paris France

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

France EFFIK Desogestrel Desobel 150/20 0,15 mg Tablet Oral use 9-11 rue Jeanne Braconnier Ethinylestradiol 0,02 mg Bâtiment « Le Newton » 92366 Meudon la Foret cedex France France EFFIK Desogestrel Desobel 150/30 0,15 mg Tablet Oral use 9-11 rue Jeanne Braconnier Ethinylestradiol 0,03 mg Bâtiment « Le Newton » 92366 Meudon la Foret cedex France France BIOGARAN Desogestrel Desogestrel 0,15 mg Film-coated tablet Oral use 15 Bd Charles de Gaulle Ethinylestradiol Ethinylestradiol 0,02 mg 92700 Colombes BIOGARAN 150/20 France France BIOGARAN Desogestrel Desogestrel 0,15 mg Film-coated tablet Oral use 15 Bd Charles de Gaulle Ethinylestradiol Ethinylestradiol 0,03 mg 92700 Colombes BIOGARAN 150/30 France France IDD (International Drug Desogestrel Desogestrel 0,15 mg Tablet Oral use Development) Ethinylestradiol Ethinylestradiol IDD 0,02 mg 5, rue Simonet 150/20 75013 Paris France France IDD (International Drug Desogestrel Desogestrel 0,15 mg Tablet Oral use Development) Ethinylestradiol Ethinylestradiol IDD 0,03 mg 5, rue Simonet 150/30 75013 Paris France

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

France IDD (International Drug Desogestrel Desogestrel 0,15 mg Tablet Oral use Development) Ethinylestradiol Ethinylestradiol 0,03 mg 5, rue Simonet IDETEC 150/20 75013 Paris France France IDD (International Drug Desogestrel Desogestrel 0,15 mg Tablet Oral use Development) Ethinylestradiol Ethinylestradiol 0,03 mg 5, rue Simonet IDETEC 150/30 75013 Paris France France EFFIK Desogestrel Desogestrel 0,15 mg Tablet Oral use 9-11 rue Jeanne Braconnier Ethinylestradiol Ethinylestradiol Quill 0,02 mg Bâtiment « Le Newton » 150/20 92366 Meudon la Foret cedex France France EFFIK Desogestrel Desogestrel 0,15 mg Tablet Oral use 9-11 rue Jeanne Braconnier Ethinylestradiol Ethinylestradiol Quill 0,03 mg Bâtiment « Le Newton » 150/30 92366 Meudon la Foret cedex France France TEVA SANTE Desogestrel Desogestrel 0,15 mg Tablet Oral use 110 Esplanade du Général de Ethinylestradiol Ethinylestradiol TEVA 0,02 mg Gaulle 150/20 92931 Paris la Defense Cedex France

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

France TEVA SANTE Desogestrel Desogestrel 0,15 mg Tablet Oral use 110 Esplanade du Général de Ethinylestradiol Ethinylestradiol TEVA 0,03 mg Gaulle 150/30 92931 Paris la Defense Cedex France France EFFIK Desogestrel Desogestrel 0,15 mg Tablet Oral use 9-11 rue Jeanne Braconnier Ethinylestradiol Ethinylestradiol 0,02 mg Bâtiment « Le Newton » Turner 150/20 92366 Meudon la Foret cedex France France EFFIK Desogestrel Desogestrel 0,15 mg Tablet Oral use 9-11 rue Jeanne Braconnier Ethinylestradiol Ethinylestradiol 0,03 mg Bâtiment « Le Newton » Turner 150/30 92366 Meudon la Foret cedex France France SANOFI AVENTIS FRANCE Desogestrel Desogestrel 0,15 mg Tablet Oral use 1-13 boulevard Romain Rolland Ethinylestradiol Ethinylestradiol 0,02 mg 75014 Paris ZENTIVA 150/20 France France SANOFI AVENTIS FRANCE Desogestrel Desogestrel 0,15 mg Tablet Oral use 1-13 boulevard Romain Rolland Ethinylestradiol Ethinylestradiol 0,03 mg 75014 Paris ZENTIVA 150/30 France France Laboratoires Majorelle Desogestrel Desopharm 150/20 0,15 mg Tablet Oral use 12 Rue de Berri Ethinylestradiol 0,02 mg F-75008 Paris France

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

France Laboratoires Majorelle Desogestrel Desopharm 150/30 0,15 mg Tablet Oral use 12 Rue de Berri Ethinylestradiol 0,03 mg F-75008 Paris France France IDD (International Drug Desogestrel Desyl 20 0,15 mg Tablet Oral use Development) Ethinylestradiol 0,02 mg 5, rue Simonet 75013 Paris France France IDD (International Drug Desogestrel Desyl 30 0,15 mg Tablet Oral use Development) Ethinylestradiol 0,03 mg 5, rue Simonet 75013 Paris France France MSD France Desogestrel Mercilon 0,15 mg Tablet Oral use 34 avenue Léonard de Vinci Ethinylestradiol 0,02 mg 92418 Courbevoie Cedex France France MSD France Desogestrel Mirtinu 150/30 0,15 mg Film-coated tablet Oral use 34 avenue Léonard de Vinci Ethinylestradiol 0,03 mg 92418 Courbevoie Cedex France France PFIZER HOLDING France Desogestrel Novantica 150/20 0,15 mg Film-coated tablet Oral use 23-25 avenue du Docteur Ethinylestradiol 0,02 mg Lannelongue 75668 PARIS Cedex 14 France

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

France PFIZER HOLDING France Desogestrel Novantica 150/30 0,15 mg Film-coated tablet Oral use 23-25 avenue du Docteur Ethinylestradiol 0,03 mg Lannelongue 75668 PARIS Cedex 14 France France CHEMICAL FARMA Desogestrel Ovulasten 20 0,15 mg Tablet Oral use 3, Quai Louis Blériot Ethinylestradiol 0,02 mg 75016 Paris France France CHEMICAL FARMA Desogestrel Ovulasten 30 0,15 mg Tablet Oral use 3, Quai Louis Blériot Ethinylestradiol 0,03 mg 75016 Paris France France MSD France Desogestrel varnoline 0,15 mg Tablet Oral use 34 avenue Léonard de Vinci Ethinylestradiol 0,03 mg 92418 Courbevoie Cedex France France MSD France Desogestrel varnoline continu 0,15 mg Film-coated tablet Oral use 34 avenue Léonard de Vinci Ethinylestradiol 0,03 mg 92418 Courbevoie Cedex France France Bayer Sante Estradiol valerate Qlaira 3 mg Film-coated tablet Oral use 220 avenue de la Recherche Dienogest 2 mg/2 mg 59120 Loos 2 mg/3 mg France 1 mg

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

France Bayer Sante Drospirenone Convuline 3mg Film-coated tablet Oral use 220 avenue de la Recherche Ethinylestradiol 0,03mg 59120 Loos France France EFFIK Drospirenone Drospibel 3mg Film-coated tablet Oral use 9-11 rue Jeanne Braconnier Ethinylestradiol 0,03mg/3mg 0,03mg Bâtiment « Le Newton » 92366 Meudon la Foret cedex France France BIOGARAN Drospirenone Drospirenone 3mg Film-coated tablet Oral use 15 Bd Charles de Gaulle Ethinylestradiol Ethinylestradiol 0,03mg 92700 Colombes BIOGARAN 3mg/30µg France France Bayer Sante Drospirenone Jasmine 3mg Film-coated tablet Oral use 220 avenue de la Recherche Ethinylestradiol 0,03mg 59120 Loos France France Bayer Sante Drospirenone Palandra 0,03mg/3mg 3mg Film-coated tablet Oral use 220 avenue de la Recherche Ethinylestradiol 0,03mg 59120 Loos France France Laboratorios Leon Farma SA Drospirenone Bellmunt 3mg Film-coated tablet Oral use Poligono Industrial Navatejera, Ethinylestradiol 0,03mg La Vallina s/n, 24008 Villaquilambre,Leon Spain

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

France SANDOZ Drospirenone Drospirenone 3mg Film-coated tablet Oral use 49 avenue Georges Pompidou Ethinylestradiol Ethinylestradiol GNR 0,03mg 92593 Levellois-Perret Cedex 3mg/30µg France France SANDOZ Drospirenone Drospirenone 3mg Film-coated tablet Oral use 49 avenue Georges Pompidou Ethinylestradiol Ethinylestradiol 0,03mg 92593 Levellois-Perret Cedex SANDOZ 3mg/30µg France France TEVA SANTE Drospirenone Drospirenone 3 mg Film-coated tablet Oral use 110 Esplanade du Général de Ethinylestradiol Ethinylestradiol TEVA 0,020 mg Gaulle 3mg/20µg 92931 Paris la Defense Cedex France France TEVA SANTE Drospirenone Drospirenone 3 mg Film-coated tablet Oral use 110 Esplanade du Général de Ethinylestradiol Ethinylestradiol TEVA 0,020 mg Gaulle 3mg/30µg 92931 Paris la Defense Cedex France France TEVA SANTE Drospirenone Drospirenone 3 mg Film-coated tablet Oral use 110 Esplanade du Général de Ethinylestradiol Ethinylestradiol TEVA 0,020 mg Gaulle SANTE 3mg/20µg 92931 Paris la Defense Cedex France France EFFIK Drospirenone Naiwanel 3mg Film-coated tablet Oral use 9-11 rue Jeanne Braconnier Ethinylestradiol 0,03mg/3mg 0,03mg Bâtiment « Le Newton » 92366 Meudon la Foret cedex France

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

France Bayer Sante Drospirenone Belanette 0,02 mg Film-coated tablet Oral use 220 avenue de la Recherche Ethinylestradiol 3 mg 59120 Loos France France EFFIK Drospirenone Drospibel 0,02 mg Film-coated tablet Oral use 9-11 rue Jeanne Braconnier Ethinylestradiol 0,02mg/3mg 3 mg Bâtiment « Le Newton » 92366 Meudon la Foret cedex France France BIOGARAN Drospirenone Drospirenone 0,02 mg Film-coated tablet Oral use 15 Bd Charles de Gaulle Ethinylestradiol Ethinylestradiol 3 mg 92700 Colombes BIOGARAN 3mg/20µg France France BIOGARAN Drospirenone Drospirenone 0,02 mg Film-coated tablet Oral use 15 Bd Charles de Gaulle Ethinylestradiol Ethinylestradiol 3 mg 92700 Colombes BIOGARAN CONTINU France 3mg/20µg France SANDOZ Drospirenone Drospirenone 0,02 mg Film-coated tablet Oral use 49 avenue Georges Pompidou Ethinylestradiol Ethinylestradiol GNR 3 mg 92593 Levallois-Perret Cedex 3mg/20µg France France SANDOZ Drospirenone Drospirenone 0,02 mg Film-coated tablet Oral use 49 avenue Georges Pompidou Ethinylestradiol Ethinylestradiol 3 mg 92593 Levallois-Perret Cedex SANDOZ 3mg/20µg France

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

France Laboratorios Leon Farma SA Drospirenone Iren 0,02 mg Film-coated tablet Oral use Poligono Industrial Navatejera, Ethinylestradiol 3 mg La Vallina s/n, 24008 Villaquilambre,Leon Spain France Bayer Sante Drospirenone Jasminellecontinu 0,02 mg Film-coated tablet Oral use 220 avenue de la Recherche Ethinylestradiol 3 mg 59120 Loos France France Bayer Sante Drospirenone Jasminelle 0,02 mg Film-coated tablet Oral use 220 avenue de la Recherche Ethinylestradiol 3 mg 59120 Loos France France EFFIK Drospirenone Naiwanel 0,02 mg Film-coated tablet Oral use 9-11 rue Jeanne Braconnier Ethinylestradiol 0,02mg/3mg 3 mg Bâtiment « Le Newton » 92366 Meudon la Foret cedex France France Bayer Sante Drospirenone Rimendia 0,02 mg Film-coated tablet Oral use 220 avenue de la Recherche Ethinylestradiol 3 mg 59120 Loos France France Laboratorios Leon Farma SA Drospirenone Vallclara 0,02 mg Film-coated tablet Oral use Poligono Industrial Navatejera, Ethinylestradiol 3 mg La Vallina s/n, 24008 Villaquilambre,Leon Spain

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

France Bayer Sante Drospirenone Yaz 0,02 mg Film-coated tablet Oral use 220 avenue de la Recherche Ethinylestradiol 3 mg 59120 Loos France France MSD France Etonogestrel Circlet 11.70 mg Vaginal delivery Vaginal use 34 avenue Léonard de Vinci Ethinylestradiol 2.7 mg system 92418 Courbevoie Cedex France France MSD France Etonogestrel Nuvaring 11.70 mg Vaginal delivery Vaginal use 34 avenue Léonard de Vinci Ethinylestradiol 2.7 mg system 92418 Courbevoie Cedex France France EFFIK Gestodene Carlin 60/15 0,06 mg Film-coated tablet Oral use 9-11 rue Jeanne Braconnier Ethinylestradiol 0,015 mg Bâtiment « Le Newton » 92366 Meudon la Foret cedex France France EFFIK Gestodene Carlin 75/20 0,075 mg Film-coated tablet Oral use 9-11 rue Jeanne Braconnier Ethinylestradiol 0,02 mg Bâtiment « Le Newton » 92366 Meudon la Foret cedex France France EFFIK Gestodene Carlin 75/30 0,075 mg Film-coated tablet Oral use 9-11 rue Jeanne Braconnier Ethinylestradiol 0,03 mg Bâtiment « Le Newton » 92366 Meudon la Foret cedex France

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

France Mylan S.A.S Gestodene Edenelle 0,06 mg Film-coated tablet Oral use 117 Allée des Parcs Ethinylestradiol 0,015 mg FR-69800 Saint Priest France France Mylan S.A.S Gestodene Efezial 75/20 0,075 mg Film-coated tablet Oral use 117 Allée des Parcs Ethinylestradiol 0,02 mg FR-69800 Saint Priest France France Mylan S.A.S Gestodene Efezial 75/30 0,075 mg Film-coated tablet Oral use 117 Allée des Parcs Ethinylestradiol 0,03 mg FR-69800 Saint Priest France France CHEMICAL FARMA Gestodene Elleogeste 60/15 0,06 mg Film-coated tablet Oral use 3, Quai Louis Blériot Ethinylestradiol 0,015 mg 75016 Paris France France Laboratoires Majorelle Gestodene Gespharm 75/20 0,075 mg Film-coated tablet Oral use 12 Rue de Berri Ethinylestradiol 0,02 mg F-75008 Paris France France Laboratoires Majorelle Gestodene Gespharm 75/30 0,075 mg Film-coated tablet Oral use 12 Rue de Berri Ethinylestradiol 0,03 mg F-75008 Paris France France Arrow génériques SAS Gestodene Gestodene 0,075 mg Film-coated tablet Oral use 26 Avenue Tony Garnier Ethinylestradiol Ethinylestradiol 75/20 0,02 mg 69007 Lyon France

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

France Arrow génériques SAS Gestodene Gestodene 0,075 mg Film-coated tablet Oral use 26 Avenue Tony Garnier Ethinylestradiol Ethinylestradiol 75/30 0,03 mg 69007 Lyon France France Arrow Generiques Gestodene Gestodene 0,06 mg Film-coated tablet Oral use 26 avenue Tony Garnier Ethinylestradiol Ethinylestradiol 0,015 mg 69007 Lyon ARROW 60/15 France France Arrow Generiques Gestodene Gestodene 0,075 mg Film-coated tablet Oral use 26 avenue Tony Garnier Ethinylestradiol Ethinylestradiol 0,02 mg 69007 Lyon ARROW 75/20 France France Arrow Generiques Gestodene Gestodene 0,075 mg Film-coated tablet Oral use 26 avenue Tony Garnier Ethinylestradiol Ethinylestradiol 0,03 mg 69007 Lyon ARROW 75/30 France France BIOGARAN Gestodene Gestodene 0,06 mg Film-coated tablet Oral use 15 Bd Charles de Gaulle Ethinylestradiol Ethinylestradiol 0,015 mg 92700 Colombes BIOGARAN 60/15 France France BIOGARAN Gestodene Gestodene 0,075 mg Film-coated tablet Oral use 15 Bd Charles de Gaulle Ethinylestradiol Ethinylestradiol 0,02 mg 92700 Colombes BIOGARAN 75/20 France France BIOGARAN Gestodene Gestodene 0,075 mg Film-coated tablet Oral use 15 Bd Charles de Gaulle Ethinylestradiol Ethinylestradiol 0,03 mg 92700 Colombes BIOGARAN 75/30 France

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

France CHEMICAL FARMA Gestodene Gestodene 0,075 mg Film-coated tablet Oral use 3, Quai Louis Blériot Ethinylestradiol Ethinylestradiol 0,02 mg 75016 Paris CHIMICAL FARMA France 75/20 France CHEMICAL FARMA Gestodene Gestodene 0,075 mg Film-coated tablet Oral use 3, Quai Louis Blériot Ethinylestradiol Ethinylestradiol 0,03 mg 75016 Paris CHIMICAL FARMA France 75/30 France LABORATOIRES CRISTERS Gestodene Gestodene 0,06 mg Film-coated tablet Oral use 22, quai Galliéni Ethinylestradiol Ethinylestradiol 0,015 mg 92150 Suresnes CRISTERS 60/15 France France EG LABO – LABORATOIRES Gestodene Gestodene 0,06 mg Film-coated tablet Oral use EUROGENERICS Ethinylestradiol Ethinylestradiol EG 0,015 mg Le Quintet – bâtiment A 60/15 12 rue Danjou 92517 Boulogne Billancourt Cedex France France EG LABO – LABORATOIRES Gestodene Gestodene 0,075 mg Film-coated tablet Oral use EUROGENERICS Ethinylestradiol Ethinylestradiol EG 0,02 mg Le Quintet – bâtiment A 75/20 12 rue Danjou 92517 Boulogne Billancourt Cedex France

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

France EG LABO – LABORATOIRES Gestodene Gestodene 0,075 mg Film-coated tablet Oral use EUROGENERICS Ethinylestradiol Ethinylestradiol EG 0,03 mg Le Quintet – bâtiment A 75/30 12 rue Danjou 92517 Boulogne Billancourt Cedex France France SANDOZ Gestodene Gestodene 0,06 mg Film-coated tablet Oral use 49 avenue Georges Pompidou Ethinylestradiol Ethinylestradiol GNR 0,015 mg 92593 Levallois-Perret Cedex 60/15 France France IDD (International Drug Gestodene Gestodene 0,075 mg Film-coated tablet Oral use Development) Ethinylestradiol Ethinylestradiol 0,02 mg 5, rue Simonet IDETECH 75/20 75013 Paris France France IDD (International Drug Gestodene Gestodene 0,075 mg Film-coated tablet Oral use Development) Ethinylestradiol Ethinylestradiol 0,03 mg 5, rue Simonet IDETECH 75/30 75013 Paris France France RANBAXY PHARMACIE Gestodene Gestodene 0,075 mg Film-coated tablet Oral use GENERIQUES Ethinylestradiol Ethinylestradiol 0,02 mg 11-15 Quai Dion Bouton RANBAXY 75/20 92816 Puteaux Cedex France

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

France RANBAXY PHARMACIE Gestodene Gestodene 0,075 mg Film-coated tablet Oral use GENERIQUES Ethinylestradiol Ethinylestradiol 0,03 mg 11-15 Quai Dion Bouton RANBAXY 75/30 92816 Puteaux Cedex France France TEVA SANTE Gestodene Gestodene 0,075 mg Film-coated tablet Oral use 110 Esplanade du Général de Ethinylestradiol Ethinylestradiol 0,02 mg Gaulle RATIOPHARM 75/20 92931 Paris la Defense Cedex France France TEVA SANTE Gestodene Gestodene 0,075 mg Film-coated tablet Oral use 110 Esplanade du Général de Ethinylestradiol Ethinylestradiol 0,03 mg Gaulle RATIOPHARM 75/30 92931 Paris la Defense Cedex France France SANDOZ Gestodene Gestodene 0,06 mg Film-coated tablet Oral use 49 avenue Georges Pompidou Ethinylestradiol Ethinylestradiol 0,015 mg 92593 Levallois-Perret Cedex SANDOZ 60/15 France France SANDOZ Gestodene Gestodene 0,075 mg Film-coated tablet Oral use 49 avenue Georges Pompidou Ethinylestradiol Ethinylestradiol 0,02 mg 92593 Levallois-Perret Cedex SANDOZ 75/20 France France SANDOZ Gestodene Gestodene 0,075 mg Film-coated tablet Oral use 49 avenue Georges Pompidou Ethinylestradiol Ethinylestradiol 0,03 mg 92593 Levallois-Perret Cedex SANDOZ 75/30 France

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

France STRAGEN France SAS Gestodene Gestodene 0,06 mg Film-coated tablet Oral use 52 rue de la République Ethinylestradiol Ethinylestradiol 0,015 mg 69002 Lyon STRAGEN 60/15 France France TEVA SANTE Gestodene Gestodene 0,06 mg Film-coated tablet Oral use 110 Esplanade du Général de Ethinylestradiol Ethinylestradiol TEVA 0,015 mg Gaulle 60/15 92931 Paris la Defense Cedex France France TEVA SANTE Gestodene Gestodene 0,075 mg Film-coated tablet Oral use 110 Esplanade du Général de Ethinylestradiol Ethinylestradiol TEVA 0,02 mg Gaulle 75/20 92931 Paris la Defense Cedex France France TEVA SANTE Gestodene Gestodene 0,075 mg Film-coated tablet Oral use 110 Esplanade du Général de Ethinylestradiol Ethinylestradiol TEVA 0,03 mg Gaulle 75/30 92931 Paris la Defense Cedex France France SANOFI AVENTIS FRANCE Gestodene Gestodene 0,06 mg Film-coated tablet Oral use 1-13 boulevard Romain Rolland Ethinylestradiol Ethinylestradiol 0,015 mg 75014 Paris ZENTIVA 60/15 France France SANOFI AVENTIS FRANCE Gestodene Gestodene 0,075 mg Film-coated tablet Oral use 1-13 boulevard Romain Rolland Ethinylestradiol Ethinylestradiol 0,02 mg 75014 Paris ZENTIVA 75/20 France

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

France SANOFI AVENTIS FRANCE Gestodene Gestodene 0,075 mg Film-coated tablet Oral use 1-13 boulevard Romain Rolland Ethinylestradiol Ethinylestradiol 0,03 mg 75014 Paris ZENTIVA 75/30 France France ZYDUS FRANCE Gestodene Gestodene 0,075 mg Film-coated tablet Oral use ZAC Les Hautes Patures Ethinylestradiol Ethinylestradiol 0,02 mg 25 Rue des peuliers ZYDUS 75/20 92752 Nanterre Cedex France France ZYDUS FRANCE Gestodene Gestodene 0,075 mg Film-coated tablet Oral use ZAC Les Hautes Patures Ethinylestradiol Ethinylestradiol 0,03 mg 25 Rue des peuliers ZYDUS 75/30 92752 Nanterre Cedex France France PFIZER HOLDING France Gestodene Harmonet 0,075 mg Film-coated tablet Oral use 23-25 avenue du Docteur Ethinylestradiol 0,02 mg Lannelongue 75668 Paris Cedex 14 France France Bayer Sante Gestodene Meliane 0,075 mg Film-coated tablet Oral use 220 avenue de la Recherche Ethinylestradiol 0,02 mg 59120 Loos France France Bayer Sante Gestodene Melodia 0,06 mg Film-coated tablet Oral use 220 avenue de la Recherche Ethinylestradiol 0,015 mg 59120 Loos France

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

France PFIZER HOLDING France Gestodene Minesse 0,06 mg Film-coated tablet Oral use 23-25 avenue du Docteur Ethinylestradiol 0,015 mg Lannelongue 75668 Paris Cedex 14 France France PFIZER HOLDING France Gestodene Minulet 0,075 mg Film-coated tablet Oral use 23-25 avenue du Docteur Ethinylestradiol 0,03 mg Lannelongue 75668 Paris Cedex 14 France France Bayer Sante Gestodene Moneva 0,075 mg Coated tablet Oral use 220 avenue de la Recherche Ethinylestradiol 0,03 mg 59120 Loos France France Laboratoires Majorelle Gestodene Optinesse 60/15 0,06 mg Film-coated tablet Oral use 12 Rue de Berri Ethinylestradiol 0,015 mg F-75008 Paris France France BIOGARAN Gestodene Perleane 0.050 mg/0.030 Film-coated tablet Oral use 15 Bd Charles de Gaulle Ethinylestradiol mg 92700 Colombes 0.070 mg/0.040mg France 0.100 mg/0.030 mg France Bayer Sante Gestodene Phaeva 0.050 mg/0.030 Coated tablet Oral use 220 avenue de la Recherche Ethinylestradiol mg 59120 Loos 0.070 mg/0.040mg France 0.100 mg/0.030 mg

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

France Bayer Sante Gestodene Sylviane 0,06 mg Film-coated tablet Oral use 220 avenue de la Recherche Ethinylestradiol 0,015 mg 59120 Loos France France PFIZER HOLDING France Gestodene Triminulet 0.050 mg/0.030 Film-coated tablet Oral use 23-25 avenue du Docteur Ethinylestradiol mg Lannelongue 0.070 mg/0.040 g 75668 Paris Cedex 14 0.100 mg/0.030 France mg France Janssen-Cilag Norgestimate Cilest 0,25 mg Tablet Oral use 1 rue Camille Desmoulins Ethinylestradiol 0,035 mg TSA 91003 92787 Issy-les-Moulineaux cedex 9 France France EFFIK Norgestimate Effiprev 0,25 mg Tablet Oral use 9-11 rue Jeanne Braconnier Ethinylestradiol 0,035 mg Bâtiment « Le Newton » 92366 Meudon la Foret cedex France France EFFIK Norgestimate Triafemi 0.18 mg /0.035 Tablet Oral use 9-11 rue Jeanne Braconnier Ethinylestradiol mg Bâtiment « Le Newton » 0.215 mg /0.035 92366 Meudon la Foret cedex mg France 0.25 mg /0.035 mg

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

France Janssen-Cilag Norgestimate Tricilest 0.18 mg /0.035 Tablet Oral use 1 rue Camille Desmoulins Ethinylestradiol mg TSA 91003 0.215 mg /0.035 92787 Issy-les-Moulineaux mg cedex 9 0.25 mg /0.035 France mg Germany Jenapharm GmbH & Co. KG Estradiol valerate Qlaira Filmtabletten 3 mg Film-coated tablet Oral use Otto-Schott-Straße 15 Dienogest 2 mg/2 mg 07745 Jena 2 mg/3 mg Germany 1 mg Germany Bayer Vital GmbH Drospirenone Yvidually 0.02 mg Film-coated tablet Oral use Kaiser-Wilhelm-Allee Ethinylestradiol 3 mg 51373 Leverkusen Germany Germany Aliud Pharma GmbH Chlormadinone Bonita AL 0,03 mg/2 0,03 mg Film-coated tablet Oral use Gottlieb-Daimler-Str. 19 Ethinylestradiol mg Filmtabletten 2 mg 89150 Laichingen Germany Germany Actavis Group PTC ehf Chlormadinone Angiletta 2 mg/0,03 0,03 mg Film-coated tablet Oral use Reykjavikurvegi 76-78 Ethinylestradiol mg Filmtabletten 2 mg 220 Hafnarfjordur Iceland Germany Gedeon Richter Plc. Chlormadinone Balanca 0,03 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 2 mg HU-1103 Budapest Hungary

100

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Germany Pfizer Pharma GmbH Chlormadinone beatrice 0,03 mg/2 0,03 mg Film-coated tablet Oral use Linkstr. 10 Ethinylestradiol mg Filmtabletten 2 mg 10785 Berlin Germany Germany Gedeon Richter Plc. Chlormadinone Belara 0,03 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 2 mg HU-1103 Budapest Hungary Germany Gedeon Richter Plc. Chlormadinone Belara 21+7 0,03 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 2 mg HU-1103 Budapest Hungary Germany Madaus GmbH Chlormadinone Bellissima 0,03 mg Film-coated tablet Oral use Colonia Allee 15 Ethinylestradiol 2 mg 51067 Köln Germany Germany Madaus GmbH Chlormadinone Bellissima 0,03 mg/2 0,03 mg Film-coated tablet Oral use Colonia Allee 15 Ethinylestradiol mg filmtabletten 2 mg 51067 Köln Germany Germany 1 A Pharma GmbH Chlormadinone Bilmon - 1 A Pharma 0,03 mg Film-coated tablet Oral use Keltenring 1 + 3 Ethinylestradiol 0,03 mg/2 mg 2 mg 82041 Oberhaching Filmtabletten Germany Germany Gedeon Richter Plc. Chlormadinone Chantal 0,03 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 2 mg HU-1103 Budapest Hungary

101

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Germany Gedeon Richter Plc. Chlormadinone Chariva 0,03 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 2 mg HU-1103 Budapest Hungary Germany Gedeon Richter Plc. Chlormadinone Chariva 21+7 0,03 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 2 mg HU-1103 Budapest Hungary Germany Zentiva Pharma GmbH Chlormadinone Chloee 0,03 mg Film-coated tablet Oral use Industriepark Frankfurt-Höchst, Ethinylestradiol 2 mg Gebäude K703 65926 Frankfurt am Main Germany Germany Jenapharm GmbH & Co. KG Chlormadinone Enriqa 2.0 mg Coated tablet Oral use Otto-Schott-Straße 15 acetate 0.03 mg 07745 Jena Ethinylestradiol Germany Germany Sandoz Pharmaceuticals GmbH Chlormadinone eufem 2 mg/0,03 mg 0,03 mg Film-coated tablet Oral use Raiffeisenstr. 11 Ethinylestradiol Filmtabletten 2 mg 83607 Holzkirchen Germany Germany TEVA GmbH Chlormadinone LaBibiane 0,03 mg Film-coated tablet Oral use Graf-Arco-Str. 3 Ethinylestradiol 2 mg 89079 Ulm Germany

102

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Germany Aristo Pharma GmbH Chlormadinone Lilia 0,03 mg/2 mg 0,03 mg Film-coated tablet Oral use Wallenroder Straße 8-10 Ethinylestradiol Filmtabletten 2 mg 13435 Berlin Germany Germany Madaus GmbH Chlormadinone Lisa 0,03 mg Film-coated tablet Oral use Colonia Allee 15 Ethinylestradiol 2 mg 51067 Köln Germany Germany Mylan dura gmbH Chlormadinone Lisette 0,03 mg/2 mg 0,03 mg Film-coated tablet Oral use Wittstichstr. 6 Ethinylestradiol Filmtabletten 2 mg 64295 Darmstadt Germany Germany mibe GmbH Arzneimittel Chlormadinone Madinette 30 0,03 mg Film-coated tablet Oral use Münchener Str. 15 Ethinylestradiol 2 mg 06796 Brehna Germany Germany Dr. Kade Pharmazeutische Chlormadinone Minette 2 mg/0,03 mg 0,03 mg Film-coated tablet Oral use Fabrik GmbH Ethinylestradiol Filmtabletten 2 mg Rigistr. 2 12277 Berlin Germany Germany Hexal Aktiengesellschaft Chlormadinone Mona HEXAL 2 0,03 mg Film-coated tablet Oral use Industriestr. 25 Ethinylestradiol mg/0,03 mg 2 mg 83607 Holzkirchen Filmtabletten Germany

103

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Germany Gedeon Richter Plc. Chlormadinone Neo-Eunomin 0,05 mg / 0,05 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 1 mg / 2 mg HU-1103 Budapest Hungary Germany Stadapharm GmbH Chlormadinone Pink Luna 0,03 mg/2 0,03 mg Film-coated tablet Oral use Stadastr. 2-18 Ethinylestradiol mg Filmtabletten 2 mg 61118 Bad Vilbel Germany Germany Hormosan Pharma GmbH Chlormadinone Solera 2 mg/0,03 mg 0,03 mg Film-coated tablet Oral use Wilhelmshoeher Str. 106 Ethinylestradiol Filmtabletten 2 mg 60389 Frankfurt Germany Germany Madaus GmbH Chlormadinone Bellissima 21+7 0,03 mg Film-coated tablet Oral use Colonia Allee 15 Ethinylestradiol 2 mg 51067 Köln Germany Germany Ratiopharm GmbH Chlormadinone Verana-ratiopharm 2 0,03 mg Film-coated tablet Oral use Graf-Arco-Strasse 3 Ethinylestradiol mg/0,03 mg 2 mg DE-89079 Ulm Filmtabletten Germany Germany Mithra Pharmaceuticals S.A. Chlormadinone Zetdinone 0,03 mg Film-coated tablet Oral use Rue Saint Georges 5 Ethinylestradiol 2 mg 4000 Liège Belgium Germany Gedeon Richter Plc. Chlormadinone Belara 0,03 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 2 mg HU-1103 Budapest Hungary

104

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Germany Gedeon Richter Plc. Desogestrel Ametist Filmtabletten 0,035 mg / 0,03 Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol mg / 0,03 mg HU-1103 Budapest 0,05 mg / 0,1 mg / Hungary 0,15 mg Germany betapharm Arzneimittel GmbH Desogestrel Aricia beta 0,02 mg Tablet Oral use Kobelweg 95 Ethinylestradiol 0,15 mg 86156 Augsburg Germany Germany Aliud Pharma GmbH Desogestrel Belinda AL 0,15 0,02 mg Tablet Oral use Gottlieb-Daimler-Str. 19 Ethinylestradiol mg/0,02 mg Tabletten 0,15 mg 89150 Laichingen Germany Germany Aliud Pharma GmbH Desogestrel Belinda AL 0,15 0,03 mg Tablet Oral use Gottlieb-Daimler-Str. 19 Ethinylestradiol mg/0,03 mg Tabletten 0,15 mg 89150 Laichingen Germany Germany MSD Sharp & Dohme Desogestrel Biviol 0,04 mg/0,025 mg Tablet Oral use Gesellschaft mit beschränkter Ethinylestradiol 0,03 mg/0,125 mg Haftung Lindenplatz 1 85540 Haar Germany Germany Aristo Pharma GmbH Desogestrel Cedia 20 20 µg/150 0,02 mg Tablet Oral use Wallenroder Straße 8-10 Ethinylestradiol µg Tabletten 0,15 mg 13435 Berlin Germany

105

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Germany Aristo Pharma GmbH Desogestrel Cedia 30 30 µg/150 0,03 mg Tablet Oral use Wallenroder Straße 8-10 Ethinylestradiol µg Tabletten 0,15 mg 13435 Berlin Germany Germany Gedeon Richter Plc. Desogestrel Desmin 20 0,02 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 0,15 mg HU-1103 Budapest Hungary Germany Gedeon Richter Plc. Desogestrel Desmin 30 0,03 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 0,15 mg HU-1103 Budapest Hungary Germany mibe GmbH Arzneimittel Desogestrel Desofemine 20 Nova 0,02 mg Film-coated tablet Oral use Münchener Str. 15 Ethinylestradiol 0,15 mg 06796 Brehna Germany Germany mibe GmbH Arzneimittel Desogestrel Desofemine 30 0,03 mg Film-coated tablet Oral use Münchener Str. 15 Ethinylestradiol 0,15 mg 06796 Brehna Germany Germany Ratiopharm GmbH Desogestrel Famina-ratiopharm 20 0,02 mg Tablet Oral use Graf-Arco-Strasse 3 Ethinylestradiol 0,15 mg DE-89079 Ulm Germany Germany Ratiopharm GmbH Desogestrel Famina-ratiopharm 30 0,03 mg Tablet Oral use Graf-Arco-Strasse 3 Ethinylestradiol 0,15 mg DE-89079 Ulm Germany

106

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Germany Mylan dura gmbH Desogestrel Gabrielle-20 0,15 0,02 mg Tablet Oral use Wittstichstr. 6 Ethinylestradiol mg/0,02 mg Tabletten 0,15 mg 64295 Darmstadt Germany Germany Mylan dura gmbH Desogestrel Gabrielle-30 0,15 0,03 mg Tablet Oral use Wittstichstr. 6 Ethinylestradiol mg/0,03 mg Tabletten 0,15 mg 64295 Darmstadt Germany Germany Zentiva Pharma GmbH Desogestrel Juliane 20 0,02 mg Tablet Oral use Industriepark Frankfurt-Höchst, Ethinylestradiol 0,15 mg Gebäude K703 65926 Frankfurt am Main Germany Germany Zentiva Pharma GmbH Desogestrel Juliane 30 0,03 mg Tablet Oral use Industriepark Frankfurt-Höchst, Ethinylestradiol 0,15 mg Gebäude K703 65926 Frankfurt am Main Germany Germany Stadapharm GmbH Desogestrel Kosima STADA 0,15 0,02 mg Tablet Oral use Stadastr. 2-18 Ethinylestradiol mg/0,02 mg Tabletten 0,15 mg 61118 Bad Vilbel Germany Germany Stadapharm GmbH Desogestrel Kosima STADA 0,15 0,03 mg Tablet Oral use Stadastr. 2-18 Ethinylestradiol mg/0,03 mg Tabletten 0,15 mg 61118 Bad Vilbel Germany

107

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Germany Hexal Aktiengesellschaft Desogestrel Lamuna 20 0,02 mg Film-coated tablet Oral use Industriestr. 25 Ethinylestradiol 0,15 mg 83607 Holzkirchen Germany Germany Hexal Aktiengesellschaft Desogestrel Lamuna 30 0,03 mg Film-coated tablet Oral use Industriestr. 25 Ethinylestradiol 0,15 mg 83607 Holzkirchen Germany Germany betapharm Arzneimittel GmbH Desogestrel Lonicera beta 0,03 mg Tablet Oral use Kobelweg 95 Ethinylestradiol 0,15 mg 86156 Augsburg Germany Germany MSD Sharp & Dohme Desogestrel Lovelle 0,02 mg Tablet Oral use Gesellschaft mit beschränkter Ethinylestradiol 0,15 mg Haftung Lindenplatz 1 85540 Haar Germany Germany MSD Sharp & Dohme Desogestrel Marvelon 0,03 mg Film-coated tablet Oral use Gesellschaft mit beschränkter Ethinylestradiol 0,15 mg Haftung Lindenplatz 1 85540 Haar Germany

108

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Germany MSD Sharp & Dohme Desogestrel Novial 0,035 mg/0,05 mg Film-coated tablet Oral use Gesellschaft mit beschränkter Ethinylestradiol 0,03 mg/0,1 mg Haftung 0,03 mg/0,15 mg Lindenplatz 1 85540 Haar Germany Germany UCB Pharma GmbH Desogestrel previva sanol 20 0,02 mg Tablet Oral use Alfred-Nobel-Str. 10 Ethinylestradiol Tabletten 0,15 mg 40789 Monheim Germany Germany UCB Pharma GmbH Desogestrel previva sanol 30 0,03 mg Tablet Oral use Alfred-Nobel-Str. 10 Ethinylestradiol Tabletten 0,15 mg 40789 Monheim Germany Germany 1 A Pharma GmbH Dienogest Amelie - 1 A Pharma 0,03 mg Film-coated tablet Oral use Keltenring 1 + 3 Ethinylestradiol 0,03 mg/0,2 mg 2 mg 82041 Oberhaching Filmtabletten Germany Germany Aristo Pharma GmbH Dienogest Aristelle 0,03 mg/2 0,03 mg Film-coated tablet Oral use Wallenroder Straße 8-10 Ethinylestradiol mg Filmtabletten 2 mg 13435 Berlin Germany Germany Zentiva Pharma GmbH Dienogest BonaDea 0,03 mg Film-coated tablet Oral use Industriepark Frankfurt-Höchst, Ethinylestradiol 2 mg Gebäude K703 65926 Frankfurt am Main Germany

109

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Germany Jenapharm GmbH & Co. KG Dienogest Celimona 0,03 mg Coated tablet Oral use Otto-Schott-Straße 15 Ethinylestradiol 2 mg 07745 Jena Germany Germany Bayer Pharma AG Dienogest Celimone 0,03 mg Coated tablet Oral use D-13342 Berlin Ethinylestradiol 2 mg Germany Germany Helm AG Dienogest Deltanogest 0,03 0,03 mg Film-coated tablet Oral use Nordkanalstrasse 28 Ethinylestradiol mg/2 mg 2 mg 20097 Hamburg Filmtabletten Germany Germany Pharbil Waltrop GmbH Dienogest Diena Pharbil 0,03 mg Film-coated tablet Oral use Im Wirrigen 25 Ethinylestradiol 2 mg 45731 Waltrop Germany Germany Zentiva Pharma GmbH Dienogest Dienestra 0,03 mg/2 0,03 mg Film-coated tablet Oral use Industriepark Frankfurt-Höchst, Ethinylestradiol mg Filmtabletten 2 mg Gebäude K703 65926 Frankfurt am Main Germany Germany mibe GmbH Arzneimittel Dienogest Dienovel 0,03 mg Film-coated tablet Oral use Münchener Str. 15 Ethinylestradiol 2 mg 06796 Brehna Germany Germany Pharbil Waltrop GmbH Dienogest Ethinylestradiol/Dieno 0,03 mg Film-coated tablet Oral use Im Wirrigen 25 Ethinylestradiol gest Pharbil Waltrop 2 mg 45731 Waltrop 0,03/2,0mg Germany Filmtabletten

110

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Germany Dr. Kade Pharmazeutische Dienogest Finic 0,03 mg Tablet Oral use Fabrik GmbH Ethinylestradiol 2 mg Rigistr. 2 12277 Berlin Germany Germany Aristo Pharma GmbH Dienogest Gamonogest 0,03 0,03 mg Film-coated tablet Oral use Wallenroder Straße 8-10 Ethinylestradiol mg/2 mg 2 mg 13435 Berlin Filmtabletten Germany Germany Helm AG Dienogest Kappanogest 0,03 0,03 mg Film-coated tablet Oral use Nordkanalstrasse 28 Ethinylestradiol mg/2 mg 2 mg 20097 Hamburg Filmtabletten Germany Germany UCB Pharma GmbH Dienogest ladonna sanol 2 mg 0,03 mg Film-coated tablet Oral use Alfred-Nobel-Str. 10 Ethinylestradiol /0,03 mg 2 mg 40789 Monheim Filmtabletten Germany Germany Helm AG Dienogest Lamdanogest 0,03 0,03 mg Film-coated tablet Oral use Nordkanalstrasse 28 Ethinylestradiol mg/2 mg 2 mg 20097 Hamburg Filmtabletten Germany Germany TEVA GmbH Dienogest LaViola 0,03 mg/2 mg 0,03 mg Film-coated tablet Oral use Graf-Arco-Str. 3 Ethinylestradiol Filmtabletten 2 mg 89079 Ulm Germany

111

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Germany Jenapharm GmbH & Co. KG Dienogest maxim 0,03 mg Coated tablet Oral use Otto-Schott-Straße 15 Ethinylestradiol 2 mg 07745 Jena Germany Germany Madaus GmbH Dienogest Mayra 0,03 mg/2 mg 0,03 mg Film-coated tablet Oral use Colonia Allee 15 Ethinylestradiol Filmtabletten 2 mg 51067 Köln Germany Germany Gedeon Richter Plc. Dienogest Sibilla 2 mg/0,03 mg 0,02 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol Filmtabletten 3 mg HU-1103 Budapest Hungary Germany Hexal Aktiengesellschaft Dienogest Starletta HEXAL 2 0,03 mg Film-coated tablet Oral use Industriestr. 25 Ethinylestradiol mg/0,03 mg 2 mg 83607 Holzkirchen Filmtabletten Germany Germany Stadapharm GmbH Dienogest Stella STADA 0,03 0,03 mg Film-coated tablet Oral use Stadastr. 2-18 Ethinylestradiol mg/2,0 mg 2 mg 61118 Bad Vilbel Filmtabletten Germany Germany Aliud Pharma GmbH Dienogest Susette AL 0,03 0,03 mg Film-coated tablet Oral use Gottlieb-Daimler-Str. 19 Ethinylestradiol mg/2,0 mg 2 mg 89150 Laichingen Filmtabletten Germany

112

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Germany "ARAC" At Regulatory Affairs Dienogest Tessa 0,03 mg/2 mg 0,03 mg Film-coated tablet Oral use Consulting GmbH Ethinylestradiol Filmtabletten 2 mg Kichengasse 48/3 1070 Wien Austria Germany Jenapharm GmbH & Co. KG Dienogest Valette 0,03 mg Coated tablet Oral use Otto-Schott-Straße 15 Ethinylestradiol 2 mg 07745 Jena Germany Germany Pfizer Pharma GmbH Dienogest vatrice 0,03 mg/2 mg 0,03 mg Film-coated tablet Oral use Linkstr. 10 Ethinylestradiol Filmtabletten 2 mg 10785 Berlin Germany Germany Velvian Germany GmbH Dienogest Velafee 0,03 mg/2 mg 0,03 mg Film-coated tablet Oral use Carl-Zeiss-Ring 9 Ethinylestradiol Filmtabletten 2 mg 85737 Ismaning Germany Germany Ratiopharm GmbH Dienogest Velvet-ratiopharm 0,03 mg Film-coated tablet Oral use Graf-Arco-Strasse 3 Ethinylestradiol 0,03 mg/2 mg 2 mg DE-89079 Ulm Filmtabletten Germany Germany Mylan dura gmbH Dienogest Violette 0,03 mg/2 mg 0,03 mg Film-coated tablet Oral use Wittstichstr. 6 Ethinylestradiol Filmtabletten 2 mg 64295 Darmstadt Germany

113

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Germany Jenapharm GmbH & Co. KG Drospirenone aida 0,02 mg Film-coated tablet Oral use Otto-Schott-Straße 15 Ethinylestradiol 3 mg 07745 Jena Germany Germany Gedeon Richter Plc. Drospirenone ARTADAL 0,03 mg/3 0,03 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol mg Filmtablette 3 mg HU-1103 Budapest Hungary Germany Gedeon Richter Plc. Drospirenone BERTELLE 0,03 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol unterbrechungsfreie 3 mg HU-1103 Budapest Einnahme 3 mg/0,03 Hungary mg Filmtabletten Germany Gedeon Richter Plc. Drospirenone Daylette 0,02 mg/3 0,02 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol mg 3 mg HU-1103 Budapest Hungary Germany Hexal Aktiengesellschaft Drospirenone Eliza HEXAL 0,02 mg Film-coated tablet Oral use Industriestr. 25 Ethinylestradiol 3 mg 83607 Holzkirchen Germany Germany Jenapharm GmbH & Co. KG Drospirenone Eloine 0,02 mg/3 mg 0,02 mg Film-coated tablet Oral use Otto-Schott-Straße 15 Ethinylestradiol Filmtabletten 3 mg 07745 Jena Germany

114

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Germany Zentiva Pharma GmbH Drospirenone Sidretella 20 0,02 0,02 mg Film-coated tablet Oral use Industriepark Frankfurt-Höchst, Ethinylestradiol mg/3 mg 3 mg Gebäude K703 Filmtabletten 65926 Frankfurt am Main Germany Germany Gedeon Richter Plc. Drospirenone ESLARILA 0,02 mg/3 0,02 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol mg Filmtabletten 3 mg HU-1103 Budapest Hungary Germany Gedeon Richter Plc. Drospirenone ESLARILA 0,02 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol unterbrechungsfreie 3 mg HU-1103 Budapest Einnahme 0,02 mg/3 Hungary mg Filmtabletten Germany Mylan dura gmbH Drospirenone Georgette-20 0,02 mg Film-coated tablet Oral use Wittstichstr. 6 Ethinylestradiol 3mg/0,02mg 3 mg 64295 Darmstadt Filmtabletten Germany Germany Laboratorios Leon Farma SA Drospirenone Iren 28 0,02 mg/3 mg 0,02 mg Film-coated tablet Oral use Poligono Industrial Navatejera, Ethinylestradiol Filmtabletten 3 mg La Vallina s/n, 24008 Villaquilambre,Leon Spain Germany Ivowen Limited Drospirenone KYLNETTA 0,03 mg/3 0,03 mg Film-coated tablet Oral use 3 Anglesa St Ethinylestradiol mg Filmtablette 3 mg Tipperary Clonmel Ireland

115

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Germany TEVA GmbH Drospirenone LaYaisa 0,02 mg Film-coated tablet Oral use Graf-Arco-Str. 3 Ethinylestradiol 3 mg 89079 Ulm Germany Germany TEVA GmbH Drospirenone LaYanina 0,03 mg Film-coated tablet Oral use Graf-Arco-Str. 3 Ethinylestradiol 3 mg 89079 Ulm Germany Germany TEVA GmbH Drospirenone LaYnes 0,02 mg Film-coated tablet Oral use Graf-Arco-Str. 3 Ethinylestradiol 3 mg 89079 Ulm Germany Germany TEVA GmbH Drospirenone LaYanina 28 0,03 mg Film-coated tablet Oral use Graf-Arco-Str. 3 Ethinylestradiol 3 mg 89079 Ulm Germany Germany Gedeon Richter Plc. Drospirenone LILADROS 0,02 mg/3 0,02 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol mg Filmtabletten 3 mg HU-1103 Budapest Hungary Germany Gedeon Richter Plc. Drospirenone LILADROS 0,02 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol unterbrechungsfreie 3 mg HU-1103 Budapest Einnnahme 0,02 mg/3 Hungary mg Filmtabletten Germany Jenapharm GmbH & Co. KG Drospirenone Liofora 0,02 mg Film-coated tablet Oral use Otto-Schott-Straße 15 Ethinylestradiol 3 mg 07745 Jena Germany

116

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Germany Gedeon Richter Plc. Drospirenone MAITALON 20 0,02 0,02 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol mg/3 mg 3 mg HU-1103 Budapest Filmtabletten Hungary Germany Gedeon Richter Plc. Drospirenone MAITALON 20/21+7 0,02 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 0,02 mg/3 mg 3 mg HU-1103 Budapest Filmtabletten Hungary Germany Gedeon Richter Plc. Drospirenone MAITALON 30 0,03 0,03 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol mg/3 mg 3 mg HU-1103 Budapest Filmtabletten Hungary Germany Gedeon Richter Plc. Drospirenone MAITALON 30/21+7 0,03 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 0,03 mg/3 mg 3 mg HU-1103 Budapest Filmtabletten Hungary Germany Gedeon Richter Plc. Drospirenone MESILARA 0,02 mg/3 0,02 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol mg Filmtabletten 3 mg HU-1103 Budapest Hungary Germany Zentiva Pharma GmbH Drospirenone Sidretella 30 0,03 0,03 mg Film-coated tablet Oral use Industriepark Frankfurt-Höchst, Ethinylestradiol mg/3 mg 3 mg Gebäude K703 Filmtabletten 65926 Frankfurt am Main Germany

117

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Germany Jenapharm GmbH & Co. KG Drospirenone Palandra 0,03 mg Coated tablet Oral use Otto-Schott-Straße 15 Ethinylestradiol 3 mg 07745 Jena Germany Germany Jenapharm GmbH & Co. KG Drospirenone Petibelle 0,03 mg/3 0,03 mg Film-coated tablet Oral use Otto-Schott-Straße 15 Ethinylestradiol mg Filmtabletten 3 mg 07745 Jena Germany Germany Mylan dura gmbH Drospirenone Georgette-30 3 0,03 mg Film-coated tablet Oral use Wittstichstr. 6 Ethinylestradiol mg/0,03 mg 3 mg 64295 Darmstadt Filmtabletten Germany Germany Laboratorios Leon Farma SA Drospirenone Rosal 28 0,03 mg/3 0,03 mg Film-coated tablet Oral use Poligono Industrial Navatejera, Ethinylestradiol mg Filmtabletten 3 mg La Vallina s/n, 24008 Villaquilambre,Leon Spain Germany Gedeon Richter Plc. Drospirenone SELIKYNE 0,02 mg/3 0,02 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol mg Filmtabletten 3 mg HU-1103 Budapest Hungary Germany Hexal Aktiengesellschaft Drospirenone YARA HEXAL 20 0,02 mg Film-coated tablet Oral use Industriestr. 25 Ethinylestradiol 3 mg 83607 Holzkirchen Germany

118

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Germany Hexal Aktiengesellschaft Drospirenone YARA HEXAL 20 und 0,02 mg Film-coated tablet Oral use Industriestr. 25 Ethinylestradiol Placebo 3 mg 83607 Holzkirchen Germany Germany Hexal Aktiengesellschaft Drospirenone YARA HEXAL 30 0,03 mg Film-coated tablet Oral use Industriestr. 25 Ethinylestradiol 3 mg 83607 Holzkirchen Germany Germany Hexal Aktiengesellschaft Drospirenone YARA HEXAL 30 und 0,03 mg Film-coated tablet Oral use Industriestr. 25 Ethinylestradiol Placebo 3 mg 83607 Holzkirchen Germany Germany Bayer Vital GmbH Drospirenone Yasmin 0,03 mg/3 mg 0,03 mg Film-coated tablet Oral use Kaiser-Wilhelm-Allee Ethinylestradiol Filmtabletten 3 mg 51373 Leverkusen Germany Germany Bayer Vital GmbH Drospirenone Yasminelle 0,02 mg/3 0,02 mg Film-coated tablet Oral use Kaiser-Wilhelm-Allee Ethinylestradiol mg Filmtabletten 3 mg 51373 Leverkusen Germany Germany Bayer Vital GmbH Drospirenone YAZ 0,02 mg/3 mg 0,02 mg Film-coated tablet Oral use Kaiser-Wilhelm-Allee Ethinylestradiol Filmtabletten 3 mg 51373 Leverkusen Germany Germany Hexal Aktiengesellschaft Gestodene Alessia HEXAL 0,06 0,015 mg Film-coated tablet Oral use Industriestr. 25 Ethinylestradiol mg/ 0,015 mg 0,06 mg 83607 Holzkirchen Filmtabletten Germany

119

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Germany Bayer Vital GmbH Gestodene Femovan 0,03 0,03 mg Coated tablet Oral use Kaiser-Wilhelm-Allee Ethinylestradiol mg/0,075 mg 0,075 mg 51373 Leverkusen überzogene Tabletten Germany Germany Velvian Germany GmbH Gestodene Jamyle 0,060 mg / 0,015 mg Film-coated tablet Oral use Carl-Zeiss-Ring 9 Ethinylestradiol 0,015 mg 0,06 mg 85737 Ismaning Filmtabletten Germany Germany 1 A Pharma GmbH Gestodene Lenisagyn - 1 A 0,015 mg Film-coated tablet Oral use Keltenring 1 + 3 Ethinylestradiol Pharma 0,06 mg 82041 Oberhaching Germany Germany Pfizer Pharma GmbH Gestodene Minulet 0,03 mg Coated tablet Oral use Linkstr. 10 Ethinylestradiol 0,075 mg 10785 Berlin Germany Germany Janssen-Cilag GmbH Norgestimate Cilest 0,035 mg Tablet Oral use Johnson & Johnson Platz 1 Ethinylestradiol 0,25 mg 41470 Neuss Germany Germany Janssen-Cilag GmbH Norgestimate Pramino 0,035 mg /0,035 Tablet Oral use Johnson & Johnson Platz 1 Ethinylestradiol mg / 0,035 mg 41470 Neuss 0,18 mg / 0,215 Germany mg / 0,25 mg

120

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Germany MSD Sharp & Dohme Etonogestrel NuvaRing vaginales 2,7 mg Vaginal delivery Vaginal use Gesellschaft mit beschränkter Ethinylestradiol Freisetzungssystem 11,7 mg system Haftung Lindenplatz 1 85540 Haar Germany Germany Varipharm Arzneimittel GmbH Etonogestrel Circlet 0,120 2,7 mg Vaginal delivery Vaginal use Lindenplatz 1 Ethinylestradiol mg/0,015 mg pro 24 11,7 mg system 85540 Haar Stunden vaginales Germany Freisetzungssystem Greece N.V. Organon Desogestrel GRACIAL 0,125 mg/0,030 Tablet Oral use Kloosterstraat 6 Ethinylestradiol mg 5349 AB, Oss 0,025 mg/0,040 The Netherlands mg Greece N.V. Organon Desogestrel LAURINA 0,035 mg/0,050 Film-coated tablet Oral use Kloosterstraat 6 Ethinylestradiol mg 5349 AB, Oss 0,030 mg/0,100 The Netherlands mg 0,030 mg/0,150 mg Greece Teva Pharma BV Drospirenone GISSELINA 3 mg Film-coated tablet Oral use Computerweg 10 Ethinylestradiol 0,02mg 3542 DR Utrecht The Netherlands Greece Teva Pharma BV Drospirenone GISSELINA 28 3 mg Film-coated tablet Oral use Computerweg 10 Ethinylestradiol 0.02mg 3542 DR Utrecht The Netherlands

121

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Greece Teva Pharma BV Drospirenone GISSELLE 3mg Film-coated tablet Oral use Computerweg 10 Ethinylestradiol 0,03mg 3542 DR Utrecht The Netherlands Greece Teva Pharma BV Drospirenone GISSELLE 28 3 mg Film-coated tablet Oral use Computerweg 10 Ethinylestradiol 0.02mg 3542 DR Utrecht The Netherlands Greece N.V. Organon Desogestrel MERCILON 0,02 mg Tablet Oral use Kloosterstraat 6 Ethinylestradiol 0.15 mg 5349 AB, Oss The Netherlands Greece Gedeon Richter Plc. Drospirenone VILUZOR 3 mg/0.3 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol HU-1103 Budapest Hungary Greece Gedeon Richter Plc. Drospirenone TREMOSAN 3 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 0.02 mg HU-1103 Budapest Hungary Greece Gedeon Richter Plc. Drospirenone TREMOSAN EDT 3 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 0.02 mg HU-1103 Budapest Hungary Greece Gedeon Richter Plc. Drospirenone CHIFLATON 3 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 0.02 mg HU-1103 Budapest Hungary

122

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Greece BAYER HELLAS AG Drospirenone YASMIN 3mg Film-coated tablet Oral use Sorou street 18-20 Ethinylestradiol 0.03mg Maroussi Athens 15125 Greece Greece BAYER HELLAS AG Drospirenone YASMINELLE 3mg Film-coated tablet Oral use Sorou street 18-20 Ethinylestradiol 0.02mg Maroussi Athens 15125 Greece Greece BAYER HELLAS AG Estradiol valerate QLAIRA 3 mg Film-coated tablet Oral use Sorou street 18-20 Dienogest 2 mg/2 mg Maroussi 2 mg/3 mg Athens 15125 1 mg Greece Greece Gedeon Richter Plc. Desogestrel HUNOGIDON 0,02 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 0.15 mg HU-1103 Budapest Hungary Greece BAYER HELLAS AG Drospirenone YAZ 0.02mg Film-coated tablet Oral use Sorou street 18-20 Ethinylestradiol 3mg Maroussi Athens 15125 Greece Greece N.V. Organon Etonogestrel NUVARING 11,7 mg Vaginal delivery Vaginal use Kloosterstraat 6 Ethinylestradiol 2,7 mg system 5349 AB, Oss The Netherlands

123

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Hungary Gedeon Richter Plc. Desogestrel AMETIST 0,05 mg/0,035 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 0,10 mg/0,03 mg HU-1103 Budapest 0,15 mg/0,03 mg Hungary Hungary Gedeon Richter Plc. Desogestrel CARICIA 0,05 mg/0,035 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 0,1 mg/0,03 mg HU-1103 Budapest 0,15 mg/0,03 mg Hungary Hungary Stragen Nordic A/S, Desogestrel CONTROVUL 0,15 mg Film-coated tablet Oral use Helsingørgade 8C, Ethinylestradiol 0,02 mg DK-3400 Hillerød, Denmark Hungary Stragen Nordic A/S, Desogestrel CONTROVUL 0,15 mg Film-coated tablet Oral use Helsingørgade 8C, Ethinylestradiol 0,03 mg DK-3400 Hillerød, Denmark Hungary N.V. Organon Desogestrel GRACIAL 0.04 mg/0,025 mg Tablet Oral use P.O. Box 20 Ethinylestradiol 0,03 mg/0,125 mg 5340 BH, Oss The Netherlands Hungary N.V. Organon Desogestrel LAURINA 0,035 mg/0,05 mg Film-coated tablet Oral use P.O. Box 20 Ethinylestradiol 0,03 mg/0,1 mg 5340 BH, Oss 0,03 mg/0,15 mg The Netherlands Hungary N.V. Organon Desogestrel MERCILON 0,15 mg Tablet Oral use P.O. Box 20 Ethinylestradiol 0,02 mg 5340 BH, Oss The Netherlands

124

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Hungary Gedeon Richter Plc. Desogestrel NOVYNETTE 0,15 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 0,02 mg HU-1103 Budapest Hungary Hungary Gedeon Richter Plc. Desogestrel NOVYNETTE 0,15 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol CONTINUOUS 0,02 mg HU-1103 Budapest Hungary Hungary Gedeon Richter Plc. Desogestrel REGULON 0,15 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 0,03 mg HU-1103 Budapest Hungary Hungary Gedeon Richter Plc. Desogestrel SAMBA 0,05 mg/0,035 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 0,1 mg/0,03 mg HU-1103 Budapest 0,15 mg/0,03 mg Hungary Hungary Bayer Hungaria ltd Drospirenone ALIANE 3 mg Film-coated tablet Oral use Alkotás street 50. Ethinylestradiol 0,02 mg Budapest 1123 Hungary Hungary Gedeon Richter Plc. Drospirenone AMAROSA 3 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 0,02 mg HU-1103 Budapest Hungary Hungary Gedeon Richter Plc. Drospirenone AMAROSA 3 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol CONTINUOUS 0,02 mg HU-1103 Budapest Hungary

125

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Hungary Bayer Hungaria ltd Drospirenone ANAESTELL 3mg Film-coated tablet Oral use Alkotás street 50. Ethinylestradiol 0,03mg Budapest 1123 Hungary Hungary Gedeon Richter Plc. Drospirenone ANEEA 3 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 0,02 mg HU-1103 Budapest Hungary Hungary Gedeon Richter Plc. Drospirenone ARANKA 3mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 0,03mg HU-1103 Budapest Hungary Hungary Gedeon Richter Plc. Drospirenone BELUSHA 3 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 0,02 mg HU-1103 Budapest Hungary Hungary Gedeon Richter Plc. Drospirenone BERTELLE 3mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 0,03mg HU-1103 Budapest Hungary Hungary Teva Hungary PLC Drospirenone CORENELLE 3 mg Film-coated tablet Oral use Pallagi street 13., Debrecen Ethinylestradiol 0,02 mg 4042 Hungary Hungary Teva Hungary PLC Drospirenone CORENELLE 3mg Film-coated tablet Oral use Pallagi street 13., Debrecen Ethinylestradiol 0,03mg 4042 Hungary

126

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Hungary Teva Hungary PLC desogestrel Sensilon 0,15 mg Film-coated tablet Oral use Pallagi street 13., Debrecen ethinylestradiol 0,02 mg 4042 Hungary Hungary Teva Hungary PLC desogestrel Sensilon 0,15 mg Film-coated tablet Oral use Pallagi street 13., Debrecen ethinylestradiol 0,03 mg 4042 Hungary Hungary Sandoz Hungary LTD Drospirenone DECIORA 3 mg Film-coated tablet Oral use Bartók Béla street 43-47. Ethinylestradiol 0,02 mg Budapest 1114 Hungary Hungary Sandoz Hungary LTD Drospirenone DECIORA 3mg Film-coated tablet Oral use Bartók Béla street 43-47. Ethinylestradiol 0,03mg Budapest 1114 Hungary Hungary Gedeon Richter Plc. Drospirenone DEREN 3mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 0,03mg HU-1103 Budapest Hungary Hungary Gedeon Richter Plc. Dienogest MISTRAL Continuous 2mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 0,03mg HU-1103 Budapest Hungary

127

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Hungary Gedeon Richter Plc. Drospirenone DEREN CONTINUOUS 3mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 0,03mg HU-1103 Budapest Hungary Hungary Gedeon Richter Plc. Drospirenone DROSINETTA 3 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 0,02 mg HU-1103 Budapest Hungary Hungary Gedeon Richter Plc. Drospirenone DROSINETTA 3 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol CONTINUOUS 0,02 mg HU-1103 Budapest Hungary Hungary Gedeon Richter Plc. Drospirenone DROSPIRENONE/ETHI 3mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol NYLESTRADIOL 0,03mg HU-1103 Budapest RICHTER Hungary Hungary Gedeon Richter Plc. Drospirenone ESLARILA 3 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 0,02 mg HU-1103 Budapest Hungary Hungary Gedeon Richter Plc. Drospirenone ESLARILA 3 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol CONTINUOUS 0,02 mg HU-1103 Budapest Hungary Hungary Gedeon Richter Plc. Drospirenone EVERISSA 3 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 0,02 mg HU-1103 Budapest Hungary

128

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Hungary Gedeon Richter Plc. Drospirenone FEDERIA 3 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 0,02 mg HU-1103 Budapest Hungary Hungary Gedeon Richter Plc. Drospirenone FEDERIA 3 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol CONTINUOUS 0,02 mg HU-1103 Budapest Hungary Hungary Laboratorios Leon Farma SA Drospirenone FERRANELLES 3 mg Film-coated tablet Oral use Calle La Vallina S/N Ethinylestradiol 0,02 mg Poligono Industrial Navatejera Navatejera, Leon E-24008 Spain Hungary Gedeon Richter Plc. Drospirenone GYNDORA 3 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 0,02 mg HU-1103 Budapest Hungary Hungary Gedeon Richter Plc. Drospirenone GYNDORA 3 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol CONTINUOUS 0,02 mg HU-1103 Budapest Hungary Hungary Gedeon Richter Plc. Drospirenone INKODESS 3 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 0,02 mg HU-1103 Budapest Hungary

129

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Hungary Gedeon Richter Plc. Drospirenone INKODESS 3 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol CONTINUOUS 0,02 mg HU-1103 Budapest Hungary Hungary LadeePharma Kft Drospirenone JANGEE 3 mg/0.02 3 mg Film-coated tablet Oral use Lajos utca 48-66 Ethinylestradiol mg 0,02 mg H-1036 Budapest Hungary Hungary LadeePharma Kft Drospirenone JANGEE 3 mg/0.03 3mg Film-coated tablet Oral use Lajos utca 48-66 Ethinylestradiol mg 0,03mg H-1036 Budapest Hungary Hungary Laboratorios Leon Farma SA Drospirenone JANGEE NAPONTA 3 3 mg Film-coated tablet Oral use Calle La Vallina S/N Ethinylestradiol mg/0.02 mg 0,02 mg Poligono Industrial Navatejera Navatejera, Leon E-24008 Spain Hungary Laboratorios Leon Farma SA Drospirenone JANGEE NAPONTA 3 3mg Film-coated tablet Oral use Calle La Vallina S/N Ethinylestradiol mg/0.03 mg 0,03mg Poligono Industrial Navatejera Navatejera, Leon E-24008 Spain Hungary Gedeon Richter Plc. Drospirenone KATUL 3mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 0,03mg HU-1103 Budapest Hungary

130

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Hungary Gedeon Richter Plc. Drospirenone KATUL CONTINUOUS 3mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 0,03mg HU-1103 Budapest Hungary Hungary Gedeon Richter Plc. Drospirenone KLEODINA 3mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 0,03mg HU-1103 Budapest Hungary Hungary Gedeon Richter Plc. Drospirenone KYLIXA 3 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 0,02 mg HU-1103 Budapest Hungary Hungary Gedeon Richter Plc. Drospirenone KYLNETTA 3mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 0,03mg HU-1103 Budapest Hungary Hungary Gedeon Richter Plc. Drospirenone KYLNETTA 3mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol CONTINUOUS 0,03mg HU-1103 Budapest Hungary Hungary Gedeon Richter Plc. Drospirenone LILAS 3mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 0,03mg HU-1103 Budapest Hungary Hungary Gedeon Richter Plc. Drospirenone LULINA 3mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 0,03mg HU-1103 Budapest Hungary

131

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Hungary Gedeon Richter Plc. Drospirenone MINKIAN 3 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 0,02 mg HU-1103 Budapest Hungary Hungary Gedeon Richter Plc. Drospirenone PERLITA 3 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 0,02 mg HU-1103 Budapest Hungary Hungary Gedeon Richter Plc. Drospirenone PYRLA 3 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 0,02 mg HU-1103 Budapest Hungary Hungary Gedeon Richter Plc. Drospirenone PYRLA CONTINUOUS 3 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 0,02 mg HU-1103 Budapest Hungary Hungary Gedeon Richter Plc. Drospirenone REZIA 3 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 0,02 mg HU-1103 Budapest Hungary Hungary Gedeon Richter Plc. Drospirenone SEELAR 3mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 0,03mg HU-1103 Budapest Hungary Hungary Gedeon Richter Plc. Drospirenone SELIKYNE 3 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 0,02 mg HU-1103 Budapest Hungary

132

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Hungary Gedeon Richter Plc. Drospirenone SVELTA 3 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 0,02 mg HU-1103 Budapest Hungary Hungary Gedeon Richter Plc. Drospirenone SYMICIA 3 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 0,02 mg HU-1103 Budapest Hungary Hungary Gedeon Richter Plc. Drospirenone TENTACIA 3 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 0.02mg HU-1103 Budapest Hungary Hungary Gedeon Richter Plc. Drospirenone TOLUKIM 3 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 0,02 mg HU-1103 Budapest Hungary Hungary LadeePharma Kft Drospirenone VELGYN 3 mg Film-coated tablet Oral use Lajos utca 48-66 Ethinylestradiol 0,02 mg H-1036 Budapest Hungary Hungary Gedeon Richter Plc. Drospirenone VESPIREA 3mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 0,03mg HU-1103 Budapest Hungary Hungary Gedeon Richter Plc. Drospirenone VIVIENNE 3mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 0,03mg HU-1103 Budapest Hungary

133

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Hungary Gedeon Richter Plc. Drospirenone VOLINA 3mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 0,03mg HU-1103 Budapest Hungary Hungary Gedeon Richter Plc. Drospirenone XINDEA 3 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 0,02 mg HU-1103 Budapest Hungary Hungary Bayer Pharma AG Drospirenone YADINE 3mg Film-coated tablet Oral use D-13342 Berlin Ethinylestradiol 0,03mg Germany Hungary Bayer Pharma AG Drospirenone YASMINELLE 3 mg Film-coated tablet Oral use D-13342 Berlin Ethinylestradiol 0,02 mg Germany Hungary Gedeon Richter Plc. Drospirenone ZEELAR CONTINUOUS 3mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 0,03mg HU-1103 Budapest Hungary Hungary Gedeon Richter Plc. Drospirenone ZEPHIRENE 3mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 0,03mg HU-1103 Budapest Hungary Hungary Gedeon Richter Plc. Drospirenone ZOA 3mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 0,03mg HU-1103 Budapest Hungary

134

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Hungary Zentiva, k.s. gestodene DALIA 0,075 mg Coated tablet Oral use U kabelovny 130 ethinylestradiol 0,02 mg 102 37 Praha 10 Dolní Měcholupy Czech Republic Hungary Zentiva, k.s. drospirenone Sidretella 3mg Film-coated tablet Oral use U kabelovny 130 ethinylestradiol 0,02mg 102 37 Praha 10 Dolní Měcholupy Czech Republic Hungary Zentiva, k.s. drospirenone Sidretella 3mg Film-coated tablet Oral use U kabelovny 130 ethinylestradiol 0,03mg 102 37 Praha 10 Dolní Měcholupy Czech Republic Hungary Bayer Pharma AG gestodene FEMODEN 0,075 mg Coated tablet Oral use D-13342 Berlin ethinylestradiol 0,03 mg Germany Hungary Aramis Pharma Kft. gestodene GESTOMIX 0,075 mg Coated tablet Oral use Mester u. 28B III/5 ethinylestradiol 0,02 mg 1095 Budapest Hungary Hungary LadeePharma Kft gestodene Gefemin 0.06 mg Film-coated tablet Oral use Lajos utca 48-66 ethinylestradiol 0.015 mg H-1036 Budapest Hungary

135

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Hungary Aramis Pharma Kft. gestodene GESTOMIX 0,075 mg Coated tablet Oral use Mester u. 28B III/5 ethinylestradiol 0,03 mg 1095 Budapest Hungary Hungary Wyeth LTD. gestodene HARMONET 0,075 mg Coated tablet Oral use Alkotás u. 53 ethinylestradiol 0,02 mg Budapest 1123 Hungary Hungary Sandoz Hungary LTD gestodene IAMNA 0,075 mg Coated tablet Oral use Bartók Béla street 43-47. ethinylestradiol 0,02 mg Budapest 1114 Hungary Hungary Sandoz Hungary LTD gestodene IAMNA 0,075 mg Coated tablet Oral use Bartók Béla street 43-47. ethinylestradiol 0,03 mg Budapest 1114 Hungary Hungary Gedeon Richter Plc. gestodene LINDYNETTE 0,075 mg Coated tablet Oral use Gyömröí út 19-21 ethinylestradiol 0,02 mg HU-1103 Budapest Hungary Hungary Gedeon Richter Plc. gestodene LINDYNETTE 0,075 mg Coated tablet Oral use Gyömröí út 19-21 ethinylestradiol 0,03 mg HU-1103 Budapest Hungary

136

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Hungary Bayer Pharma AG gestodene MELIANE 0,075 mg Coated tablet Oral use D-13342 Berlin ethinylestradiol 0,02 mg Germany Hungary Gedeon Richter Plc. gestodene MILLIGEST 0,05 mg/0,03 mg Coated tablet Oral use Gyömröí út 19-21 ethinylestradiol 0,07 mg/0,04 mg HU-1103 Budapest 0,01 mg/0,03 mg Hungary Hungary Pfizer Hungary LTD. gestodene MINULET 0,075 mg Coated tablet Oral use Alkotás street 53 ethinylestradiol 0,03 mg Budapest 1123 Hunagry Hungary Q Pharma Kft. gestodene MIRABELLA 0,075 mg Coated tablet Oral use Veres Pálné u. 4-6. ethinylestradiol 0,02 mg Budapest 1053 Hungary Hungary Q Pharma Kft. gestodene MIRABELLA 0,075 mg Coated tablet Oral use Veres Pálné u. 4-6. ethinylestradiol 0,03 mg Budapest 1053 Hungary Hungary Ratiopharm GmbH gestodene SENSONETTE 0,075 mg Coated tablet Oral use Graf-Arco-Strasse 3 ethinylestradiol 0,02 mg DE-89079 Ulm Germany Hungary Ratiopharm GmbH gestodene SENSONETTE 0,075 mg Coated tablet Oral use Graf-Arco-Strasse 3 ethinylestradiol 0,03 mg DE-89079 Ulm Germany

137

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Hungary Gedeon Richter Plc. gestodene SOLDANELLE 0,06 mg Film-coated tablet Oral use Gyömröí út 19-21 ethinylestradiol 0,015 mg HU-1103 Budapest Hungary Hungary Medico Uno Pharma Kft. gestodene STODETTE 0,075 mg Coated tablet Oral use Viadukt u. 12 ethinylestradiol 0,02 mg Biatorbágy 2051 Hungary Hungary Bayer Pharma AG gestodene TRIODENA 0,05 mg/0,03 mg Coated tablet Oral use D-13342 Berlin ethinylestradiol 0,07 mg/0,04 mg Germany 0,1 mg/0,03 mg Hungary Gedeon Richter Plc. gestodene ZULFIJA 0,075 mg Coated tablet Oral use Gyömröí út 19-21 ethinylestradiol 0,02 mg HU-1103 Budapest Hungary Hungary Gedeon Richter Plc. gestodene ZULFIJA 0,075 mg Coated tablet Oral use Gyömröí út 19-21 ethinylestradiol 0,03 mg HU-1103 Budapest Hungary Hungary Gedeon Richter Plc. Dienogest MISTRAL 2mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 0,03mg HU-1103 Budapest Hungary Hungary LadeePharma Kft Dienogest DIENILLE 2mg Film-coated tablet Oral use Lajos utca 48-66 Ethinylestradiol 0,03mg H-1036 Budapest Hungary

138

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Hungary Zentiva, k.s. Dienogest BONADEA 2mg Film-coated tablet Oral use U kabelovny 130 Ethinylestradiol 0,03mg 102 37 Praha 10 Dolní Měcholupy Czech Republic Hungary Bayer Pharma AG Estradiol valerate QLAIRA 3 mg Film-coated tablet Oral use D-13342 Berlin Dienogest 2 mg/2 mg Germany 2 mg/3 mg 1 mg Hungary N.V. Organon Etonogestrel NUVARING 11.7 mg Vaginal delivery Vaginal use P.O. Box 20 Ethinylestradiol 2.7 mg system 5340 BH, Oss The Netherlands Hungary N.V. Organon Etonogestrel CIRCLET 11.7 mg Vaginal delivery Vaginal use P.O. Box 20 Ethinylestradiol 2.7 mg system 5340 BH, Oss The Netherlands Hungary Zentiva, k.s. Desogestrel Estmar 0.15 mg Tablet Oral use U kabelovny 130 Ethinylestradiol 0.02 mg 102 37 Praha 10 Dolní Měcholupy Czech Republic Hungary Zentiva, k.s. Desogestrel Estmar 0.15 mg Tablet Oral use U kabelovny 130 Ethinylestradiol 0.03 mg 102 37 Praha 10 Dolní Měcholupy Czech Republic

139

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Hungary N.V. Organon Desogestrel Marvelon 0.15 mg Tablet Oral use P.O. Box 20 Ethinylestradiol 0.03 mg 5340 BH, Oss The Netherlands Hungary Bayer Pharma AG Drospirenone Angeliq 3mg Film-coated tablet Oral use D-13342 Berlin Ethinylestradiol 0,02mg Germany Hungary Laboratorios Leon Farma SA Drospirenone Drosetil NAPONTA 3mg Film-coated tablet Oral use Calle La Vallina S/N Ethinylestradiol 3 mg / 0,02mg 0,02mg Poligono Industrial Navatejera filmtabletta Navatejera, Leon E-24008 Spain Hungary Laboratorios Leon Farma SA Drospirenone Drosetil NAPONTA 3mg Film-coated tablet Oral use Calle La Vallina S/N Ethinylestradiol 3 mg / 0,03 mg 0,03mg Poligono Industrial Navatejera filmtabletta Navatejera, Leon E-24008 Spain Hungary Bayer Pharma AG Drospirenone Flexyess 3mg Film-coated tablet Oral use Müllerstrasse 170-178. Ethinylestradiol 0,02mg 13342 Berlin Germany Hungary Gedeon Richter Plc. Chlormadinone Belara 0,03 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 2 mg HU-1103 Budapest Hungary

140

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Hungary Ratiopharm GmbH Chlormadinone Claranette-ratiopharm 2mg Film-coated tablet Oral use Graf-Arco-Strasse 3 Ethinylestradiol 0.03mg DE-89079 Ulm Germany Hungary Laboratorios Leon Farma SA Chlormadinone Clormetin 2mg Film-coated tablet Oral use Calle La Vallina S/N Ethinylestradiol 0.03mg Poligono Industrial Navatejera Navatejera, Leon E-24008 Spain Iceland ratiopharm GmbH Desogestrel Denise 0,15 mg Tablet Oral use Graf-Arco Strasse 3 Ethinylestradiol 0,02 mg 89079 ULM Germany Iceland Bayer Pharma AG Drospirenone Yasminelle 0,02 mg Film-coated tablet Oral use Müllerstrasse 178 Ethinylestradiol 3 mg D-13342 Berlin Germany Iceland Bayer AB Drospirenone YAZ 0,02 mg Film-coated tablet Oral use Postbox 606 Ethinylestradiol 3 mg Gustav III's Boulevard 56 SE-16926 Solna Sweden Iceland N.V. Organon Desogestrel Gracial 0.04 mg/0.25 mg Tablet Oral use Kloosterstraat 6 Ethinylestradiol 0.03 mg/0.125 mg 5349 AB, Oss The Netherlands

141

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Iceland N.V. Organon Desogestrel Marvelon 0.03 mg Tablet Oral use Kloosterstraat 6 Ethinylestradiol 0.15 mg 5349 AB, Oss The Netherlands Iceland N.V. Organon Desogestrel Mercilon 0.02 mg Tablet Oral use Kloosterstraat 6 Ethinylestradiol 0.15 mg 5349 AB, Oss The Netherlands Iceland Bayer AB Drospirenone Eloine 0,02 mg Film-coated tablet Oral use Postbox 606 Ethinylestradiol 3 mg Gustav III's Boulevard 56 SE-16926 Solna Sweden Iceland Bayer AB Drospirenone Palandra 0,03 mg Film-coated tablet Oral use Postbox 606 Ethinylestradiol 3 mg Gustav III's Boulevard 56 SE-16926 Solna Sweden Iceland Bayer Pharma AG Drospirenone Yasmin 0,03 mg Film-coated tablet Oral use Müllerstrasse 178 Ethinylestradiol 3 mg D-13342 Berlin Germany Iceland Bayer Pharma AG Drospirenone Yasmin 28 0,03 mg Film-coated tablet Oral use Müllerstrasse 178 Ethinylestradiol 3 mg D-13342 Berlin Germany

142

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Iceland Pfizer ApS, Gestodene Harmonet 0.020mg + 0.075 Tablet Oral use Lautrupvang 8, Ethinylestradiol mg DK-2750 Ballerup, Denmark Iceland Actavis Group PTC ehf Desogestrel Benidette 0,15 mg Tablet Oral use Reykjavikurvegi 76-78 Ethinylestradiol 0,02 mg 220 Hafnarfjordur Iceland Iceland Actavis Group PTC ehf Desogestrel Benifema 0,15 mg Tablet Oral use Reykjavikurvegi 76-78 Ethinylestradiol 0,03 mg 220 Hafnarfjordur Iceland Iceland Bayer AB Drospirenone Flexyess 3mg Film-coated tablet Oral use Postbox 606 Ethinylestradiol 0,02 mg Gustav III's Boulevard 56 SE-16926 Solna Sweden Iceland N.V. Organon Etonogestrel NuvaRing 11,7 mg Vaginal delivery Vaginal use Kloosterstraat 6 Ethinylestradiol 2,7 mg system 5349 AB, Oss The Netherlands Iceland Bayer AB Estradiol valerate Qlaira 3 mg Film-coated tablet Oral use Postbox 606 Dienogest 2 mg/2 mg Gustav III's Boulevard 56 2 mg/3 mg SE-16926 Solna 1 mg Sweden

143

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Ireland Organon (Ireland) Ltd, Desogestrel/ Gracial 0.025 mg/0.04 mg Tablet Oral use PO Box 2857, Ethinylestradiol 0.125 mg/0.03 mg Drynam Road, Swords, Co.Dublin, Ireland Ireland Gedeon Richter Plc. Desogestrel Leticia 0.15 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 0.03 mg HU-1103 Budapest Hungary Ireland Organon (Ireland) Ltd, Desogestrel/ Marviol 0.15 mg/ Tablet Oral use PO Box 2857, Ethinylestradiol 0.03 mg Drynam Road, Swords, Co.Dublin, Ireland Ireland Organon (Ireland) Ltd, Desogestrel/ Mercilon 0.15 mg/ Tablet Oral use PO Box 2857, Ethinylestradiol 0.02 mg Drynam Road, Swords, Co.Dublin, Ireland Ireland Gedeon Richter Plc. Desogestrel Vivides 0.15 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 0.02 mg HU-1103 Budapest Hungary

144

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Ireland Bayer Limited Estradiol valerate Qlaira 3 mg Film-coated tablet Oral use The Atrium, Dienogest 2 mg/2 mg Blackthorn Road, 2 mg/3 mg Dublin 18, 1 mg Ireland Ireland Teva Pharma BV Drospirenone Dretine 0.3mg Film-coated tablet Oral use Computerweg 10 Ethinylestradiol 3mg 3542 DR Utrecht The Netherlands Ireland Bayer Limited Drospirenone Yaz 0.02mg Film-coated tablet Oral use The Atrium, Ethinylestradiol 3mg Blackthorn Road, Dublin 18, Ireland Ireland Teva Pharma BV Drospirenone Dretinelle 0.02mg Film-coated tablet Oral use Computerweg 10 Ethinylestradiol 3mg 3542 DR Utrecht The Netherlands Ireland Gedeon Richter Plc. Drospirenone Enador 0.02mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 3mg HU-1103 Budapest Hungary Ireland Gedeon Richter Plc. Drospirenone Enador&Placebo 0.02mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 3mg HU-1103 Budapest Hungary

145

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Ireland Laboratorios Leon Farma SA Drospirenone Ethinylestradiol / 0.02mg Film-coated tablet Oral use Calle La Vallina S/N Ethinylestradiol Drospirenone Leon 3mg Poligono Industrial Navatejera Farma Navatejera, Leon E-24008 Spain Ireland Laboratorios Leon Farma SA Drospirenone Ethinylestradiol / 0.02mg Film-coated tablet Oral use Calle La Vallina S/N Ethinylestradiol Drospirenone Leon 3mg Poligono Industrial Navatejera Farma & Placebo Navatejera, Leon E-24008 Spain Ireland Laboratorios Leon Farma SA Drospirenone Ethinylestradiol / 0.03mg Film-coated tablet Oral use Calle La Vallina S/N Ethinylestradiol Drospirenone Leon 3mg Poligono Industrial Navatejera Farma & Placebo Navatejera, Leon E-24008 Spain Ireland Laboratorios Leon Farma SA Drospirenone Ethinylestradiol / 0.03mg Film-coated tablet Oral use Calle La Vallina S/N Ethinylestradiol Drospirenone Leon 3mg Poligono Industrial Navatejera Farma & Placebo Navatejera, Leon E-24008 Spain Ireland Gedeon Richter Plc. Drospirenone Ethinylestradiol/Drospi 0.03mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol renone Gedeon 3mg HU-1103 Budapest Richter Hungary

146

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Ireland Rowex Ltd Drospirenone Freedo 0.03mg Film-coated tablet Oral use Bantry Ethinylestradiol 3mg Co. Cork Ireland Ireland Rowex Ltd Drospirenone Freedo&Placebo 0.03mg Film-coated tablet Oral use Bantry Ethinylestradiol 3.0mg Co. Cork Ireland Ireland Rowex Ltd Drospirenone Freedonel 0.02mg Film-coated tablet Oral use Bantry Ethinylestradiol 3mg Co. Cork Ireland Ireland Rowex Ltd Drospirenone Freedonel&Placebo 0.02mg Film-coated tablet Oral use Bantry Ethinylestradiol 3.0mg Co. Cork Ireland Ireland Bayer Limited Drospirenone Palandra 0.03mg Film-coated tablet Oral use The Atrium, Ethinylestradiol 3mg Blackthorn Road, Dublin 18, Ireland Ireland Gedeon Richter Plc. Drospirenone Svelta 0.02mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 3mg HU-1103 Budapest Hungary

147

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Ireland Teva Pharma BV Drospirenone Veyann 0.02mg Film-coated tablet Oral use Computerweg 10 Ethinylestradiol 3mg 3542 DR Utrecht The Netherlands Ireland Bayer Limited Drospirenone Yasmin 0.03mg Film-coated tablet Oral use The Atrium, Ethinylestradiol 3mg Blackthorn Road, Dublin 18, Ireland Ireland Bayer Limited Drospirenone Yasminelle 0.02mg Film-coated tablet Oral use The Atrium, Ethinylestradiol 3mg Blackthorn Road, Dublin 18, Ireland Ireland Bayer Limited Drospirenone Liofora 0.02mg Film-coated tablet Oral use The Atrium, Ethinylestradiol 3mg Blackthorn Road, Dublin 18, Ireland Ireland Bayer Limited Drospirenone Flexyess 0.02mg Film-coated tablet Oral use The Atrium, Ethinylestradiol 3mg Blackthorn Road, Dublin 18, Ireland

148

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Ireland Organon (Ireland) Ltd, Etonogestrel Circlet 11.7mg Vaginal delivery Vaginal use PO Box 2857, Ethinylestradiol 2.7mg system Drynam Road, Swords, Co.Dublin, Ireland Ireland Organon (Ireland) Ltd, Etonogestrel Nuvaring 11.7mg Vaginal delivery Vaginal use PO Box 2857, Ethinylestradiol 2.7mg system Drynam Road, Swords, Co.Dublin, Ireland Ireland Pfizer Healthcare Ireland Gestodene Tri-minulet 0.050mg/0.070mg Coated tablet Oral use 9 Riverwalk Ethinylestradiol /0.100mg National Digital Park 0.030mg/0.040mg Citywest Business Campus /0.030mg Dublin 24 Ireland Ireland Clonmel Healthcare Ltd Gestodene Estelle 0.075mg Coated tablet Oral use Waterford Road Ethinylestradiol 0.030mg Clonmel Co Tipperary Ireland Ireland Clonmel Healthcare Ltd Drospirenone Carmen 0.03mg Film-coated tablet Oral use Waterford Road Ethinylestradiol 3mg Clonmel Co Tipperary Ireland

149

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Ireland Clonmel Healthcare Ltd Drospirenone Carmenelle 0.02mg Film-coated tablet Oral use Waterford Road Ethinylestradiol 3mg Clonmel Co Tipperary Ireland Ireland Pfizer Healthcare Ireland Gestodene Harmonet 0.075mg Coated tablet Oral use 9 Riverwalk Ethinylestradiol 0.020mg National Digital Park Citywest Business Campus Dublin 24 Ireland Ireland Pfizer Healthcare Ireland Gestodene Minesse 0.060mg Film-coated tablet Oral use 9 Riverwalk Ethinylestradiol 0.015mg National Digital Park Citywest Business Campus Dublin 24 Ireland Ireland Pfizer Healthcare Ireland Gestodene Minulet 0.075mg Coated tablet Oral use 9 Riverwalk Ethinylestradiol 0.030mg National Digital Park Citywest Business Campus Dublin 24 Ireland

150

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Ireland Janssen-Cilag Limited Norgestimate Cilest 0.25 mg Tablet Oral use 50-100 Holmers Farm Way Ethinylestradiol 0.035 mg High Wycombe Buckinghamshire HP12 4EG United Kingdom Ireland Laboratorios Leon Farma SA Drospirenone Ethinylestradiol / 0.03mg Film-coated tablet Oral use C/Roa de la Vega 15 Ethinylestradiol Drospirenone Leon 3mg 1-24008 Leon Farma Spain Italy Teva Italia S.r.l. Desogestrel DENISELLE 0,15 mg Tablet Oral use via Messina 38 Ethinylestradiol 0,02 mg 20154 Milano Italy Italy MYLAN S.P.A. Desogestrel DESOGESTREL E 0,15 mg Tablet Oral use Viale dell'Innovazione, 3, Ethinylestradiol ETINILESTRADIOLO 0,02 mg 20125 Milano MYLAN GENERICS Italy Italy MYLAN S.P.A. Desogestrel DESOGESTREL E 0,15 mg Tablet Oral use Viale dell'Innovazione, 3, Ethinylestradiol ETINILESTRADIOLO 0,03 mg 20125 Milano MYLAN GENERICS Italy Italy A. Menarini Industrie Desogestrel DUEVA 0,04 mg/0,025 mg Tablet Oral use Farmaceutiche Riunite s.r.l., Ethinylestradiol 0,03 mg/0,125 mg via Sette Santi, 3 - 50131 Florence Italy

151

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Italy Farmitalia Industrie Chimico Desogestrel ANTELA 0,02 mg Tablet Oral use Farmaceutiche Ethinylestradiol 0,15 mg Via Alcide De Gasperi, 165 B 95127 Catania Italy Italy Farmitalia Industrie Chimico Desogestrel ANTELA 0,03 mg Tablet Oral use Farmaceutiche Ethinylestradiol 0,15 mg Via Alcide De Gasperi, 165 B 95127 Catania Italy Italy N.V. Organon Desogestrel GRACIAL 0,025 mg/ 0,04 Tablet Oral use Kloosterstraat 6 Ethinylestradiol mg 5349 AB, Oss 0,125 mg/ 0,03 The Netherlands mg Italy N.V. Organon Desogestrel LUCILLE 0,035 mg/0,05 mg Film-coated tablet Oral use Kloosterstraat 6 Ethinylestradiol 0,03 mg/0,1 mg 5349 AB, Oss 0,03 mg/0,15 mg The Netherlands Italy N.V. Organon Desogestrel MERCILON 0,15 mg Tablet Oral use Kloosterstraat 6 Ethinylestradiol 0,02 mg 5349 AB, Oss The Netherlands Italy Farmitalia Industria chimico Desogestrel NOVYNETTE 0,15 mg Film-coated tablet Oral use farmaceutica S.R.L Ethinylestradiol 0,02 mg Via Alcide De Gasperi 165/B - 95100 Catania Italy

152

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Italy A. Menarini Industrie Desogestrel PLANUM 0,15 mg Tablet Oral use Farmaceutiche Riunite s.r.l., Ethinylestradiol 0,03 mg via Sette Santi, 3 - 50131 Florence Italy Italy N.V. Organon Desogestrel PRACTIL 0,15 mg Tablet Oral use Kloosterstraat 6 Ethinylestradiol 0,03 mg 5349 AB, Oss The Netherlands Italy A. Menarini Industrie Desogestrel SECURGIN 0,15 mg Tablet Oral use Farmaceutiche Riunite s.r.l., Ethinylestradiol 0,02 mg via Sette Santi, 3 - 50131 Florence Italy Italy EG S.p.A. Desogestrel ZAKIRA 0,15 mg Tablet Oral use Via D. Scarlatti, 31 Ethinylestradiol 0,02 mg 20124 Milano Italy Italy EG S.p.A. Desogestrel ZAKIRA 0,15 mg Tablet Oral use Via D. Scarlatti, 31 Ethinylestradiol 0,03 mg 20124 Milano Italy Italy Effik Italia S.p.A. Dienogest EFFIPREV 2 mg Film-coated tablet Oral use Via Lincoln 7/A, Ethinylestradiol 0,003 mg 20092 Cinisello Balsamo (MI) Italy

153

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Italy Gedeon Richter Plc. Dienogest SIBILLA 2 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 0,003 mg HU-1103 Budapest Hungary Italy Bayer S.p.A. Drospirenone ALIANE 3 mg Film-coated tablet Oral use Viale Certosa, 130 - Ethinylestradiol 0,02 mg 20156 Milano (MI) Italy Italy Bayer S.p.A. Drospirenone Yvidually 3 mg Film-coated tablet Oral use Viale Certosa, 130 - Ethinylestradiol 0,02 mg 20156 Milano (MI) Italy Italy Sandoz Spa Drospirenone CALINDIR 3mg Film-coated tablet Oral use Largo U. Boccioni, 1 Ethinylestradiol 0,03mg 21040 Origgio (VA) Italy Italy Effik Italia S.p.A. Drospirenone CREDIGYNE 3mg Film-coated tablet Oral use Via Lincoln 7/A, Ethinylestradiol 0,03mg 20092 Cinisello Balsamo (MI) Italy Italy Effik Italia S.p.A. Drospirenone CREDIGYNETTE 3 mg Film-coated tablet Oral use Via Lincoln 7/A, Ethinylestradiol 0,02 mg 20092 Cinisello Balsamo (MI) Italy Italy Gedeon Richter Plc. Drospirenone DAYLETTE 3mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 0,03mg HU-1103 Budapest Hungary

154

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Italy Doc Generici S.R.L. Drospirenone DOCGYN 3 mg Film-coated tablet Oral use Via Manuzio 7 Ethinylestradiol 0,02 mg 20124 - Milano Italy Italy Doc Generici S.R.L. Drospirenone DOCTYNE 3mg Film-coated tablet Oral use Via Manuzio 7 Ethinylestradiol 0,03mg 20124 - Milano Italy Italy Effik Italia S.p.A. Drospirenone DROSPIL 3mg Film-coated tablet Oral use Via Lincoln 7/A, Ethinylestradiol 0,03mg 20092 Cinisello Balsamo (MI) Italy Italy Effik Italia S.p.A. Drospirenone DROSURE 3mg Film-coated tablet Oral use Via Lincoln 7/A, Ethinylestradiol 0,03mg 20092 Cinisello Balsamo (MI) Italy Italy Effik Italia S.p.A. Drospirenone DROSURELLE 3 mg Film-coated tablet Oral use Via Lincoln 7/A, Ethinylestradiol 0,02 mg 20092 Cinisello Balsamo (MI) Italy Italy Bayer S.p.A. Drospirenone ELOINE 3 mg Film-coated tablet Oral use Viale Certosa, 130 - Ethinylestradiol 0,02 mg 20156 Milano (MI) Italy Italy Doc Generici S.R.L. Drospirenone ETINILESTRADIOLO E 3 mg Film-coated tablet Oral use Via Manuzio 7 Ethinylestradiol DROSPIRENONE DOC 0,02 mg 20124 - Milano Italy

155

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Italy Doc Generici S.R.L. Drospirenone ETINILESTRADIOLO E 3 mg Film-coated tablet Oral use Via Manuzio 7 Ethinylestradiol DROSPIRENONE DOC 0,02 mg 20124 - Milano GENERICI Italy Italy Doc Generici S.R.L. Drospirenone ETINILESTRADIOLO E 3mg Film-coated tablet Oral use Via Manuzio 7 Ethinylestradiol DROSPIRENONE 0,03mg 20124 - Milano DOCGEN Italy Italy Farmitalia Industria chimico Drospirenone LERNA 3 mg Film-coated tablet Oral use farmaceutica S.R.L Ethinylestradiol 0,02 mg Via Alcide De Gasperi 165/B - 95100 Catania Italy Italy Gedeon Richter Plc. Drospirenone LILADROS 3 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 0,02 mg HU-1103 Budapest Hungary Italy Teva Italia S.r.l. Drospirenone LUSINE 3mg Film-coated tablet Oral use via Messina 38 Ethinylestradiol 0,03mg 20154 Milano Italy Italy Teva Italia S.r.l. Drospirenone LUSINELLE 3 mg Film-coated tablet Oral use via Messina 38 Ethinylestradiol 0,02 mg 20154 Milano Italy

156

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Italy Gedeon Richter Plc. Drospirenone MIDIANA 3mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 0,03mg HU-1103 Budapest Hungary Italy Sandoz Spa Drospirenone RUBIRA 3 mg Film-coated tablet Oral use Largo U. Boccioni, 1 Ethinylestradiol 0,02 mg 21040 Origgio (VA) Italy Italy Bayer S.p.A. Drospirenone YASMIN 3mg Film-coated tablet Oral use Viale Certosa, 130 - Ethinylestradiol 0,03mg 20156 Milano (MI) Italy Italy Bayer S.p.A. Drospirenone YASMINELLE 3 mg Film-coated tablet Oral use Viale Certosa, 130 - Ethinylestradiol 0,02 mg 20156 Milano (MI) Italy Italy Bayer S.p.A. Drospirenone YAZ 3 mg Film-coated tablet Oral use Viale Certosa, 130 - Ethinylestradiol 0,02 mg 20156 Milano (MI) Italy Italy Farmitalia Industria chimico Gestodene ALCMENA 0,06 mg Film-coated tablet Oral use farmaceutica S.R.L Ethinylestradiol 0,015 mg Via Alcide De Gasperi 165/B - 95100 Catania Italy

157

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Italy Bayer S.p.A. Gestodene ARIANNA 0,06 mg Film-coated tablet Oral use Viale Certosa, 130 - Ethinylestradiol 0,015 mg 20156 Milano (MI) Italy Italy Gedeon Richter Plc. Gestodene EDESIA 0,075 mg Coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 0,03 mg HU-1103 Budapest Hungary Italy Gedeon Richter Plc. Gestodene EDESIA 0,075 mg Coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 0,02 mg HU-1103 Budapest Hungary Italy Effik Italia S.p.A. Gestodene ESTINETTE 0,075 mg Coated tablet Oral use Via Lincoln 7/A, Ethinylestradiol 0,02 mg 20092 Cinisello Balsamo (MI) Italy Italy Mylan S.p.A. Desogestrel DESOGESTREL E 0,15 mg Tablet Oral use Via Vittor Pisani 20 Ethinylestradiol ETINILESTRADIOLO 0,02 mg 20124 Milano MYLAN GENERICS Italy Italy Mylan S.p.A. Desogestrel DESOGESTREL E 0,15 mg Tablet Oral use Via Vittor Pisani 20 Ethinylestradiol ETINILESTRADIOLO 0,03 mg 20124 Milano MYLAN GENERICS Italy Italy Mylan S.p.A. Gestodene ETINILESTRADIOLO E 0,075 mg Coated tablet Oral use Via Vittor Pisani 20 Ethinylestradiol GESTODENE MYLAN 0,02 mg 20124 Milano GENERICS Italy

158

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Italy Mylan S.p.A. Gestodene ETINILESTRADIOLO E 0,075 mg Coated tablet Oral use Via Vittor Pisani 20 Ethinylestradiol GESTODENE MYLAN 0,03 mg 20124 Milano GENERICS Italy Italy Bayer S.p.A. Gestodene FEDRA 0,075 mg Coated tablet Oral use Viale Certosa, 130 - Ethinylestradiol 0,02 mg 20156 Milano (MI) Italy Italy Farmitalia Industria chimico Gestodene GESTODIOL 0,075 mg Coated tablet Oral use farmaceutica S.R.L Ethinylestradiol 0,02 mg Via Alcide De Gasperi 165/B - 95100 Catania Italy Italy Farmitalia Industria chimico Gestodene GESTODIOL 0,075 mg Coated tablet Oral use farmaceutica S.R.L Ethinylestradiol 0,03 mg Via Alcide De Gasperi 165/B - 95100 Catania Italy Italy Bayer S.p.A. Gestodene GINODEN 0,075 mg Coated tablet Oral use Viale Certosa, 130 - Ethinylestradiol 0,03 mg 20156 Milano (MI) Italy Italy WYETH MEDICA IRELAND Gestodene HARMONET 0,075 mg Coated tablet Oral use Little Connell Ethinylestradiol 0,02 mg Newbridge County Kildare Ireland

159

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Italy Effik Italia S.p.A. Gestodene KIPLING 0,075 mg Coated tablet Oral use Via Lincoln 7/A, Ethinylestradiol 0,03 mg 20092 Cinisello Balsamo (MI) Italy Italy Teva Italia S.r.l. Gestodene LIUDA 0,075 mg Coated tablet Oral use via Messina 38 Ethinylestradiol 0,02 mg 20154 Milano Italy Italy Teva Italia S.r.l. Gestodene LIUDA 0,075 mg Coated tablet Oral use via Messina 38 Ethinylestradiol 0,03 mg 20154 Milano Italy Italy Bayer S.p.A. Gestodene MILVANE 0,05 mg/0,03 mg Coated tablet Oral use Viale Certosa, 130 - Ethinylestradiol 0,07 mg/0,04 mg 20156 Milano (MI) 0,1 mg/0,03 mg Italy Italy Pfizer Italia S.r.l., Gestodene MINESSE 0,06 mg Film-coated tablet Oral use via Isonzo, 71 Ethinylestradiol 0,015 mg 04100 Latina Italy Italy WYETH MEDICA IRELAND Gestodene MINULET 0,075 mg Coated tablet Oral use Little Connell Ethinylestradiol 0,03 mg Newbridge County Kildare Ireland

160

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Italy WYETH MEDICA IRELAND Gestodene TRIMINULET 0,05 mg/0,03 mg Coated tablet Oral use Little Connell Ethinylestradiol 0,07 mg/0,04 mg Newbridge 0,1 mg/0,03 mg County Kildare Ireland Italy Sandoz Spa Gestodene YVETTE 0,06 mg Film-coated tablet Oral use Largo U. Boccioni, 1 Ethinylestradiol 0,015 mg 21040 Origgio (VA) Italy Italy Actavis Group PTC ehf Gestodene ZOE 0,075 mg Coated tablet Oral use Reykjavikurvegi 76-78 Ethinylestradiol 0,02 mg 220 Hafnarfjordur Iceland Italy Actavis Group PTC ehf Gestodene ZOE 0,075 mg Coated tablet Oral use Reykjavikurvegi 76-78 Ethinylestradiol 0,03 mg 220 Hafnarfjordur Iceland Italy N.V. Organon Etonogestrel NUVARING 0,120 mg/ Vaginal delivery Vaginal use Kloosterstraat 6 Ethinylestradiol 0,015 mg/24 hours system 5349 AB, Oss The Netherlands Italy N.V. Organon Etonogestrel CIRCLET 0,120 mg/ Vaginal delivery Vaginal use Kloosterstraat 6 Ethinylestradiol 0,015 mg/24 hours system 5349 AB, Oss The Netherlands

161

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Italy Bayer S.p.A. Estradiol valerate KLAIRA 3 mg Film-coated tablet Oral use Viale Certosa, 130 - Dienogest 2 mg/2 mg 20156 Milano (MI) 2 mg/3 mg Italy 1 mg

Italy Teva Italia S.r.l. Drospirenone LUTIZ 3 mg Film-coated tablet Oral use via Messina 38 Ethinylestradiol 0,02mg 20154 Milano Italy Italy Bayer S.p.A. Drospirenone YARINA 3mg Film-coated tablet Oral use Viale Certosa, 130 - Ethinylestradiol 0,03mg 20156 Milano (MI) Italy Italy Teva Italia S.r.l. Chlormadinone TYARENA 2 mg Film-coated tablet Oral use via Messina 38 Ethinylestradiol 0,03 mg 20154 Milano Italy Italy Gedeon Richter Plc. Chlormadinone BELARA 2 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 0,03 mg HU-1103 Budapest Hungary Italy Sandoz Spa Chlormadinone EVE 2 mg Film-coated tablet Oral use Largo U. Boccioni, 1 Ethinylestradiol 0,03 mg 21040 Origgio (VA) Italy

162

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Italy Ratiopharm GmbH Chlormadinone CLORETINYL 2 mg Film-coated tablet Oral use Graf-Arco-Strasse 3 Ethinylestradiol 0,03 mg DE-89079 Ulm Germany Italy Mylan S.p.A. Chlormadinone CLORMADINONE 2 mg Film-coated tablet Oral use Via Vittor Pisani 20 Ethinylestradiol ETINILESTRADIOLO 0,03 mg 20124 Milano MYLAN Italy Italy EG S.p.A. Chlormadinone NAVEEN 2 mg Film-coated tablet Oral use Via D. Scarlatti, 31 Ethinylestradiol 0,03 mg 20124 Milano Italy Latvia UAB „Ladee Pharma Baltics“ Chlormadinone Clormetin 2 mg/0,03 2 mg Film-coated tablet Oral use Zemaitijos g.13/Siauliu g.10 Ethinylestradiol mg film-coated tablets 0,03 mg Vilnius LT-01134 Lithuania Latvia Zentiva, k.s. Desogestrel Estmar 150/20 0,15 mg Tablet Oral use U kabelovny 130 Ethinylestradiol micrograms tablets 0,02 mg 102 37 Praha 10 Dolní Měcholupy Czech Republic Latvia Zentiva, k.s. Desogestrel Estmar 150/30 0,15 mg Tablet Oral use U kabelovny 130 Ethinylestradiol micrograms tablets 0,03 mg 102 37 Praha 10 Dolní Měcholupy Czech Republic

163

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Latvia N.V. Organon Desogestrel Gracial tablets 0.125 mg/0.030 Tablet Oral use P.O. Box 20 Ethinylestradiol mg Kloosterstraat 6 0.025 mg/0.040 5340 BH, Oss mg The Netherlands

Latvia N.V. Organon Desogestrel Marvelon 150/30 0,15 mg Tablet Oral use P.O. Box 20 Ethinylestradiol micrograms tablets 0,03 mg Kloosterstraat 6 5340 BH, Oss The Netherlands

Latvia Organon (Ireland) Ltd, Desogestrel Mercilon 150/20 0,15 mg Tablet Oral use PO Box 2857, Ethinylestradiol micrograms tablets 0,02 mg Drynam Road, Swords, Co.Dublin, Ireland Latvia Gedeon Richter Plc. Desogestrel Novynette 150/20 0,15 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol microgram film- 0,02 mg HU-1103 Budapest coated tablets Hungary Latvia Gedeon Richter Plc. Desogestrel Novynette Plus 150 0,15 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol micrograms/ 20 0,02 mg HU-1103 Budapest micrograms film- Hungary coated tablets

164

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Latvia Gedeon Richter Plc. Desogestrel Regulon 150/30 0,15 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol micrograms film- 0,03 mg HU-1103 Budapest coated tablets Hungary Latvia Orivas UAB Dienogest Ammily 2 mg/0,03 mg 2 mg Film-coated tablet Oral use J.Jasinskio 16B Ethinylestradiol film-coated tablets 0,03 mg LT-01112 Vilinius Lithuania Latvia Bayer Pharma AG Dienogest Jeanine 2000/30 2 mg Film-coated tablet Oral use D-13342 Berlin Ethinylestradiol micrograms film- 0,03 mg Germany coated tablets Latvia Gedeon Richter Plc. Dienogest Sibilla 2 mg/0,03 mg 2 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol film-coated tablets 0,03 mg HU-1103 Budapest Hungary Latvia Zentiva, k.s. Dienogest Zenadea 2 mg/0,03 2 mg Film-coated tablet Oral use U kabelovny 130 Ethinylestradiol mg film-coated tablets 0,03 mg 102 37 Praha 10 Dolní Měcholupy Czech Republic Latvia Ivowen Limited Drospirenone Lulina 3 mg/0,03 mg 3mg Film-coated tablet Oral use 3 Anglesa St Ethinylestradiol film-coated tablets 0,03mg Tipperary Clonmel Ireland Latvia Gedeon Richter Plc. Drospirenone Midiana 3mg/0,03 mg 3mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol film-coated tablets 0,03mg HU-1103 Budapest Hungary

165

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Latvia Bayer Pharma AG Drospirenone Yarina 3000/30 3mg Film-coated tablet Oral use D-13342 Berlin Ethinylestradiol micrograms film- 0,03mg Germany coated tablets Latvia Bayer Pharma AG Dienogest Qlaira film-coated 3 mg Film-coated tablet Oral use D-13342 Berlin Estradiol tablets 2 mg/2 mg Germany 2 mg /3 mg 1 mg Latvia Gedeon Richter Plc. Chlormadinone Belara 0,03 mg/2 mg 0,03 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol film-coated tablets 2 mg HU-1103 Budapest Hungary Latvia Gedeon Richter Plc. Drospirenone Aneea 3 mg/0,02 mg 3 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol film-coated tablets 0,02 mg HU-1103 Budapest Hungary Latvia Gedeon Richter Plc. Drospirenone Belusha 3 mg/0,02 3 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol mg film-coated tablets 0,02 mg HU-1103 Budapest Hungary Latvia Gedeon Richter Plc. Drospirenone Daylette 3 mg/0,02 3 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol mg film-coated tablets 0,02 mg HU-1103 Budapest Hungary Latvia UAB „Ladee Pharma Baltics“ Drospirenone Etindros 0,02 mg/3 0,02 mg Film-coated tablet Oral use Zemaitijos g.13/Siauliu g.10 Ethinylestradiol mg film-coated tablets 3 mg Vilnius LT-01134 Lithuania

166

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Latvia UAB „Ladee Pharma Baltics“ Drospirenone Etindros 0,03 mg/3 0,03 mg Film-coated tablet Oral use Zemaitijos g.13/Siauliu g.10 Ethinylestradiol mg film-coated 3 mg Vilnius LT-01134 tablets Lithuania Latvia Zentiva, k.s. Drospirenone LETHE 0,02 mg/3 mg 0,02 mg Film-coated tablet Oral use U kabelovny 130 Ethinylestradiol film-coated tablets 3 mg 102 37 Praha 10 Dolní Měcholupy Czech Republic Latvia Zentiva, k.s. Drospirenone Sidretella 0,02 mg/3 0,02 mg Film-coated tablet Oral use U kabelovny 130 Ethinylestradiol mg film-coated tablets 3 mg 102 37 Praha 10 Dolní Měcholupy Czech Republic Latvia Zentiva, k.s. Drospirenone Sidretella 0,03 mg/3 0,03 mg Film-coated tablet Oral use U kabelovny 130 Ethinylestradiol mg film-coated tablets 3 mg 102 37 Praha 10 Dolní Měcholupy Czech Republic Latvia Gedeon Richter Plc. Drospirenone Teenia 3 mg/0,02 mg 3 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol film-coated tablets 0,02 mg HU-1103 Budapest Hungary Latvia UAB „Ladee Pharma Baltics“ Drospirenone Velgyn 0,02 mg/3 mg 0,02 mg Film-coated tablet Oral use Zemaitijos g.13/Siauliu g.10 Ethinylestradiol film-coated tablets 3 mg Vilnius LT-01134 Lithuania

167

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Latvia Bayer Pharma AG Ethinylestradiol Yasminelle 0,02 mg/3 0,02 mg Film-coated tablet Oral use D-13342 Berlin Drospirenone mg film-coated tablets 3 mg Germany Latvia Bayer Pharma AG Ethinylestradiol YAZ 0,02 mg/3 mg 0,02 mg Film-coated tablet Oral use D-13342 Berlin Drospirenone film-coated tablets 3 mg Germany Latvia Bayer Pharma AG Ethinylestradiol Yvidually 0,02 mg/3 0,02 mg Film-coated tablet Oral use D-13342 Berlin Drospirenone mg film-coated tablets 3 mg Germany Latvia N.V. Organon Etonogestrel NuvaRing 120/15 11.7 mg Vaginal delivery Vaginal use P.O. Box 20 Ethinylestradiol micrograms/24 hours 2.7 mg system Kloosterstraat 6 vaginal delivery 5340 BH, Oss system The Netherlands

Latvia Zentiva, k.s. Gestodene ARTIZIA 75 0,075 mg Coated tablet Oral use U kabelovny 130 Ethinylestradiol micrograms/20 0,02 mg 102 37 Praha 10 micrograms coated Dolní Měcholupy tablets Czech Republic Latvia Gedeon Richter Plc. Gestodene Edesia 75 0,075 mg Coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol micrograms/20 0,02 mg HU-1103 Budapest micrograms coated Hungary tablets Latvia Bayer Pharma AG Gestodene Femoden 75/30 0,075 mg Film-coated tablet Oral use D-13342 Berlin Ethinylestradiol micrograms film- 0,03 mg Germany coated tablets

168

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Latvia Ratiopharm GmbH Gestodene Gesytil 75/20 0,075 mg Coated tablet Oral use Graf-Arco-Strasse 3 Ethinylestradiol micrograms coated 0,02 mg DE-89079 Ulm tablets Germany Latvia Ratiopharm GmbH Gestodene Gesytil 75/30 0,075 mg Coated tablet Oral use Graf-Arco-Strasse 3 Ethinylestradiol micrograms coated 0,03 mg DE-89079 Ulm tablets Germany Latvia Pfizer Europe MA EEIG Gestodene Harmonet 75 0,075 mg Coated tablet Oral use Ramsgate Road Ethinylestradiol micrograms/20 0,02 mg Sandwich micrograms film- Kent CT13 9NJ coated tablets United Kingdom Latvia Gedeon Richter Plc. Gestodene Lindynette 75/20 0,075 mg Coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol micrograms coated 0,02 mg HU-1103 Budapest tablets Hungary Latvia Gedeon Richter Plc. Gestodene Lindynette 75/30 0,075 mg Coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol micrograms coated 0,03 mg HU-1103 Budapest tablets Hungary Latvia Bayer Pharma AG Gestodene Logest 75 0,075 mg Film-coated tablet Oral use D-13342 Berlin Ethinylestradiol micrograms/20 0,02 mg Germany micrograms film- coated tablets

169

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Latvia Pfizer Europe MA EEIG Gestodene Minulet 75 0,075 mg Coated tablet Oral use Ramsgate Road Ethinylestradiol micrograms/30 0,03 mg Sandwich micrograms coated Kent CT13 9NJ tablets United Kingdom Latvia Bayer Pharma AG Gestodene Mirelle 60/15 0,06 mg Coated tablet Oral use D-13342 Berlin Ethinylestradiol micrograms film- 0,015 mg Germany coated tablets Latvia Gedeon Richter Plc. Gestodene Violetta 60 0,06 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol micrograms/15 0,015 mg HU-1103 Budapest micrograms film- Hungary coated tablets Latvia UAB „Ladee Pharma Baltics“ Gestodene VONILLE 60 0,06 mg Film-coated tablet Oral use Zemaitijos g.13/Siauliu g.10 Ethinylestradiol micrograms/15 0,015 mg Vilnius LT-01134 micrograms film- Lithuania coated tablets Latvia Gedeon Richter Plc. Gestodene Zulfija 75 0,075 mg Coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol micrograms/30 0,03 mg HU-1103 Budapest micrograms coated Hungary tablets Latvia UAB „Johnson & Johnson“ Norgestimate Cilest 250/35 0,25 mg Tablet Oral use Geležinio Vilko g. 18A Ethinylestradiol micrograms tablets 0,035 mg LT-08104 Vilnius Lithuania Lithuania UAB Orivas Dienogest Ammily 2 mg Film-coated tablet Oral use J.Jasinskio 16B, Ethinylestradiol 0,03 mg LT-01112 Vilnius Lithuania

170

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Lithuania Bayer Pharma AG Dienogest Jeanine 2 mg Coated tablet Oral use D-13342 Berlin Ethinylestradiol 0,03 mg Germany Lithuania Gedeon Richter Plc. Dienogest SIBILLA 2 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 0,03 mg HU-1103 Budapest Hungary Lithuania Zentiva, k.s. Dienogest Zenadea 2 mg Film-coated tablet Oral use U kabelovny 130 Ethinylestradiol 0,03 mg 102 37 Praha 10 Dolní Měcholupy Czech Republic Lithuania Laboratorios Leon Farma SA Drospirenone Espirol 3mg Film-coated tablet Oral use Poligono Industrial Navatejera, Ethinylestradiol 0,03mg La Vallina s/n, 24008 Villaquilambre,Leon Spain Lithuania Ivowen Limited Drospirenone LULINA 3mg Film-coated tablet Oral use 3 Anglesa St Ethinylestradiol 0,03mg Tipperary Clonmel Ireland Lithuania Gedeon Richter Plc. Drospirenone MIDIANA 3mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 0,03mg HU-1103 Budapest Hungary

171

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Lithuania Laboratorios Leon Farma SA Drospirenone Pirestrol 3mg Film-coated tablet Oral use Poligono Industrial Navatejera, Ethinylestradiol 0,03mg La Vallina s/n, 24008 Villaquilambre,Leon Spain Lithuania Zentiva, k.s. Dienogest Zenadea 2 mg Film-coated tablet Oral use U kabelovny 130 Ethinylestradiol 0,03 mg 102 37 Praha 10 Dolní Měcholupy Czech Republic Lithuania Zentiva, k.s. Drospirenone Sidretella 3mg Film-coated tablet Oral use U kabelovny 130 Ethinylestradiol 0,03mg 102 37 Praha 10 Dolní Měcholupy Czech Republic Lithuania Bayer Pharma AG Drospirenone Yarina 3mg Film-coated tablet Oral use D-13342 Berlin Ethinylestradiol 0,03mg Germany Lithuania Bayer Pharma AG Drospirenone Yvidually 0.02 mg Film-coated tablet Oral use D-13342 Berlin Ethinylestradiol 3 mg Germany Lithuania Bayer Pharma AG Estradiol valerate Qlaira 3 mg Film-coated tablet Oral use D-13342 Berlin Dienogest 2 mg/2 mg Germany 2 mg /3 mg 1 mg

172

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Lithuania Gedeon Richter Plc. Chlormadinone Belara 0,03 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 2 mg HU-1103 Budapest Hungary Lithuania Gedeon Richter Plc. Drospirenone ANEEA 0,02 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 3 mg HU-1103 Budapest Hungary Lithuania Gedeon Richter Plc. Drospirenone BELUSHA 0,02 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 3 mg HU-1103 Budapest Hungary Lithuania Gedeon Richter Plc. Drospirenone DAYLETTE 0,02 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 3 mg HU-1103 Budapest Hungary Lithuania Laboratorios Leon Farma SA Drospirenone Espirol 0,02 mg Film-coated tablet Oral use Poligono Industrial Navatejera, Ethinylestradiol 3 mg La Vallina s/n, 24008 Villaquilambre,Leon Spain Lithuania UAB „Ladee Pharma Baltics“ Drospirenone Etindros 0,02 mg Film-coated tablet Oral use Zemaitijos g.13/Siauliu g.10 Ethinylestradiol 3 mg Vilnius LT-01134 Lithuania

173

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Lithuania UAB „Ladee Pharma Baltics“ Drospirenone Etindros 0,03 mg Film-coated tablet Oral use Zemaitijos g.13/Siauliu g.10 Ethinylestradiol 3 mg Vilnius LT-01134 Lithuania Lithuania Zentiva, k.s. Drospirenone LETHE 0,02 mg Film-coated tablet Oral use U kabelovny 130 Ethinylestradiol 3 mg 102 37 Praha 10 Dolní Měcholupy Czech Republic Lithuania Laboratorios Leon Farma SA Drospirenone Pirestrol 0,02 mg Film-coated tablet Oral use Poligono Industrial Navatejera, Ethinylestradiol 3 mg La Vallina s/n, 24008 Villaquilambre,Leon Spain Lithuania Zentiva, k.s. Drospirenone Sidretella 0,02 mg Film-coated tablet Oral use U kabelovny 130 Ethinylestradiol 3 mg 102 37 Praha 10 Dolní Měcholupy Czech Republic Lithuania Gedeon Richter Plc. Drospirenone TEENIA 0,02 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 3 mg HU-1103 Budapest Hungary Lithuania UAB „Ladee Pharma Baltics“ Drospirenone Velgyn 0,02 mg Film-coated tablet Oral use Zemaitijos g.13/Siauliu g.10 Ethinylestradiol 3 mg Vilnius LT-01134 Lithuania

174

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Lithuania Bayer Pharma AG Drospirenone Yasminelle 0,02 mg Film-coated tablet Oral use D-13342 Berlin Ethinylestradiol 3 mg Germany Lithuania Bayer Pharma AG Drospirenone YAZ 0,02 mg Film-coated tablet Oral use D-13342 Berlin Ethinylestradiol 3 mg Germany Lithuania Pfizer Europe MA EEIG Gestodene Harmonet 0,02 mg Coated tablet Oral use Ramsgate Road Ethinylestradiol 0,075 mg Sandwich Kent CT13 9NJ United Kingdom Lithuania Pfizer Europe MA EEIG Gestodene Minulet 0.03 mg Coated tablet Oral use Ramsgate Road Ethinylestradiol 0.075 mg Sandwich Kent CT13 9NJ United Kingdom Lithuania Zentiva, k.s. Gestodene ARTIZIA 0,075 mg Coated tablet Oral use U kabelovny 130 Ethinylestradiol 0,02 mg 102 37 Praha 10 Dolní Měcholupy Czech Republic Lithuania Bayer Pharma AG Gestodene Femoden 0,075 mg Coated tablet Oral use D-13342 Berlin Ethinylestradiol 0,03 mg Germany Lithuania Ratiopharm GmbH Gestodene Gesytil 0,075 mg Coated tablet Oral use Graf-Arco-Strasse 3 Ethinylestradiol 0,03 mg DE-89079 Ulm Germany

175

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Lithuania Ratiopharm GmbH Gestodene Gesytil 0,075 mg Coated tablet Oral use Graf-Arco-Strasse 3 Ethinylestradiol 0,02 mg DE-89079 Ulm Germany Lithuania Gedeon Richter Plc. Gestodene Lindynette 0,075 mg Coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 0,03 mg HU-1103 Budapest Hungary Lithuania Gedeon Richter Plc. Gestodene Lindynette 0,075 mg Coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 0,02 mg HU-1103 Budapest Hungary Lithuania Bayer Pharma AG Gestodene Logest 0,075 mg Coated tablet Oral use D-13342 Berlin Ethinylestradiol 0,02 mg Germany Lithuania Bayer Pharma AG Gestodene Mirelle 0,06 mg Film-coated tablet Oral use D-13342 Berlin Ethinylestradiol 0,015 mg Germany Lithuania Gedeon Richter Plc. Gestodene VIOLETTA 0,06 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 0,015 mg HU-1103 Budapest Hungary Lithuania UAB „Ladee Pharma Baltics“ Gestodene VONILLE 0,06 mg Film-coated tablet Oral use Zemaitijos g.13/Siauliu g.10 Ethinylestradiol 0,015 mg Vilnius LT-01134 Lithuania

176

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Lithuania Gedeon Richter Plc. Gestodene ZULFIJA 0,075 mg Coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 0,03 mg HU-1103 Budapest Hungary Lithuania Gedeon Richter Plc. Gestodene ZULFIJA 0,075 mg Coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 0,02 mg HU-1103 Budapest Hungary Lithuania UAB „Johnson & Johnson“ Norgestimate Cilest 0,25 mg Tablet Oral use Geležinio Vilko g. 18A Ethinylestradiol 0,035 mg LT-08104 Vilnius Lithuania Lithuania Zentiva, k.s. Desogestrel ESTMAR 0,15 mg Tablet Oral use U kabelovny 130 Ethinylestradiol 0,02 mg 102 37 Praha 10 Dolní Měcholupy Czech Republic Lithuania Zentiva, k.s. Desogestrel ESTMAR 0,15 mg Tablet Oral use U kabelovny 130 Ethinylestradiol 0,03 mg 102 37 Praha 10 Dolní Měcholupy Czech Republic Lithuania N.V. Organon Desogestrel Gracial 0,04 mg/0,025 mg Tablet Oral use P.O.Box 20 Ethinylestradiol 0,03 mg/0,125 mg 5340 BH Oss The Netherlands

177

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Lithuania N.V. Organon Desogestrel Marvelon 0,15 mg Tablet Oral use P.O.Box 20 Ethinylestradiol 0,03 mg 5340 BH Oss The Netherlands Lithuania N.V. Organon Desogestrel Mercilon 0,15 mg Tablet Oral use P.O.Box 20 Ethinylestradiol 0,02 mg 5340 BH Oss The Netherlands Lithuania Gedeon Richter Plc. Desogestrel NOVYNETTE 0,15 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 0,02 mg HU-1103 Budapest Hungary Lithuania Gedeon Richter Plc. Desogestrel REGULON 0,15 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 0,03 mg HU-1103 Budapest Hungary Lithuania Gedeon Richter Plc. Desogestrel NOVYNETTE 0,15 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol CONTINUOUS 0,02 mg HU-1103 Budapest Hungary Lithuania N.V. Organon Etonogestrel NuvaRing 11.7 mg Vaginal delivery Vaginal use P.O.Box 20 Ethinylestradiol 2.7 mg system 5340 BH Oss The Netherlands Lithuania UAB „Johnson & Johnson“ Norgestimate Cilest 0,25mg Tablet Oral use Geležinio Vilko g. 18A Ethinylestradiol 0,035mg LT-08104 Vilnius Lithuania

178

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Lithuania Teva Pharma B.V. Desogestrel Destele 0,15 mg Tablet Oral use Computerweg 10 Ethinylestradiol 0,03 mg 3542 DR Utrecht The Netherlands

Lithuania Teva Pharma B.V. Desogestrel Destele 0,15 mg Tablet Oral use Computerweg 10 Ethinylestradiol 0,02 mg 3542 DR Utrecht The Netherlands

Luxembourg BAYER SA-NV Estradiol valerate Qlaira 3 mg Coated tablet Oral use J.E. Mommaertslaan 14 Dienogest 2 mg/2 mg 1831 Diegem 2 mg/3 mg Belgium 1 mg Luxembourg Gedeon Richter Plc. Chlormadinone Bellina 0,03 mg Coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 2 mg HU-1103 Budapest Hungary Luxembourg Madaus GmbH Chlormadinone Bellissima 0,03 mg Coated tablet Oral use Colonia Allee 15 Ethinylestradiol 2 mg 51067 Köln Germany Luxembourg Mithra Pharmaceuticals S.A. Chlormadinone Helen 0,03 mg Coated tablet Oral use Rue Saint Georges 5 Ethinylestradiol 2 mg 4000 Liège Belgium

179

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Luxembourg Ratiopharm GmbH Chlormadinone Verana-ratiopharm 0,03 mg Coated tablet Oral use Graf-Arco-Strasse 3 Ethinylestradiol 2 mg DE-89079 Ulm Germany Luxembourg Gedeon Richter Plc. Desogestrel Deso 20 0,02 mg Coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 0,15 mg HU-1103 Budapest Hungary Luxembourg N.V. Organon Desogestrel Gracial 0.04 mg /0,025 Tablet Oral use Kloosterstraat 6 Ethinylestradiol mg 5349 AB, Oss 0.03 mg /0,125 The Netherlands mg Luxembourg N.V. Organon Desogestrel Marvelon 0,03 mg Tablet Oral use Kloosterstraat 6 Ethinylestradiol 0,15 mg 5349 AB, Oss The Netherlands Luxembourg N.V. Organon Desogestrel Mercilon 0,02 mg Tablet Oral use Kloosterstraat 6 Ethinylestradiol 0,15 mg 5349 AB, Oss The Netherlands Luxembourg Gedeon Richter Plc. Desogestrel Regulon 0,03 mg Coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 0,15 mg HU-1103 Budapest Hungary Luxembourg Mithra Pharmaceuticals S.A. Dienogest Louise 0,03 mg Coated tablet Oral use Rue Saint Georges 5 Ethinylestradiol 2 mg 4000 Liège Belgium

180

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Luxembourg Gedeon Richter Plc. Drospirenone Annabelle 0,02 mg Coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 3 mg HU-1103 Budapest Hungary Luxembourg Gedeon Richter Plc. Drospirenone Annais 0,03 mg Coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 3 mg HU-1103 Budapest Hungary Luxembourg Teva Pharma Belgium N.V. Drospirenone LaYaisa 0,02 mg Coated tablet Oral use Laarstraat 16 Ethinylestradiol 3 mg 2610 Wilrijk Belgium Luxembourg Teva Pharma Belgium N.V. Drospirenone LaYanina 0,03 mg Coated tablet Oral use Laarstraat 16 Ethinylestradiol 3 mg 2610 Wilrijk Belgium Luxembourg Teva Pharma Belgium N.V. Drospirenone LaYnes 0,02 mg Coated tablet Oral use Laarstraat 16 Ethinylestradiol 3 mg 2610 Wilrijk Belgium Luxembourg Teva Pharma Belgium N.V. Drospirenone LaYva 0,03 mg Coated tablet Oral use Laarstraat 16 Ethinylestradiol 3 mg 2610 Wilrijk Belgium Luxembourg BAYER SA-NV Drospirenone Yasmin 0,03 mg Coated tablet Oral use J.E. Mommaertslaan 14 Ethinylestradiol 3 mg 1831 Diegem Belgium

181

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Luxembourg BAYER SA-NV Drospirenone Yasminelle 0,02 mg Coated tablet Oral use J.E. Mommaertslaan 14 Ethinylestradiol 3 mg 1831 Diegem Belgium Luxembourg BAYER SA-NV Drospirenone Yaz 0,02 mg Coated tablet Oral use J.E. Mommaertslaan 14 Ethinylestradiol 3 mg 1831 Diegem Belgium Luxembourg N.V. Organon Etonogestrel Circlet 2,7 mg Vaginal delivery Vaginal use Kloosterstraat 6 Ethinylestradiol 11,7 mg system 5349 AB, Oss The Netherlands Luxembourg N.V. Organon Etonogestrel NuvaRing 2,7 mg Vaginal delivery Vaginal use Kloosterstraat 6 Ethinylestradiol 11,7 mg system 5349 AB, Oss The Netherlands Luxembourg BAYER SA-NV Gestodene Femodene 0,03 mg Coated tablet Oral use J.E. Mommaertslaan 14 Ethinylestradiol 0,075 mg 1831 Diegem Belgium Luxembourg Gedeon Richter France SARL Gestodene Gestodelle 20 0,02 mg Coated tablet oral use 1-3 rue Caumartin Ethinylestradiol 0,075 mg 75009 Paris France Luxembourg Gedeon Richter France SARL Gestodene Gestofeme 30 0,03 mg / 0,075 Coated tablet oral use 1-3 rue Caumartin Ethinylestradiol mg 75009 Paris France

182

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Luxembourg PFIZER S.A. Gestodene Harmonet 0,02 mg Coated tablet Oral use 17 Boulevard de la Plaine Ethinylestradiol 0,075 mg 1050 Brussels Belgium Luxembourg BAYER SA-NV Gestodene Meliane 0,02 mg Coated tablet Oral use J.E. Mommaertslaan 14 Ethinylestradiol 0,075 mg 1831 Diegem Belgium Luxembourg PFIZER S.A. Gestodene Minulet 0,03 mg Coated tablet Oral use 17 Boulevard de la Plaine Ethinylestradiol 0,075 mg 1050 Brussels Belgium Luxembourg BAYER SA-NV Gestodene Mirelle 0,015 mg Coated tablet Oral use J.E. Mommaertslaan 14 Ethinylestradiol 0,06 mg 1831 Diegem Belgium Luxembourg PFIZER S.A. Gestodene Tri-Minulet 0,03 mg / 0,05 mg Coated tablet Oral use 17 Boulevard de la Plaine Ethinylestradiol 0,04 mg / 0,07 mg 1050 Brussels 0,03 mg / 0,1 mg Belgium Luxembourg BAYER SA-NV Gestodene Triodene 0,03 mg /0,05 mg Coated tablet Oral use J.E. Mommaertslaan 14 Ethinylestradiol 0,04 mg / 0,07 mg 1831 Diegem 0,03 mg / 0,1 mg Belgium Luxembourg JANSSEN-CILAG N.V. Norgestimate Cilest 0,035 mg Tablet Oral use Antwerpseweg 15-17 Ethinylestradiol 0,25 mg 2340 Beerse Belgium

183

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Luxembourg Helm AG Dienogest Deltanogest 0,03 0,03 mg Film-coated tablet Oral use Nordkanalstrasse 28 Ethinylestradiol mg/2 mg 2 mg 20097 Hamburg Filmtabletten Germany Luxembourg Helm AG Dienogest Gamanogest 0,03 0,03 mg Film-coated tablet Oral use Nordkanalstrasse 28 Ethinylestradiol mg/2 mg 2 mg 20097 Hamburg Filmtabletten Germany Luxembourg Helm AG Drospirenone Ema 0,03 mg/3 mg 0,03 mg Film-coated tablet Oral use Nordkanalstrasse 28 Ethinylestradiol Filmtabletten 3 mg 20097 Hamburg Germany Luxembourg Helm AG Drospirenone Emalia 0,02 mg/3 mg 0,02 mg Film-coated tablet Oral use Nordkanalstrasse 28 Ethinylestradiol Filmtabletten 3 mg 20097 Hamburg Germany Luxembourg Helm AG Drospirenone Emanuela 0,0 mg/3 0,02 mg Film-coated tablet Oral use Nordkanalstrasse 28 Ethinylestradiol mg Filmtabletten 3 mg 20097 Hamburg Germany Luxembourg Helm AG Drospirenone Nanami 0,02 mg Film-coated tablet Oral use Nordkanalstrasse 28 Ethinylestradiol 3 mg 20097 Hamburg Germany Luxembourg Helm AG Drospirenone Nanette 0,02 mg Film-coated tablet Oral use Nordkanalstrasse 28 Ethinylestradiol 3 mg 20097 Hamburg Germany

184

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Luxembourg Helm AG Drospirenone Nannina 0,03 mg Film-coated tablet Oral use Nordkanalstrasse 28 Ethinylestradiol 3 mg 20097 Hamburg Germany Luxembourg Helm AG Drospirenone Pea 0,03 mg Film-coated tablet Oral use Nordkanalstrasse 28 Ethinylestradiol 3 mg 20097 Hamburg Germany Luxembourg Helm AG Drospirenone Pearline 0,02 mg Film-coated tablet Oral use Nordkanalstrasse 28 Ethinylestradiol 3 mg 20097 Hamburg Germany Luxembourg Helm AG Drospirenone Pearly 0,03 mg Film-coated tablet Oral use Nordkanalstrasse 28 Ethinylestradiol 3 mg 20097 Hamburg Germany Luxembourg EFFIK BENELUX Drospirenone CORNELIA 0.03 mg Film-coated tablet Oral use Lenniksebaan 451 Ethinylestradiol 3.00 mg 1070 Anderlecht Belgium Luxembourg EFFIK BENELUX Drospirenone DROSEFIKK 0.02 mg Film-coated tablet Oral use Lenniksebaan 451 Ethinylestradiol 3.00 mg 1070 Anderlecht Belgium Luxembourg EFFIK BENELUX Drospirenone DROSPIBEL 20 0.02 mg Film-coated tablet Oral use Lenniksebaan 451 Ethinylestradiol 3.00 mg 1070 Anderlecht Belgium

185

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Luxembourg EFFIK BENELUX Drospirenone DROSPIBEL 30 0.03 mg Film-coated tablet Oral use Lenniksebaan 451 Ethinylestradiol 3.00 mg 1070 Anderlecht Belgium Luxembourg BAYER SA-NV Drospirenone Flexyess 0,02 mg Film-coated tablet Oral use J.E. Mommaertslaan 14 Ethinylestradiol 3 mg 1831 Diegem Belgium Luxembourg EFFIK BENELUX Drospirenone NAIWANEL 0.02 mg Film-coated tablet Oral use Lenniksebaan 451 Ethinylestradiol 3.00 mg 1070 Anderlecht Belgium Luxembourg Ratiopharm GmbH Dienogest Velvet-ratiopharm 0,03 mg Film-coated tablet Oral use Graf-Arco-Strasse 3 Ethinylestradiol 0,03 mg/2 mg 2 mg DE-89079 Ulm Filmtabletten Germany Malta Organon Laboratories Limited, Desogestrel Mercilon 0.15 mg Tablet Oral use Cambridge Science Park, Ethinylestradiol 0.02 mg Milton Road, Cambridge CB4 0FL, United Kingdom Malta Bayer PLC Dienogest Qlaira, film-coated 3 mg Coated tablet Oral use Bayer House Estradiol tablets 2 mg/2 mg Strawberry Hill 2 mg /3 mg Newbury 1 mg Berkshire RG14 1JA United Kingdom

186

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Malta Bayer PLC Drospirenone ELOINE 0.02 mg / 3 0.02 mg Film-coated tablet Oral use Bayer House Ethinylestradiol mg film coated tablets 3 mg Strawberry Hill Newbury Berkshire RG14 1JA United Kingdom Malta Bayer PLC Drospirenone Palandra 0.03 mg / 3 0.03 mg Film-coated tablet Oral use Bayer House Ethinylestradiol mg film-coated tablets 3mg Strawberry Hill Newbury Berkshire RG14 1JA United Kingdom Malta Bayer PLC Drospirenone Yasmin film-coated 0.03 mg Film-coated tablet Oral use Bayer House Ethinylestradiol tablets 0.03 mg/3 mg 3mg Strawberry Hill Newbury Berkshire RG14 1JA United Kingdom Malta Bayer PLC Drospirenone Yaz 0.02mg/3mg film- 0.02 mg Film-coated tablet Oral use Bayer House Ethinylestradiol coated tablets 3 mg Strawberry Hill Newbury Berkshire RG14 1JA United Kingdom

187

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Malta Bayer Limited Drospirenone Aliane 0.02 mg / 3 mg 0.02 mg Film-coated tablet Oral use The Atrium, Ethinylestradiol film-coated tablets 3mg Blackthorn Road, Dublin 18, Ireland Malta Bayer Limited Drospirenone Yasminelle 0.02 mg/3 0.02 mg Film-coated tablet Oral use The Atrium, Ethinylestradiol mg film-coated tablets 3mg Blackthorn Road, Dublin 18, Ireland Malta Pfizer Hellas S.A. Gestodene Minesse 0.06 mg Film-coated tablet Oral use 243 Messoghion Avenue, Ethinylestradiol 0.015 mg 154 51 N. Psychiko, Greece Malta Janssen-Cilag International N.V. Norgestimate CILEST 250/35 0.25 mg Tablet Oral use Turnhoutseweg 30 Ethinylestradiol microgram Oral 0.035 mg B 2340 Beerse Contraceptive Tablets Belgium Malta Stragen UK Limited, Gestodene Sunya 20/75 0.02 mg Film-coated tablet Oral use Castle Court, Ethinylestradiol 0.075 mg 41 London Road, Reigate, Surrey RH2 9RJ United Kingdom

188

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Malta Stragen UK Limited, Gestodene Katya 30/75 0.03 mg Film-coated tablet Oral use Castle Court, Ethinylestradiol 0.075 mg 41 London Road, Reigate, Surrey RH2 9RJ United Kingdom Malta Organon Laboratories Limited, Desogestrel Marvelon 0.15 mg Tablet Oral use Cambridge Science Park, Ethinylestradiol 0.03 mg Milton Road, Cambridge CB4 0FL, United Kingdom Malta N.V. Organon Etonogestrel NuvaRing 11.7 mg Vaginal delivery Vaginal use Kloosterstraat 6 Ethinylestradiol 2.7 mg system 5349 AB, Oss The Netherlands Malta Bayer PLC Drospirenone Flexyess 0.02mg/3mg 0.02 mg Film - coated tablet Oral use Bayer House Ethinylestradiol film-coated tablets 3mg Strawberry Hill Newbury Berkshire RG14 1JA United Kingdom Malta Actavis Group PTC ehf Desogestrel Benifema 0.15mg Film-coated tablet Oral use Reykjavikurvegi 76-78 Ethinylestradiol 150micrograms/30mic 0.03 mg 220 Hafnarfjordur rograms film-coated Iceland tablets

189

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Norway Gedeon Richter Plc. Desogestrel Desodiolcont 0,02 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 0,15 mg HU-1103 Budapest Hungary Norway Medimpex UK Ltd, Desogestrel Igixon 0,02 mg Film-coated tablet Oral use 127 Shirland Road, Ethinylestradiol 0,15 mg London W9 2EP United Kingdom Norway Mylan AB, Desogestrel Lestramyl 0,02 mg Tablet Oral use Postbox 23033, Ethinylestradiol 0,15 mg Ynglingagatan 14, SE-10435 Stockholm, Sweden Norway Mylan AB, Desogestrel Lestramyl 0.03 mg Tablet Oral use Postbox 23033, Ethinylestradiol 0.15 mg Ynglingagatan 14, SE-10435 Stockholm, Sweden Norway N.V. Organon Desogestrel Marvelon 0.15 mg Tablet Oral use Kloosterstraat 6 Ethinylestradiol 0.03 mg 5349 AB, Oss The Netherlands Norway N.V. Organon Desogestrel Marvelon 28 0.15 mg Tablet Oral use Kloosterstraat 6 Ethinylestradiol 0.03 mg 5349 AB, Oss The Netherlands

190

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Norway N.V. Organon Desogestrel Mercilon 28 0,15 mg Tablet Oral use Kloosterstraat 6 Ethinylestradiol 0,02 mg 5349 AB, Oss The Netherlands Norway Medimpex UK Ltd, Desogestrel Regulon 0.03 mg Film-coated tablet Oral use 127 Shirland Road, Ethinylestradiol 0.15 mg London W9 2EP United Kingdom Norway Bayer AB Estradiol valerate Qlaira 3 mg Film-coated tablet Oral use Postbox 606 Dienogest 2 mg/2 mg Gustav III's Boulevard 56 2 mg/3 mg SE-16926 Solna 1 mg Sweden Norway Laboratorios Leon Farma SA Drospirenone Calima 0,02 mg Film-coated tablet Oral use Poligono Industrial Navatejera, Ethinylestradiol 3 mg La Vallina s/n, 24008 Villaquilambre,Leon Spain Norway Laboratorios Leon Farma SA Drospirenone Calima 28 0,02 mg Film-coated tablet Oral use Poligono Industrial Navatejera, Ethinylestradiol 3 mg La Vallina s/n, 24008 Villaquilambre,Leon Spain Norway Teva Sweden AB Drospirenone Dretine 0,03 mg Film-coated tablet Oral use Järnvägsgatan 11 Ethinylestradiol 3 mg Box 1070 25110 Helsingborg Sweden

191

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Norway Teva Sweden AB Drospirenone Dretine 28 0,03 mg Film-coated tablet Oral use Järnvägsgatan 11 Ethinylestradiol 3 mg Box 1070 25110 Helsingborg Sweden Norway Teva Sweden AB Drospirenone Dretinelle 0,02 mg Film-coated tablet Oral use Järnvägsgatan 11 Ethinylestradiol 3 mg Box 1070 25110 Helsingborg Sweden Norway Teva Sweden AB Drospirenone Dretinelle 28 0,02 mg Film-coated tablet Oral use Järnvägsgatan 11 Ethinylestradiol 3 mg Box 1070 25110 Helsingborg Sweden Norway Laboratorios Leon Farma SA Drospirenone Drosetil 28 0,02 mg Film-coated tablet Oral use Poligono Industrial Navatejera, Ethinylestradiol 3 mg La Vallina s/n, 24008 Villaquilambre,Leon Spain Norway Laboratorios Leon Farma SA Drospirenone Drosetil 28 0,03 mg Film-coated tablet Oral use Poligono Industrial Navatejera, Ethinylestradiol 3 mg La Vallina s/n, 24008 Villaquilambre,Leon Spain

192

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Norway Gedeon Richter Plc. Drospirenone Drosinetta 0,02 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 3 mg HU-1103 Budapest Hungary Norway Gedeon Richter Plc. Drospirenone Drosinetta 28 0,02 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 3 mg HU-1103 Budapest Hungary Norway Gedeon Richter Plc. Drospirenone Drospirenone/Ethinyle 0,03 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol stradiol Richter 3 mg HU-1103 Budapest Hungary Norway Bayer AB Drospirenone Eloine 0,02 mg Film-coated tablet Oral use Postbox 606 Ethinylestradiol 3 mg Gustav III's Boulevard 56 SE-16926 Solna Sweden Norway Sandoz A/S Drospirenone Elyra 0,03 mg Film-coated tablet Oral use Edward Thomsens Vej 14 Ethinylestradiol 3 mg DK-2300 København S Denmark Norway Sandoz A/S Drospirenone Elyra 28 0,03 mg Film-coated tablet Oral use Edward Thomsens Vej 14 Ethinylestradiol 3 mg DK-2300 København S Denmark

193

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Norway Ratiopharm GmbH Drospirenone Estez 0,02 mg Film-coated tablet Oral use Graf-Arco-Strasse 3 Ethinylestradiol 3 mg DE-89079 Ulm Germany Norway Sandoz A/S Drospirenone Finminette 0,02 mg Film-coated tablet Oral use Edward Thomsens Vej 14 Ethinylestradiol 3 mg DK-2300 København S Denmark Norway Sandoz A/S Drospirenone Finminette 0,03 mg Film-coated tablet Oral use Edward Thomsens Vej 14 Ethinylestradiol 3 mg DK-2300 København S Denmark Norway Laboratorios Leon Farma SA Drospirenone Iradier 0,02 mg Film-coated tablet Oral use Poligono Industrial Navatejera, Ethinylestradiol 3 mg La Vallina s/n, 24008 Villaquilambre,Leon Spain Norway Laboratorios Leon Farma SA Drospirenone Iren 0,02 mg Film-coated tablet Oral use Poligono Industrial Navatejera, Ethinylestradiol 3 mg La Vallina s/n, 24008 Villaquilambre,Leon Spain Norway Laboratorios Leon Farma SA Drospirenone Iren 28 0,02 mg Film-coated tablet Oral use Poligono Industrial Navatejera, Ethinylestradiol 3 mg La Vallina s/n, 24008 Villaquilambre,Leon Spain

194

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Norway Bayer Pharma AG Drospirenone Liofora 0,02 mg Film-coated tablet Oral use D-13342 Berlin Ethinylestradiol 3 mg Germany Norway Bayer Pharma AG Drospirenone Liofora 28 0,02 mg Film-coated tablet Oral use D-13342 Berlin Ethinylestradiol 3 mg Germany Norway Orifarm Generics A/S Drospirenone Movinella 21 0,02 mg Film-coated tablet Oral use Postbox 69 Ethinylestradiol 3 mg Energivej 15 DK-5260 Odense S Denmark Norway Orifarm Generics A/S Drospirenone Movinella 21 0,03 mg Film-coated tablet Oral use Postbox 69 Ethinylestradiol 3 mg Energivej 15 DK-5260 Odense S Denmark Norway Orifarm Generics A/S Drospirenone Movinella 28 0,02 mg Film-coated tablet Oral use Postbox 69 Ethinylestradiol 3 mg Energivej 15 DK-5260 Odense S Denmark Norway Orifarm Generics A/S Drospirenone Movinella 28 0,03 mg Film-coated tablet Oral use Postbox 69 Ethinylestradiol 3 mg Energivej 15 DK-5260 Odense S Denmark

195

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Norway Laboratorios Leon Farma SA Drospirenone Naiwanel 0,02 mg Film-coated tablet Oral use Poligono Industrial Navatejera, Ethinylestradiol 3 mg La Vallina s/n, 24008 Villaquilambre,Leon Spain Norway Laboratorios Leon Farma SA Drospirenone Naiwanel 28 0,02 mg Film-coated tablet Oral use Poligono Industrial Navatejera, Ethinylestradiol 3 mg La Vallina s/n, 24008 Villaquilambre,Leon Spain Norway Laboratorios Leon Farma SA Drospirenone Ospen 0,03 mg Film-coated tablet Oral use Poligono Industrial Navatejera, Ethinylestradiol 3 mg La Vallina s/n, 24008 Villaquilambre,Leon Spain Norway Laboratorios Leon Farma SA Drospirenone Ospen 28 0,03 mg Film-coated tablet Oral use Poligono Industrial Navatejera, Ethinylestradiol 3 mg La Vallina s/n, 24008 Villaquilambre,Leon Spain Norway Bayer AB Drospirenone Palandra 0,03 mg Film-coated tablet Oral use Postbox 606 Ethinylestradiol 3 mg Gustav III's Boulevard 56 SE-16926 Solna Sweden

196

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Norway Gedeon Richter Plc. Drospirenone Perlita 0,02 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 3 mg HU-1103 Budapest Hungary Norway Laboratorios Leon Farma SA Drospirenone Rosal 0,03 mg Film-coated tablet Oral use Poligono Industrial Navatejera, Ethinylestradiol 3 mg La Vallina s/n, 24008 Villaquilambre,Leon Spain Norway Laboratorios Leon Farma SA Drospirenone Rosal 28 0,03 mg Film-coated tablet Oral use Poligono Industrial Navatejera, Ethinylestradiol 3 mg La Vallina s/n, 24008 Villaquilambre,Leon Spain Norway Sandoz A/S Drospirenone Rubira 0,02 mg Film-coated tablet Oral use Edward Thomsens Vej 14 Ethinylestradiol 3 mg DK-2300 København S Denmark Norway Sandoz A/S Drospirenone Rubira 0,03 mg Film-coated tablet Oral use Edward Thomsens Vej 14 Ethinylestradiol 3 mg DK-2300 København S Denmark Norway Zentiva, k.s. Drospirenone Sidreta 0,03 mg Film-coated tablet Oral use U kabelovny 130 Ethinylestradiol 3 mg 102 37 Praha 10 Dolní Měcholupy Czech Republic

197

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Norway Zentiva, k.s. Drospirenone Sidretella 0,02 mg Film-coated tablet Oral use U kabelovny 130 Ethinylestradiol 3 mg 102 37 Praha 10 Dolní Měcholupy Czech Republic Norway Teva Sweden AB Drospirenone Varena 0,03 mg Film-coated tablet Oral use Järnvägsgatan 11 Ethinylestradiol 3 mg Box 1070 25110 Helsingborg Sweden Norway Teva Sweden AB Drospirenone Varena 28 0,03 mg Film-coated tablet Oral use Järnvägsgatan 11 Ethinylestradiol 3 mg Box 1070 25110 Helsingborg Sweden Norway Teva Sweden AB Drospirenone Varenelle 0,02 mg Film-coated tablet Oral use Järnvägsgatan 11 Ethinylestradiol 3 mg Box 1070 25110 Helsingborg Sweden Norway Teva Sweden AB Drospirenone Varenelle 28 0,02 mg Film-coated tablet Oral use Järnvägsgatan 11 Ethinylestradiol 3 mg Box 1070 25110 Helsingborg Sweden

198

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Norway Bayer AB Drospirenone Yalisca 0,02 mg Film-coated tablet Oral use Postbox 606 Ethinylestradiol 3 mg Gustav III's Boulevard 56 SE-16926 Solna Sweden Norway Bayer Pharma AG Drospirenone Yasmin 0,03 mg Film-coated tablet Oral use D-13342 Berlin Ethinylestradiol 3 mg Germany Norway Bayer Pharma AG Drospirenone Yasmin 28 0,03 mg Film-coated tablet Oral use D-13342 Berlin Ethinylestradiol 3 mg Germany Norway Bayer Pharma AG Drospirenone Yasminelle 0,02 mg Film-coated tablet Oral use D-13342 Berlin Ethinylestradiol 3 mg Germany Norway Bayer Pharma AG Drospirenone Yasminelle 28 0,02 mg Film-coated tablet Oral use D-13342 Berlin Ethinylestradiol 3 mg Germany Norway Bayer AB Drospirenone Yaz 0,02 mg Film-coated tablet Oral use Postbox 606 Ethinylestradiol 3 mg Gustav III's Boulevard 56 SE-16926 Solna Sweden Norway N.V. Organon Etonogestrel Nuvaring 0,120 0.12 mg/0.015 mg Vaginal delivery Vaginal use Kloosterstraat 6 Ethinylestradiol mg/0,015 mg/ 24 system 5349 AB, Oss timer, vaginalinlegg The Netherlands

199

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Norway Janssen-Cilag AS Norgestimate Cilest 0,25 mg Tablet Oral use Drammensveien 288 Ethinylestradiol 0,035 mg 0283 Oslo Norway Poland N.V. Organon Desogestrel Marvelon 0,15 mg Tablet Oral use Kloosterstraat 6 Ethinylestradiol 0,03 mg 5349 AB, Oss The Netherlands Poland N.V. Organon Etonogestrel NuvaRing 0,12 mg Vaginal delivery Vaginal use Kloosterstraat 6 Ethinylestradiol 0,015 mg system 5349 AB, Oss The Netherlands Poland N.V. Organon Etonogestrel Circlet 0,12 mg Vaginal delivery Vaginal use Kloosterstraat 6 Ethinylestradiol 0,015 mg system 5349 AB, Oss The Netherlands Poland Organon (Ireland) Ltd, Desogestrel Mercilon 0,15 mg Tablet Oral use PO Box 2857, Ethinylestradiol 0,02 mg Drynam Road, Swords, Co.Dublin, Ireland Poland Gedeon Richter Plc. Desogestrel Novynette 0,15 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 0,02 mg HU-1103 Budapest Hungary

200

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Poland Pabianickie Zakłady Desogestrel Ovulastan 0,15 mg Tablet Oral use Farmaceutyczne Polfa S.A. Ethinylestradiol 0,02 mg ul. Marszałka J. Piłsudskiego 5 95-200 Pabianice Poland Poland Pabianickie Zakłady Desogestrel Ovulastan Forte 0,15 mg Tablet Oral use Farmaceutyczne Polfa S.A. Ethinylestradiol 0,03 mg ul. Marszałka J. Piłsudskiego 5 95-200 Pabianice Poland Poland Gedeon Richter Polska Sp. z Desogestrel Samba tabletka 0,05 mg/0,035 mg Film-coated tablet Oral use o.o. Ethinylestradiol powlekana 0,1 mg/0,03 mg 5 Ks. J. Poniatowskiego Street 0,15 mg/0,03 mg 05-825 Grodzisk Mazowiecki Poland Poland Temapharm Sp. z o.o. Drospirenone Asubtela 3mg Film-coated tablet Oral use ul. Żwirki i Wigury 81 Ethinylestradiol 0,03mg 02-091 Warszawa Poland Poland Teva Pharmaceuticals Polska Drospirenone Cortelle 3mg Film-coated tablet Oral use Sp. z o.o. Ethinylestradiol 0,03mg ul. Emilii Plater 53 00-113 Warszawa Poland

201

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Poland Teva Pharmaceuticals Polska Drospirenone Lesine 3mg Film-coated tablet Oral use Sp. z o.o. Ethinylestradiol 0,03mg ul. Emilii Plater 53 00-113 Warszawa Poland Poland Ivowen Limited Drospirenone Lulina 3mg Film-coated tablet Oral use 3 Anglesa St Ethinylestradiol 0,03mg Tipperary Clonmel Ireland Poland Gedeon Richter Polska Sp. z Drospirenone Midiana 3mg Film-coated tablet Oral use o.o. Ethinylestradiol 0,03mg 5 Ks. J. Poniatowskiego Street 05-825 Grodzisk Mazowiecki Poland Poland Bayer Pharma AG Drospirenone Palandra 3mg Film-coated tablet Oral use D-13342 Berlin Ethinylestradiol 0,03mg Germany Poland Bayer Pharma AG Drospirenone Flexyess 0.02 mg Film-coated tablet Oral use D-13342 Berlin Ethinylestradiol 3 mg Germany Poland Zentiva, k.s. Drospirenone Sidretella 30 3mg Film-coated tablet Oral use U kabelovny 130 Ethinylestradiol 0,03mg 102 37 Praha 10 Dolní Měcholupy Czech Republic

202

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Poland Zakłady Farmaceutyczne Drospirenone Vibin 3mg Film-coated tablet Oral use POLPHARMA S.A. Ethinylestradiol 0,03mg ul. Pelplińska 19 83-200 Starogard Gdański Poland Poland Bayer Pharma AG Estradiol valerate Qlaira 3 mg Film-coated tablet Oral use D-13342 Berlin Dienogest 2 mg/2 mg Germany 2 mg/3 mg 1 mg Poland Sun-Farm Sp. z o.o. Chlormadinone Madinette 0,03 mg Film-coated tablet Oral use Człekówka 75 Ethinylestradiol 2 mg 05-340 Kołbiel, Poland Poland Sun-Farm Sp. z o.o. Desogestrel Dessette 0.02 mg Film-coated tablet oral use Człekówka 75 Ethinylestradiol 0.15 mg 05-340 Kołbiel, Poland Poland Sun-Farm Sp. z o.o. Desogestrel Dessette Forte 0.03 mg Film-coated tablet oral use Człekówka 75 Ethinylestradiol 0.15 mg 05-340 Kołbiel, Poland Poland Gedeon Richter Plc. Desogestrel Regulon 0,03 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 0,15 mg HU-1103 Budapest Hungary

203

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Poland Cyndea Pharma S.L. Dienogest Aidee 0,03 mg Film-coated tablet Oral use Polígono Industrial Emiliano Ethinylestradiol 2 mg Revilla Sanz Av. De Ágreda 31 42110 Ólvega (Soria) Spain Poland Temapharm Sp. z o.o. Dienogest Atywia 0,03 mg Film-coated tablet Oral use ul. Żwirki i Wigury 81 Ethinylestradiol 2 mg 02-091 Warszawa Poland Poland Zentiva, k.s. Dienogest Bonadea 0,03 mg Film-coated tablet Oral use U kabelovny 130 Ethinylestradiol 2 mg 102 37 Praha 10 Dolní Měcholupy Czech Republic Poland Dr. Kade Pharmazeutische Dienogest Dionelle 0,03 mg Tablet Oral use Fabrik GmbH Ethinylestradiol 2 mg Rigistr. 2 12277 Berlin Germany Poland Sun-Farm Sp. z o.o. Dienogest Dorin 0,03 mg Film-coated tablet Oral use Człekówka 75 Ethinylestradiol 2 mg 05-340 Kołbiel, Poland Poland Pharbil Waltrop GmbH Dienogest Ethinylestradiol/Dieno 0,03 mg Film-coated tablet Oral use Im Wirrigen 25 Ethinylestradiol gest Pharbil 2 mg 45731 Waltrop Germany

204

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Poland Bayer Pharma AG Dienogest Jeanine 0,03 mg Film-coated tablet Oral use D-13342 Berlin Ethinylestradiol 2 mg Germany Poland Bayer Pharma AG Drospirenone Aliane 0,02 mg Film-coated tablet Oral use D-13342 Berlin Ethinylestradiol 3 mg Germany Poland Gedeon Richter Polska Sp. z Dienogest Sibilla 0,03 mg Film-coated tablet Oral use o.o. Ethinylestradiol 2 mg ul.Graniczna 35 05-825 Grodzisk Mazowiecki Poland Poland Gedeon Richter Polska Sp. z Drospirenone Aneea 0,02 mg Film-coated tablet Oral use o.o. Ethinylestradiol 3 mg ul.Graniczna 35 05-825 Grodzisk Mazowiecki Poland Poland Gedeon Richter Polska Sp. z Drospirenone Belusha 0,02 mg Film-coated tablet Oral use o.o. Ethinylestradiol 3 mg ul.Graniczna 35 05-825 Grodzisk Mazowiecki Poland Poland Gedeon Richter Plc. Drospirenone Daylette 0,02 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 3 mg HU-1103 Budapest Hungary

205

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Poland Teva Pharmaceuticals Polska Drospirenone Lesinelle 0,02 mg Film-coated tablet Oral use Sp. z o.o. Ethinylestradiol 3 mg ul. Emilii Plater 53 00-113 Warszawa Poland Poland Bayer Pharma AG Drospirenone Linatera 0,02 mg Film-coated tablet Oral use D-13342 Berlin Ethinylestradiol 3 mg Germany Poland Temapharm Sp. z o.o. Drospirenone Naraya 0,02 mg Film-coated tablet Oral use ul. Żwirki i Wigury 81 Ethinylestradiol 3 mg 02-091 Warszawa Poland Poland Temapharm Sp. z o.o. Drospirenone Naraya Plus 0,02 mg Film-coated tablet Oral use ul. Żwirki i Wigury 81 Ethinylestradiol 3 mg 02-091 Warszawa Poland Poland Zentiva, k.s. Drospirenone Sidretella 20 0,02 mg Film-coated tablet Oral use U kabelovny 130 Ethinylestradiol 3 mg 102 37 Praha 10 Dolní Měcholupy Czech Republic Poland Gedeon Richter Polska Sp. z Drospirenone Teenia 0,02 mg Film-coated tablet Oral use o.o. Ethinylestradiol 3 mg ul.Graniczna 35 05-825 Grodzisk Mazowiecki Poland

206

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Poland Teva Pharmaceuticals Polska Drospirenone Varenelle 0,02 mg Film-coated tablet Oral use Sp. z o.o. Ethinylestradiol 3 mg ul. Emilii Plater 53 00-113 Warszawa Poland Poland Teva Pharmaceuticals Polska Drospirenone Lesiplus 0,02 mg Film-coated tablet Oral use Sp. z o.o. Ethinylestradiol 3 mg ul. Emilii Plater 53 00-113 Warszawa Poland Poland Zakłady Farmaceutyczne Drospirenone Vibin mini 0,02 mg Film-coated tablet Oral use POLPHARMA S.A. Ethinylestradiol 3 mg ul. Pelplińska 19 83-200 Starogard Gdański Poland Poland Bayer Pharma AG Drospirenone Yasmin 0,03 mg Film-coated tablet Oral use D-13342 Berlin Ethinylestradiol 3 mg Germany Poland Bayer Pharma AG Drospirenone Yasminelle 0,02 mg Film-coated tablet Oral use D-13342 Berlin Ethinylestradiol 3 mg Germany Poland Bayer Pharma AG Drospirenone Yaz 0,02 mg Film-coated tablet Oral use D-13342 Berlin Ethinylestradiol 3 mg Germany

207

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Poland Pabianickie Zakłady Gestodene Femipol 0,03 mg Coated tablet Oral use Farmaceutyczne Polfa S.A. Ethinylestradiol 0,075 mg ul. Marszałka J. Piłsudskiego 5 95-200 Pabianice Poland Poland Bayer Pharma AG Gestodene Femoden 0.075 mg Film-coated tablet Oral use D-13342 Berlin Ethinylestradiol 0.03 mg Germany Poland Pfizer Europe MA EEIG Gestodene Harmonet 0,02 mg Film-coated tablet Oral use Ramsgate Road Ethinylestradiol 0,075 mg Sandwich Kent CT13 9NJ United Kingdom Poland Pabianickie Zakłady Gestodene Kontracept 0,02 mg Coated tablet Oral use Farmaceutyczne Polfa S.A. Ethinylestradiol 0,075 mg ul. Marszałka J. Piłsudskiego 5 95-200 Pabianice Poland Poland SymPhar Sp. z o.o. Gestodene Sylvie 20 0,02 mg Coated tablet Oral use ul. Włoska 1 Ethinylestradiol 0,075 mg 00-777 Warszawa Poland Poland SymPhar Sp. z o.o. Gestodene Sylvie 30 0.03 mg Coated tablet Oral use ul. Włoska 1 Ethinylestradiol 0.075 mg 00-777 Warszawa Poland

208

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Poland Zentiva, k.s. Gestodene Artilla 0,075 mg Coated tablet Oral use U kabelovny 130 Ethinylestradiol 0,02 mg 102 37 Praha 10 Dolní Měcholupy Czech Republic Poland Temapharm Sp. z o.o. Gestodene Gefemin 0,06 mg Coated tablet Oral use ul. Żwirki i Wigury 81 Ethinylestradiol 0,015 mg 02-091 Warszawa Poland Poland Actavis Group PTC ehf Gestodene Gestodene/Ethinylestr 0,075 mg Film-coated tablet Oral use Reykjavikurvegi 76-78 Ethinylestradiol adiol Actavis 0,02 mg 220 Hafnarfjordur Iceland Poland Actavis Group PTC ehf Chlormadinone Angiletta 2 mg Film-coated tablet Oral use Reykjavikurvegi 76-78 Ethinylestradiol 0,03 mg 220 Hafnarfjordur Iceland Poland Actavis Group PTC ehf Gestodene Gestodene/Ethinylestr 0,075 mg Film-coated tablet Oral use Reykjavikurvegi 76-78 Ethinylestradiol adiol Actavis 0,03 mg 220 Hafnarfjordur Iceland Poland Gedeon Richter Polska Sp. z Gestodene Kostya 0,075 mg Coated tablet Oral use o.o. Ethinylestradiol 0,02 mg ul.Graniczna 35 05-825 Grodzisk Mazowiecki Poland

209

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Poland Gedeon Richter Polska Sp. z Gestodene Lindynette 0,075 mg Coated tablet Oral use o.o. Ethinylestradiol 0,03 mg ul.Graniczna 35 05-825 Grodzisk Mazowiecki Poland Poland Bayer Pharma AG Gestodene Logest 0,075 mg Film-coated tablet Oral use D-13342 Berlin Ethinylestradiol 0,02 mg Germany Poland Bayer Pharma AG Gestodene Milvane 0,05 mg/0,03 mg Film-coated tablet Oral use D-13342 Berlin Ethinylestradiol 0,07 mg/ 0,04 mg Germany 0,10 mg /0,03 mg Poland Pfizer Europe MA EEIG Gestodene Minulet 0,075 mg Coated tablet Oral use Ramsgate Road Ethinylestradiol 0,03 mg Sandwich Kent CT13 9NJ United Kingdom Poland Gedeon Richter Plc. Gestodene Vendiol 0,06 mg Coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 0,015 mg HU-1103 Budapest Hungary Poland Gedeon Richter Polska Sp. z Gestodene Zulfija 0,075 mg Coated tablet Oral use o.o. Ethinylestradiol 0,03 mg ul.Graniczna 35 05-825 Grodzisk Mazowiecki Poland

210

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Poland Janssen-Cilag International N.V. Norgestimate Cilest 0,25 mg Tablet Oral use Turnhoutseweg 30 Ethinylestradiol 0,035 mg B 2340 Beerse Belgium Poland Zentiva, k.s. Desogestrel Estmar 0,15 mg Tablet Oral use U kabelovny 130 Ethinylestradiol 0,02 mg 102 37 Praha 10 Dolní Měcholupy Czech Republic Poland Zentiva, k.s. Desogestrel Estmar 0,15 mg Tablet Oral use U kabelovny 130 Ethinylestradiol 0,03 mg 102 37 Praha 10 Dolní Měcholupy Czech Republic Portugal Gedeon Richter Plc. Chlormadinone Belara 2 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 0.03 mg HU-1103 Budapest Hungary Portugal Laboratorios Leon Farma SA Chlormadinone Bonae 2 mg Film-coated tablet Oral use Poligono Industrial Navatejera, Ethinylestradiol 0.03 mg La Vallina s/n, 24008 Villaquilambre,Leon Spain

211

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Portugal Italfarmaco - Produtos Chlormadinone Clarissa 2 mg Film-coated tablet Oral use Farmacêuticos, Lda. Ethinylestradiol 0.03 mg Rua Consiglieri Pedroso, 123 - Queluz de Baixo 2730-056 Barcarena Portugal Portugal Actavis Group PTC ehf Chlormadinone Jeniasta 2 mg Film-coated tablet Oral use Reykjavikurvegi 76-78 Ethinylestradiol 0.03 mg 220 Hafnarfjordur Iceland Portugal Gedeon Richter Plc. Chlormadinone Libeli 2 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 0.03 mg HU-1103 Budapest Hungary Portugal Merck Sharp & Dohme, Lda. Desogestrel Gracial 0,03 mg/0,125 mg Tablet Oral use Quinta da Fonte 19 Ethinylestradiol 0,04 mg/0,025 mg Edificio Vasco da Gama 2770-192 Paço d' Arcos Portugal Portugal Actavis Group PTC ehf Desogestrel Benidette 0.15 mg Tablet Oral use Reykjavikurvegi 76-78 Ethinylestradiol 0.02 mg 220 Hafnarfjordur Iceland Portugal Actavis Group PTC ehf Desogestrel Benifema 0.15 mg Tablet Oral use Reykjavikurvegi 76-78 Ethinylestradiol 0.03 mg 220 Hafnarfjordur Iceland

212

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Portugal Stragen Nordic A/S, Desogestrel Desogestrel + 0.15 mg Tablet Oral use Helsingørgade 8C, Ethinylestradiol Etinilestradiol Generis 0.02 mg DK-3400 Hillerød, Denmark Portugal Stragen Nordic A/S, Desogestrel Desogestrel + 0.15 mg Tablet Oral use Helsingørgade 8C, Ethinylestradiol Etinilestradiol Generis 0.03 mg DK-3400 Hillerød, Denmark Portugal Mylan, Lda. Desogestrel Desogestrel + 0.15 mg Tablet Oral use Rua Doutor António Loureiro Ethinylestradiol Etinilestradiol Mylan 0.02 mg Borges, Edificio Arquiparque 1, R/C Esq 1499-016 Algés Portugal Portugal Mylan, Lda. Desogestrel Desogestrel + 0.15 mg Tablet Oral use Rua Doutor António Loureiro Ethinylestradiol Etinilestradiol Mylan 0.03 mg Borges, Edificio Arquiparque 1, R/C Esq 1499-016 Algés Portugal Portugal Merck Sharp & Dohme, Lda. Desogestrel Laurina 0,035 mg/0,05mg Film-coated tablet Oral use Quinta da Fonte 19 Ethinylestradiol 0,03 mg/0,10 mg Edificio Vasco da Gama 0,03 mg/0,15 mg 2770-192 Paço d' Arcos Portugal

213

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Portugal Merck Sharp & Dohme, Lda. Desogestrel Laurina 28 0,035 mg/0,05mg Film-coated tablet Oral use Quinta da Fonte 19 Ethinylestradiol 0,03 mg/0,10 mg Edificio Vasco da Gama 0,03 mg/0,15 mg 2770-192 Paço d' Arcos Portugal Portugal Merck Sharp & Dohme, Lda. Desogestrel Marvelon 0.15 mg Tablet Oral use Quinta da Fonte 19 Ethinylestradiol 0.03 mg Edificio Vasco da Gama 2770-192 Paço d' Arcos Portugal Portugal Merck Sharp & Dohme, Lda. Desogestrel Mercilon 0.15 mg Tablet Oral use Quinta da Fonte 19 Ethinylestradiol 0.02 mg Edificio Vasco da Gama 2770-192 Paço d' Arcos Portugal Portugal Gedeon Richter Plc. Desogestrel Novynette 0.15 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 0.02 mg HU-1103 Budapest Hungary Portugal Gedeon Richter Plc. Desogestrel Regulon 0.15 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 0.03 mg HU-1103 Budapest Hungary Portugal Stragen Nordic A/S, Desogestrel Ydeza 0.15 mg Tablet Oral use Helsingørgade 8C, Ethinylestradiol 0.02 mg DK-3400 Hillerød, Denmark

214

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Portugal Stragen Nordic A/S, Desogestrel Ydeza 0.15 mg Tablet Oral use Helsingørgade 8C, Ethinylestradiol 0.03 mg DK-3400 Hillerød, Denmark Portugal Berlifarma, Especialidades Estradiol valerate Qlaira 3 mg Film-coated tablet Oral use Farmacêuticas, Lda. Dienogest 2 mg/2 mg Rua Quinta Pinheiro, 5 3 mg/2 mg 2794-003 Carnaxide 1 mg Portugal Portugal Laboratórios EFFIK, Sociedade Dienogest Denille 2 mg Film-coated tablet Oral use Unipessoal, Lda. Ethinylestradiol 0.03 mg Rua Consiglieri Pedroso, 123 2730-056 Barcarena Portugal Portugal Gedeon Richter Plc. Dienogest Sibilla 2 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 0.03 mg HU-1103 Budapest Hungary Portugal Berlifarma, Especialidades Dienogest Valette 2 mg Coated tablet Oral use Farmacêuticas, Lda. Ethinylestradiol 0.03 mg Rua Quinta Pinheiro, 5 2794-003 Carnaxide Portugal Portugal Lusal, Produção Químico Drospirenone Aliane 3 mg Film-coated tablet Oral use Farmacêutica Luso Alemã, Lda. Ethinylestradiol 0.02 mg Rua Quinta do Pinheiro, 5 2794-003 Carnaxide Portugal

215

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Portugal Gedeon Richter Plc. Drospirenone Aranka 3 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 0.03 mg HU-1103 Budapest Hungary Portugal Gedeon Richter Plc. Drospirenone Arankelle 3 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 0.02 mg HU-1103 Budapest Hungary Portugal Gedeon Richter Plc. Drospirenone Arankitelle 3 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 0.02 mg HU-1103 Budapest Hungary Portugal Gedeon Richter Plc. Drospirenone Daylette 3 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 0.02 mg HU-1103 Budapest Hungary Portugal Sandoz Farmaceutica, Lda. Drospirenone Dioz 3 mg Film-coated tablet Oral use Alameda da Beloura Ethinylestradiol 0.02 mg Edificio 1, 2º Escritorio 15 2710-693 Sintra Portugal Portugal Sandoz Farmaceutica, Lda. Drospirenone Drosianne 3 mg Film-coated tablet Oral use Alameda da Beloura Ethinylestradiol 0,03 mg Edificio 1, 2º Escritorio 15 2710-693 Sintra Portugal

216

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Portugal Teva Pharma - Produtos Drospirenone Dretine 3 mg Film-coated tablet Oral use Farmaceuticos, Lda Ethinylestradiol 0.03 mg Edifício Cyprium, Av. 25 de Abril, 15, 2º F 2795-195 Linda-a-Velha Portugal Portugal Teva Pharma - Produtos Drospirenone Dretinelle 3 mg Film-coated tablet Oral use Farmaceuticos, Lda Ethinylestradiol 0.02 mg Edifício Cyprium, Av. 25 de Abril, 15, 2º F 2795-195 Linda-a-Velha Portugal Portugal Laboratórios EFFIK, Sociedade Drospirenone Droseffik 3 mg Film-coated tablet Oral use Unipessoal, Lda. Ethinylestradiol 0.02 mg Rua Consiglieri Pedroso, 123 2730-056 Barcarena Portugal Portugal Sandoz Farmaceutica, Lda. Drospirenone Drosianelle 3 mg Film-coated tablet Oral use Alameda da Beloura Ethinylestradiol 0.02 mg Edificio 1, 2º Escritorio 15 2710-693 Sintra Portugal Portugal Laboratórios EFFIK, Sociedade Drospirenone Drosurall 3 mg Film-coated tablet Oral use Unipessoal, Lda. Ethinylestradiol 0.02 mg Rua Consiglieri Pedroso, 123 2730-056 Barcarena Portugal

217

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Portugal Laboratórios EFFIK, Sociedade Drospirenone Drosure 3 mg Film-coated tablet Oral use Unipessoal, Lda. Ethinylestradiol 0.03 mg Rua Consiglieri Pedroso, 123 2730-056 Barcarena Portugal Portugal Gedeon Richter Plc. Drospirenone Liladros 3 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 0.02 mg HU-1103 Budapest Hungary Portugal Berlifarma, Especialidades Drospirenone Linatera 3 mg Film-coated tablet Oral use Farmacêuticas, Lda. Ethinylestradiol 0.02 mg Rua Quinta Pinheiro, 5 2794-003 Carnaxide Portugal Portugal Laboratorios Leon Farma SA Drospirenone Nelecta 3 mg Film-coated tablet Oral use Poligono Industrial Navatejera, Ethinylestradiol 0.02 mg La Vallina s/n, 24008 Villaquilambre,Leon Spain Portugal Lusal, Produção Químico Drospirenone Palandra 3 mg Film-coated tablet Oral use Farmacêutica Luso Alemã, Lda. Ethinylestradiol 0.03 mg Rua Quinta do Pinheiro, 5 2794-003 Carnaxide Portugal

218

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Portugal Lusal, Produção Químico Drospirenone Petibelle 3 mg Film-coated tablet Oral use Farmacêutica Luso Alemã, Lda. Ethinylestradiol 0.03 mg Rua Quinta do Pinheiro, 5 2794-003 Carnaxide Portugal Portugal Sanofi - Produtos Drospirenone Sidreta 3 mg Film-coated tablet Oral use Farmaceuticos, Lda. Ethinylestradiol 0.03 mg Empreendimento Lagoas Park, Edifício 7 - 3º Piso - Porto Salvo 2740-244 Portugal Portugal Sanofi - Produtos Drospirenone Sidretella 3 mg Film-coated tablet Oral use Farmaceuticos, Lda. Ethinylestradiol 0.02 mg Empreendimento Lagoas Park, Edifício 7 - 3º Piso - Porto Salvo 2740-244 Portugal Portugal Laboratorios Leon Farma SA Drospirenone Tunile 3 mg Film-coated tablet Oral use Poligono Industrial Navatejera, Ethinylestradiol 0.03 mg La Vallina s/n, 24008 Villaquilambre,Leon Spain Portugal Bayer Portugal, S.A. Drospirenone Yasmin 3 mg Film-coated tablet Oral use Rua Quinta do Pinheiro 5 Ethinylestradiol 0.03 mg 2794-003 Carnaxide Portugal

219

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Portugal Berlex Especialidades Drospirenone Yasminelle 3 mg Film-coated tablet Oral use Farmacêuticas Lda. Ethinylestradiol 0.02 mg Rua Quinta do Pinheiro, 5 2794-003 Carnaxide Portugal Portugal Berlex Especialidades Drospirenone Flexyess 3 mg Film-coated tablet Oral use Farmacêuticas Lda. Ethinylestradiol 0.02 mg Rua Quinta do Pinheiro, 5 2794-003 Carnaxide Portugal Portugal Berlex Especialidades Drospirenone Yaz 3 mg Film-coated tablet Oral use Farmacêuticas Lda. Ethinylestradiol 0.02 mg Rua Quinta do Pinheiro, 5 2794-003 Carnaxide Portugal Portugal Laboratórios EFFIK, Sociedade Gestodene Effiplen 0.03 mg Coated tablet Oral use Unipessoal, Lda. Ethinylestradiol 0.075 mg Rua Consiglieri Pedroso, 123 2730-056 Barcarena Portugal Portugal Laboratórios EFFIK, Sociedade Gestodene Estinette 0.02 mg Coated tablet Oral use Unipessoal, Lda. Ethinylestradiol 0.075 mg Rua Consiglieri Pedroso, 123 2730-056 Barcarena Portugal

220

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Portugal Actavis Group PTC ehf Gestodene Sofiperla 0.03 mg Coated tablet Oral use Reykjavikurvegi 76-78 Ethinylestradiol 0.075 mg 220 Hafnarfjordur Iceland Portugal Actavis Group PTC ehf Gestodene Juliperla 0.02 mg Coated tablet Oral use Reykjavikurvegi 76-78 Ethinylestradiol 0.075 mg 220 Hafnarfjordur Iceland Portugal Medimpex France, S.A Gestodene Etinilestradiol + 0.03 mg Coated tablet Oral use 1-3, Rue Caumartin Ethinylestradiol Gestodeno Dorinette 0.075 mg F-75009 Paris France Portugal Generis Farmacêutica, S.A. Gestodene Etinilestradiol + 0.03 mg Coated tablet Oral use Rua João de Deus, 19 Ethinylestradiol Gestodeno Generis 0.075 mg 2700-487 Amadora Portugal Portugal Generis Farmacêutica, S.A. Gestodene Etinilestradiol + 0.02 mg Coated tablet Oral use Rua João de Deus, 19 Ethinylestradiol Gestodeno Generis 0.075 mg 2700-487 Amadora Portugal Portugal Medimpex France, S.A Gestodene Etinilestradiol + 0.02 mg Coated tablet Oral use 1-3, Rue Caumartin Ethinylestradiol Gestodeno Gestilla 0.075 mg F-75009 Paris France Portugal Stragen Nordic A/S, Gestodene Etinilestradiol + 0.015 mg Film-coated tablet Oral use Helsingørgade 8C, Ethinylestradiol Gestodeno Phagecon 0.06 mg DK-3400 Hillerød, Denmark

221

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Portugal Bayer Portugal, S.A. Gestodene Gynera 0.075 mg Coated tablet Oral use Rua Quinta do Pinheiro 5 Ethinylestradiol 0.03 mg 2794-003 Carnaxide Portugal Portugal Laboratórios Pfizer, Lda. Gestodene Harmonet 0.02 mg Coated tablet Oral use Lagoas Park, Edificio 10 Ethinylestradiol 0.075 mg 2740-271 Porto Salvo Portugal Portugal Bayer Portugal, S.A. Gestodene Microgeste 0.06 mg Film-coated tablet Oral use Rua Quinta do Pinheiro 5 Ethinylestradiol 0.015 mg 2794-003 Carnaxide Portugal Portugal Laboratórios Pfizer, Lda. Gestodene Minesse 0.015 mg Film-coated tablet Oral use Lagoas Park, Edificio 10 Ethinylestradiol 0.06 mg 2740-271 Porto Salvo Portugal Portugal Bayer Portugal, S.A. Gestodene Minigeste 0.075 mg Coated tablet Oral use Rua Quinta do Pinheiro 5 Ethinylestradiol 0.02 mg 2794-003 Carnaxide Portugal Portugal Laboratórios Pfizer, Lda. Gestodene Minulet 0.03 mg Coated tablet Oral use Lagoas Park, Edificio 10 Ethinylestradiol 0.075 mg 2740-271 Porto Salvo Portugal

222

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Portugal Bayer Portugal, S.A. Gestodene Tri-Gynera 0.050 mg/0.030 Coated tablet Oral use Rua Quinta do Pinheiro 5 Ethinylestradiol mg 2794-003 Carnaxide 0.070 mg/0.040 Portugal mg 0.100 mg/0.030 mg Portugal Laboratórios Pfizer, Lda. Gestodene Tri-Minulet 0,03 mg / 0,05 mg Coated tablet Oral use Lagoas Park, Edificio 10 Ethinylestradiol 0,04 mg / 0,07 mg 2740-271 Porto Salvo 0,03 mg / 0,1 mg Portugal Portugal Gedeon Richter Plc. Gestodene Varianta 0.015 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 0.06 mg HU-1103 Budapest Hungary Portugal Merck Sharp & Dohme, Lda. Etonogestrel Circlet 11.7 mg Vaginal delivery Vaginal use Quinta da Fonte 19 Ethinylestradiol 2.7 mg system Edificio Vasco da Gama 2770-192 Paço d' Arcos Portugal Portugal Merck Sharp & Dohme, Lda. Etonogestrel NuvaRing 11.7 mg Vaginal delivery Vaginal use Quinta da Fonte 19 Ethinylestradiol 2.7 mg system Edificio Vasco da Gama 2770-192 Paço d' Arcos Portugal Romania Gedeon Richter România S.A. Chlormadinone BELARA 2 mg Film-coated tablet Oral use Str. Cuza-Vodă, nr. 99-105 Ethinylestradiol 0,03 mg 540306 Târgu Mureş România

223

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Romania Gedeon Richter România S.A. Desogestrel NOVYNETTE 0,15 mg Film-coated tablet Oral use Str. Cuza-Vodă, nr. 99-105 Ethinylestradiol CONTINUU 0,02 mg 540306 Târgu Mureş România Romania Gedeon Richter Plc. Desogestrel SAMBA 0,05 mg/0,035 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 0,1 mg/0,03 mg HU-1103 Budapest 0,15 mg/0,03 mg Hungary Romania Gedeon Richter România S.A. Desogestrel SIBILLA 2 mg Film-coated tablet Oral use Str. Cuza-Vodă, nr. 99-105 Ethinylestradiol 0,03 mg 540306 Târgu Mureş România Romania LadeePharma Kft Dienogest DIENILLE 2 mg Film-coated tablet Oral use Lajos utca 48-66 Ethinylestradiol 0,03 mg H-1036 Budapest Hungary Romania Jenapharm GmbH & Co. KG Dienogest JEANINE 2 mg Coated tablet Oral use Otto-Schott-Straße 15 Ethinylestradiol 0,03 mg 07745 Jena Germany Romania Zentiva, k.s. Dienogest ZENADEA 2 mg Film-coated tablet Oral use U kabelovny 130 Ethinylestradiol 0,03 mg 102 37 Praha 10 Dolní Měcholupy Czech Republic

224

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Romania Medico Uno Pharma Kft. Drospirenone JOLINA 3mg Film-coated tablet Oral use Viadukt u. 12 Ethinylestradiol 0,03mg Biatorbágy 2051 Hungary Romania Ivowen Limited Drospirenone LULINA 3mg Film-coated tablet Oral use 3 Anglesa St Ethinylestradiol 0,03mg Tipperary Clonmel Ireland Romania Gedeon Richter România S.A. Drospirenone MIDIANA 3mg Film-coated tablet Oral use Str. Cuza-Vodă, nr. 99-105 Ethinylestradiol 0,03mg 540306 Târgu Mureş România Romania Bayer Pharma AG Drospirenone YASMIN 0,03 mg/ 3 3mg Film-coated tablet Oral use Muellerstr. 178 Ethinylestradiol mg comprimate 0,03mg D-13353 Berlin filmate Germany Romania Bayer Pharma AG Estradiol valerate QLAIRA, comprimate 3 mg Film-coated tablet Oral use Muellerstrasse 170-178 Dienogest filmate 2 mg/2 mg D-13353 Berlin 2 mg/3 mg Germany 1 mg Romania Gedeon Richter România S.A. Drospirenone ANEEA 0,02 mg Film-coated tablet Oral use Str. Cuza-Vodă, nr. 99-105 Ethinylestradiol 3 mg 540306 Târgu Mureş România Romania Gedeon Richter România S.A. Drospirenone BELUSHA 0,02 mg Film-coated tablet Oral use Str. Cuza-Vodă, nr. 99-105 Ethinylestradiol 3 mg 540306 Târgu Mureş România

225

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Romania Gedeon Richter România S.A. Drospirenone DAYLETTE 0,02 mg Film-coated tablet Oral use Str. Cuza-Vodă, nr. 99-105 Ethinylestradiol 3 mg 540306 Târgu Mureş România Romania Laboratorios Leon Farma SA Drospirenone DROSETIL 0,02 mg Film-coated tablet Oral use Poligono Industrial Navatejera, Ethinylestradiol 3 mg La Vallina s/n, 24008 Villaquilambre,Leon Spain Romania Teva Pharmaceuticals S.R.L. Drospirenone DROSPIR 0,03 mg/3 mg Film-coated tablet Oral use Str. Domniţa Ruxandra nr. 12, Ethinylestradiol parter, Sector 2 Bucureşti România Romania S.C. SANDOZ S.R.L. Drospirenone FELICITY 0,03 mg/3 mg Film-coated tablet Oral use Str. Livezeni nr. 7A, Ethinylestradiol 540472 Târgu Mureş, România. Romania Laboratorios Leon Farma SA Drospirenone JANGEE 0,02 mg Film-coated tablet Oral use Poligono Industrial Navatejera, Ethinylestradiol 3 mg La Vallina s/n, 24008 Villaquilambre,Leon Spain Romania Laboratorios Leon Farma SA Drospirenone MYWY 0,02 mg Film-coated tablet Oral use Poligono Industrial Navatejera, Ethinylestradiol 3 mg La Vallina s/n, 24008 Villaquilambre,Leon Spain

226

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Romania Bayer Pharma AG Drospirenone PALANDRA 0,03 mg/ 0,03 mg Film-coated tablet Oral use Muellerstr. 178 Ethinylestradiol 3 mg comprimate 3 mg D-13353 Berlin filmate Germany Romania Zentiva, k.s. Drospirenone SIDRETELLA 0,03 mg Film-coated tablet Oral use U kabelovny 130 Ethinylestradiol 3 mg 102 37 Praha 10 Dolní Měcholupy Czech Republic Romania Medico Uno Pharma Kft. Drospirenone TAISA 0,02 mg Film-coated tablet Oral use Viadukt u. 12 Ethinylestradiol 3 mg Biatorbágy 2051 Hungary Romania LadeePharma Kft Drospirenone VELGYN 0,02 mg Film-coated tablet Oral use Lajos utca 48-66 Ethinylestradiol 3 mg H-1036 Budapest Hungary Romania Bayer Pharma AG Drospirenone YAZ 0,02 mg/ 3 mg 0,02 mg Film-coated tablet Oral use Muellerstr. 178 Ethinylestradiol comprimate filmate 3 mg D-13353 Berlin Germany Romania N.V. Organon Etonogestrel CIRCLET0,120 0,12 mg Vaginal delivery Vaginal use Kloosterstraat 6 Ethinylestradiol mg/0,015 mg per 24 0,015 mg system 5349 AB, Oss ore sistem cu cedare The Netherlands vaginală

227

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Romania N.V. Organon Etonogestrel NUVARING 0,120 0,12 mg Vaginal delivery Vaginal use Kloosterstraat 6 Ethinylestradiol mg/0,015 mg per 24 0,015 mg system 5349 AB, Oss ore sistem cu cedare The Netherlands vaginală Romania N.V. Organon Desogestrel/ MARVELON 21, 0,15 mg Tablet Oral use Kloosterstraat 6 Ethinylestradiol comprimate 0,03 mg 5349 AB, Oss The Netherlands Romania N.V. Organon Desogestrel/ LAURINA comprimate 0,05mg/0,035mg Film-coated tablet Oral use Kloosterstraat 6 Etinylestradiol filmate 0,035 mg/0,05mg 5349 AB, Oss 0,10mg/0,03mg The Netherlands Romania N.V. Organon Desogestrel/ MARVELON 28 0,15mg Tablet Oral use Kloosterstraat 6 Ethinylestradiol FAMILY PLANNINGS, 0,03mg 5349 AB, Oss comprimate The Netherlands Romania N.V. Organon Desogestrel/ MERCILON, 0,15 mg Tablet Oral use Kloosterstraat 6 Ethinylestradiol comprimate 0,02 mg 5349 AB, Oss The Netherlands Romania Zentiva, k.s. Gestodene ARTIZIA 0,075 mg Coated tablet Oral use U kabelovny 130 Ethinylestradiol 0,02 mg 102 37 Praha 10 Dolní Měcholupy Czech Republic

228

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Romania Medico Uno Pharma Kft. Gestodene STODETTE 0,075 mg Coated tablet Oral use Viadukt u. 12 Ethinylestradiol 0,02 mg Biatorbágy 2051 Hungary Romania Pfizer Europe MA EEIG Gestodene HARMONET 0,075 mg Coated tablet Oral use Ramsgate Road Ethinylestradiol 0,02 mg Sandwich Kent CT13 9NJ United Kingdom Romania Gedeon Richter Plc. Gestodene KARISSA 0,075 mg Coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 0,02 mg HU-1103 Budapest Hungary Romania Gedeon Richter România S.A. Gestodene KOSTYA 0,075 mg Coated tablet Oral use Str. Cuza-Vodă, nr. 99-105 Ethinylestradiol 0,02 mg 540306 Târgu Mureş România Romania Bayer Pharma AG Gestodene LOGEST 0,075 mg Coated tablet Oral use D-13342 Berlin Ethinylestradiol 0,02 mg Germany Romania Gedeon Richter Plc. Gestodene MILLIGEST 0,03 mg/0,05 mg Coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 0,04 mg/0,07 mg HU-1103 Budapest 0,03 mg/0,1 mg Hungary Romania Gedeon Richter Plc. Gestodene VENDIOL 0,06 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 0,015 mg HU-1103 Budapest Hungary

229

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Romania Gedeon Richter România S.A. Gestodene ZULFIJA 0,075 mg Coated tablet Oral use Str. Cuza-Vodă, nr. 99-105 Ethinylestradiol 0,03 mg 540306 Târgu Mureş România Romania Johnson & Johnson d.o.o. Norgestimate CILEST 0,25 mg Tablet Oral use Šmartinska cesta 53 Ethinylestradiol 0,035 mg 1000 Ljubljana Slovenija Romania Teva Pharmaceuticals S.R.L. Drospirenone VEYANN 3 mg/0,02 3 mg Coated tablet Oral use Str. Domniţa Ruxandra nr. 12, Ethinylestradiol mg 0,02 mg parter, Sector 2 Bucureşti România Romania Famy Care Europe Ltd. Norgestimate NORGESTIMAT/ETINIL 0,25 mg Tablet Oral use One Wood Street Ethinylestradiol ESTRADIOL FAMY 0,035 mg EC2V 7WS CARE 250 London micrograme/35 United Kingdom micrograme Romania Bayer Pharma AG Drospirenone YVIDUALLY 0,02 mg/3 0,02 mg Coated tablet Oral use Muellerstrasse 170-178 Ethinylestradiol mg comprimate 3 mg Berlin D-13353 filmate Germany Romania Teva Pharmaceuticals S.R.L. Chlormadinone TYARENA 200 0,2 mg Coated tablet Oral use Str. Domniţa Ruxandra nr. 12, Ethinylestradiol micrograme/30 0,03 mg parter, Sector 2 microgrmae Bucureşti România

230

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Romania Zentiva, k.s. Desogestrel JULIANE 0,15 mg Tablet Oral use U kabelovny 130 Ethinylestradiol 0,03 mg 102 37 Praha 10 Dolní Měcholupy Czech Republic Romania Zentiva, k.s. Desogestrel JULIANE 0,15 mg Tablet Oral use U kabelovny 130 Ethinylestradiol 0,02 mg 102 37 Praha 10 Dolní Měcholupy Czech Republic Slovak Actavis Group PTC ehf Chlormadinone Angiletta 2 mg / 0,03 2 mg Film-coated tablet Oral use Republic Reykjavikurvegi 76-78 Ethinylestradiol mg 0,03 mg 220 Hafnarfjordur Iceland Slovak Gedeon Richter Plc. Chlormadinone Belara 2 mg Film-coated tablet Oral use Republic Gyömröí út 19-21 Ethinylestradiol 0,03 mg HU-1103 Budapest Hungary Slovak Stada Arzneimittel AG, Chlormadinone Belissa 2 mg Film-coated tablet Oral use Republic Stadastrasse 2-8, Ethinylestradiol 0,03 mg DE-61118 Bad Vibel, Germany Slovak Ratiopharm GmbH Chlormadinone Egretta 2 mg/0,03 mg 2 mg Film-coated tablet Oral use Republic Graf-Arco-Strasse 3 Ethinylestradiol 0,03 mg DE-89079 Ulm Germany

231

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Slovak mibe GmbH Arzneimittel Chlormadinone Etinylestradiol 0,03 2 mg Film-coated tablet Oral use Republic Münchener Str. 15 Ethinylestradiol mg/ 0,03 mg 06796 Brehna Chlormadinoniumacet Germany at 2 mg mibe filmom obalene tablety Slovak Heaton a.s. Desogestrel Adele 0,15 mg Tablet Oral use Republic Na Pankráci 14 Ethinylestradiol 0,03 mg 14000 Praha 4 Czech Republic Slovak N.V. Organon Desogestrel Laurina 0.035 mg/0,05 mg Film-coated tablet Oral use Republic Kloosterstraat 6 Ethinylestradiol 0,03 mg/0,1 mg 5349 AB, Oss 0,03 mg / 0,15 mg The Netherlands Slovak N.V. Organon Desogestrel Marvelon 0,15 mg Tablet Oral use Republic Kloosterstraat 6 Ethinylestradiol 0,03 mg 5349 AB, Oss The Netherlands Slovak N.V. Organon Desogestrel Mercilon 0,15 mg Tablet Oral use Republic Kloosterstraat 6 Ethinylestradiol 0,02 mg 5349 AB, Oss The Netherlands Slovak Heaton a.s. Desogestrel Natalya 0,15 mg Tablet Oral use Republic Na Pankráci 14 Ethinylestradiol 0,02 mg 14000 Praha 4 Czech Republic

232

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Slovak Gedeon Richter Plc. Desogestrel Novynette 0,15 mg Film-coated tablet Oral use Republic Gyömröí út 19-21 Ethinylestradiol 0,02 mg HU-1103 Budapest Hungary Slovak Zentiva, k.s. Desogestrel Regisha 0,150 0,15 mg Tablet Oral use Republic U kabelovny 130 Ethinylestradiol mg/0,02 mg 0,02 mg 102 37 Praha 10 Dolní Měcholupy Czech Republic Slovak Zentiva, k.s. Desogestrel Regisha 0,150 0,15 mg Tablet Oral use Republic U kabelovny 130 Ethinylestradiol mg/0,03 mg 0,03 mg 102 37 Praha 10 Dolní Měcholupy Czech Republic Slovak Gedeon Richter Plc. Desogestrel REGULON 0,15 mg Film-coated tablet Oral use Republic Gyömröí út 19-21 Ethinylestradiol 0,03 mg HU-1103 Budapest Hungary Slovak VIVAX EuroAsia s.r.o. Dienogest AIDEE 2 mg/0,03 mg 2 mg Film-coated tablet Oral use Republic Karloveske rameno 6 Ethinylestradiol filmom obalene 0,03 mg 841 01 Bratislava tablety Slovensko Slovak LADEEPHARMA Slovakia s.r.o. Dienogest Dienorette filmom 2 mg Film-coated tablet Oral use Republic Prievozská 4D Ethinylestradiol obalene tablety 0,03 mg 82109 Bratislava Slovak Republic

233

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Slovak Bayer Pharma AG Dienogest Jeanine 2 mg Coated tablet Oral use Republic D-13342 Berlin Ethinylestradiol 0,03 mg Germany Slovak Gedeon Richter Plc. Dienogest Mistra 2 mg Film-coated tablet Oral use Republic Gyömröí út 19-21 Ethinylestradiol 0,03 mg HU-1103 Budapest Hungary Slovak Sandoz Pharmaceuticals d.d. Dienogest SEEGEE 2 mg/0,03 2 mg Film-coated tablet Oral use Republic Verovškova 57 Ethinylestradiol mg 0,03 mg 1000 Ľubľana Slovenia Slovak Zentiva, k.s. Dienogest ZENADEA 2 mg Film-coated tablet Oral use Republic U kabelovny 130 Ethinylestradiol 0,03 mg 102 37 Praha 10 Dolní Měcholupy Czech Republic Slovak LADEEPHARMA Slovakia s.r.o. Drospirenone KarHla 3mg Film-coated tablet Oral use Republic Prievozská 4D Ethinylestradiol 0,03mg 82109 Bratislava Slovak Republic Slovak LADEEPHARMA Slovakia s.r.o. Drospirenone KarHleight 3mg Film-coated tablet Oral use Republic Prievozská 4D Ethinylestradiol 0,03mg 82109 Bratislava Slovak Republic Slovak Gedeon Richter Plc. Drospirenone MAITALON 3 mg/ 0,03 3mg Film-coated tablet Oral use Republic Gyömröí út 19-21 Ethinylestradiol mg filmom obalene 0,03mg HU-1103 Budapest tablety Hungary

234

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Slovak Gedeon Richter Plc. Drospirenone Narayeight 3mg Film-coated tablet Oral use Republic Gyömröí út 19-21 Ethinylestradiol 0,03mg HU-1103 Budapest Hungary Slovak Bayer, spol. s r.o. Drospirenone Palandra 3mg Film-coated tablet Oral use Republic Digital Park II Ethinylestradiol 0,03mg Einsteinova 25 851 01 Bratislava Slovak republic Slovak Bayer, spol. s r.o. Drospirenone Flexyess 0,02 mg/3 3 mg Film-coated tablet Oral use Republic Digital Park II Ethinylestradiol mg filmom obalené 0.02 mg Einsteinova 25 tablety 851 01 Bratislava Slovak republic Slovak Sandoz Pharmaceuticals d.d. Drospirenone Phaenya 21 3mg Film-coated tablet Oral use Republic Verovškova 57 Ethinylestradiol 0,03mg 1000 Ľubľana Slovenia Slovak Sandoz Pharmaceuticals d.d. Drospirenone Phaenya 28 3mg Film-coated tablet Oral use Republic Verovškova 57 Ethinylestradiol 0,03mg 1000 Ľubľana Slovenia Slovak Zentiva, k.s. Drospirenone Sidreta 3mg Film-coated tablet Oral use Republic U kabelovny 130 Ethinylestradiol 0,03mg 102 37 Praha 10 Dolní Měcholupy Czech Republic

235

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Slovak Teva Pharmaceuticals Slovakia Drospirenone Softine 0,03 mg/3 mg 3mg Film-coated tablet Oral use Republic s.r.o. Ethinylestradiol filmom obalené 0,03mg Teslova 26 tablety 821 02 Bratislava Slovak republic Slovak Ivowen Limited Drospirenone WERRCA 3mg Film-coated tablet Oral use Republic 3 Anglesa St Ethinylestradiol 0,03mg Tipperary Clonmel Ireland Slovak Bayer Pharma AG Drospirenone Yadine 3mg Film-coated tablet Oral use Republic D-13342 Berlin Ethinylestradiol 0,03mg Germany Slovak Bayer, spol. s r.o. Estradiol valerate Qlaira 3 mg Film-coated tablet Oral use Republic Digital Park II Dienogest 2 mg/2 mg Einsteinova 25 2 mg/3 mg 851 01 Bratislava 1 mg Slovak republic Slovak Bayer Pharma AG Drospirenone Aliane 0,02 mg Film-coated tablet Oral use Republic D-13342 Berlin Ethinylestradiol 3 mg Germany Slovak Gedeon Richter Plc. Drospirenone BELUSHA 0,02 mg Film-coated tablet Oral use Republic Gyömröí út 19-21 Ethinylestradiol 3 mg HU-1103 Budapest Hungary Slovak Gedeon Richter Plc. Drospirenone DAYLETTE 0,02 mg Film-coated tablet Oral use Republic Gyömröí út 19-21 Ethinylestradiol 3 mg HU-1103 Budapest Hungary

236

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Slovak Gedeon Richter Plc. Drospirenone DAYLLA 0,02 mg Film-coated tablet Oral use Republic Gyömröí út 19-21 Ethinylestradiol 3 mg HU-1103 Budapest Hungary Slovak Gedeon Richter Plc. Drospirenone KIRGA 0,02 mg Film-coated tablet Oral use Republic Gyömröí út 19-21 Ethinylestradiol 3 mg HU-1103 Budapest Hungary Slovak Bayer, spol. s r.o. Drospirenone Linatera 0,02 mg Film-coated tablet Oral use Republic Digital Park II Ethinylestradiol 3 mg Einsteinova 25 851 01 Bratislava Slovak republic Slovak Laboratorios Leon Farma SA Drospirenone LluviEight 0,02 mg Film-coated tablet Oral use Republic Poligono Industrial Navatejera, Ethinylestradiol 3 mg La Vallina s/n, 24008 Villaquilambre,Leon Spain Slovak LADEEPHARMA Slovakia s.r.o. Drospirenone Lunytta 0,02 mg Film-coated tablet Oral use Republic Prievozská 4D Ethinylestradiol 3 mg 82109 Bratislava Slovak Republic Slovak LADEEPHARMA Slovakia s.r.o. Drospirenone Lunytteight 0,02 mg Film-coated tablet Oral use Republic Prievozská 4D Ethinylestradiol 3 mg 82109 Bratislava Slovak Republic

237

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Slovak Sandoz Pharmaceuticals d.d. Drospirenone Phaenyela 21 0,02 mg Film-coated tablet Oral use Republic Verovškova 57 Ethinylestradiol 3 mg 1000 Ľubľana Slovenia Slovak Sandoz Pharmaceuticals d.d. Drospirenone Phaenyela 28 0,02 mg Film-coated tablet Oral use Republic Verovškova 57 Ethinylestradiol 3 mg 1000 Ľubľana Slovenia Slovak Zentiva, k.s. Drospirenone Sidretella 0,02 mg Film-coated tablet Oral use Republic U kabelovny 130 Ethinylestradiol 3 mg 102 37 Praha 10 Dolní Měcholupy Czech Republic Slovak Teva Pharmaceuticals Slovakia Drospirenone Softinelle 0,02 mg/3 0,02 mg Film-coated tablet Oral use Republic s.r.o. Ethinylestradiol mg filmom obalené 3 mg Teslova 26 tablety 821 02 Bratislava Slovak republic Slovak Bayer Pharma AG Drospirenone Yasminelle 0,02 mg Film-coated tablet Oral use Republic D-13342 Berlin Ethinylestradiol 3 mg Germany Slovak Bayer, spol. s r.o. Drospirenone YAZ 0,02 mg Film-coated tablet Oral use Republic Digital Park II Ethinylestradiol 3 mg Einsteinova 25 851 01 Bratislava Slovak republic

238

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Slovak N.V. Organon Etonogestrel Circlet 0,12 mg Vaginal delivery Vaginal use Republic Kloosterstraat 6 Ethinylestradiol 0,015 mg system 5349 AB, Oss The Netherlands Slovak N.V. Organon Etonogestrel NuvaRing 0,12 mg Vaginal delivery Vaginal use Republic Kloosterstraat 6 Ethinylestradiol 0,015 mg system 5349 AB, Oss The Netherlands Slovak Zentiva, k.s. Gestodene ARTIZIA 0,075 mg/ 0,075 mg Coated tablet Oral use Republic U kabelovny 130 Ethinylestradiol 0,020 mg obalene 0,02 mg 102 37 Praha 10 tablety Dolní Měcholupy Czech Republic Slovak Bayer Pharma AG Gestodene Femoden 0,075 mg Coated tablet Oral use Republic D-13342 Berlin Ethinylestradiol 0,03 mg Germany Slovak LADEEPHARMA Slovakia s.r.o. Gestodene Gefemin 0,060 0,06 mg Film-coated tablet Oral use Republic Prievozská 4D Ethinylestradiol mg/0,015 mg 0,015 mg 82109 Bratislava Slovak Republic Slovak Medico Uno Pharma Kft. Gestodene Gestodette 0,075 mg Coated tablet Oral use Republic Viadukt u. 12 Ethinylestradiol 0,02 mg Biatorbágy 2051 Hungary Slovak Heaton a.s. Gestodene Katya 0,075 mg Coated tablet Oral use Republic Na Pankráci 14 Ethinylestradiol 0,03 mg 14000 Praha 4 Czech Republic

239

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Slovak Gedeon Richter Plc. Gestodene KOSTYA 0,02 0,075 mg Coated tablet Oral use Republic Gyömröí út 19-21 Ethinylestradiol mg/0,075 mg obalene 0,02 mg HU-1103 Budapest tablety Hungary Slovak Gedeon Richter Plc. Gestodene LINDYNETTE 20 0,075 mg Coated tablet Oral use Republic Gyömröí út 19-21 Ethinylestradiol 0,02 mg HU-1103 Budapest Hungary Slovak Gedeon Richter Plc. Gestodene Lindynette 30 0,075 mg Coated tablet Oral use Republic Gyömröí út 19-21 Ethinylestradiol 0,03 mg HU-1103 Budapest Hungary Slovak Bayer Pharma AG Gestodene Logest 0,075 mg Coated tablet Oral use Republic D-13342 Berlin Ethinylestradiol 0,02 mg Germany Slovak Bayer Pharma AG Gestodene Mirelle 0,06 mg Film-coated tablet Oral use Republic D-13342 Berlin Ethinylestradiol 0,015 mg Germany Slovak Heaton a.s. Gestodene Sunya 0,075 mg Coated tablet Oral use Republic Na Pankráci 14 Ethinylestradiol 0,02 mg 14000 Praha 4 Czech Republic Slovak Gedeon Richter Plc. Gestodene Violetta 0,06 mg Film-coated tablet Oral use Republic Gyömröí út 19-21 Ethinylestradiol 0,015 mg HU-1103 Budapest Hungary

240

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Slovak Gedeon Richter Plc. Gestodene ZULFIJA 0,03 0,075 mg Coated tablet Oral use Republic Gyömröí út 19-21 Ethinylestradiol mg/0,075 mg obalené 0,03 mg HU-1103 Budapest tablety Hungary Slovak Johnson & Johnson, s. r. o. Norgestimate Cilest 0,25 mg Tablet Oral use Republic Karadžičova 12 Ethinylestradiol 0,035 mg 821 08 Bratislava Slovak republic Slovenia Gedeon Richter Plc. Chlormadinone Belara 0,03 mg/2 mg 0,03 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol filmsko obložene 2 mg HU-1103 Budapest tablete Hungary Slovenia Bayer d.o.o., Drospirenone Linatera 0,02 mg/3 0,02 mg Film-coated tablet Oral use Bravničarjeva 13, Ethinylestradiol mg filmsko obložene 3 mg Ljubljana, tablete Slovenia Slovenia Bayer d.o.o., Estradiol valerate Qlaira filmsko 3 mg Film-coated tablet Oral use Bravničarjeva 13, Dienogest obložene tablete 2 mg/2 mg Ljubljana, 2 mg/3 mg Slovenia 1 mg Slovenia Bayer Pharma AG Drospirenone Liofora 0,02 mg/3 mg 0,02 mg Film-coated tablet Oral use D-13342 Berlin Ethinylestradiol filmsko obložene 3 mg Germany tablete Slovenia Bayer Pharma AG Ethinylestradiol Yarina 0,03 mg/3 mg 0,03 mg Film-coated tablet Oral use D-13342 Berlin Drospirenone filmsko obložene 3 mg Germany tablete

241

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Slovenia Bayer Pharma AG Drospirenone Yasminelle 0,02 mg/3 0,02 mg Film-coated tablet Oral use D-13342 Berlin Ethinylestradiol mg filmsko obložene 3 mg Germany tablete Slovenia Bayer d.o.o., Drospirenone YAZ 0,02 mg/3 mg 0,02 mg Film-coated tablet Oral use Bravničarjeva 13, Ethinylestradiol filmsko obložene 3 mg Ljubljana, tablete Slovenia Slovenia N.V. Organon Etonogestrel NuvaRing 0,120 0.12 mg Vaginal delivery Vaginal use Kloosterstraat 6 Ethinylestradiol mg/0,015 mg na 24 0.015 mg system 5349 AB, Oss ur vaginalni dostavni The Netherlands sistem Slovenia N.V. Organon Etonogestrel Circlet 0,120 0.12 mg Vaginal delivery Vaginal use Kloosterstraat 6 Ethinylestradiol mg/0,015 mg na 24 0.015 mg system 5349 AB, Oss ur vaginalni dostavni The Netherlands sistem Slovenia Bayer Pharma AG Gestodene Femoden 0,03 0,075 mg Coated tablet Oral use D-13342 Berlin Ethinylestradiol mg/0,075 mg 0,03 mg Germany obložene tablete Slovenia Pfizer Europe MA EEIG Gestodene Harmonet 75 0,075 mg Coated tablet Oral use Ramsgate Road Ethinylestradiol mikrogramov/20 0,02 mg Sandwich mikrogramov Kent CT13 9NJ obložene tablete United Kingdom Slovenia Chemical Works of Gedeon Gestodene LINDYNETTE 0,075 0,075 mg Coated tablet Oral use Richter Plc., Ethinylestradiol mg/0,02 mg obložene 0,02 mg Gyömrői ut 19-21, tablete H-1103 Budapest, Hungary

242

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Slovenia Chemical Works of Gedeon Gestodene LINDYNETTE 0,075 0,075 mg Coated tablet Oral use Richter Plc., Ethinylestradiol mg/0,03 mg obložene 0,03 mg Gyömrői ut 19-21, tablete H-1103 Budapest, Hungary Slovenia Bayer Pharma AG Gestodene Logest 0,02 mg/0,075 0,075 mg Coated tablet Oral use D-13342 Berlin Ethinylestradiol mg obložene tablete 0,02 mg Germany Slovenia Pfizer Europe MA EEIG Gestodene MINULET 75 0,075 mg Coated tablet Oral use Ramsgate Road Ethinylestradiol mikrogramov/30 0,03 mg Sandwich mikrogramov Kent CT13 9NJ obložene tablete United Kingdom Slovenia Johnson & Johnson d.o.o. Norgestimate Cilest 0,25 mg/0,035 0,25 mg Tablet Oral use Šmartinska cesta 53 Ethinylestradiol mg tablete 0,035 mg 1000 Ljubljana Slovenija Slovenia Gedeon Richter Plc. Desogestrel Leticia 150 0,15 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol mikrogramov/20 0,02 mg HU-1103 Budapest mikrogramov filmsko Hungary obložene tablete Slovenia Gedeon Richter Plc. Desogestrel Rozetta 150 0,15 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol mikrogramov/30 0,03 mg HU-1103 Budapest mikrogramov filmsko Hungary obložene tablete

243

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Slovenia Gedeon Richter Plc. Gestodene Kostya 75 0,075 mg Coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol mikrogramov/20 0,02 mg HU-1103 Budapest mikrogramov Hungary obložene tablete Slovenia Gedeon Richter Plc. Gestodene Zulfija 75 0,075 mg Coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol mikrogramov/30 0,03 mg HU-1103 Budapest mikrogramov Hungary obložene tablete Slovenia Gedeon Richter Plc. Drospirenone Aneea 3 mg/0,02 mg 3 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol filmsko obložene 0,02 mg HU-1103 Budapest tablete Hungary Slovenia Gedeon Richter Plc. Drospirenone Daylette 3 mg/0,02 3 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol mg filmsko obložene 0,02 mg HU-1103 Budapest tablete Hungary Slovenia Gedeon Richter Plc. Drospirenone Daylla 3 mg/0,02 mg 3 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol filmsko obložene 0,02 mg HU-1103 Budapest tablete Hungary Slovenia Bayer d.o.o., Ethinylestradiol Flexyess 0,02 mg/3 0,02 mg Film-coated tablet Oral use Bravničarjeva 13, Drospirenone mg filmsko obložene 3 mg Ljubljana, tablete Slovenia Slovenia Gedeon Richter Plc. Drospirenone Hedfor 3 mg/0,02 mg 3 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol filmsko obložene 0,02 mg HU-1103 Budapest tablete Hungary

244

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Slovenia Laboratorios Leon Farma SA Drospirenone MYWY 3 mg/0,02 mg 3 mg Film-coated tablet Oral use Poligono Industrial Navatejera, Ethinylestradiol filmsko obložene 0,02 mg La Vallina s/n, tablete 24008 Villaquilambre,Leon Spain Slovenia Bayer d.o.o., Ethinylestradiol Palandra 0,03 mg/3 0,03 mg Film-coated tablet Oral use Bravničarjeva 13, Drospirenone mg filmsko obložene 3 mg Ljubljana, tablete Slovenia Slovenia sanofi-aventis d.o.o. Drospirenone Sidretella 0,02 mg/3 3 mg Film-coated tablet Oral use Dunajska cesta 151 Ethinylestradiol mg filmsko obložene 0,02 mg 1000 Ljubljana tablete Slovenia Slovenia sanofi-aventis d.o.o. Drospirenone Sidretella 0,03 mg/3 3 mg Film-coated tablet Oral use Dunajska cesta 151 Ethinylestradiol mg filmsko obložene 0,03 mg 1000 Ljubljana tablete Slovenia Slovenia LadeePharma Kft Drospirenone Velgyn 3 mg/0,02 mg 3 mg Film-coated tablet Oral use Lajos utca 48-66 Ethinylestradiol filmsko obložene 0,02 mg H-1036 Budapest tablete Hungary Slovenia Ivowen Limited Drospirenone Werrca 3 mg/0,03 mg 3 mg Film-coated tablet Oral use 3 Anglesa St Ethinylestradiol filmsko obložene 0,03 mg Tipperary Clonmel tablete Ireland

245

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Slovenia LadeePharma Kft Dienogest Dienille 2 mg/0,03 mg 2 mg Film-coated tablet Oral use Lajos utca 48-66 Ethinylestradiol filmsko obložene 0,03 mg H-1036 Budapest tablete Hungary Spain Actavis Group PTC ehf Chlormadinone ANGILETTA 0,03 mg 2 mg Film-coated tablet Oral use Reykjavikurvegi 76-78 Ethinylestradiol /2 mg COMPRIMIDOS 0,03 mg 220 Hafnarfjordur RECUBIERTOS CON Iceland PELICULA EFG Spain FAES FARMA, S.A. Chlormadinone BALIANCA 0,03 2 mg Film-coated tablet Oral use Maximo Aguirre, 14. Ethinylestradiol mg/2mg 0,03 mg 48940 Lamiaco-Lejona COMPRIMIDOS (Vizcaya) RECUBIERTOS CON Spain PELICULA Spain FAES FARMA, S.A. Chlormadinone BALIANCA DIARIO 2 mg Film-coated tablet Oral use Maximo Aguirre, 14. Ethinylestradiol 0,03 mg/2 mg 0,03 mg 48940 Lamiaco-Lejona COMPRIMIDOS (Vizcaya) RECUBIERTOS CON Spain PELICULA Spain Gedeon Richter Plc. Chlormadinone BELARA 0,03 mg/2 2 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol mg COMPRIMIDOS 0,03 mg HU-1103 Budapest RECUBIERTOS CON Hungary PELICULA Spain Gedeon Richter Plc. Chlormadinone BELARA DIARIO 0,03 2 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol mg/2 mg 0,03 mg HU-1103 Budapest COMPRIMIDOS Hungary RECUBIERTOS CON PELICULA

246

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Spain BRILL PHARMA, S.L. Chlormadinone ELYNOR 0.03 mg/2 2 mg Film-coated tablet Oral use Mandri Ethinylestradiol mg COMPRIMIDOS 0,03 mg 66 Escalera A RECUBIERTOS CON despacho 2 PELICULA EFG 08022 Barcelona Spain Spain Pharmacia Grupo Pfizer S.L. Chlormadinone TEYDA 0,03 mg/ 2 mg 2 mg Film-coated tablet Oral use Avda. de Europa 20 B Ethinylestradiol comprimidos 0,03 mg Parque Empresarial la Moraleja recubiertos con 28108 Alcobendas (Madrid) película EFG Spain Spain LABORATORIO STADA, S.L. Chlormadinone ETINILESTRADIOL/CL 2 mg Film-coated tablet Oral use Frederic Mompou, 5 Ethinylestradiol ORMADINONA STADA 0,03 mg 08960 Sant Just Desvern 0,03 mg/2 mg Barcelona COMPRIMIDOS Spain RECUBIERTOS CON PELICULA EFG Spain TEVA PHARMA S.L.U. Chlormadinone TYARENA 0,03 mg/2 2 mg Film-coated tablet Oral use C/ Anabel Segura, 11 Ethinylestradiol mg COMPRIMIDOS 0,03 mg Edificio Albatros B RECUBIERTOS CON 1ª planta PELICULA EFG 28108 Alcobendas Madrid Spain

247

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Spain Merck Sharp and Dohme de Ethinylestradiol GRACIAL comprimidos 0,03 mg/0,125 mg Tablet Oral use España, S.A Desogestrel 0,04 mg/0,025 mg c/ Josefa Valcárcel, 38 28027 Madrid España (Spain) Spain GYNEA LABORATORIOS, S.L. Desogestrel BEMASIVE 150 0,15 mg Coated tablet Oral use Colón, 5 Ethinylestradiol microgramos/20 0,02 mg 08184 Palau-Solitá i Plegamans microgramos Barcelona comprimidos Spain recubiertos Spain Actavis Group PTC ehf Desogestrel BENIDETTE 0,15 mg Tablet Oral use Reykjavikurvegi 76-78 Ethinylestradiol 0,15 mg/0,02 mg 0,02 mg 220 Hafnarfjordur comprimidos EFG Iceland Spain Actavis Group PTC ehf Desogestrel BENIFEMA 0,15 mg Tablet Oral use Reykjavikurvegi 76-78 Ethinylestradiol 0,15 mg/0,03 mg 0,03 mg 220 Hafnarfjordur comprimidos EFG Iceland Spain Famy Care Europe Ltd. Desogestrel DESOGESTREL/ETINIL 0,15 mg Tablet Oral use One Wood Street Ethinylestradiol ESTRADIOL 0,02 mg EC2V 7WS FAMYCARE London 0,15 mg/0,02 mg United Kingdom comprimidos EFG Spain Famy Care Europe Ltd. Desogestrel DESOGESTREL/ETINIL 0,15 mg Tablet Oral use One Wood Street Ethinylestradiol ESTRADIOL 0,03 mg EC2V 7WS FAMYCARE London 0,15 mg/0,03 mg United Kingdom comprimidos EFG

248

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Spain MYLAN PHARMACEUTICALS S.L. Desogestrel DESOGESTREL/ETINIL 0,15 mg Tablet Oral use Plom, 2-4, 5ª planta Ethinylestradiol ESTRADIOL MYLAN 0,02 mg 08038 Barcelona 0,15 mg/0,02 mg Spain comprimidos EFG Spain MYLAN PHARMACEUTICALS S.L. Desogestrel DESOGESTREL/ETINIL 0,15 mg Tablet Oral use Plom, 2-4, 5ª planta Ethinylestradiol ESTRADIOL MYLAN 0,03 mg 08038 Barcelona 0,15 mg/0,03 mg Spain comprimidos EFG Spain Merck Sharp and Dohme de Desogestrel MICRODIOL 0,15 mg Tablet Oral use España, S.A Ethinylestradiol comprimidos 0,03 mg c/ Josefa Valcárcel, 38 28027 Madrid España (Spain) Spain Gedeon Richter Plc. Desogestrel REGULON 150 0,15 mg Coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol microgramos/30 0,03 mg HU-1103 Budapest microgramos Hungary comprimidos recubiertos Spain Merck Sharp and Dohme de Desogestrel SUAVURET 0,15 mg Tablet Oral use España, S.A Ethinylestradiol comprimidos 0,02 mg c/ Josefa Valcárcel, 38 28027 Madrid España (Spain) Spain BAYER HISPANIA, Estradiol valerate Qlaira comprimidos 3 mg Film-coated tablet Oral use S.L Avda. Baix Llobregat 3 y 5 Dienogest recubiertos con 2 mg/2 mg 08970 Sant Joan Despi película 3 mg/2 mg Barcelona 1 mg Spain

249

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Spain BIAL INDUSTRIAL Dienogest AILYN 2 mg/0,03 mg 2 mg Film-coated tablet Oral use FARMACEUTICA, S.A. Ethinylestradiol comprimidos 0,03 mg Parque Científico y Tecnológico recubiertos con de Bizkaia, película EFG Edificio 401 48170 Zamudio (Vizcaya) Spain Spain GYNEA LABORATORIOS, S.L. Dienogest DANIELLE 2 mg/0,03 2 mg Film-coated tablet Oral use Colón, 5 Ethinylestradiol mg comprimidos 0,03 mg 08184 Palau-Solitá i Plegamans recubiertos con Barcelona película Spain Spain LABORATORIOS EFFIK, S.A. Dienogest DONABEL 2 mg Film-coated tablet Oral use San Rafael, 3 Ethinylestradiol comprimidos 0,03 mg 28108 Alcobendas recubiertos con Madrid película Spain Spain KERN PHARMA, S.L. Drospirenone ANTIN 0,03 mg/3 mg 3mg Film-coated tablet Oral use Venus, 72 Ethinylestradiol comprimidos con 0,03mg Polígono Industrial Colón II película EFG 08228 Tarrasa Barcelona Spain

250

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Spain KERN PHARMA, S.L. Drospirenone ANTIN DIARIO 3mg Film-coated tablet Oral use Venus, 72 Ethinylestradiol 0,03 mg/3 mg 0,03mg Polígono Industrial Colón II comprimidos con 08228 Tarrasa película EFG Barcelona Spain Spain Gedeon Richter Plc. Drospirenone ARANKA 3mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 0,03 mg/3 mg 0,03mg HU-1103 Budapest comprimidos Hungary recubiertos con película EFG Spain TEVA PHARMA S.L.U. Drospirenone DRETINE 0,03 mg/3 3mg Film-coated tablet Oral use C/ Anabel Segura, 11 Ethinylestradiol mg comprimidos 0,03mg Edificio Albatros B recubiertos con 1ª planta película EFG 28108 Alcobendas Madrid Spain Spain TEVA PHARMA S.L.U. Drospirenone DRETINE 0,03 mg/3 3mg Film-coated tablet Oral use C/ Anabel Segura, 11 Ethinylestradiol mg 28 comprimidos 0,03mg Edificio Albatros B recubiertos con 1ª planta película EFG 28108 Alcobendas Madrid Spain

251

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Spain LABORATORIOS CINFA, S.A. Drospirenone ETINILESTRADIOL/DR 3mg Film-coated tablet Oral use Olaz-Chipi, 10 Ethinylestradiol OSPIRENONA DIARIO 0,03mg Polígon Industrial Areta CINFA 31620 Huarte-Pamplona 0,03 mg/3 mg (Navarra) comprimidos Spain recubiertos con película EFG Spain LABORATORIOS CINFA, S.A. Chlormadinone ETINILESTRADIOL/CL 2 mg Film-coated tablet Oral use Olaz-Chipi, 10 Ethinylestradiol ORMADINONA CINFA 0,03 mg Polígono Industrial Areta 0,03 mg/2 mg 31620 Huarte-Pamplona comprimidos (Navarra) recubiertos con Spain película EFG Spain LABORATORIOS CINFA, S.A. Desogestrel DESOGESTREL/ETINIL 0,15 mg Tablet Oral use Olaz-Chipi, 10 Ethinylestradiol ESTRADIOL CINFA 0,02 mg Polígono Industrial Areta 0,15 mg/0,02 mg 31620 Huarte-Pamplona comprimidos EFG (Navarra) Spain Spain LABORATORIOS CINFA, S.A. Drospirenone ESTINILESTRADIOL/D 3mg Film-coated tablet Oral use Olaz-Chipi, 10 Ethinylestradiol ROSPIRENONA CINFA 0,03mg Polígono Industrial Areta 0,03 mg/3 mg 31620 Huarte-Pamplona comprimidos (Navarra) recubiertos con Spain película EFG

252

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Spain LABORATORIOS CINFA, S.A. Drospirenone ETINILESTRADIOL/DR 3 mg Film-coated tablet Oral use Olaz-Chipi, 10 Ethinylestradiol OSPIRENONA CINFA 0,02 mg Polígono Industrial Areta 0,02 mg/3 mg 31620 Huarte-Pamplona comprimidos (Navarra) recubiertos con Spain película EFG Spain LABORATORIOS CINFA, S.A. Drospirenone ETINILESTRADIOL/DR 3 mg Film-coated tablet Oral use Olaz-Chipi, 10 Ethinylestradiol OSPIRENONA CINFA 0,02 mg Polígono Industrial Areta 0,02 mg/3 mg 31620 Huarte-Pamplona comprimidos (Navarra) recubiertos con Spain película EFG Spain SANDOZ FARMACEUTICA, S.A. Drospirenone DROSIANELLE 0,03 3 mg Film-coated tablet Oral use Avda. Osa Mayor, 4 Ethinylestradiol mg/3 mg comprimido 0,03 mg 28023 Aravaca recubiertos con Madrid película EFG Spain Spain SANDOZ FARMACEUTICA, S.A. Drospirenone DROSIANE DIARIO 3mg Film-coated tablet Oral use Avda. Osa Mayor, 4 Ethinylestradiol 0,03 mg/3 mg 0,03mg 28023 Aravaca comprimidos Madrid recubiertos con Spain película EFG Spain LABORATORIOS EFFIK, S.A. Drospirenone DROSURE 0,03 mg/3 3mg Film-coated tablet Oral use San Rafael, 3 Ethinylestradiol mg comprimidos 0,03mg 28108 Alcobendas recubiertos con Madrid película EFG Spain

253

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Spain LABORATORIOS EFFIK, S.A. Drospirenone DROSURE DIARIO 3mg Film-coated tablet Oral use San Rafael, 3 Ethinylestradiol 0,03 mg/3 mg 0,03mg 28108 Alcobendas comprimidos Madrid recubiertos con Spain película EFG Spain ACTAVIS SPAIN, S.A. Drospirenone CLEOSENSA DIARIO 3mg Film-coated tablet Oral use Avda. de Burgos, 16-D Ethinylestradiol 0,03 mg/3 mg 0,03mg 28036 Madrid comprimidos Spain recubiertos con película EFG Spain ACTAVIS SPAIN, S.A. Drospirenone CLEOSENSA 0,03 3mg Film-coated tablet Oral use Avda. de Burgos, 16-D Ethinylestradiol mg/3 mg comprimidos 0,03mg 28036 Madrid recubiertos con Spain película EFG Spain LABORATORIO STADA, S.L. Drospirenone ESTINILESTRADIOL/D 3mg Film-coated tablet Oral use Frederic Mompou, 5 Ethinylestradiol ROSPIRENONA 0,03mg 08960 Sant Just Desvern DIARIO STADA 0,03 Barcelona mg/3 mg comprimidos Spain recubiertos con película EFG Spain LABORATORIO STADA, S.L. Drospirenone ESTINILESTRADIOL/D 3mg Film-coated tablet Oral use Frederic Mompou, 5 Ethinylestradiol ROSPIRENONA STADA 0,03mg 08960 Sant Just Desvern 0,03 mg/3 mg Barcelona comprimidos Spain recubiertos con película EFG

254

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Spain Zentiva, k.s. Drospirenone ESTINILESTRADIOL/D 3mg Film-coated tablet Oral use U kabelovny 130 Ethinylestradiol ROSPIRENONA 0,03mg 102 37 Praha 10 ZENTIVA 0,03 mg/3 Dolní Měcholupy mg comprimidos Czech Republic recubiertos con película EFG Spain BAYER HISPANIA, Ethinylestradiol Palandra 0,03 mg/3 0,03mg Film-coated tablet Oral use S.L Avda. Baix Llobregat 3 y 5 Drospirenone mg comprimidos 3mg 08970 Sant Joan Despi recubiertos con Barcelona película Spain Spain BAYER HISPANIA, Ethinylestradiol Flexyess 0,02 mg/3 0,02 mg Film-coated tablet Oral use S.L Avda. Baix Llobregat 3 y 5 Drospirenone mg comprimidos 3 mg 08970 Sant Joan Despi recubiertos con Barcelona película Spain Spain BAYER HISPANIA, Ethinylestradiol Yasmin 0,03 mg/3 mg 0,03 mg Film-coated tablet Oral use S.L Avda. Baix Llobregat 3 y 5 Drospirenone comprimidos 3 mg 08970 Sant Joan Despi recubiertos con Barcelona película Spain Spain BAYER HISPANIA, Ethinylestradiol Yasmin Diario 0,03 0,03 mg Film-coated tablet Oral use S.L Avda. Baix Llobregat 3 y 5 Drospirenone mg/3 mg comprimidos 3 mg 08970 Sant Joan Despi recubiertos con Barcelona película Spain

255

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Spain BAYER HISPANIA, Ethinylestradiol Yira 0,03 mg/3 mg 0,03 mg Film-coated tablet Oral use S.L Avda. Baix Llobregat 3 y 5 Drospirenone comprimidos 3 mg 08970 Sant Joan Despi recubiertos con Barcelona película Spain Spain KERN PHARMA, S.L. Drospirenone ANTINELLE 0,02 mg/3 0,02 mg Film-coated tablet Oral use Venus, 72 Ethinylestradiol mg comprimidos 3 mg Polígono Industrial Colón II recubiertos con 08228 Tarrasa película EFG Barcelona Spain Spain KERN PHARMA, S.L. Drospirenone ANTINELLE DIARIO 0,02 mg Film-coated tablet Oral use Venus, 72 Ethinylestradiol 0,02 mg/3 mg 3 mg Polígono Industrial Colón II comprimidos 08228 Tarrasa recubiertos con Barcelona película EFG Spain Spain Gedeon Richter Plc. Drospirenone ARANKELLE 0,02 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 0,02 mg/3 mg 3 mg HU-1103 Budapest comprimidos Hungary recubiertos con película EFG Spain Gedeon Richter Plc. Drospirenone ARANKELLE DIARIO 0,02 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 0,02 mg/3 mg 3 mg HU-1103 Budapest comprimidos Hungary recubiertos con película EFG

256

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Spain Gedeon Richter Plc. Drospirenone DAYLETTE 0,02 mg/3 0,02 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol mg comprimidos 3 mg HU-1103 Budapest recubiertos con Hungary película EFG Spain SANDOZ FARMACEUTICA, S.A. Drospirenone DRELLE 0,02 mg/3 0,02 mg Film-coated tablet Oral use Avda. Osa Mayor, 4 Ethinylestradiol mg comprimidos 3 mg 28023 Aravaca recubiertos con Madrid película EFG Spain Spain TEVA PHARMA S.L.U. Drospirenone DRETINELLE 0,02 mg Film-coated tablet Oral use C/ Anabel Segura, 11 Ethinylestradiol 0,02 mg/3 mg 28 3 mg Edificio Albatros B comprimidos 1ª planta recubiertos con 28108 Alcobendas película EFG Madrid Spain Spain TEVA PHARMA S.L.U. Drospirenone DRETINELLE 0,02 mg Film-coated tablet Oral use C/ Anabel Segura, 11 Ethinylestradiol 0,02 mg/3 mg 3 mg Edificio Albatros B comprimidos 1ª planta recubiertos con 28108 Alcobendas película EFG Madrid Spain

257

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Spain LABORATORIOS CINFA, S.A. Drospirenone ETINILESTRADIOL/DR 0,02 mg Film-coated tablet Oral use Olaz-Chipi, 10 Ethinylestradiol OSPIRENONA DIARIO 3 mg Polígon Industrial Areta CINFA 0,02 mg/3 mg 31620 Huarte-Pamplona comprimidos (Navarra) recubiertos con Spain película EFG Spain SANDOZ FARMACEUTICA, S.A. Drospirenone DROSIANELLE 0,02 mg Film-coated tablet Oral use Avda. Osa Mayor, 4 Ethinylestradiol 0,02 mg/3 mg 3 mg 28023 Aravaca comprimidos Madrid recubiertos con Spain película EFG Spain SANDOZ FARMACEUTICA, S.A. Drospirenone DROSIANELLE DIARIO 0,02 mg Film-coated tablet Oral use Avda. Osa Mayor, 4 Ethinylestradiol 0,02 mg/3 mg 3 mg 28023 Aravaca comprimido Madrid recubiertos con Spain película EFG Spain LABORATORIOS EFFIK, S.A. Drospirenone DROSPIL 0,02 mg/3 0,02 mg Film-coated tablet Oral use San Rafael, 3 Ethinylestradiol mg comprimidos 3 mg 28108 Alcobendas recubiertos con Madrid película EFG Spain Spain LABORATORIOS EFFIK, S.A. Drospirenone DROSURELLE 0,02 0,02 mg Film-coated tablet Oral use San Rafael, 3 Ethinylestradiol mg/3 mg comprimido 3 mg 28108 Alcobendas recubiertos con Madrid película EFG Spain

258

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Spain LABORATORIOS EFFIK, S.A. Drospirenone DROSURELLE DIARIO 0,02 mg Film-coated tablet Oral use San Rafael, 3 Ethinylestradiol 0,02 mg/3 mg 3 mg 28108 Alcobendas comprimidos Madrid recubiertos con Spain película EFG Spain BAYER HISPANIA, Drospirenone Eloine 0,02 mg/3 mg 0,02 mg Film-coated tablet Oral use S.L Avda. Baix Llobregat 3 y 5 Ethinylestradiol comprimidos 3 mg 08970 Sant Joan Despi recubiertos con Barcelona película Spain Spain ACTAVIS SPAIN, S.A. Drospirenone CLEODETTE DIARIO 3 mg Film-coated tablet Oral use Avda. de Burgos, 16-D Ethinylestradiol 0,02 mg/3 mg 0,02 mg 28036 Madrid comprimidos Spain recubiertos con película EFG Spain ACTAVIS SPAIN, S.A. Drospirenone CLEODETTE 0,02 3 mg Film-coated tablet Oral use Avda. de Burgos, 16-D Ethinylestradiol mg/3 mg comprimidos 0,02 mg 28036 Madrid recubiertos con Spain película EFG Spain Zentiva, k.s. Drospirenone ESTINILESTRADIOL/D 3 mg Film-coated tablet Oral use U kabelovny 130 Ethinylestradiol ROSPERINONA 0,02 mg 102 37 Praha 10 ZENTIVA 0,02 mg/3 Dolní Měcholupy mg comprimidos Czech Republic recubiertos con película EFG

259

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Spain LABORATORIO STADA, S.L. Drospirenone ESTINILESTRADIOL/D 0,02 mg Film-coated tablet Oral use Frederic Mompou, 5 Ethinylestradiol ROSPIRENONA 3 mg 08960 Sant Just Desvern DIARIO STADA 0,02 Barcelona mg/3 mg comprimidos Spain recubiertos con película EFG Spain LABORATORIO STADA, S.L. Drospirenone ESTINILESTRADIOL/D 0,02 mg Film-coated tablet Oral use Frederic Mompou, 5 Ethinylestradiol ROSPIRENONA STADA 3 mg 08960 Sant Just Desvern 0,02 mg/3 mg Barcelona comprimidos Spain recubiertos con película EFG Spain BAYER HISPANIA, Drospirenone Liofora 0,02 mg/3 mg 0,02 mg Film-coated tablet Oral use S.L Avda. Baix Llobregat 3 y 5 Ethinylestradiol comprimidos 3 mg 08970 Sant Joan Despi recubiertos con Barcelona película Spain Spain BAYER HISPANIA, Drospirenone Liofora Diario 0,02 0,02 mg Film-coated tablet Oral use S.L Avda. Baix Llobregat 3 y 5 Ethinylestradiol mg/3 mg comprimidos 3 mg 08970 Sant Joan Despi recubiertos con Barcelona película Spain Spain BAYER HISPANIA, Drospirenone Yasminelle 0,02 mg/3 0,02 mg Film-coated tablet Oral use S.L Avda. Baix Llobregat 3 y 5 Ethinylestradiol mg comprimidos 3 mg 08970 Sant Joan Despi recubiertos con Barcelona película Spain

260

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Spain BAYER HISPANIA, Drospirenone Yasminelle Diario 0,02 0,02 mg Film-coated tablet Oral use S.L Avda. Baix Llobregat 3 y 5 Ethinylestradiol mg/3 mg comprimidos 3 mg 08970 Sant Joan Despi recubiertos con Barcelona película Spain Spain BAYER HISPANIA, Drospirenone YAZ 0,02 mg/3 mg 0,02 mg Film-coated tablet Oral use S.L Avda. Baix Llobregat 3 y 5 Ethinylestradiol comprimidos 3 mg 08970 Sant Joan Despi recubiertos con Barcelona película Spain Spain Schering – Plough S.A. Etonogestrel CIRCLET 0,120 11,7 mg Vaginal delivery Vaginal use c/ Josefa Valcárcel, 38 Ethinylestradiol mg/0,015 mg CADA 2,7 mg system 28027 Madrid 24 HORAS, SISTEMA España (Spain) DE LIBERACION VAGINAL Spain Merck Sharp and Dohme de Etonogestrel NUVARING 0,120 11,7 mg Vaginal delivery Vaginal use España, S.A Ethinylestradiol mg/0,015 mg CADA 2,7 mg system c/ Josefa Valcárcel, 38 24 HORAS, SISTEMA 28027 Madrid DE LIBERACION España (Spain) VAGINAL Spain SANDOZ FARMACEUTICA, S.A. Gestodene ETINILESTRADIOL/G 0,075 mg Coated tablet Oral use Avda. Osa Mayor, 4 Ethinylestradiol ESTODENO SANDOZ 0,02 mg 28023 Aravaca 0,02 mg/0,075 mg Madrid comprimidos Spain recubiertos

261

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Spain LABORATORIOS EFFIK, S.A. Gestodene GESTINYL 20/75 0,075 mg Coated tablet Oral use San Rafael, 3 Ethinylestradiol microgramos 0,02 mg 28108 Alcobendas comprimidos Madrid recubiertos Spain Spain BAYER HISPANIA, Gestodene Gynovin 0,075 mg Coated tablet Oral use S.L Avda. Baix Llobregat 3 y 5 Ethinylestradiol 0,03 mg 08970 Sant Joan Despi Barcelona Spain Spain WYETH FARMA, S.A. Gestodene HARMONET 75/20 0,075 mg Coated tablet Oral use Ctra. de Burgos, Km 23. Ethinylestradiol microgramos 0,02 mg Desvio Algete, Km. 1 comprimidos 28700 San Sebastián de los recubiertos Reyes - Madrid Spain Spain Actavis Group PTC ehf Gestodene JULIPERLA 0,02 0,075 mg Film-coated tablet Oral use Reykjavikurvegi 76-78 Ethinylestradiol mg/0,075 mg 0,02 mg 220 Hafnarfjordur comprimidos Iceland recubiertos con película Spain BAYER HISPANIA, Gestodene Meliane 0,075 mg Coated tablet Oral use S.L Avda. Baix Llobregat 3 y 5 Ethinylestradiol 0,02 mg 08970 Sant Joan Despi Barcelona Spain

262

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Spain BAYER HISPANIA, Gestodene Meliane Diario 0,075 mg Coated tablet Oral use S.L Avda. Baix Llobregat 3 y 5 Ethinylestradiol 0,02 mg 08970 Sant Joan Despi Barcelona Spain Spain BAYER HISPANIA, Gestodene Melodene-15 0,06 mg 0,06 mg Film-coated tablet Oral use S.L Avda. Baix Llobregat 3 y 5 Ethinylestradiol /0,015 mg 0,015 mg 08970 Sant Joan Despi comprimidos Barcelona recubiertos con Spain película Spain TEVA PHARMA S.L.U. Gestodene MELTEVA 0,02 0,075 mg Film-coated tablet Oral use C/ Anabel Segura, 11 Ethinylestradiol mg/0,075 mg 0,02 mg Edificio Albatros B comprimidos 1ª planta recubiertos con 28108 Alcobendas película Madrid Spain Spain WYETH FARMA, S.A. Gestodene MINESSE 60 0,0618 mg Coated tablet Oral use Ctra. de Burgos, Km 23. Ethinylestradiol microgramos/15 0,0154 mg Desvio Algete, Km. 1 microgramos 28700 San Sebastián de los comprimidos Reyes - recubiertos Madrid Spain

263

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Spain WYETH FARMA, S.A. Gestodene MINULET 75/30 0,075 mg Coated tablet Oral use Ctra. de Burgos, Km 23. Ethinylestradiol microgramos 0,03 mg Desvio Algete, Km. 1 comprimidos 28700 San Sebastián de los recubiertos Reyes - Madrid Spain Spain Actavis Group PTC ehf Gestodene SOFIPERLA 0,03 0,075 mg Film-coated tablet Oral use Reykjavikurvegi 76-78 Ethinylestradiol mg/0,075 mg 0,03 mg 220 Hafnarfjordur comprimidos Iceland recubiertos con película Spain TEVA PHARMA S.L.U. Gestodene TEVALET 0,03 0,075 mg Coated tablet Oral use C/ Anabel Segura, 11 Ethinylestradiol mg/0,075 mg 0,02 mg Edificio Albatros B comprimidos 1ª planta recubiertos 28108 Alcobendas Madrid Spain Spain BAYER HISPANIA, Gestodene Trigynovin 0,05 mg/0,03 mg Coated tablet Oral use S.L Avda. Baix Llobregat 3 y 5 Ethinylestradiol comprimidos 0,07 mg/ 0,04 mg 08970 Sant Joan Despi recubiertos 0,10 mg/0,03 mg Barcelona Spain

264

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Spain WYETH FARMA, S.A. Gestodene TRI-MINULET 0,05 mg/0,03 mg Coated tablet Oral use Ctra. de Burgos, Km 23. Ethinylestradiol comprimidos 0,07 mg/0,04 mg Desvio Algete, Km. 1 recubiertos 0,10 mg/0,03 mg 28700 San Sebastián de los Reyes - Madrid Spain Spain Gedeon Richter Plc. Gestodene VARIANTA 60 0,06 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol microgramos/15 0,015 mg HU-1103 Budapest microgramos Hungary comprimidos recubiertos con película Spain LABORATORIOS EFFIK, S.A. Norgestimate EDELSIN comprimidos 0,25 mg Tablet Oral use San Rafael, 3 Ethinylestradiol 0,035 mg 28108 Alcobendas Madrid Spain Spain MADAUS GmbH Chlormadinone ETINILESTRADIOL/CL 2 mg Film-coated tablet Oral use Colonia Allee 15 Ethinylestradiol ORMADINONA 0,03 mg 51101 Colonia MADAUS 0,03 mg/2 Germany mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG Spain SANDOZ FARMACÉUTICA, S.A. Desogestrel DESOGESTREL/ETINIL 0,15 mg Tablet Oral use Avda. Osa Mayor, 4 Ethinylestradiol ESTRADIOL SANDOZ 0,02 mg 28023 Aravaca (Madrid) 0,15 mg/0,02 mg Spain comprimidos EFG

265

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Spain SANDOZ FARMACÉUTICA, S.A. Desogestrel DESOGESTREL/ETINIL 0,15 mg Tablet Oral use Avda. Osa Mayor, 4 Ethinylestradiol ESTRADIOL SANDOZ 0,03 mg 28023 Aravaca (Madrid) 0,15 mg/0,03 mg Spain comprimidos EFG Spain BIAL INDUSTRIAL Dienogest AILYN 2 DIARIO 2 2 mg Film-coated tablet Oral use FARMACEUTICA, S.A. Ethinylestradiol mg/0,03 mg 0,03 mg Parque Científico y Tecnológico comprimidos de Bizkaia, recubiertos con Edificio 401 película EFG 48170 Zamudio (Vizcaya) Spain Spain GEDEON RICHTER, PLC Dienogest SIBILLA 2 mg/0,03 2 mg Film-coated tablet Oral use Gyömroi ut 19-21 Ethinylestradiol mg comprimidos 0,03 mg H-1103 Budapest recubiertos con Hungary película Spain MYLAN PHARMACEUTICALS S.L. Drospirenone ESTINILESTRADIOL/D 0,03 mg Film-coated tablet Oral use Plom, 2-4, 5ª planta Ethinylestradiol ROSPIRENONA MYLAN 3 mg 08038 Barcelona PHARMACEUTICALS Spain 0,03 mg/3 mg comprimidos recubiertos con película

266

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Spain MYLAN PHARMACEUTICALS S.L. Drospirenone ESTINILESTRADIOL/D 0,03 mg Film-coated tablet Oral use Plom, 2-4, 5ª planta Ethinylestradiol ROSPIRENONA 3 mg 08038 Barcelona DIARIO MYLAN Spain PHARMACEUTICALS 0,03 mg/3 mg comprimidos recubiertos con película EFG Spain QUALITEC EUROPA, S.L Drospirenone ESTINILESTRADIOL/D 3 mg Film-coated tablet Oral use Paseo Pintor Rosales, 42 Ethinylestradiol ROSPIRENONA 0,03 mg 28008 Madrid DIARIO QUALITEC Spain 0,03 mg/3 mg comprimidos recubiertos con película Spain QUALITEC EUROPA, S.L Drospirenone ESTINILESTRADIOL/D 3 mg Film-coated tablet Oral use Paseo Pintor Rosales, 42 Ethinylestradiol ROSPIRENONA 0,03 mg 28008 Madrid DIARIO QUALITEC Spain 0,03 mg/3 mg comprimidos recubiertos con película EFG

267

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Spain QUALITEC EUROPA, S.L Drospirenone ESTINILESTRADIOL/D 3 mg Film-coated tablet Oral use Paseo Pintor Rosales, 42 Ethinylestradiol ROSPIRENONA 0,03 mg 28008 Madrid DIARIO QUASSET Spain 0,03 mg/3 mg comprimidos recubiertos con película EFG Spain TEVA PHARMA S.L.U. Drospirenone DRAZ 0,02 mg/3 mg 0,02 mg Film-coated tablet Oral use C/ Anabel Segura, 11 Ethinylestradiol 28 comprimidos 3 mg Edificio Albatros B recubiertos con 1ª planta película EFG 28108 Alcobendas Madrid Spain Spain QUALITEC EUROPA, S.L Drospirenone ESTINILESTRADIOL/D 3 mg Film-coated tablet Oral use Paseo Pintor Rosales, 42 Ethinylestradiol ROSPIRENONA 0,02 mg 28008 Madrid DIARIO QUALITEC Spain 0,02 mg/3 mg comprimidos recubiertos con película EFG Spain QUALITEC EUROPA, S.L Drospirenone ESTINILESTRADIOL/D 3 mg Film-coated tablet Oral use Paseo Pintor Rosales, 42 Ethinylestradiol ROSPIRENONA 0,02 mg 28008 Madrid QUALITEC 0,02 mg/3 Spain mg comprimidos recubiertos con película

268

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Spain QUALITEC EUROPA, S.L Drospirenone ESTINILESTRADIOL/D 3 mg Film-coated tablet Oral use Paseo Pintor Rosales, 42 Ethinylestradiol ROSPIRENONA 0,02 mg 28008 Madrid DIARIO QUASSET Spain 0,02 mg/3 mg comprimidos recubiertos con película EFG Spain MYLAN PHARMACEUTICALS S.L. Drospirenone ESTINILESTRADIOL/D 0,02 mg Film-coated tablet Oral use Plom, 2-4, 5ª planta Ethinylestradiol ROSPIRENONA MYLAN 3 mg 08038 Barcelona PHARMACEUTICALS Spain 0,02 mg/3 mg comprimidos recubiertos con película EFG Spain MYLAN PHARMACEUTICALS S.L. Drospirenone ESTINILESTRADIOL/D 0,02 mg Film-coated tablet Oral use Plom, 2-4, 5ª planta Ethinylestradiol ROSPIRENONA 3 mg 08038 Barcelona DIARIO MYLAN Spain PHARMACEUTICALS 0,02 mg/3 mg comprimidos recubiertos con película EFG Spain LABORATORIO STADA, S.L. Drospirenone ESTINILESTRADIOL/D 3 mg Film-coated tablet Oral use Frederic Mompou, 5 Ethinylestradiol ROSPIRENONA STADA 0,02 mg 08960 Sant Just Desvern 0,02 mg/3 mg Barcelona comprimidos Spain recubiertos con película (24+4) EFG

269

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Sweden Bayer AB Estradiol valerate Qlaira 3 mg Film-coated tablet Oral use Postbox 606 Dienogest 2 mg/2 mg Gustav III's Boulevard 56 2 mg/3 mg SE-16926 Solna 1 mg Sweden Sweden Gedeon Richter Plc. Desogestrel Aroletta 28 0,03 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 0,15 mg HU-1103 Budapest Hungary Sweden Gedeon Richter Plc. Desogestrel Asphalia 0,03 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 0,15 mg HU-1103 Budapest Hungary Sweden Gedeon Richter Plc. Desogestrel Caricia 0,03 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 0,15 mg HU-1103 Budapest Hungary Sweden Gedeon Richter Plc. Desogestrel Desodiol 0,02 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 0,15 mg HU-1103 Budapest Hungary Sweden Gedeon Richter Plc. Desogestrel Desodiolcont 0,02 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 0,15 mg HU-1103 Budapest Hungary

270

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Sweden N.V. Organon Desogestrel Desolett 0,03 mg Tablet Oral use Kloosterstraat 6 Ethinylestradiol 0,15 mg 5349 AB, Oss The Netherlands Sweden N.V. Organon Desogestrel Desolett 28 0,03 mg Tablet Oral use Kloosterstraat 6 Ethinylestradiol 0,15 mg 5349 AB, Oss The Netherlands Sweden Gedeon Richter Plc. Desogestrel Docrelen 28 0,02 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 0,15 mg HU-1103 Budapest Hungary Sweden Stada Arzneimittel AG, Desogestrel Femistad 0,03 mg Tablet Oral use Stadastrasse 2-8, Ethinylestradiol 0,15 mg DE-61118 Bad Vibel, Germany Sweden Stada Arzneimittel AG, Desogestrel Femistad 0,02 mg Tablet Oral use Stadastrasse 2-8, Ethinylestradiol 0,15 mg DE-61118 Bad Vibel, Germany Sweden Mylan AB, Desogestrel Lestramyl 0,03 mg Tablet Oral use Postbox 23033, Ethinylestradiol 0,15 mg Ynglingagatan 14, SE-10435 Stockholm, Sweden

271

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Sweden N.V. Organon Desogestrel Mercilon 28 0,02 mg Tablet Oral use Kloosterstraat 6 Ethinylestradiol 0,15 mg 5349 AB, Oss The Netherlands Sweden Gedeon Richter Plc. Desogestrel Sablona 28 0,03 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 0,15 mg HU-1103 Budapest Hungary Sweden Ivowen Limited Drospirenone Artadal 0,03 mg Film-coated tablet Oral use 3 Anglesa St Ethinylestradiol 3 mg Tipperary Clonmel Ireland Sweden Gedeon Richter Plc. Drospirenone Artadal 28 0,03 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 3 mg HU-1103 Budapest Hungary Sweden Teva Sweden AB Drospirenone Dretine 0,03 mg Film-coated tablet Oral use Järnvägsgatan 11 Ethinylestradiol 3 mg Box 1070 25110 Helsingborg Sweden Sweden Teva Sweden AB Drospirenone Dretine 28 0,03 mg Film-coated tablet Oral use Järnvägsgatan 11 Ethinylestradiol 3 mg Box 1070 25110 Helsingborg Sweden

272

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Sweden Teva Sweden AB Drospirenone Dretinelle 0,02 mg Film-coated tablet Oral use Järnvägsgatan 11 Ethinylestradiol 3 mg Box 1070 25110 Helsingborg Sweden Sweden Teva Sweden AB Drospirenone Dretinelle 28 0,02 mg Film-coated tablet Oral use Järnvägsgatan 11 Ethinylestradiol 3 mg Box 1070 25110 Helsingborg Sweden Sweden Bayer AB Drospirenone Eloine 0,02 mg Film-coated tablet Oral use Postbox 606 Ethinylestradiol 3 mg Gustav III's Boulevard 56 SE-16926 Solna Sweden Sweden Teva Sweden AB Drospirenone Ethinylestradiol / 0,02 mg Film-coated tablet Oral use Järnvägsgatan 11 Ethinylestradiol Drospirenone Teva 3 mg Box 1070 25110 Helsingborg Sweden Sweden Bayer AB Drospirenone Flexyess 0,02 mg Film-coated tablet Oral use Postbox 606 Ethinylestradiol 3 mg Gustav III's Boulevard 56 SE-16926 Solna Sweden

273

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Sweden Laboratorios Leon Farma SA Drospirenone Iradier 0,02 mg Film-coated tablet Oral use Poligono Industrial Navatejera, Ethinylestradiol 3 mg La Vallina s/n, 24008 Villaquilambre,Leon Spain Sweden Bayer Pharma AG Drospirenone Liofora 0,02 mg Film-coated tablet Oral use D-13342 Berlin Ethinylestradiol 3 mg Germany Sweden Gedeon Richter Plc. Drospirenone Mesilara 0,02 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 3 mg HU-1103 Budapest Hungary Sweden Bayer AB Drospirenone Palandra 0,03 mg Film-coated tablet Oral use Postbox 606 Ethinylestradiol 3 mg Gustav III's Boulevard 56 SE-16926 Solna Sweden Sweden Sandoz A/S Drospirenone Stefaminelle 0,02 mg Film-coated tablet Oral use Edward Thomsens Vej 14 Ethinylestradiol 3 mg DK-2300 København S Denmark Sweden Gedeon Richter Plc. Drospirenone Valdorin 0,02 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 3 mg HU-1103 Budapest Hungary

274

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Sweden Gedeon Richter Plc. Drospirenone Valdorin 28 0,02 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol 3 mg HU-1103 Budapest Hungary Sweden Bayer Pharma AG Drospirenone Yasmin 0,03 mg Film-coated tablet Oral use D-13342 Berlin Ethinylestradiol 3 mg Germany Sweden Bayer Pharma AG Drospirenone Yasmin 28 0,03 mg Film-coated tablet Oral use D-13342 Berlin Ethinylestradiol 3 mg Germany Sweden Bayer Pharma AG Drospirenone Yasminelle 0,02 mg Film-coated tablet Oral use D-13342 Berlin Ethinylestradiol 3 mg Germany Sweden Bayer Pharma AG Drospirenone Yasminelle 28 0,02 mg Film-coated tablet Oral use D-13342 Berlin Ethinylestradiol 3 mg Germany Sweden Bayer AB Drospirenone Yaz 0,02 mg Film-coated tablet Oral use Postbox 606 Ethinylestradiol 3 mg Gustav III's Boulevard 56 SE-16926 Solna Sweden Sweden N.V. Organon Etonogestrel NuvaRing 0,015 mg Vaginal delivery Vaginal use Kloosterstraat 6 Ethinylestradiol 0,12 mg system 5349 AB, Oss The Netherlands

275

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

Sweden Janssen-Cilag AB, Norgestimate Cilest® 0,035 mg Tablet Oral use Box 7073, Ethinylestradiol 0,25 mg 192 07 Sollentuna, Sweden Sweden Janssen-Cilag AB, Norgestimate Cilest® 28 0,035 mg Tablet Oral use Box 7073, Ethinylestradiol 0,25 mg 192 07 Sollentuna, Sweden The betapharm Arzneimittel GmbH Desogestrel Desogestrel 150 0,15 mg Tablet Oral use Netherlands Kobelweg 95 Ethinylestradiol microgram en 0,02 mg 86156 Augsburg Ethinylestradiol 20 Germany microgram betapharm tabletten The Actavis Group PTC ehf Desogestrel Desogestrel/Ethinylest 0,15 mg Tablet Oral use Netherlands Reykjavikurvegi 76-78 Ethinylestradiol radiol Actavis 150/20 0,02 mg 220 Hafnarfjordur microgram tabletten Iceland The Actavis Group PTC ehf Desogestrel Desogestrel/Ethinylest 0,15 mg Tablet Oral use Netherlands Reykjavikurvegi 76-78 Ethinylestradiol radiol Actavis 150/30 0,03 mg 220 Hafnarfjordur microgram tabletten Iceland The Centrafarm B.V. Desogestrel Desogestrel/Ethinylest 0,15 mg Tablet Oral use Netherlands Nieuwe Donk 3 Ethinylestradiol radiol CF 0,15/0,02 0,02 mg 4879 AC Etten-Leur mg, tabletten The Netherlands

276

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

The Centrafarm B.V. Desogestrel Desogestrel/Ethinylest 0,15 mg Tablet Oral use Netherlands Nieuwe Donk 3 Ethinylestradiol radiol CF 0,15/0,03 0,03 mg 4879 AC Etten-Leur mg, tabletten The Netherlands The Stada Arzneimittel AG, Desogestrel Desogestrel/Ethinylest 0,15 mg Tablet Oral use Netherlands Stadastrasse 2-8, Ethinylestradiol radiol STADA 0,02 mg DE-61118 Bad Vibel, 0,15/0,02 mg, Germany tabletten The Stada Arzneimittel AG, Desogestrel Desogestrel/Ethinylest 0,15 mg Tablet Oral use Netherlands Stadastrasse 2-8, Ethinylestradiol radiol STADA 0,03 mg DE-61118 Bad Vibel, 0,15/0,03 mg, Germany tabletten The Teva Nederland B.V. Desogestrel Ethinylestradiol/Desog 0,15 mg Tablet Oral use Netherlands Swensweg 5 Ethinylestradiol estrel 0,02/0,15 mg 0,02 mg 2031 GA Haarlem Teva, tabletten The Netherlands The WeCare, Desogestrel Ethinylestradiol/desog 0,15 mg Tablet Oral use Netherlands Lagedijk 1-3; Ethinylestradiol estrel 0,020 mg/0,150 0,02 mg 1541 KA Koog aan de Zaan, mg WEC tabletten The Netherlands The Teva Nederland B.V. Desogestrel Ethinylestradiol/Desog 0,15 mg Tablet Oral use Netherlands Swensweg 5 Ethinylestradiol estrel 0,03/0,15 mg 0,03 mg 2031 GA Haarlem Teva, tabletten The Netherlands The WeCare, Desogestrel Ethinylestradiol/desog 0,15 mg Tablet Oral use Netherlands Lagedijk 1-3; Ethinylestradiol estrel 0,030 mg/0,150 0,03 mg 1541 KA Koog aan de Zaan, mg WEC tabletten The Netherlands

277

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

The Mylan B.V. Desogestrel Ethinylestradiol/Desog 0,15 mg Tablet Oral use Netherlands Dieselweg 25 Ethinylestradiol estrel Mylan 0,02 mg 3752 LB BUNSCHOTEN 0,02/0,15 mg, The Netherlands tabletten The Mylan B.V. Desogestrel Ethinylestradiol/Desog 0,15 mg Tablet Oral use Netherlands Dieselweg 25 Ethinylestradiol estrel Mylan 0,03 mg 3752 LB BUNSCHOTEN 0,03/0,15 mg, The Netherlands tabletten The Gedeon Richter Plc. Desogestrel Ethinylestradiol/desog 0,15 mg Film-coated tablet Oral use Netherlands Gyömröí út 19-21 Ethinylestradiol estrel Richter 0,02 0,02 mg HU-1103 Budapest mg/0,15 mg Hungary filmomhulde tabletten The Gedeon Richter Plc. Desogestrel Ethinylestradiol/desog 0,15 mg Film-coated tablet Oral use Netherlands Gyömröí út 19-21 Ethinylestradiol estrel Richter 0,03 0,03 mg HU-1103 Budapest mg/0,15 mg Hungary filmomhulde tabletten The Gedeon Richter Plc. Desogestrel Ethinylestradiol/Desog 0,15 mg Film-coated tablet Oral use Netherlands Gyömröí út 19-21 Ethinylestradiol estrel Richter 0.02 0,02 mg HU-1103 Budapest mg/0.15mg -28 Hungary filmomhulde tabletten The Gedeon Richter Plc. Desogestrel Ethinylestradiol/Desog 0,15 mg Film-coated tablet Oral use Netherlands Gyömröí út 19-21 Ethinylestradiol estrel Richter 150 0,03 mg HU-1103 Budapest microgram/30 Hungary microgram -28 filmomhulde tabletten

278

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

The Zentiva, k.s. Desogestrel Juliane 150/20 0,15 mg Tablet Oral use Netherlands U kabelovny 130 Ethinylestradiol microgram tabletten 0,02 mg 102 37 Praha 10 Dolní Měcholupy Czech Republic The Zentiva, k.s. Desogestrel Juliane 150/30 0,15 mg Tablet Oral use Netherlands U kabelovny 130 Ethinylestradiol microgram tabletten 0,03 mg 102 37 Praha 10 Dolní Měcholupy Czech Republic The N.V. Organon Desogestrel Laurina, tabletten 0,035 mg/0,05 mg Film-coated tablet Oral use Netherlands Kloosterstraat 6 Ethinylestradiol 0,03 mg/0,1 mg 5349 AB, Oss 0,03 mg/0,15 mg The Netherlands The N.V. Organon Desogestrel Gracial, tabletten 0,03 mg/0,125 mg Tablet Oral use Netherlands Kloosterstraat 6 Ethinylestradiol 0,04 mg/0,025 mg 5349 AB, Oss The Netherlands The betapharm Arzneimittel GmbH Desogestrel Lonicera 150/30 0,15 mg Tablet Oral use Netherlands Kobelweg 95 Ethinylestradiol microgram tabletten 0,03 mg 86156 Augsburg Germany The N.V. Organon Desogestrel Marvelon, tabletten 0,15 mg Tablet Oral use Netherlands Kloosterstraat 6 Ethinylestradiol 0,03 mg 5349 AB, Oss The Netherlands

279

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

The N.V. Organon Desogestrel Mercilon, tabletten 0,15 mg Tablet Oral use Netherlands Kloosterstraat 6 Ethinylestradiol 0,02 mg 5349 AB, Oss The Netherlands The Sandoz B.V. Drospirenone Armarrok 28, 3mg Film-coated tablet Oral use Netherlands Veluwezoom 22 Ethinylestradiol filmomhulde tabletten 0,03mg 1327 AH Almere 0,03 mg/3 mg The Netherlands The Berlipharm B.V. Ethinylestradiol Ethinylestradiol/ 3mg Film-coated tablet Oral use Netherlands Energieweg 1 Drospirenone Drospirenon 0,03 mg/ 0,03mg 3641 RT Mijdrecht 3 mg Berlipharm, The Netherlands filmomhulde tabletten 0,03/3 mg The Teva Nederland B.V. Drospirenone Ethinylestradiol/Drospi 3mg Film-coated tablet Oral use Netherlands Swensweg 5 Ethinylestradiol renon 0,03 mg/3 mg 0,03mg 2031 GA Haarlem Teva, filmomhulde The Netherlands tabletten The Gedeon Richter Plc. Drospirenone Ethinylestradiol/Drospi 3mg Film-coated tablet Oral use Netherlands Gyömröí út 19-21 Ethinylestradiol renon Richter 0,03 0,03mg HU-1103 Budapest mg/3 mg filmomhulde Hungary tabletten 28x The Sandoz B.V. Drospirenone Ethinylestradiol/Drospi 3mg Film-coated tablet Oral use Netherlands Veluwezoom 22 Ethinylestradiol renon Sandoz 0,03/3 0,03mg 1327 AH Almere mg, filmomhulde The Netherlands tabletten

280

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

The Bayer B.V. Drospirenone Palandra, filmomhulde 3mg Film-coated tablet Oral use Netherlands Pharmaceuticals Ethinylestradiol tabletten 0,03 mg/3 0,03mg Energieweg 1 mg 3641 RT Mijdrecht The Netherlands The Mylan B.V. Drospirenone Rosal 0,03 mg/3 mg, 3mg Film-coated tablet Oral use Netherlands Dieselweg 25 Ethinylestradiol filmomhulde tabletten 0,03mg 3752 LB BUNSCHOTEN The Netherlands The Laboratorios Leon Farma SA Drospirenone Rosal 28, filmomhulde 3mg Film-coated tablet Oral use Netherlands Poligono Industrial Navatejera, Ethinylestradiol tabletten 0,03mg La Vallina s/n, 24008 Villaquilambre,Leon Spain The Gedeon Richter Plc. Drospirenone Volina 0,03 mg / 3 mg 3mg Film-coated tablet Oral use Netherlands Gyömröí út 19-21 Ethinylestradiol filmomhulde tabletten 0,03mg HU-1103 Budapest Hungary The Bayer B.V. Drospirenone Yasmin 28, 3mg Film-coated tablet Oral use Netherlands Pharmaceuticals Ethinylestradiol filmomhulde tabletten 0,03mg Energieweg 1 0,03/3 mg 3641 RT Mijdrecht The Netherlands The Bayer B.V. Drospirenone Yasmin, omhulde 3mg Film-coated tablet Oral use Netherlands Pharmaceuticals Ethinylestradiol tabletten 0,03/3 mg 0,03mg Energieweg 1 3641 RT Mijdrecht The Netherlands

281

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

The Bayer B.V. Dienogest Qlaira filmomhulde 3 mg Film-coated tablet Oral use Netherlands Pharmaceuticals Estradiol tabletten 2 mg/2 mg Energieweg 1 2 mg/3 mg 3641 RT Mijdrecht 1 mg The Netherlands The Sandoz B.V. Drospirenone Armunia 28, 0,02 mg Film-coated tablet Oral use Netherlands Veluwezoom 22 Ethinylestradiol filmomhulde tabletten 3 mg 1327 AH Almere 0,02 mg/3 mg The Netherlands The Sandoz B.V. Drospirenone Armunia, filmomhulde 0,02 mg Film-coated tablet Oral use Netherlands Veluwezoom 22 Ethinylestradiol tabletten 0,02 mg/3 3 mg 1327 AH Almere mg The Netherlands The Bayer B.V. Drospirenone Belanette 28, 0,02 mg Film-coated tablet Oral use Netherlands Pharmaceuticals Ethinylestradiol filmomhulde tabletten 3 mg Energieweg 1 0,02 mg/3 mg 3641 RT Mijdrecht The Netherlands The Bayer B.V. Drospirenone Belanette, 0,02 mg Film-coated tablet Oral use Netherlands Pharmaceuticals Ethinylestradiol filmomhulde tabletten 3 mg Energieweg 1 0,02 mg/3 mg 3641 RT Mijdrecht The Netherlands The Berlipharm B.V. Drospirenone Ethinylestradiol/Drospi 0,02 mg Film-coated tablet Oral use Netherlands Energieweg 1 Ethinylestradiol renon 24+4 0,02 3 mg 3641 RT Mijdrecht mg/3 mg Berlipharm The Netherlands filmomhulde tabletten

282

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

The Gedeon Richter Plc. Drospirenone Daylette 0,02 mg/3 0,02 mg Film-coated tablet Oral use Netherlands Gyömröí út 19-21 Ethinylestradiol mg filmomhulde 3 mg HU-1103 Budapest tabletten 24 + 4 Hungary The Bayer B.V. Drospirenone Liofora, filmomhulde 0,02 mg Film-coated tablet Oral use Netherlands Pharmaceuticals Ethinylestradiol tabletten 0,02 mg/3 3 mg Energieweg 1 mg 3641 RT Mijdrecht The Netherlands The Laboratorios Leon Farma SA Drospirenone Vallclara 0,02 mg/3 0,02 mg Film-coated tablet Oral use Netherlands Poligono Industrial Navatejera, Ethinylestradiol mg, filmomhulde 3 mg La Vallina s/n, tabletten 24008 Villaquilambre,Leon Spain The Laboratorios Leon Farma SA Drospirenone Vallclara 28 0,02 0,02 mg Film-coated tablet Oral use Netherlands Poligono Industrial Navatejera, Ethinylestradiol mg/3 mg, 3 mg La Vallina s/n, filmomhulde tabletten 24008 Villaquilambre,Leon Spain The Gedeon Richter Plc. Drospirenone Volina 0,02 mg/3 mg 0,02 mg Film-coated tablet Oral use Netherlands Gyömröí út 19-21 Ethinylestradiol filmomhulde tabletten 3 mg HU-1103 Budapest Hungary The Bayer B.V. Drospirenone Yasminelle 28, 0,02 mg Film-coated tablet Oral use Netherlands Pharmaceuticals Ethinylestradiol filmomhulde tabletten 3 mg Energieweg 1 0,02 mg/3 mg 3641 RT Mijdrecht The Netherlands

283

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

The Bayer B.V. Drospirenone Yasminelle, 0,02 mg Film-coated tablet Oral use Netherlands Pharmaceuticals Ethinylestradiol filmomhulde tabletten 3 mg Energieweg 1 0,02 mg/3 mg 3641 RT Mijdrecht The Netherlands The Bayer B.V. Drospirenone Yaz 24+4 0,02 mg/3 0,02 mg Film-coated tablet Oral use Netherlands Pharmaceuticals Ethinylestradiol mg filmomhulde 3 mg Energieweg 1 tabletten 3641 RT Mijdrecht The Netherlands The Bayer B.V. Drospirenone Yvidually 0,02 mg/3 0,02 mg Film-coated tablet Oral use Netherlands Pharmaceuticals Ethinylestradiol mg, filmomhulde 3 mg Energieweg 1 tabletten 3641 RT Mijdrecht The Netherlands The Laboratorios Leon Farma SA Gestodene Annantah 0,060 0,015 mg Film-coated tablet Oral use Netherlands Poligono Industrial Navatejera, Ethinylestradiol mg/0,015 mg, 0,06 mg La Vallina s/n, filmomhulde tabletten 24008 Villaquilambre,Leon Spain The Apothecon B.V. Gestodene Ethinylestradiol/gesto 0,015 mg Film-coated tablet Oral use Netherlands Nijverheidsweg 3 Ethinylestradiol deen 0,015/0,060 A 0,06 mg 3771 ME Barneveld filmomhulde tabletten The Netherlands 0,015/0,060 mg The Apothecon B.V. Gestodene Ethinylestradiol/gesto 0,02 mg Coated tablet Oral use Netherlands Nijverheidsweg 3 Ethinylestradiol deen 0,02/0,075 A, 0,075 mg 3771 ME Barneveld omhulde tabletten The Netherlands 0,02 mg/0,075 mg

284

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

The Apothecon B.V. Gestodene Ethinylestradiol/gesto 0,03 mg Coated tablet Oral use Netherlands Nijverheidsweg 3 Ethinylestradiol deen 0,03/0,075 A, 0,075 mg 3771 ME Barneveld omhulde tabletten The Netherlands 0,03 mg/0,075 mg The Mylan B.V. Gestodene Ethinylestradiol/Gesto 0,02 mg Coated tablet Oral use Netherlands Dieselweg 25 Ethinylestradiol deen Mylan 0,075 mg 3752 LB BUNSCHOTEN 0,02/0,075 mg, The Netherlands omhulde tabletten The Mylan B.V. Gestodene Ethinylestradiol/Gesto 0,03 mg Coated tablet Oral use Netherlands Dieselweg 25 Ethinylestradiol deen Mylan 0,075 mg 3752 LB BUNSCHOTEN 0,03/0,075 mg, The Netherlands omhulde tabletten The Sandoz B.V. Gestodene Ethinylestradiol/Gesto 0,02 mg Coated tablet Oral use Netherlands Veluwezoom 22 Ethinylestradiol deen Sandoz 0,075 mg 1327 AH Almere 0,020/0,075 mg, The Netherlands omhulde tabletten The Sandoz B.V. Gestodene Ethinylestradiol/Gesto 0,03 mg Coated tablet Oral use Netherlands Veluwezoom 22 Ethinylestradiol deen Sandoz 0,075 mg 1327 AH Almere 0,030/0,075 mg, The Netherlands omhulde tabletten The Bayer B.V. Gestodene Femodeen 0,075 mg / 0,03 mg Coated tablet Oral use Netherlands Pharmaceuticals Ethinylestradiol 0,030 mg omhulde 0,075 mg Energieweg 1 tabletten 3641 RT Mijdrecht The Netherlands

285

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

The Pharmachemie B.V. Gestodene Gestodeen/Ethinylestr 0,02 mg Coated tablet Oral use Netherlands Swensweg 5 Ethinylestradiol adiol 0,075 mg/0,020 0,075 mg 2031 GA Haarlem mg PCH, omhulde The Netherlands tabletten The Pharmachemie B.V. Gestodene Gestodeen/Ethinylestr 0,03 mg Coated tablet Oral use Netherlands Swensweg 5 Ethinylestradiol adiol 0,075 mg/0,030 0,075 mg 2031 GA Haarlem mg PCH, omhulde The Netherlands tabletten The Velvian Germany GmbH Gestodene Jamyle 0,060 mg / 0,015 mg Film-coated tablet Oral use Netherlands Carl-Zeiss-Ring 9 Ethinylestradiol 0,015 mg, 0,06 mg 85737 Ismaning filmomhulde tabletten Germany The Pfizer B.V. Gestodene Minulet, dragees 0,03 mg Coated tablet Oral use Netherlands Rivium Westlaan 142 Ethinylestradiol 0,075 mg 2909 LD Capelle a/d IJssel The Netherlands The N.V. Organon Etonogestrel Circlet 0,120 11,7 mg Vaginal delivery Vaginal use Netherlands Kloosterstraat 6 Ethinylestradiol mg/0,015 mg per 24 2,7 mg system 5349 AB, Oss uur, hulpmiddel voor The Netherlands vaginaal gebruik The N.V. Organon Etonogestrel NuvaRing 0,120 11,7 mg Vaginal delivery Vaginal use Netherlands Kloosterstraat 6 Ethinylestradiol mg/0,015 mg per 24 2,7 mg system 5349 AB, Oss uur, hulpmiddel voor The Netherlands vaginaal gebruik

286

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

The Laboratorios Leon Farma SA Desogestrel Bryoronna 150/30 0,15 mg Film-coated tablet Oral use Netherlands Poligono Industrial Navatejera, Ethinylestradiol microgram, 0,03 mg La Vallina s/n, filmomhulde tabletten 24008 Villaquilambre,Leon Spain The Laboratorios Leon Farma SA Desogestrel Bryoronna 28 150/30 0,15 mg Film-coated tablet Oral use Netherlands Poligono Industrial Navatejera, Ethinylestradiol microgram, 0,03 mg La Vallina s/n, filmomhulde tabletten 24008 Villaquilambre,Leon Spain The Teva Nederland B.V. Desogestrel Ethinylestradiol/Desog 0,15 mg Tablet Oral use Netherlands Swensweg 5 Ethinylestradiol estrel 0,02 mg/0,15 0,02 mg 2031 GA Haarlem mg Teva, tabletten The Netherlands The Actavis Group PTC ehf Gestodene Gestodeen/ethinylestr 0,06 mg Film-coated tablet Oral use Netherlands Reykjavikurvegi 76-78 Ethinylestradiol adiol Actavis 0,060 0,015 mg 220 Hafnarfjordur mg/0,015 mg, Iceland filmomhulde tabletten The LadeePharma Kft Drospirenone Drospirenon/Ethinyles 0,02 mg Film-coated tablet Oral use Netherlands Lajos u 48-66 1036 Ethinylestradiol tradiol 3/0,02 mg 3 mg Budapest 24+4 Ladee, Hungary filmomhulde tabletten The EFFIK Drospirenone Drospirenon/Ethinyles 0,02 mg Film-coated tablet Oral use Netherlands Bâtument le Newton Ethinylestradiol tradiol 3/0,02 mg 3 mg 9-11, rue Jeanne Braconnier 24+4 Effik, 92366 Meudon la Forêt filmomhulde tabletten Frankrijk

287

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

The Sandoz B.V. Drospirenone Drospirenon/Ethinyles 0,02 mg Film-coated tablet Oral use Netherlands Veluwezoom 22 Ethinylestradiol tradiol 3/0,02 mg 3 mg 1327 AH Almere 24+4 Sandoz, The Netherlands filmomhulde tabletten The Teva Nederland B.V. Drospirenone Drosperinon/Ethinyles 0,02 mg Film-coated tablet Oral use Netherlands Swensweg 5 Ethinylestradiol tradiol 3/0,02 mg 3 mg 2031 GA Haarlem 24+4 Teva, The Netherlands filmomhulde tabletten The Laboratorios Leon Farma SA Drospirenone MYWY 0,02 mg / 3 0,02 mg Film-coated tablet Oral use Netherlands Poligono Industrial Navatejera, Ethinylestradiol mg, filmomhulde 3 mg La Vallina s/n, tabletten 24008 Villaquilambre,Leon Spain The Laboratorios Leon Farma SA Drospirenone Iradier 3 mg/0,02 mg, 0,02 mg Film-coated tablet Oral use Netherlands Poligono Industrial Navatejera, Ethinylestradiol filmomhulde tabletten 3 mg La Vallina s/n, 24008 Villaquilambre,Leon Spain The DOC Generici Srl Drospirenone Drospirenon/Ethinyles 0,02 mg Film-coated tablet Oral use Netherlands Via Turati 40 Ethinylestradiol tradiol 3/0,02 mg 3 mg 20121 Milano 24+4 DOC Generici, Italy filmomhulde tabletten The Centrafarm B.V. Drospirenone Ethinylestradiol/Drospi 0,02 mg Film-coated tablet Oral use Netherlands Nieuwe Donk 3 Ethinylestradiol renon CF 0,02 mg/3 3 mg 4879 AC Etten-Leur mg, 24+4 The Netherlands filmomhulde tabletten

288

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

The Centrafarm B.V. Drospirenone Ethinylestradiol/Drospi 0,02 mg Film-coated tablet Oral use Netherlands Nieuwe Donk 3 Ethinylestradiol renon CF 0,02 mg/3 3 mg 4879 AC Etten-Leur mg, 24+4 The Netherlands filmomhulde tabletten The Stada Arzneimittel AG, Drospirenone Ethinylestradiol/Drospi 0,02 mg Film-coated tablet Oral use Netherlands Stadastrasse 2-8, Ethinylestradiol renon STADA 0,02 3 mg DE-61118 Bad Vibel, mg/3 mg, 24+4 Germany filmomhulde tabletten The Mylan B.V. Drospirenone Ethinylestradiol/Drospi 0,02 mg Film-coated tablet Oral use Netherlands Dieselweg 25 Ethinylestradiol renon Mylan 24+4 3 mg 3752 LB BUNSCHOTEN 0,02/3 mg, The Netherlands filmomhulde tabletten The Janssen-Cilag B.V. Norgestimate Cilest, tabletten 0,25 mg Tablet Oral use Netherlands Dr. Paul Janssenweg 150 Ethinylestradiol 0,035 mg 5026 RH Tilburg The Netherlands United Gedeon Richter Plc. Desogestrel Gedarel 150/20 0,15 mg Film-coated tablet Oral use Kingdom Gyömröí út 19-21 Ethinylestradiol Micrograms Film- 0,02 mg HU-1103 Budapest Coated Tablets Hungary United Gedeon Richter Plc. Desogestrel Gedarel 150/30 0,15 mg Film-coated tablet Oral use Kingdom Gyömröí út 19-21 Ethinylestradiol Micrograms Film- 0,03 mg HU-1103 Budapest Coated Tablets Hungary United Gedeon Richter Plc. Desogestrel Gedarel ED 20 0,15 mg Film-coated tablet Oral use Kingdom Gyömröí út 19-21 Ethinylestradiol micrograms/150 0,02 mg HU-1103 Budapest micrograms Hungary

289

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

United Gedeon Richter Plc. Desogestrel Gedarel ED 30 0,15 mg Film-coated tablet Oral use Kingdom Gyömröí út 19-21 Ethinylestradiol micrograms/150 0,03 mg HU-1103 Budapest micrograms Hungary United Bayer PLC Dienogest Qlaira, film-coated 3 mg Film-coated tablet Oral use Kingdom Bayer House Estradiol tablets 2 mg/2 mg Strawberry Hill 2 mg/3 mg Newbury 1 mg Berkshire RG14 1JA United Kingdom United Merck Sharp & Dohme Limited, Etonogestrel NuvaRing 0.015 mg Vaginal delivery Vaginal use Kingdom Hertford Road, Ethinylestradiol 0.12 mg system Hoddesdon, Hertfordshire EN11 9BU, United Kingdom United Morningside Healthcare Limited, Desogestrel Cimizt Tablets 150 0,03 mg Tablet Oral use Kingdom 115 Narborough Road, Ethinylestradiol mg/30 mg 0,15 mg Leicester LE3 0PA United Kingdom United Generics (UK) Limited Desogestrel Lestramyl Tablets 150 0,02 mg Tablet Oral use Kingdom Station Close, Potters Bar Ethinylestradiol microgram/20 0,15 mg Hertfordshire EN6 1TL microgram United Kingdom United Generics (UK) Limited Desogestrel Lestramyl Tablets 150 0,03 mg Tablet Oral use Kingdom Station Close, Potters Bar Ethinylestradiol microgram/30 0,15 mg Hertfordshire EN6 1TL microgram United Kingdom

290

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

United Merck Sharp & Dohme Limited, Desogestrel Marvelon 150/30 0,03 mg Tablet Oral use Kingdom Hertford Road, Ethinylestradiol Tablets 0,15 mg Hoddesdon, Hertfordshire EN11 9BU, United Kingdom United Merck Sharp & Dohme Limited, Desogestrel Mercilon Tablets 0.02 mg Tablet Oral use Kingdom Hertford Road, Ethinylestradiol 0.15 mg Hoddesdon, Hertfordshire EN11 9BU, United Kingdom United Laboratorios Leon Farma SA Drospirenone Armentinar Tablets 0,02 mg Film-coated tablet Oral use Kingdom Poligono Industrial Navatejera, Ethinylestradiol 0.02 mg/3 mg 3 mg La Vallina s/n, 24008 Villaquilambre,Leon Spain United Laboratorios Leon Farma SA Drospirenone Bellmunt 28 Film- 0,03 mg Film-coated tablet Oral use Kingdom Poligono Industrial Navatejera, Ethinylestradiol coated Tablets 0.03 3 mg La Vallina s/n, mg/3 mg 24008 Villaquilambre,Leon Spain United Laboratorios Leon Farma SA Drospirenone Bellmunt Film-coated 0,03 mg Film-coated tablet Oral use Kingdom Poligono Industrial Navatejera, Ethinylestradiol Tablets 0.03 mg/3 mg 3 mg La Vallina s/n, 24008 Villaquilambre,Leon Spain

291

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

United Gedeon Richter Plc. Drospirenone Daylette film-coated 0,02 mg Film-coated tablet Oral use Kingdom Gyömröí út 19-21 Ethinylestradiol tablets 0.02mg/3mg 3 mg HU-1103 Budapest Hungary United Teva UK Limited, Drospirenone Dretine 28 Tablets 0,03 mg Film-coated tablet Oral use Kingdom Brampton Road, Ethinylestradiol 0.03mg/3.0mg 3 mg Hampden Park, Eastbourne, East Sussex BN22 9AG, United Kingdom United Teva UK Limited, Drospirenone Dretine Tablets 0,03 mg Film-coated tablet Oral use Kingdom Brampton Road, Ethinylestradiol 0.03mg/3.0mg 3 mg Hampden Park, Eastbourne, East Sussex BN22 9AG, United Kingdom United Bayer PLC Drospirenone ELOINE 0.02 mg / 3 0,02 mg Film-coated tablet Oral use Kingdom Bayer House Ethinylestradiol mg film coated tablets 3 mg Strawberry Hill Newbury Berkshire RG14 1JA United Kingdom United Gedeon Richter Plc. Drospirenone Eslarilla ED Film- 0,02 mg Film-coated tablet Oral use Kingdom Gyömröí út 19-21 Ethinylestradiol coated tablets 3 mg HU-1103 Budapest 0.02mg/3mg Hungary

292

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

United Gedeon Richter Plc. Drospirenone Eslarilla Film-coated 0,02 mg Film-coated tablet Oral use Kingdom Gyömröí út 19-21 Ethinylestradiol tablets 0.02mg/3mg 3 mg HU-1103 Budapest Hungary United Bayer PLC Drospirenone Flexyess 0.02 mg / 3 0,02 mg Film-coated tablet Oral use Kingdom Bayer House Ethinylestradiol mg film-coated tablets 3 mg Strawberry Hill Newbury Berkshire RG14 1JA United Kingdom United Gedeon Richter Plc. Drospirenone Kylnetta ED film- 0,03 mg Film-coated tablet Oral use Kingdom Gyömröí út 19-21 Ethinylestradiol coated tablets 3 mg HU-1103 Budapest 0.03mg/3mg Hungary United Gedeon Richter Plc. Drospirenone Kylnetta film-coated 0,03 mg Film-coated tablet Oral use Kingdom Gyömröí út 19-21 Ethinylestradiol tablets 0.03mg/3mg 3 mg HU-1103 Budapest Hungary United Gedeon Richter Plc. Drospirenone Lovette ED film- 0,02 mg Film-coated tablet Oral use Kingdom Gyömröí út 19-21 Ethinylestradiol coated tablets 3 mg HU-1103 Budapest 0.02mg/3mg Hungary United Gedeon Richter Plc. Drospirenone Lovette film-coated 0,02 mg Film-coated tablet Oral use Kingdom Gyömröí út 19-21 Ethinylestradiol tablets 0.02mg/3mg 3 mg HU-1103 Budapest Hungary

293

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

United Gedeon Richter Plc. Drospirenone Lucette ED film- 0,03 mg Film-coated tablet Oral use Kingdom Gyömröí út 19-21 Ethinylestradiol coated tablets 3 mg HU-1103 Budapest 0.03mg/3mg Hungary United Gedeon Richter Plc. Drospirenone Lucette Film-coated 0,03 mg Film-coated tablet Oral use Kingdom Gyömröí út 19-21 Ethinylestradiol tablets 0.03mg/3mg 3 mg HU-1103 Budapest Hungary United Gedeon Richter Plc. Drospirenone Minkian film-coated 0,02 mg Film-coated tablet Oral use Kingdom Gyömröí út 19-21 Ethinylestradiol tablets 0.02mg/3mg 3 mg HU-1103 Budapest Hungary United Bayer PLC Drospirenone Palandra 0.03 mg / 3 0,03 mg Film-coated tablet Oral use Kingdom Bayer House Ethinylestradiol mg film-coated tablets 3 mg Strawberry Hill Newbury Berkshire RG14 1JA United Kingdom United Laboratorios Leon Farma SA Drospirenone Vallclara 28 Film- 0,02 mg Film-coated tablet Oral use Kingdom Poligono Industrial Navatejera, Ethinylestradiol coated Tablets 0.02 3 mg La Vallina s/n, mg/3 mg 24008 Villaquilambre,Leon Spain United Laboratorios Leon Farma SA Drospirenone Vallclara Film-coated 0,02 mg Film-coated tablet Oral use Kingdom Poligono Industrial Navatejera, Ethinylestradiol Tablets 0.02 mg/3 mg 3 mg La Vallina s/n, 24008 Villaquilambre,Leon Spain

294

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

United Bayer PLC Drospirenone Yasmin ED, film- 0,03 mg Film-coated tablet Oral use Kingdom Bayer House Ethinylestradiol coated tablets, 0.03 3 mg Strawberry Hill mg / 3 mg Newbury Berkshire RG14 1JA United Kingdom United Bayer PLC Drospirenone Yasmin, film-coated 0,03 mg Film-coated tablet Oral use Kingdom Bayer House Ethinylestradiol tablets, 0.03 mg / 3 3 mg Strawberry Hill mg Newbury Berkshire RG14 1JA United Kingdom United Bayer PLC Drospirenone Yasminelle 0.02 mg / 0,02 mg Film-coated tablet Oral use Kingdom Bayer House Ethinylestradiol 3 mg film-coated 3 mg Strawberry Hill tablets Newbury Berkshire RG14 1JA United Kingdom United Bayer PLC Drospirenone Yaz 0.02 mg / 3 mg 0,02 mg Film-coated tablet Oral use Kingdom Bayer House Ethinylestradiol film coated tablets 3 mg Strawberry Hill Newbury Berkshire RG14 1JA United Kingdom United Gedeon Richter Plc. Gestodene Edesia Coated Tablets 0,02 mg Coated tablet Oral use Kingdom Gyömröí út 19-21 Ethinylestradiol 75 micrograms / 20 0,075 mg HU-1103 Budapest micrograms Hungary

295

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

United Gedeon Richter Plc. Gestodene Edesia Coated Tablets 0.03 mg Coated tablet Oral use Kingdom Gyömröí út 19-21 Ethinylestradiol 75 micrograms / 30 0.075 mg HU-1103 Budapest micrograms Hungary United Bayer PLC Ethinylestradiol Femodene ED Tablets 0.03 mg Sugar-coated tablet Oral use Kingdom Bayer House Gestodene 0.075 mg Strawberry Hill Newbury Berkshire RG14 1JA United Kingdom United Bayer PLC Ethinylestradiol Femodene Tablets 0.03 mg Sugar-coated tablet Oral use Kingdom Bayer House Gestodene 0.075 mg Strawberry Hill Newbury Berkshire RG14 1JA United Kingdom United Bayer PLC Ethinylestradiol Femodette 0,02 mg Sugar-coated tablet Oral use Kingdom Bayer House Gestodene 0,075 mg Strawberry Hill Newbury Berkshire RG14 1JA United Kingdom United Gedeon Richter France, Gestodene Gestilla Coated 0.03 mg Coated tablet Oral use Kingdom 1-3 Ruse Caumartin, Ethinylestradiol Tablets 75 0.075 mg Paris 75009, micrograms / 30 France micrograms

296

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

United Stragen UK Limited, Gestodene Katya Coated Tablets 0.03 mg Coated tablet Oral use Kingdom Castle Court, Ethinylestradiol 30/75 0.075 mg 41 London Road, Reigate, Surrey RH2 9RJ United Kingdom United Gedeon Richter France, Gestodene Millinette Coated 0.03 mg Coated tablet Oral use Kingdom 1-3 Ruse Caumartin, Ethinylestradiol Tablets 75 0.075 mg Paris 75009, micrograms / 30 France micrograms United Gedeon Richter Plc. Gestodene Millinette ED 0,015 mg Film-coated tablet Oral use Kingdom Gyömröí út 19-21 Ethinylestradiol Micrograms Film- 0,06 mg HU-1103 Budapest Coated Tablets 15 / Hungary 60 United Stragen UK Limited, Gestodene Sunya 20/75 Coated 0,02 mg Coated tablet Oral use Kingdom Castle Court, Ethinylestradiol Tablets 0,075 mg 41 London Road, Reigate, Surrey RH2 9RJ United Kingdom United Bayer PLC Ethinylestradiol Triadene 0,03 mg / 0,05 mg Sugar-coated tablet Oral use Kingdom Bayer House Gestodene 0,04 mg / 0,07 mg Strawberry Hill 0,03 mg / 0,1 mg Newbury Berkshire RG14 1JA United Kingdom

297

Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA)

United Morningside Healthcare Limited, Norgestimate Lizinna Tablets 0.035 mg Tablet Oral use Kingdom 115 Narborough Road, Ethinylestradiol 250/35mcg 0,25 mg Leicester LE3 0PA United Kingdom United Janssen-Cilag Limited Norgestimate Cilest Tablets 0,25 mg Tablet Oral use Kingdom 50-100 Holmers Farm Way Ethinylestradiol 0,035 mg High Wycombe Buckinghamshire HP12 4EG United Kingdom

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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.

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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.

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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.

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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.

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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.

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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 Risk increases substantially as BMI rises. kg/m²) Particularly important to consider if other risk factors also present.

Prolonged immobilisation, major In these situations it is advisable to discontinue use of surgery, any surgery to the legs or the patch/pill/ring (in the case of elective surgery at 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.

Antithrombotic treatment should be considered if

[invented name] has not been discontinued in advance.

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

Positive family history (venous If a hereditary predisposition is suspected, the woman thromboembolism ever in a sibling or should be referred to a specialist for advice before parent especially at a relatively early deciding about any CHC use. age e.g. before 50).

308

Other medical conditions associated Cancer, systemic lupus erythematosus, haemolytic with VTE 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

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

Increasing age Particularly above 35 years

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 Risk increases substantially as BMI increases. kg/m2) Particularly important in women with additional risk factors

Positive family history (arterial If a hereditary predisposition is suspected, the woman thromboembolism ever in a sibling or should be referred to a specialist for advice before parent especially at relatively early deciding about any CHC use age e.g. below 50).

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 Diabetes mellitus, hyperhomocysteinaemia, valvular with adverse vascular events heart disease and atrial fibrillation, dyslipoproteinaemia and systemic lupus erythematosus.

Symptoms of ATE

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 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.]

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II. Package Leaflet

[The folllowing text should be included as these products will be in the Additional monitoring list]

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 Deep vein thrombosis 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

• sudden unexplained breathlessness or rapid breathing; Pulmonary embolism • 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’). Symptoms most commonly occur in one eye: Retinal vein thrombosis • immediate loss of vision or (blood clot in the eye) • painless blurring of vision which can progress to loss of

315

vision

• chest pain, discomfort, pressure, heaviness Heart attack • 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

• sudden weakness or numbness of the face, arm or leg, Stroke 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.

• swelling and slight blue discolouration of an extremity; Blood clots blocking other • severe pain in your stomach (acute abdomen) 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.

[The below wording should be inserted in this section]

- […] - 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 About 2 out of 10,000 women pill/patch/ring and are not pregnant

Women using a combined hormonal contraceptive pill About 5-7 out of 10,000 women containing levonorgestrel, norethisterone or norgestimate

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)

[…]

[The folllowing text should be included as these products will be in the Additional monitoring list]

Reporting of side effects If you get any side effects, talk to your <,> . 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

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]

I. Summary of Product Characteristics

Section 4.1 - Therapeutic indications

[The wording below should be inserted at the end of this section]

[...]

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).

321

[...]

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.

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. 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

Obesity (body mass index over 30 Risk increases substantially as BMI rises. kg/m²) Particularly important to consider if other risk factors also present.

of contraception should be used to avoid unintentional pregnancy.

Antithrombotic treatment should be considered if

[invented name] has not been discontinued in advance.

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

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 pulmonary embolism (PE) can include: - sudden onset of unexplained shortness of breath or rapid breathing;

324

- 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)

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 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

Increasing age Particularly above 35 years

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 Risk increases substantially as BMI increases. kg/m2) Particularly important in women with additional risk factors

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

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 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).

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

326

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]

[…]

[VTE or ATE should be listed in the adverse events table, under the frequency “Rare”.]

327

II. Package Leaflet

[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

[…]

When you should not use [Invented name]

[This section should be amended to include the below wording]

• 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 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 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)

328

– 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

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 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.

BLOOD CLOTS

329

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.

330

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.

• swelling and slight blue discolouration of an extremity; Blood clots blocking other • severe pain in your stomach (acute abdomen) blood vessels

BLOOD CLOTS IN A VEIN

What can happen if a blood clot forms in a vein?

• 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 combined hormonal contraceptive (the same product or a different product) after a break of 4 weeks or more

331

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.

[The below wording should be inserted in this section]

- […] - 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.

- 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. - 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 About 2 out of 10,000 women pill/patch/ring and are not pregnant

Women using a combined hormonal contraceptive pill About 5-7 out of 10,000 women containing levonorgestrel, norethisterone or norgestimate

Women using [Invented name] About 9-12 out of 10,000 women

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);

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.

• 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.

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 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.

333

[…]

Section 4. Possible side effects

[The following text should be inserted in this section]

[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)

[…]

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]

I. Summary of Product Characteristics

Section 4.1 - Therapeutic indications

[The wording below should be inserted at the end of this section]

[...]

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).

336

• 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.

Risk of venous thromboembolism (VTE)

[The wording below should be inserted at the top of this section]

[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.

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

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

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.

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

[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 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).

Table: Risk factors for VTE

Risk factor Comment

Obesity (body mass index over 30 Risk increases substantially as BMI rises.

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

338

kg/m²) Particularly important to consider if other risk factors also present.

of contraception should be used to avoid unintentional pregnancy.

Antithrombotic treatment should be considered if

[invented name] has not been discontinued in advance.

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

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 pulmonary embolism (PE) can include: - sudden onset of unexplained shortness of breath or rapid breathing; - sudden coughing which may be associated with haemoptysis;

339

- 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)

Risk factors for ATE

Table: Risk factors for ATE

Risk factor Comment

Increasing age Particularly above 35 years

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 Risk increases substantially as BMI increases. kg/m2) Particularly important in women with additional risk factors

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

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 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).

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

341

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]

[…]

[VTE or ATE should be listed in the adverse events table, under the frequency “Rare”.]

342

II. Package Leaflet

[The wording below should be inserted at the top of the package leaflet]

[…]

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

[…]

When you should not use [Invented name]

[This section should be amended to include the below wording]

• 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 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 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)

343

– 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

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 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.

BLOOD CLOTS

344

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.

345

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.

• swelling and slight blue discolouration of an extremity; Blood clots blocking other • severe pain in your stomach (acute abdomen) blood vessels

BLOOD CLOTS IN A VEIN

What can happen if a blood clot forms in a vein?

• 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?

346

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.

[The below wording should be inserted in this section]

- […] - 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.

- […].

Risk of developing a blood clot in a year

Women who are not using a combined hormonal About 2 out of 10,000 women pill/patch/ring and are not pregnant

Women using a combined hormonal contraceptive pill About 5-7 out of 10,000 women containing levonorgestrel, norethisterone or norgestimate

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 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

• 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.

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 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.

348

[…]

Section 4. Possible side effects

[The following text should be inserted in this section]

[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)

[…]

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]

I. Summary of Product Characteristics

Section 4.1 - Therapeutic indications

[The wording below should be inserted at the end of this section]

[...]

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).

351

• 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.

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. 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.

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

1 These incidences were estimated from the totality of the epidemiological study data, using relative risks for the different products compared with levonorgestrel-containing CHCs. 2 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

352

[The following graph should be inserted here.]

Number of VTE events per 10,000 women in one year

[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).

Table: Risk factors for VTE

Risk factor Comment

Obesity (body mass index over 30 Risk increases substantially as BMI rises. kg/m²) Particularly important to consider if other risk factors also present.

353

of contraception should be used to avoid unintentional pregnancy.

Antithrombotic treatment should be considered if

[invented name] has not been discontinued in advance.

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

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.

354

- 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)

Risk factors for ATE

Table: Risk factors for ATE

Risk factor Comment

Increasing age Particularly above 35 years

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 Risk increases substantially as BMI increases. kg/m2) Particularly important in women with additional risk factors

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 Diabetes mellitus, hyperhomocysteinaemia, valvular

355

with adverse vascular events heart disease and atrial fibrillation, dyslipoproteinaemia and systemic lupus erythematosus.

Symptoms of ATE

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 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).

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

356

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]

[…]

[VTE or ATE should be listed in the adverse events table, under the frequency “Rare”.]

357

II. Package Leaflet

[The wording below should be inserted at the top of the package leaflet]

[…]

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

[…]

When you should not use [Invented name]

[This section should be amended to include the below wording]

• 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 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 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)

358

– 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

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 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.

BLOOD CLOTS

359

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.

360

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.

• swelling and slight blue discolouration of an extremity; Blood clots blocking other • severe pain in your stomach (acute abdomen) blood vessels

BLOOD CLOTS IN A VEIN

What can happen if a blood clot forms in a vein?

• 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?

361

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.

[The below wording should be inserted in this section]

- […] - 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.

- 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).

- […].

Risk of developing a blood clot in a year

Women who are not using a combined hormonal About 2 out of 10,000 women pill/patch/ring and are not pregnant

Women using a combined hormonal contraceptive pill About 5-7 out of 10,000 women containing levonorgestrel, norethisterone or norgestimate

Women using [Invented name] About 9-12 out of 10,000 women

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);

362

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.

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 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.

363

[…]

Section 4. Possible side effects

[The following text should be inserted in this section]

[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)

[…]

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]

I. Summary of Product Characteristics

Section 4.1 - Therapeutic indications

[The wording below should be inserted at the end of this section]

[...]

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).

366

[...]

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.

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. 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 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.

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

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

367

of contraception should be used to avoid unintentional pregnancy.

Antithrombotic treatment should be considered if

[invented name] has not been discontinued in advance.

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

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.

369

Risk of arterial thromboembolism (ATE)

Risk factors for ATE

Table: Risk factors for ATE

Risk factor Comment

Increasing age Particularly above 35 years

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 Risk increases substantially as BMI increases. kg/m2) Particularly important in women with additional risk factors

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 Diabetes mellitus, hyperhomocysteinaemia, valvular

370

with adverse vascular events heart disease and atrial fibrillation, dyslipoproteinaemia and systemic lupus erythematosus.

Symptoms of ATE

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 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).

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

371

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]

[…]

[VTE or ATE should be listed in the adverse events table, under the frequency “Rare”.]

372

II. Package Leaflet

[The wording below should be inserted at the top of the package leaflet]

[…]

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

[…]

When you should not use [Invented name]

[This section should be amended to include the below wording]

• 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 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 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)

373

– 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

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 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 using [invented name];

• If you have an inflammation in the veins under the skin (superficial thrombophlebitis);

• If you have varicose veins.

BLOOD CLOTS

374

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.

375

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.

• swelling and slight blue discolouration of an extremity; Blood clots blocking other • severe pain in your stomach (acute abdomen) blood vessels

BLOOD CLOTS IN A VEIN

What can happen if a blood clot forms in a vein?

• 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?

376

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.

[The below wording should be inserted in this section]

- […] - 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.

- 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. - 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 About 2 out of 10,000 women pill/patch/ring and are not pregnant

Women using a combined hormonal contraceptive pill About 5-7 out of 10,000 women containing levonorgestrel, norethisterone or norgestimate

Women using [Invented name] About 6-12 out of 10,000 women

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);

377

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.

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 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.

378

[…]

Section 4. Possible side effects

[The following text should be inserted in this section]

[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)

[…]

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]

I. Summary of Product Characteristics

Section 4.1 - Therapeutic indications

[The wording below should be inserted at the end of this section]

[...]

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).

381

[...]

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.

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. 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 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.

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

382

[The following graph should be inserted here.]

Number of VTE events per 10,000 women in one year

[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).

Table: Risk factors for VTE

Risk factor Comment

Obesity (body mass index over 30 Risk increases substantially as BMI rises. kg/m²) Particularly important to consider if other risk factors also present.

Prolonged immobilisation, major In these situations it is advisable to discontinue use of surgery, any surgery to the legs or 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.

Antithrombotic treatment should be considered if

[invented name] has not been discontinued in advance.

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

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.

384

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)

Risk factors for ATE

Table: Risk factors for ATE

Risk factor Comment

Increasing age Particularly above 35 years

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 Risk increases substantially as BMI increases. kg/m2) Particularly important in women with additional risk factors

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 Diabetes mellitus, hyperhomocysteinaemia, valvular with adverse vascular events heart disease and atrial fibrillation,

385

dyslipoproteinaemia and systemic lupus erythematosus.

Symptoms of ATE

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 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).

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

Women should be advised that hormonal contraceptives do not protect against HIV infections (AIDS) and other sexually transmitted diseases.

[...]

386

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]

[…]

[VTE or ATE should be listed in the adverse events table, under the frequency “Rare”.]

387

II. Package Leaflet

[The wording below should be inserted at the top of the package leaflet]

[…]

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

[…]

When you should not use [Invented name]

[This section should be amended to include the below wording]

• 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 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 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

388

• 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

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 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.

BLOOD CLOTS

389

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.

• chest pain, discomfort, pressure, heaviness Heart attack • sensation of squeezing or fullness in the chest, arm or below the breastbone;

390

• 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

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..

• swelling and slight blue discolouration of an extremity; Blood clots blocking other • severe pain in your stomach (acute abdomen) blood vessels

BLOOD CLOTS IN A VEIN

What can happen if a blood clot forms in a vein?

• 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?

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.

391

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.

[The below wording should be inserted in this section]

- […] - 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.

- 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. - 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 About 2 out of 10,000 women pill/patch/ring and are not pregnant

Women using a combined hormonal contraceptive pill About 5-7 out of 10,000 women containing levonorgestrel, norethisterone or norgestimate

Women using [Invented name] About 9-12 out of 10,000 women

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);

• as you get older (particularly above about 35 years);

• if you gave birth less than a few weeks ago

392

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.

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 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.

[…]

Section 4. Possible side effects

393

[The following text should be inserted in this section]

[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)

[…]

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]

I. Summary of Product Characteristics

Section 4.1 - Therapeutic indications

[The wording below should be inserted at the end of this section]

[...]

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).

396

[...]

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.

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 (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.

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

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

397

[The following graph should be inserted here]

Number of VTE events per 10,000 women in one year

[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).

Table: Risk factors for VTE

Risk factor Comment

Obesity (body mass index over 30 Risk increases substantially as BMI rises. kg/m²) Particularly important to consider if other risk factors also present.

398

of contraception should be used to avoid unintentional pregnancy.

Antithrombotic treatment should be considered if

[invented name] has not been discontinued in advance.

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

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.

399

Risk of arterial thromboembolism (ATE)

Risk factors for ATE

Table: Risk factors for ATE

Risk factor Comment

Increasing age Particularly above 35 years

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 Risk increases substantially as BMI increases. kg/m2) Particularly important in women with additional risk factors

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 Diabetes mellitus, hyperhomocysteinaemia, valvular

400

with adverse vascular events heart disease and atrial fibrillation, dyslipoproteinaemia and systemic lupus erythematosus.

Symptoms of ATE

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 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).

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

Women should be advised that hormonal contraceptives do not protect against HIV infections (AIDS) and other sexually transmitted diseases.

401

[...]

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]

[…]

[VTE or ATE should be listed in the adverse events table, under the frequency “Rare”.]

402

II. Package Leaflet

[The wording below should be inserted at the top of the package leaflet]

[…]

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

[…]

When you should not use [Invented name]

[This section should be amended to include the below wording]

• 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 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 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)

403

– 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

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 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.

BLOOD CLOTS

404

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.

405

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..

• swelling and slight blue discolouration of an extremity; Blood clots blocking other • severe pain in your stomach (acute abdomen) blood vessels

BLOOD CLOTS IN A VEIN

What can happen if a blood clot forms in a vein?

• 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?

406

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.

[The below wording should be inserted in this section]

- 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.

- 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 About 2 out of 10,000 women pill/patch/ring and are not pregnant

Women using a combined hormonal contraceptive pill About 5-7 out of 10,000 women containing levonorgestrel, norethisterone or norgestimate

Women using [Invented name] About 5-7 out of 10,000 women

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);

• 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.

407

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.

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 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.

408

[…]

Section 4. Possible side effects

[The following text should be inserted in this section]

[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)

[…]

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

411