Article 31 of Directive 2001/83/EC resulting from pharmacovigilance data

Transcription

1 7 March 2013 EMA/713187/2012 Rev 1 Patient Health Protection Annex I List of the names, pharmaceutical s, strengths of the medicinal products, routes of, marketing authorisation holders in the member states for Combined hormonal contraceptives Article 31 of Directive 2001/83/EC resulting from pharmacovigilance data Procedure number: EMEA/H/A-31/1356 Zoely EMEA/H/A-31/1356/C/1213/0010 Ioa EMEA/H/A-31/1356/C/2068/0007 EVRA EMEA/H/A-31/1356/C/410/ Westferry Circus Canary Wharf London E14 4HB United Kingdom Telephone +44 (0) Facsimile +44 (0) [email protected] Website An agency of the European Union European Medicines Agency, Reproduction is authorised provided the source is acknowledged.

2 Centrally Authorised Products MA (EU) number (Invented) name Strength Pharmaceutical Form Administration Immediate Packaging Pack size EU/1/02/223/001 Evra 6 mg,600 µg Transdermal patch Transdermal use sachet 3 transdermal patches EU/1/02/223/002 Evra 6 mg,600 µg Transdermal patch Transdermal use sachet 9 transdermal patches EU/1/02/223/003 Evra 6 mg,600 µg Transdermal patch Transdermal use sachet 18 transdermal patches MA (EU) number (Invented) name Strength Pharmaceutical Form Administration Immediate Packaging Pack size EU/1/11/689/001 Ioa 1.5 mg,2.5 mg blister (PVC/alu) EU/1/11/689/002 Ioa 1.5 mg,2.5 mg blister (PVC/alu) 28 tablets (24 active + 4 placebo) 3 x 28 tablets (24 active + 4 placebo) MA (EU) number (Invented) name Strength Pharmaceutical Form Administration Immediate Packaging Pack size EU/1/11/690/001 Zoely 1.5 mg,2.5 mg blister (PVC/alu) EU/1/11/690/002 Zoely 1.5 mg,2.5 mg blister (PVC/alu) EU/1/11/690/003 Zoely 1.5 mg,2.5 mg blister (PVC/alu) EU/1/11/690/004 Zoely 1.5 mg,2.5 mg blister (PVC/alu) 28 tablets (24 active + 4 placebo) 84 tablets (72 active + 12 placebo) 168 tablets (144 active + 24 placebo) 364 tablets (312 active + 52 placebo) EMA/713187/2012 Page 2/253

3 Decentralised procedure, Mutual recognition procedure or National procedure Member State Janssen - Cilag Pharma GmbH Vorgartenstraße 206b A-1020 Wien N.V. Organon Kloosterstraat AB, Oss Bayer GmbH Herbststrasse Wien Gynial GmbH Gablenzgasse 11/III 1150 Wien Kwizda Pharma GmbH Effingergasse Wien Jenapharm GmbH & Co. KG Otto-Schott-Straße Jena Deutschland Dermapharm GmbH Türkenstraße 25/ Wien Norgestimate Estradiolvalerate Dionegest Chlormadinone acetate Chlormadinone acetate Chlormadinone acetate Chlormadinone acetate Cileste - ten Gracial - ten 0,25 mg 0,035 mg 0,025/0,125 mg 0,040/0,030 mg Qlaira Filmtabletten 3,00/2,00/2,00/1,00 mg /2,00,3,00/- mg Bilinda 0,0/ Filmtabletten Delia 0,0/ Filmtabletten Enriqa 0,030 mg/2,0 mg Filmtabletten Madinette 0,0/ Filmtabletten 0,0 0,0 0,0 0,0 EMA/713187/2012 Page 3/253

4 Teva Pharma BV Computerweg DR Utrecht Actavis Group PTC ehf Reykjavikurvegi Hafnarfjordur Iceland Pfizer Corporation GmbH Floridsdorfer Hauptstraße Wien Madaus GmbH Colonia Allee Köln Hexal GmbH Stella-Klein-Löw-Weg Wien Dermapharm GmbH Türkenstraße 25/ Wien Chlormadinone acetate Chlormadinone acetate Chlormadinone acetate Chlormadinone acetate Chlormadinone acetate Chlormadinone acetate Chlormadinone acetate Mellow ratiopharm 0,03 mg/ Filmtabletten Angiletta 0,0/ Filmtabletten Balanca 0,0/ - Filmtabletten Beatrice 0,0/ Filmtabletten Belara 0,0/ - Filmtabletten Bellissima 0,0/ Filmtabletten /Chlormadi non Hexal 0,0/ - Filmtabletten Desofemine 20 Mikrogramm/150 Mikrogramm Filmtabletten 0,0 0,0 0,0 0,0 0,0 0,0 0,0 EMA/713187/2012 Page 4/253

5 Dermapharm GmbH Türkenstraße 25/ Wien Kwizda Pharma GmbH Effingergasse Wien Kwizda Pharma GmbH Effingergasse Wien N.V. Organon Kloosterstraat AB, Oss N.V. Organon Kloosterstraat AB, Oss Pfizer Corporation GmbH Floridsdorfer Hauptstraße Wien Dienogest Desofemine 30 Mikrogramm/150 Mikrogramm Filmtabletten Desorelle 30 Mikrogramm/150 Mikrogramm 21+7 Filmtabletten Desorelle Mite 20 Mikrogramm/150 Mikrogramm 21+7 Filmtabletten Liberel - Filmtabletten Liberel mite - Filmtabletten Marvelon - ten Mercilon - ten Bonisara 0,0/ Filmtabletten 0,0 0,0 0,0 0,0 0,0 EMA/713187/2012 Page 5/253

6 Aristo Pharma GmbH Wallenroder Straße Berlin Dermapharm GmbH Türkenstraße 25/ Wien Pharbil Waltrop GmbH Im Wirrigen Waltrop Helm AG Nordkanalstrasse Hamburg Helm AG Nordkanalstrasse Hamburg Gynial GmbH Gablenzgasse 11/III 1150 Wien Madaus GmbH Colonia Allee Köln Dienogest Dienogest Dienogest Dienogest Dienogest Dienogest Dienogest Cara 0,0/ Filmtabletten Dienovel 0,0/2,0 mg Filmtabletten /Dienogest Pharbil 0,0/ Filmtabletten Kappanogest 0,0/2 mg Filmtabletten Lamdanogest 0,0/2 mg Filmtabletten Larissa 0,0/ Filmtabletten Mayra 0,0/ Filmtabletten 0,0 0,0 0,0 0,0 0,0 0,0 0,0 EMA/713187/2012 Page 6/253

7 Ratiopharm Arzneimittel Vertriebs- GmbH Albert-Schweitzer- Gasse Wien Stada Arzneimittel GmbH Muthgasse 36/ Wien "ARAC" At Regulatory Affairs Consulting GmbH Kichengasse 48/ Wien Bayer GmbH Herbststrasse Wien Velvian GmbH Carl-Zeiss-Ring Ismaning Bayer GmbH Herbststrasse Wien Dienogest Dienogest Dienogest Dienogest Dienogest Dienogest Motion ratiopharm 2 mg/0,0 Filmtabletten Sibilla 0,0/ Filmtabletten Stella 0,0/2,0 mg Filmtabletten Tessa 0,0/ Filmtabletten Valette Dragees Viola 0,0/ Filmtabletten Aliane / Filmtabletten 0,0 0,0 0,0 0,0 0,0 0,0 EMA/713187/2012 Page 7/253

8 Ratiopharm Arzneimittel Vertriebs- GmbH Albert-Schweitzer- Gasse Wien Ratiopharm Arzneimittel Vertriebs- GmbH Albert-Schweitzer- Gasse Wien Ratiopharm Arzneimittel Vertriebs- GmbH Albert-Schweitzer- Gasse Wien Ratiopharm Arzneimittel Vertriebs- GmbH Albert-Schweitzer- Gasse Wien Ratiopharm Arzneimittel Vertriebs- GmbH Albert-Schweitzer- Gasse Wien Balancette / Filmtabletten Danselle / Filmtabletten Danselle / 21 Filmtabletten Danseo 0,0/ Filmtabletten Danseo 0,0/ 21 Filmtabletten 0,0 0,0 EMA/713187/2012 Page 8/253

9 Bayer GmbH Herbststrasse Wien Bayer GmbH Herbststrasse Wien Sandoz GmbH Biochemiestrase Kundl Sandoz GmbH Biochemiestrase Kundl Sandoz GmbH Biochemiestrase Kundl Sandoz GmbH Biochemiestrase Kundl Laboratorios Leon Farma SA Calle La Vallina S/N Poligono Industrial Navatejera Navatejera, Leon E Eloine / Filmtabletten /Drospiren on Bayer 0,0/ Filmtabletten /Drospiren on Sandoz / 21 Filmtabletten /Drospiren on Sandoz / 21+7 Filmtabletten /Drospiren on Sandoz 0,0/ 21 Filmtabletten /Drospiren on Sandoz 0,0/ 21+7 Filmtabletten Etindros / Filmtabletten 0,0 0,0 0,0 EMA/713187/2012 Page 9/253

10 Laboratorios Leon Farma SA Calle La Vallina S/N Poligono Industrial Navatejera Navatejera, Leon E Bayer GmbH Herbststrasse Wien Laboratorios Leon Farma SA Calle La Vallina S/N Poligono Industrial Navatejera Navatejera, Leon E Laboratorios Leon Farma SA Calle La Vallina S/N Poligono Industrial Navatejera Navatejera, Leon E Velvian GmbH Carl-Zeiss-Ring Ismaning Etindros 0,0/ Filmtabletten Flexyess / Filmtabletten Jangee / Filmtabletten Jangee 0,0/ Filmtabletten Lamiva / Filmtabletten 0,0 0,0 EMA/713187/2012 Page 10/253

11 Laboratorios Leon Farma SA Calle La Vallina S/N Poligono Industrial Navatejera Navatejera, Leon E Laboratorios Leon Farma SA Calle La Vallina S/N Poligono Industrial Navatejera Navatejera, Leon E Bayer GmbH Herbststrasse Wien Bayer GmbH Herbststrasse Wien Naraya / Filmtabletten Naraya 0,0/ Filmtabletten Volina 0,0/ Filmtabletten Volina mite / Filmtabletten Yasmin 0,0/ - Filmtabletten Yasminelle / Filmtabletten 0,0 0,0 0,0 EMA/713187/2012 Page 11/253

12 Bayer GmbH Herbststrasse Wien Bayer GmbH Herbststrasse Wien Laboratorios Leon Farma SA Calle La Vallina S/N Poligono Industrial Navatejera Navatejera, Leon E Ratiopharm Arzneimittel Vertriebs- GmbH Albert-Schweitzer- Gasse Wien Bayer GmbH Herbststrasse Wien Pfizer Corporation GmbH Floridsdorfer Hauptstraße Wien YAZ / Filmtabletten Yirala 0,0/ - Filmtabletten Annantah 15 Mikrogramm/60 Mikrogramm Filmtabletten Flow 15 µg / 60 µg Filmtabletten Gynovin - Dragees Harmonette - Dragees 0,0 0,015 mg 0,06 mg 0,015 mg 0,06 mg 0,0 EMA/713187/2012 Page 12/253

13 Velvian GmbH Carl-Zeiss-Ring Ismaning Gynial GmbH Gablenzgasse 11/III 1150 Wien Bayer GmbH Herbststrasse Wien Pfizer Corporation GmbH Floridsdorfer Hauptstraße Wien Pfizer Corporation GmbH Floridsdorfer Hauptstraße Wien Bayer GmbH Herbststrasse Wien Actavis Group PTC ehf Reykjavikurvegi Hafnarfjordur Iceland Jamyle 15 Mikrogramm/60 Mikrogramm Filmtabletten Lenea 20 µg/75 µg überzogene ten Meliane - Dragees Minesse 15 Mikrogramm/60 Mikrogramm Filmtabletten Minulet - Dragees Mirelle 15 Mikrogramm/60 Mikrogramm - Filmtabletten Sylgestrel 75 Mikrogramm + 30 Mikrogramm Dragees 0,015 mg 0,06 mg 0,015 mg 0,06 mg 0,0 0,015 mg 0,06 mg 0,0 EMA/713187/2012 Page 13/253

14 Actavis Group PTC ehf Reykjavikurvegi Hafnarfjordur Iceland Bayer GmbH Herbststrasse Wien Ratiopharm Arzneimittel Vertriebs- GmbH Albert-Schweitzer- Gasse Wien Kwizda Pharma GmbH Effingergasse Wien Kwizda Pharma GmbH Effingergasse Wien N.V. Organon Kloosterstraat AB, Oss N.V. Organon Kloosterstraat AB, Oss Etonogestrel Etonogestrel Sylgestrel mite 75 Mikrogramm + 20 Mikrogramm Dragees Triodena - Dragees Varianta 15 Mikrogramm/60 Mikrogramm Filmtabletten Wave ratiopharm 75 Mikrogramm/20 Mikrogramm überzogene ten Yris - Dragees Yris mite - Dragees Circlet 0,120 mg / 0,015 mg pro 24 Stunden - Vaginalring NuvaRing 0,120 mg/0,015 mg pro 24 Stunden - Vaginalring 0,030mg /0,040 mg 0,050mg /0,070 mg 0,015 mg 0,06 mg 0,0 11,7 mg 2,7 mg 11,7 mg 2,7 mg Vaginal delivery system Vaginal delivery system Vaginal use EMA/713187/2012 Page 14/253

15 Janssen - Cilag Pharma GmbH Vorgartenstraße 206b A-1020 Wien Janssen - Cilag Pharma GmbH Vorgartenstraße 206b A-1020 Wien BAYER N.V. J.E. Mommaertslaan Diegem Mithra Pharmaceuticals S.A. Rue Saint Georges Liège mibe GmbH Arzneimittel Münchener Str Brehna Madaus GmbH Colonia Allee Köln Norgestimate Norgestimate Estradiol Valerate Dienogest Chlormadinone Acetate Chlormadinone Acetate Chlormadinone Acetate Chlormadinone Acetate TriCilest- ten Vivelle - ten QLAIRA BELLINA HELEN MADINELLE ORCHIDEA 0,18/0,215/0,25 mg 0,035/0,035/0,035 mg 0,18/0,215/0,25 mg 0,035/0,035/0,035 mg 2.00 mg 3.00 mg mg mg mg mg EMA/713187/2012 Page 15/253

16 N.V. Organon Kloosterstraat AB, Oss N.V. Organon Kloosterstraat AB, Oss N.V. Organon Kloosterstraat AB, Oss Mithra Pharmaceuticals S.A. Rue Saint Georges Liège Teva Pharma N.V. Laarstraat Wilrijk Dienogest Dienogest DESO 20 DESO 30 GRACIAL EX DIMIREL MARVELON MERCILON LOUISE VEREZANA ANNABELLE mg mg mg mg mg mg mg mg mg mg EMA/713187/2012 Page 16/253

17 SANDOZ N.V. Telecom Gardens Medialaan Vilvoorde SANDOZ N.V. Telecom Gardens Medialaan Vilvoorde EFFIK BENELUX Lenniksebaan Anderlecht EFFIK BENELUX Lenniksebaan Anderlecht SANDOZ N.V. Telecom Gardens Medialaan Vilvoorde SANDOZ N.V. Telecom Gardens Medialaan Vilvoorde ANNAIS ARMUNIA 20 ARMUNIA 30 DROSPIBEL 20 DROSPIBEL 30 RHONYA 20 RHONYA mg mg mg mg mg mg mg EMA/713187/2012 Page 17/253

18 BAYER N.V. J.E. Mommaertslaan Diegem BAYER N.V. J.E. Mommaertslaan Diegem N.V. Organon Kloosterstraat AB, Oss N.V. Organon Kloosterstraat AB, Oss MPCA BVBA Vrijestraat Assenede EFFIK BENELUX Lenniksebaan Anderlecht EFFIK BENELUX Lenniksebaan Anderlecht BAYER N.V. J.E. Mommaertslaan Diegem Etonogestrel Etonogestrel YASMIN YAZ CIRCLET NUVARING CAOIMHE ESTINETTE 20 ESTINETTE 30 FEMODENE mg mg 2.70 mg mg 2.70 mg mg mg mg 0.030mg mg 0.030mg mg Vaginal delivery system Vaginal delivery system Vaginal use Vaginal use EMA/713187/2012 Page 18/253

19 MYLAN BVBA/SPRL Terhulpsesteenweg 6A 1560 Hoeilaart MYLAN BVBA/SPRL Terhulpsesteenweg 6A 1560 Hoeilaart L.F. WILL & CIE SA Rue du Manil Wavre L.F. WILL & CIE SA Rue du Manil Wavre MPCA BVBA Vrijestraat Assenede PFIZER S.A. 17 Boulevard de la Plaine 1050 Brussels GESICAMYLAN GESICAMYLAN GESTODELLE 20 GESTODENOL 20 GESTODENOL 30 GESTOFEME 30 GRAINNE HARMONET mg 0.030mg mg mg mg 0.030mg mg 0.030mg mg 0.030mg mg mg EMA/713187/2012 Page 19/253

20 SANDOZ N.V. Telecom Gardens Medialaan Vilvoorde SANDOZ N.V. Telecom Gardens Medialaan Vilvoorde BAYER N.V. J.E. Mommaertslaan Diegem PFIZER S.A. 17 Boulevard de la Plaine 1050 Brussels BAYER N.V. J.E. Mommaertslaan Diegem PFIZER S.A. 17 Boulevard de la Plaine 1050 Brussels BAYER N.V. J.E. Mommaertslaan Diegem LIOSANNE 20 LIOSANNE 30 MELIANE MINULET MIRELLE TRI- MINULET TRIODENE mg 0.030mg mg mg mg MCG MCG mg mg EMA/713187/2012 Page 20/253

21 JANSSEN-CILAG N.V. Antwerpseweg Beerse BAYER N.V. J.E. Mommaertslaan Diegem Teva Pharma N.V. Laarstraat Wilrijk MYLAN BVBA/SPRL Terhulpsesteenweg 6A 1560 Hoeilaart MYLAN BVBA/SPRL Terhulpsesteenweg 6A 1560 Hoeilaart Norgestimate ETHINYLESTRADIOL (BETADEXCLADRAS) DROSPIRENONE YVELLIS CILEST YASMINELLE DENISE 20 EMMAMYLAN EMMAMYLAN TRENDESO 20 TRENDESO mg 0.060mg mg 0.25 mg mg MCG MCG mg mg mg mg mg mg EMA/713187/2012 Page 21/253

22 SANDOZ N.V. Telecom Gardens Medialaan Vilvoorde EFFIK BENELUX Lenniksebaan Anderlecht Teva Pharma N.V. Laarstraat Wilrijk Teva Pharma N.V. Laarstraat Wilrijk Teva Pharma N.V. Laarstraat Wilrijk Teva Pharma N.V. Laarstraat Wilrijk EFFIK BENELUX Lenniksebaan Anderlecht BRADLEY 20 CORNELIA DORINELLETEVA DORINELLETEVA CONTINU DORINTEVA DORINTEVA CONTINU DROSEFIKK mg mg mg mg mg mg mg EMA/713187/2012 Page 22/253

23 Bulgaria Bulgaria Bulgaria Bulgaria EFFIK BENELUX Lenniksebaan Anderlecht Teva Pharma N.V. Laarstraat Wilrijk BAYER N.V. J.E. Mommaertslaan Diegem N.V. Organon Kloosterstraat AB, Oss N.V. Organon Kloosterstraat AB, Oss NAIWANEL REZEDIA YADERE Yvidually /, filmomhulde tabletten Marvelon Novynette Regulon Mercillon mg mg mg 0, 150 mg 0,0 0, 150 mg 0, 150 mg 0,0 EMA/713187/2012 Page 23/253

24 Bulgaria Bulgaria Bulgaria Bulgaria Bulgaria Bulgaria Bulgaria Bulgaria Bayer Pharma AG Müllerstraße 178 D Berlin Bayer Pharma AG Müllerstraße 178 D Berlin Medico Uno Pharma Kft. Viadukt u. 12 Biatorbágy 2051 Medico Uno Pharma Kft. Viadukt u. 12 Biatorbágy 2051 Novynette 28 Aneea Belusha Daylette Eloine Flexyess Jangee Jangee 0,0 EMA/713187/2012 Page 24/253

25 Bulgaria Bulgaria Bulgaria Bulgaria Bulgaria Bulgaria Laboratorios Leon Farma SA Poligono Industrial Navatejera, La Vallina s/n, Villaquilambre,Leon Laboratorios Leon Farma SA Poligono Industrial Navatejera, La Vallina s/n, Villaquilambre,Leon Bayer Pharma AG Müllerstraße 178 D Berlin Zentiva, k.s. U kabelovny Praha 10 Dolní Měcholupy Zentiva, k.s. U kabelovny Praha 10 Dolní Měcholupy Jangee 28 Jangee 28 Midiana Palandra Sidretella Sidretella 0,0 0,0 0,0 0,0 EMA/713187/2012 Page 25/253

26 Bulgaria Bulgaria Bulgaria Bulgaria Bulgaria Bulgaria Bulgaria Teva Pharmaceuticals Bulgaria EOOD Gogol 15 Sofia 1124 Bulgaria Bayer Pharma AG Müllerstraße 178 D Berlin Bayer Pharma AG Muellerstrasse 178+Berlin D Zentiva, k.s. U kabelovny Praha 10 Dolní Měcholupy Bayer Pharma AG Müllerstraße 178 D Berlin Medico Uno Pharma Kft. Viadukt u. 12 Biatorbágy 2051 Teenia Veyann Yasmin Yaz Artizia Femoden Gestodette 0,0 0,020 mg 0,0 EMA/713187/2012 Page 26/253

27 Bulgaria Bulgaria Bulgaria Bulgaria Bulgaria Bulgaria Bulgaria Bulgaria Bayer Pharma AG Müllerstraße 178 D Berlin Actavis Group PTC ehf Reykjavikurvegi Hafnarfjordur Iceland Actavis Group PTC ehf Reykjavikurvegi Hafnarfjordur Iceland Kostya Logest Milligest 6 tabl. - 0,03 mg/0,05 mg 5 tabl. - 0,04 mg/0,07 mg 10 tabl.- 0,03 mg/0,1 mg Sylgestrel 20 Sylgestrel 30 Vendiol Zulfija Lindynette 20 0,0 0,015 mg 0,06 mg 0,0 0, 075 mg 0,020 mg EMA/713187/2012 Page 27/253

28 Bulgaria Bulgaria Bulgaria Bulgaria Cyprus Cyprus Cyprus Johnson & Johnson d.o.o. Šmartinska cesta Ljubljana Slovenija Bayer Pharma AG Müllerstraße 178 D Berlin N.V. Organon Kloosterstraat AB, Oss BAYER HELLAS AG Sorou Maroussi Athens Greece Janssen-Cilag International N.V. Turnhoutseweg 30 B 2340 Beerse N.V. Organon Kloosterstraat AB, Oss Norgestimate Estradiol valerate/ Dienogest Etonogestrel Estradiol Norgestimate Ethinyloestradiol Lindynette 30 Cilest Qlaira NuvaRing Angeliq film coated tablets Cilest s Marvelon s 0, 075 mg 0,030 mg 0, 250 mg 0,035 mg 0mg/ / / 0mg/1 mg 2.7mg 11.7mg 1mg 2mg 0.25mg 0.035mg 0.150mg 0.030mg Vaginal delivery system Vaginal use EMA/713187/2012 Page 28/253

29 Cyprus Cyprus Cyprus Cyprus Cyprus Cyprus Cyprus BAYER HELLAS AG Sorou Maroussi Athens Greece BAYER HELLAS AG Sorou Maroussi Athens Greece N.V. Organon Kloosterstraat AB, Oss N.V. Organon Kloosterstraat AB, Oss BAYER HELLAS AG Sorou Maroussi Athens Greece BAYER HELLAS AG Sorou Maroussi Athens Greece N.V. Organon Kloosterstraat AB, Oss Estradiol valerate Dienogest+Estradiol Estradiol valeratel+dienogest Estradiol valerate Etonogestrel Yasminelle film coated tablets Yaz film coted tablets Mercilon tablets Gracial tablets Qlaira film coated tablets Palandra film coated tablets Nuvaring 0.120mg/0.015mg per 24 hours,vaginal delivery system 0.02mg 3mg 0.02mg 3mg 0.150mg 0.020mg 0.025mg 0.040mg 3mg 2mg+2mg 2mg+3mg 1mg 0.03mg 3mg 0.12mg 0.015mg Vaginal delivery system Vaginal use EMA/713187/2012 Page 29/253

30 Stada Arzneimittel Aktiengesellschaft Stadastrasse 2/ Bad Vilbel WH-Pharma s.r.o. Talafusova Kutná Hora Teva Pharmaceuticals CR, s.r.o. Radlická 3185/1c Praha 5 Heaton a.s. Na Pankráci Praha 4 mibe GmbH Arzneimittel Münchener Str Brehna Heaton a.s. Na Pankráci Praha 4 Chlormadinon acetate Chlormadinon acetate Chlormadinon acetate Chlormadinon acetate Chlormadinon acetate Chlormadinon acetate BELARA BONISSA 0,03 MG/2 MG POTAHOVANÉ TABLETY CLORMETIN 2 MG/0,03 MG ESETE 2 MG/0,03 MG FLAYA 0,030 MG/2 MG POTAHOVANÉ TABLETY MADINELLE 0,03 MG/2 MG ADELE 0,0 0,0 0,0 0,0 0,0 0,0 0,0 EMA/713187/2012 Page 30/253

31 Teva Pharmaceuticals CR, s.r.o. Radlická 3185/1c Praha 5 Teva Pharmaceuticals CR, s.r.o. Radlická 3185/1c Praha 5 N.V. Organon Kloosterstraat AB, Oss N.V. Organon Kloosterstraat AB, Oss N.V. Organon Kloosterstraat AB, Oss N.V. Organon Kloosterstraat AB, Oss Heaton a.s. Na Pankráci Praha 4 ARNETTE 0,15 MG/0,03 MG GAIA 0,15 MG/0,02 MG GRACIAL LAURINA MARVELON MERCILON NATALYA NOVYNETTE 150 MCG/20 MCG POTAHOVANÉ TABLETY 0,0 0,025 mg/ 0,04 mg 0,125 mg/ 0,0 0,05 mg/ 0,035 mg 0,1 mg/ 0,0 / 0,0 0,0 EMA/713187/2012 Page 31/253

32 Zentiva, k.s. U kabelovny Praha 10 Dolní Měcholupy Zentiva, k.s. U kabelovny Praha 10 Dolní Měcholupy Bayer Pharma AG Müllerstraße 178 D Berlin Cyndea Pharma S.L. Polígono Industrial Emiliano Revilla Sanz Av. De Ágreda Ólvega (Soria) WH-Pharma s.r.o. Talafusova Kutná Hora Zentiva, k.s. U kabelovny Praha 10 Dolní Měcholupy Dienogest Estradiol valerat Dienogest Dienogest Dienogest REGISHA 0,150 MG/0,02 MG TABLETY REGISHA 0,150 MG/0,03 MG TABLETY REGULON 150 MCG/30 MCG POTAHOVANÉ TABLETY QLAIRA AIDEE 2 MG/0,03 MG POTAHOVANÉ TABLETY AYREEN BONADEA 0,0 0,0 / / /1 mg 0,0 0,0 0,0 EMA/713187/2012 Page 32/253

33 Jenapharm GmbH & Co. KG Otto-Schott-Straße Jena Deutschland Teva Pharmaceuticals CR, s.r.o. Radlická 3185/1c Praha 5 Pharbil Waltrop GmbH Im Wirrigen Waltrop Laboratorios Leon Farma SA Calle La Vallina S/N Poligono Industrial Navatejera Navatejera, Leon E LadeePharma Pharmaceutical Limited Lajos utca E. ép. 5.em H-1036 Budapest Dienogest Dienogest Dienogest Dienogest Drospirenon Drospirenon JEANINE MISTRA 2 MG/0,03 MG POTAHOVANÉ TABLETY VEREZANA 0,03 MG/2 MG POTAHOVANÉ TABLETY YANELA DROSETIL 0,03 MG/3 MG 28 POTAHOVANÝCH TABLET JANGEE 0,03 MG/3 MG 28 POTAHOVANÝCH TABLET 0,0 0,0 0,0 0,0 0,0 0,0 EMA/713187/2012 Page 33/253

34 LadeePharma Pharmaceutical Limited Lajos utca E. ép. 5.em H-1036 Budapest Sandoz s.r.o. Nagano III, U Nákladového nádraží Praha - 3 Zentiva, k.s. U kabelovny Praha 10 Dolní Měcholupy Teva Pharmaceuticals CR, s.r.o. Radlická 3185/1c Praha 5 Bayer Pharma AG Müllerstraße 178 D Berlin Drospirenon Drospirenon Drospirenon Drospirenon Drospirenon Drospirenon JANGEE 0,03 MG/3 MG POTAHOVANÉ TABLETY MAITALON 3 MG/0,03 MG POTAHOVANÉ TABLETY RHONYA 3 MG/30 MCG SIDRETA 0,03 MG/3 MG POTAHOVANÉ TABLETY SOFTINE 0,03 MG/3 MG POTAHOVANÉ TABLETY SYLVIANE 0,03 MG/3 MG POTAHOVANÉ TABLETY 0,0 0,0 0,0 0,0 0,0 0,0 EMA/713187/2012 Page 34/253

35 Ivowen Limited Gurtnafleur Business Park 1/B Co.Tipperary Gurtnafleur, Clonmel Ireland Bayer Pharma AG Müllerstraße 178 D Berlin LadeePharma Pharmaceutical Limited Lajos utca E. ép. 5.em H-1036 Budapest Laboratorios Leon Farma SA Calle La Vallina S/N Poligono Industrial Navatejera Navatejera, Leon E Sandoz s.r.o. Nagano III, U Nákladového nádraží Praha - 3 Bayer Pharma AG Müllerstraße 178 D Berlin Drospirenon Drospirenon Dienogest Dienogest Dienogest Drospirenon WERRCA 3 MG/0,03 MG POTAHOVANÉ TABLETY YADINE DIENILLE POTAHOVANÁ TABLETA FOXINETTE 2 MG/0,03 MG FOXINETTE NEO BELANETTE 0,02 MG/3 MG POTAHOVANÉ TABLETY 0,0 0,0 0,0 0,0 0,0 EMA/713187/2012 Page 35/253

36 Laboratorios Leon Farma SA Calle La Vallina S/N Poligono Industrial Navatejera Navatejera, Leon E Bayer Pharma AG Müllerstraße 178 D Berlin Bayer Pharma AG Müllerstraße 178 D Berlin Laboratorios Leon Farma SA Calle La Vallina S/N Poligono Industrial Navatejera Navatejera, Leon E Sandoz s.r.o. Nagano III, U Nákladového nádraží Praha - 3 Zentiva, k.s. U kabelovny Praha 10 Dolní Měcholupy Drospirenon Drospirenon Drospirenon Drospirenon Drospirenon Drospirenon DROSETIL 0,02 MG/3 MG 28 POTAHOVANÝCH TABLET ELOINE 0,02 MG/3 MG POTAHOVANÉ TABLETY FLEXYESS 0,02 MG/3 MG POTAHOVANÉ TABLETY MYWY 0,02 MG/3 MG NYSSIELA 3 MG/0,02 MG SIDRETELLA 0,02 MG/3 MG POTAHOVANÉ TABLETY EMA/713187/2012 Page 36/253

37 Teva Pharmaceuticals CR, s.r.o. Radlická 3185/1c Praha 5 LadeePharma Kft Lajos utca E. ép.em H-1036 Budapest Teva Pharmaceuticals CR, s.r.o. Radlická 3185/1c Praha 5 Bayer Pharma AG Müllerstraße 178 D Berlin Bayer Pharma AG Müllerstraße 178 D Berlin WH-Pharma s.r.o. Talafusova Kutná Hora Drospirenon Drospirenon Drospirenon Drospirenon Drospirenon Drospirenon SOFTINELLE 0,02 MG/3 MG POTAHOVANÉ TABLETY VELMARI 3 MG/0,02 MG VEYANNE 0,02 MG/3 MG YASMINELLE 0,02 MG/3 MG POTAHOVANÉ TABLETY YAZ 0,02 MG/3 MG POTAHOVANÉ TABLETY YOSEFINNE BELUSHA 3 MG/0,02 MG POTAHOVANÉ TABLETY DAYLETTE 3 MG/0,02 MG POTAHOVANÉ TABLETY EMA/713187/2012 Page 37/253

38 LadeePharma Pharmaceutical Limited Lajos utca E. ép. 5.em H-1036 Budapest LadeePharma Pharmaceutical Limited Lajos utca E. ép. 5.em H-1036 Budapest Sandoz s.r.o. Nagano III, U Nákladového nádraží Praha - 3 Zentiva, k.s. U kabelovny Praha 10 Dolní Měcholupy DAYLLA 3 MG/0,02 MG POTAHOVANÉ TABLETY JANGEE 0,02 MG/3 MG 28 POTAHOVANÝCH TABLET JANGEE 0,02 MG/3 MG POTAHOVANÉ TABLETY KIRGA 3 MG/0,02 MG POTAHOVANÉ TABLETY RHONYA 3 MG/20 MCG ARTIZIA 0,075 MG/0,020 MG OBALENÉ TABLETY EMA/713187/2012 Page 38/253

39 Pfizer, spol. s r.o. Stroupežnického Praha 5 Heaton a.s. Na Pankráci Praha 4 Bayer Pharma AG Müllerstraße 178 D Berlin Bayer Pharma AG Müllerstraße 178 D Berlin Pfizer, spol. s r.o. Stroupežnického Praha 5 Pfizer, spol. s r.o. Stroupežnického Praha 5 HARMONET OBALENÉ TABLETY KATYA LINDYNETTE 20 LOGEST LUNAFEM MILLIGEST OBALENÉ TABLETY MINESSE POTAHOVANÉ TABLETY MINULET OBALENÉ TABLETY 0,0 50 mcg/30 mcg 70 mcg/ 40 mcg 100 mcg/ 30 mcg 0,06 mg 0,015 mg 0,0 EMA/713187/2012 Page 39/253

40 Bayer Pharma AG Müllerstraße 178 D Berlin Heaton a.s. Na Pankráci Praha 4 Medico Uno Pharma Kft. Viadukt u. 12 Biatorbágy 2051 Heaton a.s. Na Pankráci Praha 4 Pfizer, spol. s r.o. Stroupežnického Praha 5 LadeePharma Kft Lajos utca E. ép.em H-1036 Budapest MIRELLE NELYA 0,015 MG/0,06 MG STODETTE OBALENÉ TABLETY SUNYA TRI-MINULET OBALENÉ TABLETY VIOLETTA 60 MIKROGRAMŮ/15 MIKROGRAMŮ POTAHOVANÉ TABLETY VONILLE 0,060 MG/0,015 MG ZULFIJA 75 MIKROGRAMŮ/ 20 MIKROGRAMŮ OBALENÉ TABLETY 0,06 mg 0,015 mg 0,06 mg 0,015 mg 0,05 mg/ 0,0 0,07 mg/ 0,04 mg 0,1 mg/ 0,0 0,06 mg 0,015 mg 0,06 mg 0,015 mg EMA/713187/2012 Page 40/253

41 Janssen-Cilag s.r.o. Karla Engliše 3201/ Praha 5 - Smíchov Czech Republic Janssen-Cilag s.r.o. Karla Engliše 3201/ Praha 5 - Smíchov Czech Republic Janssen-Cilag s.r.o. Karla Engliše 3201/ Praha 5 - Smíchov Czech Republic N.V. Organon Kloosterstraat AB, Oss N.V. Organon Kloosterstraat AB, Oss Stragen Nordic A/S, Helsingørgade 8C, DK-3400 Hillerød, Norgestimat Norgestimat Norgestimate Etonogestrel Etonogestrel ZULFIJA 75 MIKROGRAMŮ/ 30 MIKROGRAMŮ OBALENÉ TABLETY PRAMINO PRAMINO 28 CILEST NUVARING 0,120 MG/0,015 MG ZA 24 HODIN, VAGINÁLNÍ INZERT Circlet Asphalia 28 Daisynelle 0, mg/ 35 mcg 215 mcg/ 35 mcg 250 mcg/ 35 mcg 0,18 mg/ 0,035 mg 0,215 mg/ 0,035 mg 0,25 mg/ 0,035 mg 0,25 mg 0,035 mg mg 0.015mg 11.7mg 2.7mg Vaginal insert Vaginal insert Vaginal use Vaginal use EMA/713187/2012 Page 41/253

42 Stragen Nordic A/S, Helsingørgade 8C, DK-3400 Hillerød, Actavis Group PTC ehf Reykjavikurvegi Hafnarfjordur Iceland Actavis Group PTC ehf Reykjavikurvegi Hafnarfjordur Iceland Sandoz A/S Edward Thomsens Vej 14 DK-2300 København S Stada Arzneimittel AG, Stadastrasse 2-8, DE Bad Vibel, Stada Arzneimittel AG, Stadastrasse 2-8, DE Bad Vibel, Medimpex UK Ltd, 127 Shirland Road, London W9 2EP United Kingdom N.V. Organon Kloosterstraat AB, Oss Daisynelle /ethinylestradi ol Actavis /ethinylestradi ol Actavis Desorelle Femistad Femistad Gedarel Gracial 0,0 0,0 0,0 0,0 0,0 0,025/0,04 mg 0,125/0,030 mg EMA/713187/2012 Page 42/253

43 Medimpex UK Ltd, 127 Shirland Road, London W9 2EP United Kingdom Mylan AB, Postbox 23033, Ynglingagatan 14, SE Stockholm, Sweden Mylan AB, Postbox 23033, Ynglingagatan 14, SE Stockholm, Sweden Hunogidon Hunogidon 28 Hunogidon 28 Igixon Lestramyl Lestramyl Leticia Leticia 28 0,0 0,0 0,0 0,0 EMA/713187/2012 Page 43/253

44 N.V. Organon Kloosterstraat AB, Oss N.V. Organon Kloosterstraat AB, Oss N.V. Organon Kloosterstraat AB, Oss Sandoz A/S Edward Thomsens Vej 14 DK-2300 København S Letione 28 Marvelon Marvelon 28 Mercilon Myrzi Myrzi 28 Novynette Novypil 28 0,0 0,0 0,0 EMA/713187/2012 Page 44/253

45 Bayer AB Postbox 606 Gustav III's Boulevard 56 SE Solna Sweden Teva Danmark A/S, Parallelvej 10-12, DK-2800 Kongens Lyngby, Teva Danmark A/S, Parallelvej 10-12, DK-2800 Kongens Lyngby, Dienogest Estradiol valerate Rigetrux Rigetrux 28 Vivides 28 Qlaira Dretine Dretine 28 Drospirenon/ethinylestradi ol Gedeon Richter 0,0 0,0 / / /1 mg 0,0 0,0 0,0 EMA/713187/2012 Page 45/253

46 Laboratorios Leon Farma SA Poligono Industrial Navatejera, La Vallina s/n, Villaquilambre,Leon Sandoz A/S Edward Thomsens Vej 14 DK-2300 København S Orifarm Generics A/S Postbox 69 Energivej 15 DK-5260 Odense S Orifarm Generics A/S Postbox 69 Energivej 15 DK-5260 Odense S Bayer AB Postbox 606 Gustav III's Boulevard 56 SE Solna Sweden Sandoz A/S Edward Thomsens Vej 14 DK-2300 København S Estron 28 Finminette Movinella Movinella 28 Palandra Rubira 0,0 0,0 0,0 0,0 0,0 0,0 EMA/713187/2012 Page 46/253

47 BAYER SCHERING PHARMA AG Müllerstrasse 178 D Berlin BAYER SCHERING PHARMA AG Müllerstrasse 178 D Berlin Teva Danmark A/S, Parallelvej 10-12, DK-2800 Kongens Lyngby, Teva Danmark A/S, Parallelvej 10-12, DK-2800 Kongens Lyngby, Bayer AB Postbox 606 Gustav III's Boulevard 56 SE Solna Sweden Yasmin Yasmin 28 Dretine Dretine 28 Drosinetta Drosinetta 28 Eloine 0,0 0,0 EMA/713187/2012 Page 47/253

48 Laboratorios Leon Farma SA Poligono Industrial Navatejera, La Vallina s/n, Villaquilambre,Leon Sandoz A/S Edward Thomsens Vej 14 DK-2300 København S Bayer AB Postbox 606 Gustav III's Boulevard 56 SE Solna Sweden Bayer Pharma AG Müllerstraße 178 D Berlin Orifarm Generics A/S Postbox 69 Energivej 15 DK-5260 Odense S Orifarm Generics A/S Postbox 69 Energivej 15 DK-5260 Odense S Estron 28 Finminette Flexyess Liofora Movinella Movinella 28 EMA/713187/2012 Page 48/253

49 Sandoz A/S Edward Thomsens Vej 14 DK-2300 København S Sandoz A/S Edward Thomsens Vej 14 DK-2300 København S Teva Danmark A/S, Parallelvej 10-12, DK-2800 Kongens Lyngby, BAYER SCHERING PHARMA AG Müllerstrasse 178 D Berlin Bayer Pharma AG Müllerstraße 178 D Berlin Bayer AB Postbox 606 Gustav III's Boulevard 56 SE Solna Sweden Perlkala Rubira Stefaminelle Veyann Yasminelle Yasminelle 28 Yaz EMA/713187/2012 Page 49/253

50 N.V. Organon Kloosterstraat AB, Oss Stragen Nordic A/S, Helsingørgade 8C, DK-3400 Hillerød, Etonogestrel NuvaRing Celia Dorinette Edesia Edesia Estinette Gestilla Gestinyl 120mg 0,015mg 0,06 mg 0,015 mg 0,0 0,0 Vaginal ring Vaginal use EMA/713187/2012 Page 50/253

51 Stragen Nordic A/S, Helsingørgade 8C, DK-3400 Hillerød, Mylan S.A.S 117 Allée des Parcs FR Saint Priest Bayer A/S, Postbox 2090, Nøregaardsvej 32, DK-2800 Kongens Lyngby, Mylan S.A.S 117 Allée des Parcs FR Saint Priest Actavis Group PTC ehf Reykjavikurvegi Hafnarfjordur Iceland Actavis Group PTC ehf Reykjavikurvegi Hafnarfjordur Iceland Ratiopharm GmbH Graf-Arco-Strasse 3 DE Ulm Gestinyl Gestoden/ethinylestradiol 75/20 Mylan Gestoden/ethinylestradiol 75/30 Berlipharm Gestoden/ethinylestradiol 75/30 Mylan Gestoden/ethinylestradiol Actavis Gestoden/ethinylestradiol Actavis Gestoden/ethinylestradiol Gedion Richter Gestodilat 0,0 0,0 0,0 0,0 0,06 mg 0,015 mg EMA/713187/2012 Page 51/253

52 Ratiopharm GmbH Graf-Arco-Strasse 3 DE Ulm Sandoz A/S Edward Thomsens Vej 14 DK-2300 København S Pfizer ApS, Lautrupvang 8, DK-2750 Ballerup, Sandoz A/S Edward Thomsens Vej 14 DK-2300 København S Sandoz A/S Edward Thomsens Vej 14 DK-2300 København S Gestodilat Gestonette Halogest Harmonet Lindynette Mandolina Melitta Milligest 0,0 0,05 mg 0,0 0,0 0,06 mg 0,015 mg 0,0 0,05 mg 0,0 EMA/713187/2012 Page 52/253

53 Stragen Nordic A/S, Helsingørgade 8C, DK-3400 Hillerød, Stragen Nordic A/S, Helsingørgade 8C, DK-3400 Hillerød, BAYER SCHERING PHARMA AG Müllerstrasse 178 D Berlin Orifarm Generics A/S Postbox 69 Energivej 15 DK-5260 Odense S Pfizer ApS, Lautrupvang 8, DK-2750 Ballerup, Orifarm Generics A/S Postbox 69 Energivej 15 DK-5260 Odense S Actavis Group PTC ehf Reykjavikurvegi Hafnarfjordur Iceland Milna Milna Milvane Minero Minulet Modina Varianta Vellena 0,0 0,05 mg 0,0 0,0 0,0 0,06 mg 0,015 mg EMA/713187/2012 Page 53/253

54 Estonia Actavis Group PTC ehf Reykjavikurvegi Hafnarfjordur Iceland Janssen-Cilag A/S, Postbox 149, Hammerbakken 19, DK-3460 Birkerød, N.V. Organon Kloosterstraat AB, Oss Norgestimate Etonogestrel Chlormadinone Vellena Vendiol Violetta Zulfija Zulfija Cilest Circlet BELARA 0,0 0,06 mg 0,015 mg 0,06 mg 0,015 mg 0,0 0,25 mg 0,035 mg 120mg 0,015mg 0,0 Vaginal ring Vaginal use EMA/713187/2012 Page 54/253

55 Estonia Estonia Estonia Estonia Estonia Estonia Estonia Estonia Ladee Pharma Baltics UAB Žemaitijos g.13/šiaulių g.10, LT Vilnius Lithuania N.V. Organon Kloosterstraat AB, Oss N.V. Organon Kloosterstraat AB, Oss N.V. Organon Kloosterstraat AB, Oss Chlormadinone CLORMETIN 2 MG/0,03 MG GRACIAL MARVELON MERCILON NOVYNETTE NOVYNETTE PLUS REGULON SAMBA 0,0 0,025/0,04 mg 0,125/0,030 mg 0,0 0,0 0,05mg/0,035mg 0,1mg/0,03mg 0,15mg/0,03mg EMA/713187/2012 Page 55/253

56 Estonia Estonia Estonia Estonia Estonia Bayer Pharma AG Müllerstraße 178 D Berlin Orivas UAB J.Jasinskio 16B LT Vilinius Lithuania Jenapharm GmbH & Co. KG Otto-Schott-Straße Jena Deutschland Bayer Pharma AG Müllerstraße 178 D Berlin Dienogest Estradiol valerate Dienogest Dienogest Dienogest Estradiol QLAIRA AMMILY 2 MG / 0,03 MG JEANINE SIBILLA ANGELIQ tabl 0+3mg N2;0+1mg N2;0+0 N2;2mg+2mg N5;3mg+2mg N17;0+3mg N6;0+1mg N6;0+0 N6;2mg+2mg N15;3mg+2mg N51;0+3mg N12;0+1mg N12;0+0 N12;2mg+2mg N30;3mg+2mg N102 0,0 0,0 0,0 1mg EMA/713187/2012 Page 56/253

57 Estonia Estonia Estonia Estonia Estonia Estonia Ladee Pharma Baltics UAB Žemaitijos g.13/šiaulių g.10, LT Vilnius Lithuania Laboratorios Leon Farma SA Poligono Industrial Navatejera, La Vallina s/n, Villaquilambre,Leon Ivowen Limited 3, Anglesea Street Clonmel Co. Tipperary Ireland Laboratorios Leon Farma SA Poligono Industrial Navatejera, La Vallina s/n, Villaquilambre,Leon Bayer Pharma AG Müllerstraße 178 D Berlin JANGEE 0,03 MG/3 MG LLUVIEIGHT 0,03 MG/3 MG LULINA MIDIANA MINAYEIGHT 0,03 MG/3 MG YARINA 0,0 0,0 0,0 0,0 0,0 0,0 EMA/713187/2012 Page 57/253

58 Estonia Estonia Estonia Estonia Estonia Estonia Laboratorios Leon Farma SA Poligono Industrial Navatejera, La Vallina s/n, Villaquilambre,Leon Ladee Pharma Baltics UAB Žemaitijos g.13/šiaulių g.10, LT Vilnius Lithuania Laboratorios Leon Farma SA Poligono Industrial Navatejera, La Vallina s/n, Villaquilambre,Leon ANEEA BELUSHA DAYLETTE FERRANELLES 3MG/0,02MG JANGEE 0,02 MG/3 MG LLUVIEIGHT 0,02 MG/3 MG EMA/713187/2012 Page 58/253

59 Estonia Estonia Estonia Estonia Estonia Estonia Estonia Sandoz d.d. Verovskova 57 SI-1000 Ljubljana Slovenia Sandoz d.d. Verovskova 57 SI-1000 Ljubljana Slovenia Laboratorios Leon Farma SA Poligono Industrial Navatejera, La Vallina s/n, Villaquilambre,Leon Ladee Pharma Baltics UAB Žemaitijos g.13/šiaulių g.10, LT Vilnius Lithuania Bayer Pharma AG Müllerstraße 178 D Berlin Bayer Pharma AG Müllerstraße 178 D Berlin MADELEINE MARIONELLE MINAYEIGHT 0,02 MG/3 MG TEENIA VELGYN YASMINELLE YAZ EMA/713187/2012 Page 59/253

60 Estonia Estonia Estonia Estonia Estonia Estonia Estonia Estonia Bayer Pharma AG Müllerstraße 178 D Berlin Bayer Pharma AG Müllerstraße 178 D Berlin Ratiopharm GmbH Graf-Arco-Strasse 3 DE Ulm Ratiopharm GmbH Graf-Arco-Strasse 3 DE Ulm Pfizer Europe MA EEIG Ramsgate Road, Sandwich, Kent CT 13 9NJ United Kingdom YVIDUALLY EDESIA FEMODEN GESYTIL 75/20 MIKROGRAMMI GESYTIL 75/30 MIKROGRAMMI HARMONET LINDYNETTE 20 LINDYNETTE 30 0,0 0,0 0,0 EMA/713187/2012 Page 60/253

61 Estonia Estonia Estonia Estonia Estonia Estonia Finland Bayer Pharma AG Müllerstraße 178 D Berlin Pfizer Europe MA EEIG Ramsgate Road, Sandwich, Kent CT 13 9NJ United Kingdom Bayer Pharma AG Müllerstraße 178 D Berlin Ladee Pharma Baltics UAB Žemaitijos g.13/šiaulių g.10, LT Vilnius Lithuania Stragen Nordic A/S Hesselvej 41 Ganlose 3660 Stenlose LOGEST MINULET MIRELLE VIOLETTA VONILLE ZULFIJA DAISYNELLE 0,0 0,06 mg 0,015 mg 0,06 mg 0,015 mg 0,06 mg 0,015 mg EMA/713187/2012 Page 61/253

62 Finland Finland Finland Finland Finland Finland Finland Finland Actavis Group PTC ehf Reykjavikurvegi Hafnarfjordur Iceland N.V. Organon Kloosterstraat AB, Oss N.V. Organon Kloosterstraat AB, Oss MYLAN AB Nenacovice Beroun the N.V. Organon Kloosterstraat AB, Oss Organon (Ireland) Ltd, PO Box 2857, Drynam Road, Swords, Co.Dublin, Ireland DESODIOLCONT DESOGESTREL/ETHINYLE STRADIOL ACTAVIS GRACIAL LAURINA, LAURINA 28 LESTRAMYL MARVELON MERCILON NOVYNETTE (28) 0, mg /0.125 mg mg/0.030 mg mg/0.100 mg/0.150 mg mg/0.030 mg/0.030 mg 0,0 EMA/713187/2012 Page 62/253

63 Finland Finland Finland Finland Finland Finland Finland BAYER OY Pansiontie 47 PL Turku Finland Teva Sweden AB Järnvägsgatan 11 Box Helsingborg Sweden Orifarm Generics A/S Postbox 69 Energivej 15 DK-5260 Odense S LEON FARMA C/ La Vallina s/n, Pol. Ind., Navatejera León Dienogest Estradiol valerate RIGETRUX (28) SABLONA (28) QLAIRA DRETINE ETHINYLESTRADIOL/DRO SPIRENON ORIFARM ETHINYLESTRADIOL/DRO SPIRENONE RICHTER LLUVIANE 0,0 0,0 2/ 3/2/1 mg 0, mg/0.030 mg 0, mg/0.030 mg EMA/713187/2012 Page 63/253

64 Finland Finland Finland Finland Finland Finland Finland BAYER OY Pansiontie 47 PL Turku Finland Sandoz A/S Edward Thomsens Vej 14 DK-2300 København S Sandoz A/S Edward Thomsens Vej 14 DK-2300 København S BAYER OY Pansiontie 47 PL Turku Finland ORIFARM OY Metsänneidonkuja Espoo Finland Teva Sweden AB Järnvägsgatan 11 Box Helsingborg Sweden PALANDRA PERLITA RUBIRA TASMINETTA YASMIN YASMIN DRETINELLE 0,0 0,0 0, mg/0.030 mg 0,0 0,0 EMA/713187/2012 Page 64/253

65 Finland Finland Finland Finland Finland Finland Finland BAYER OY Pansiontie 47 PL Turku Finland BAYER OY Pansiontie 47 PL Turku Finland Sandoz A/S Edward Thomsens Vej 14 DK-2300 København S Sandoz A/S Edward Thomsens Vej 14 DK-2300 København S Ratiopharm GmbH Graf-Arco-Strasse 3 DE Ulm BAYER OY Pansiontie 47 PL Turku Finland DROSINETTE LINATERA LIOFORA RUBIRA STEFAMINELLE VEYANN YASMINELLE EMA/713187/2012 Page 65/253

66 Finland Finland Finland Finland Finland Finland Finland Finland BAYER OY Pansiontie 47 PL Turku Finland N.V. Organon Kloosterstraat AB, Oss BAYER OY Pansiontie 47 PL Turku Finland PARANOVA Rajatorpantie 41 C Vantaa Finland Stragen Nordic A/S Hesselvej 41 Ganlose 3660 Stenlose Actavis Group PTC ehf Reykjavikurvegi Hafnarfjordur Iceland Ratiopharm GmbH Graf-Arco-Strasse 3 DE Ulm PFIZER Tietokuja Helsinki Finland Etonogestrel Gestoden Gestoden Gestoden Gestoden Gestoden Gestoden YAZ NUVARING FEMODEN FEMODEN GESTINYL GESTODEN/ETHINYLESTR ADIOL ACTAVIS GESTODILAT HARMONET 11,7 mg 2,7 mg 0,0 0, mg 0.020/0.030 mg 0.075mg 0.020/0.030 mg 0.075mg 0.020/0.030 mg Vaginal device Vaginal use EMA/713187/2012 Page 66/253

67 Finland Finland Finland Finland Finland Finland Finland BAYER OY Pansiontie 47 PL Turku Finland Orifarm Generics A/S Postbox 69 Energivej 15 DK-5260 Odense S PFIZER Tietokuja Helsinki Finland BAYER OY Pansiontie 47 PL Turku Finland Orifarm Generics A/S Postbox 69 Energivej 15 DK-5260 Odense S BAYER OY Pansiontie 47 PL Turku Finland JANSSEN-CILAG OY Vaisalantie Espoo Finland Gestoden Gestoden Gestoden Gestoden Gestoden Gestoden Norgestimate MELIANE MINERO MINULET MIRELLE MODINA TRI-FEMODEN CILEST, CILEST 28 0,0 0,06 mg 0,015 mg 0, mg/0.070 mg/0.100 mg mg/0.040 mg/0.030 mg 0,25 mg 0,035 mg EMA/713187/2012 Page 67/253

68 LABORATOIRES GRUNENTHAL 19, rue Ernest Renan Immeuble Eureka Nanterre FRANCE LABORATOIRES GRUNENTHAL 19, rue Ernest Renan Immeuble Eureka Nanterre FRANCE LABORATOIRES GRUNENTHAL 19, rue Ernest Renan Immeuble Eureka Nanterre FRANCE LABORATOIRES GRUNENTHAL 19, rue Ernest Renan Immeuble Eureka Nanterre FRANCE Actavis Centre d'affaires La Boursidière BP Le Plessis- Robinson cedex FRANCE PIERRE FABRE MEDICAMENT 45 place Abel Gance Boulogne FRANCE Chlormadinone acetate Chlormadinone acetate Chlormadinone acetate Chlormadinone acetate Chlormadinone acetate Chlormadinone acetate Balanca Balancacontinu Belara Belaracontinu Chlormadinone Actavis 2 mg/0.0 Chlormadinone Pierre Fabre Medicament 2 mg/0,0 0,0 0,0 0,0 0,0 0,0 0,0 EMA/713187/2012 Page 68/253

69 MSD 34 avenue Léonard de Vinci Courbevoie Cedex MSD 34 avenue Léonard de Vinci Courbevoie Cedex IDD (International Drug Development) 5, rue Simonet PARIS FRANCE IDD (International Drug Development) 5, rue Simonet PARIS FRANCE EFFIK 9-11 rue Jeanne Braconnier Bâtiment «Le Newton» MEUDON LA FORET cedex FRANCE Cycleane 20 Cycleane 30 Desiol 20 Desiol 30 Desobel 150/20 0,0 EMA/713187/2012 Page 69/253

70 EFFIK 9-11 rue Jeanne Braconnier Bâtiment «Le Newton» MEUDON LA FORET cedex FRANCE BIOGARAN 15 Bd Charles de Gaulle Colombes FRANCE BIOGARAN 15 Bd Charles de Gaulle Colombes FRANCE IDD (International Drug Development) 5, rue Simonet PARIS FRANCE IDD (International Drug Development) 5, rue Simonet PARIS FRANCE IDD (International Drug Development) 5, rue Simonet PARIS FRANCE Desobel 150/30 BIOGARAN 150/20 BIOGARAN 150/30 IDD 150/20 IDD 150/30 IDETEC 150/20 0,0 0,0 0,0 0,0 EMA/713187/2012 Page 70/253

71 IDD (International Drug Development) 5, rue Simonet PARIS FRANCE EFFIK 9-11 rue Jeanne Braconnier Bâtiment «Le Newton» MEUDON LA FORET cedex FRANCE EFFIK 9-11 rue Jeanne Braconnier Bâtiment «Le Newton» MEUDON LA FORET cedex FRANCE TEVA SANTE 110 Esplanade du Général de Gaulle PARIS LA DEFENSE CEDEX FRANCE TEVA SANTE 110 Esplanade du Général de Gaulle PARIS LA DEFENSE CEDEX FRANCE IDETEC 150/30 Quill 150/20 Quill 150/30 TEVA 150/20 TEVA 150/30 0,0 0,0 0,0 EMA/713187/2012 Page 71/253

72 EFFIK 9-11 rue Jeanne Braconnier Bâtiment «Le Newton» MEUDON LA FORET cedex FRANCE EFFIK 9-11 rue Jeanne Braconnier Bâtiment «Le Newton» MEUDON LA FORET cedex FRANCE SANOFI AVENTIS FRANCE 1-13 boulevard Romain Rolland PARIS FRANCE SANOFI AVENTIS FRANCE 1-13 boulevard Romain Rolland PARIS FRANCE MAJORELLE Rue Gallieni Boulogne- Billancourt FRANCE Turner 150/20 Turner 150/30 ZENTIVA 150/20 ZENTIVA 150/30 Desopharm 150/20 0,0 0,0 EMA/713187/2012 Page 72/253

73 MAJORELLE Rue Gallieni Boulogne- Billancourt FRANCE IDD (International Drug Development) 5, rue Simonet PARIS FRANCE IDD (International Drug Development) 5, rue Simonet PARIS FRANCE MSD 34 avenue Léonard de Vinci Courbevoie Cedex MSD 34 avenue Léonard de Vinci Courbevoie Cedex PFIZER HOLDING avenue du Docteur Lannelongue PARIS Cedex 14 FRANCE Desopharm 150/30 Desyl 20 Desyl 30 Mercilon Mirtinu 150/30 Novantica 150/20 0,0 0,0 0,0 EMA/713187/2012 Page 73/253

74 PFIZER HOLDING avenue du Docteur Lannelongue PARIS Cedex 14 FRANCE CHEMICAL FARMA 3, Quai Louis Blériot PARIS FRANCE CHEMICAL FARMA 3, Quai Louis Blériot PARIS FRANCE Jenapharm GmbH & Co. KG Otto-Schott-Straße Jena Deutschland Jenapharm GmbH & Co. KG Otto-Schott-Straße Jena Deutschland MSD 34 avenue Léonard de Vinci Courbevoie Cedex Novantica 150/30 Ovulasten 20 Ovulasten 30 Sinovulon 150/20 Sinovulon 150/30 varnoline 0,0 0,0 0,0 0,0 EMA/713187/2012 Page 74/253

75 MSD 34 avenue Léonard de Vinci Courbevoie Cedex Bayer Sante 220 avenue de la Recherche Loos Bayer Sante 220 avenue de la Recherche Loos EFFIK 9-11 rue Jeanne Braconnier Bâtiment «Le Newton» MEUDON LA FORET cedex FRANCE BIOGARAN 15 Bd Charles de Gaulle Colombes FRANCE Bayer Sante 220 avenue de la Recherche Loos Dienogest Estradiol valerate varnoline continu Qlaira Convuline Drospibel 0,03mg/3mg BIOGARAN 3mg/30µg Jasmine 0,0 0mg/ / / 0mg/1 mg 0,0 0,0 0,0 0,0 EMA/713187/2012 Page 75/253

76 Bayer Sante 220 avenue de la Recherche Loos Laboratorios Leon Farma SA Poligono Industrial Navatejera, La Vallina s/n, Villaquilambre,Leon SANDOZ 49 avenue Georges Pompidou LEVALLOIS- PERRET Cedex FRANCE SANDOZ 49 avenue Georges Pompidou LEVALLOIS- PERRET Cedex FRANCE TEVA SANTE 110 Esplanade du Général de Gaulle PARIS LA DEFENSE CEDEX FRANCE Ethynilestradiol Ethynilestradiol Ethynilestradiol Ethynilestradiol Palandra 0,03mg/3mg Bellmunt GNR 3mg/30µg SANDOZ 3mg/30µg TEVA 3mg/20µg 0,0 0,0 0,0 0,0 0,020 mg EMA/713187/2012 Page 76/253

77 TEVA SANTE 110 Esplanade du Général de Gaulle PARIS LA DEFENSE CEDEX FRANCE TEVA SANTE 110 Esplanade du Général de Gaulle PARIS LA DEFENSE CEDEX FRANCE EFFIK 9-11 rue Jeanne Braconnier Bâtiment «Le Newton» MEUDON LA FORET cedex FRANCE Bayer Sante 220 avenue de la Recherche Loos EFFIK 9-11 rue Jeanne Braconnier Bâtiment «Le Newton» MEUDON LA FORET cedex FRANCE Ethynilestradiol Ethynilestradiol Ethynilestradiol TEVA 3mg/30µg TEVA SANTE 3mg/20µg Naiwanel 0,03mg/3mg Belanette Drospibel 0,02mg/3mg 0,020 mg 0,020 mg 0,0 EMA/713187/2012 Page 77/253

78 BIOGARAN 15 Bd Charles de Gaulle Colombes FRANCE BIOGARAN 15 Bd Charles de Gaulle Colombes FRANCE SANDOZ 49 avenue Georges Pompidou LEVALLOIS- PERRET Cedex FRANCE SANDOZ 49 avenue Georges Pompidou LEVALLOIS- PERRET Cedex FRANCE Laboratorios Leon Farma SA Poligono Industrial Navatejera, La Vallina s/n, Villaquilambre,Leon Bayer Sante 220 avenue de la Recherche Loos BIOGARAN 3mg/20µg BIOGARAN CONTINU 3mg/20µg GNR 3mg/20µg SANDOZ 3mg/20µg Iren Jasminelle continu EMA/713187/2012 Page 78/253

79 Bayer Sante 220 avenue de la Recherche Loos EFFIK 9-11 rue Jeanne Braconnier Bâtiment «Le Newton» MEUDON LA FORET cedex FRANCE Bayer Sante 220 avenue de la Recherche Loos Laboratorios Leon Farma SA Poligono Industrial Navatejera, La Vallina s/n, Villaquilambre,Leon Bayer Sante 220 avenue de la Recherche Loos Jasminelle Naiwanel 0,02mg/3mg Rimendia Vallclara Yaz EMA/713187/2012 Page 79/253

80 MSD 34 avenue Léonard de Vinci Courbevoie Cedex MSD 34 avenue Léonard de Vinci Courbevoie Cedex EFFIK 9-11 rue Jeanne Braconnier Bâtiment «Le Newton» MEUDON LA FORET cedex FRANCE EFFIK 9-11 rue Jeanne Braconnier Bâtiment «Le Newton» MEUDON LA FORET cedex FRANCE EFFIK 9-11 rue Jeanne Braconnier Bâtiment «Le Newton» MEUDON LA FORET cedex FRANCE Etonogestrel Etonogestrel Circlet mg/0.015mg Vaginal delivery system Nuvaring mg/0.015mg Vaginal delivery system Carlin 60/15 Carlin 75/20 Carlin 75/30 0,06 mg 0,015 mg 0,0 Vaginal use Vaginal use EMA/713187/2012 Page 80/253

81 Mylan S.A.S 117 Allée des Parcs FR Saint Priest Mylan S.A.S 117 Allée des Parcs FR Saint Priest Mylan S.A.S 117 Allée des Parcs FR Saint Priest CHEMICAL FARMA 3, Quai Louis Blériot PARIS FRANCE MAJORELLE Rue Gallieni Boulogne- Billancourt FRANCE MAJORELLE Rue Gallieni Boulogne- Billancourt FRANCE Actavis Centre d'affaires La Boursidière BP Le Plessis- Robinson cedex FRANCE Edenelle Efezial 75/20 Efezial 75/30 Elleogeste 60/15 Gespharm 75/20 Gespharm 75/30 75/20 0,06 mg 0,015 mg 0,0 0,06 mg 0,015 mg 0,0 EMA/713187/2012 Page 81/253

82 Actavis Centre d'affaires La Boursidière BP Le Plessis- Robinson cedex FRANCE ARROW GENERIQUES 26 avenue Tony Garnier LYON FRANCE ARROW GENERIQUES 26 avenue Tony Garnier LYON FRANCE ARROW GENERIQUES 26 avenue Tony Garnier LYON FRANCE BIOGARAN 15 Bd Charles de Gaulle Colombes FRANCE BIOGARAN 15 Bd Charles de Gaulle Colombes FRANCE BIOGARAN 15 Bd Charles de Gaulle Colombes FRANCE 75/30 ARROW 60/15 ARROW 75/20 ARROW 75/30 BIOGARAN 60/15 BIOGARAN 75/20 BIOGARAN 75/30 0,0 0,06 mg 0,015 mg 0,0 0,06 mg 0,015 mg 0,0 EMA/713187/2012 Page 82/253

83 CHEMICAL FARMA 3, Quai Louis Blériot PARIS FRANCE CHEMICAL FARMA 3, Quai Louis Blériot PARIS FRANCE LABORATOIRES CRISTERS 22, quai Galliéni SURESNES FRANCE EG LABO LABORATOIRES EUROGENERICS Le Quintet bâtiment A 12 rue Danjou BOULOGNE BILLANCOURT cedex FRANCE EG LABO LABORATOIRES EUROGENERICS Le Quintet bâtiment A 12 rue Danjou BOULOGNE BILLANCOURT cedex FRANCE CHIMICAL FARMA 75/20 CHIMICAL FARMA 75/30 CRISTERS 60/15 EG 60/15 EG 75/20 0,0 0,06 mg 0,015 mg 0,06 mg 0,015 mg EMA/713187/2012 Page 83/253

84 EG LABO LABORATOIRES EUROGENERICS Le Quintet bâtiment A 12 rue Danjou BOULOGNE BILLANCOURT cedex FRANCE SANDOZ 49 avenue Georges Pompidou LEVALLOIS- PERRET Cedex FRANCE IDD (International Drug Development) 5, rue Simonet PARIS FRANCE IDD (International Drug Development) 5, rue Simonet PARIS FRANCE RANBAXY PHARMACIE GENERIQUES Quai Dion Bouton PUTEAUX Cedex FRANCE EG 75/30 GNR 60/15 IDETECH 75/20 IDETECH 75/30 RANBAXY 75/20 0,0 0,06 mg 0,015 mg 0,0 EMA/713187/2012 Page 84/253

85 RANBAXY PHARMACIE GENERIQUES Quai Dion Bouton PUTEAUX Cedex FRANCE TEVA SANTE 110 Esplanade du Général de Gaulle PARIS LA DEFENSE CEDEX FRANCE TEVA SANTE 110 Esplanade du Général de Gaulle PARIS LA DEFENSE CEDEX FRANCE SANDOZ 49 avenue Georges Pompidou LEVALLOIS- PERRET Cedex FRANCE SANDOZ 49 avenue Georges Pompidou LEVALLOIS- PERRET Cedex FRANCE RANBAXY 75/30 RATIOPHARM 75/20 RATIOPHARM 75/30 SANDOZ 60/15 SANDOZ 75/20 0,0 0,0 0,06 mg 0,015 mg EMA/713187/2012 Page 85/253

86 SANDOZ 49 avenue Georges Pompidou LEVALLOIS- PERRET Cedex FRANCE STRAGEN SAS 52 rue de la République Lyon TEVA SANTE 110 Esplanade du Général de Gaulle PARIS LA DEFENSE CEDEX FRANCE TEVA SANTE 110 Esplanade du Général de Gaulle PARIS LA DEFENSE CEDEX FRANCE TEVA SANTE 110 Esplanade du Général de Gaulle PARIS LA DEFENSE CEDEX FRANCE SANOFI AVENTIS FRANCE 1-13 boulevard Romain Rolland PARIS FRANCE SANDOZ 75/30 STRAGEN 60/15 TEVA 60/15 TEVA 75/20 TEVA 75/30 ZENTIVA 60/15 0,0 0,06 mg 0,015 mg 0,06 mg 0,015 mg 0,0 0,06 mg 0,015 mg EMA/713187/2012 Page 86/253

87 SANOFI AVENTIS FRANCE 1-13 boulevard Romain Rolland PARIS FRANCE SANOFI AVENTIS FRANCE 1-13 boulevard Romain Rolland PARIS FRANCE ZYDUS FRANCE ZAC Les Hautes Patures 25 Rue des peuliers NANTERRE CEDEX FRANCE ZYDUS FRANCE ZAC Les Hautes Patures 25 Rue des peuliers NANTERRE CEDEX FRANCE PFIZER HOLDING avenue du Docteur Lannelongue PARIS Cedex 14 FRANCE ZENTIVA 75/20 ZENTIVA 75/30 ZYDUS 75/20 ZYDUS 75/30 Harmonet 0,0 0,0 EMA/713187/2012 Page 87/253

88 Bayer Sante 220 avenue de la Recherche Loos Bayer Sante 220 avenue de la Recherche Loos PFIZER HOLDING avenue du Docteur Lannelongue PARIS Cedex 14 FRANCE PFIZER HOLDING avenue du Docteur Lannelongue PARIS Cedex 14 FRANCE Bayer Sante 220 avenue de la Recherche Loos MAJORELLE Rue Gallieni Boulogne- Billancourt FRANCE Meliane Melodia Minesse Minulet Moneva Optinesse 60/15 0,06 mg 0,015 mg 0,06 mg 0,015 mg 0,0 0,0 0,06 mg 0,015 mg EMA/713187/2012 Page 88/253

89 BIOGARAN 15 Bd Charles de Gaulle Colombes FRANCE Bayer Sante 220 avenue de la Recherche Loos Bayer Sante 220 avenue de la Recherche Loos PFIZER HOLDING avenue du Docteur Lannelongue PARIS Cedex 14 FRANCE JANSSEN-CILAG 1 rue Camille Desmoulins TSA ISSY LES MOULINEAUX cedex 9 FRANCE Norgestimate Perleane Phaeva Sylviane Triminulet Cilest mg/0.030 mg mg/0.040mg mg/0.030 mg mg/0.030 mg mg/0.040mg mg/0.030 mg 0,06 mg 0,015 mg mg/0.030 mg mg/0.040 g mg/0.030 mg 0,25 mg 0,035 mg EMA/713187/2012 Page 89/253

90 EFFIK 9-11 rue Jeanne Braconnier Bâtiment «Le Newton» MEUDON LA FORET cedex FRANCE EFFIK 9-11 rue Jeanne Braconnier Bâtiment «Le Newton» MEUDON LA FORET cedex FRANCE JANSSEN-CILAG 1 rue Camille Desmoulins TSA ISSY LES MOULINEAUX cedex 9 FRANCE Laboratoire THERAMEX 6 avenue Albert II, BP 59-MC Monaco Cedex Principality of Monaco Laboratoire THERAMEX 6 avenue Albert II, BP 59-MC Monaco Cedex Principality of Monaco Norgestimate Norgestimate Norgestimate Effiprev Triafemi Tricilest Felixita Felixita 0,25 mg 0,035 mg mg /0.035 mg mg /0.035 mg mg /0.035 mg mg /0.035 mg mg /0.035 mg mg /0.035 mg 0,0 EMA/713187/2012 Page 90/253

91 Bayer Vital GmbH Kaiser-Wilhelm-Allee Leverkusen Aliud Pharma GmbH Gottlieb-Daimler-Str Laichingen Actavis Group PTC ehf Reykjavikurvegi Hafnarfjordur Iceland Pfizer Pharma GmbH Linkstr Berlin Madaus GmbH Colonia Allee Köln Estradiolvalerat Dienogest Ethinyestradiol Chlormadinon acetate Chlormadinon acetate Chlormadinon acetate Chlormadinon acetate Chlormadinon acetate Chlormadinon acetate Chlormadinon acetate Qlaira Filmtabletten Bonita AL 0,0/ Filmtabletten Angiletta /0,0 Filmtabletten Balanca beatrice 0,0/ Filmtabletten Belara Belara 21+7 Bellissima / / / 1 mg - / / / - 0,0 0,0 0,0 0,0 0,0 0,0 0,0 EMA/713187/2012 Page 91/253

92 Madaus GmbH Colonia Allee Köln 1 A Pharma GmbH Keltenring Oberhaching Zentiva Pharma GmbH Industriepark Frankfurt-Höchst, Gebäude K Frankfurt am Main Jenapharm GmbH & Co. KG Otto-Schott-Straße Jena Deutschland Chlormadinon acetate Chlormadinon acetate Chlormadinon acetate Chlormadinon acetate Chlormadinon acetate Chlormadinon acetate Chlormadinon acetate Bellissima 0,0/ filmtabletten Bilmon - 1 A Pharma 0,03 mg/ Filmtabletten Chantal Chariva Chariva 21+7 Chloee Enriqa 0,0 0,0 0,0 0,0 0,0 0,0 0,0 EMA/713187/2012 Page 92/253

93 Sandoz Pharmaceuticals GmbH Raiffeisenstr Holzkirchen CT Arzneimittel GmbH Graf-Arco-Str Ulm Aristo Pharma GmbH Wallenroder Straße Berlin Madaus GmbH Colonia Allee Köln Mylan dura gmbh Wittstichstr Darmstadt mibe GmbH Arzneimittel Münchener Str Brehna Dr. Kade Pharmazeutische Fabrik GmbH Rigistr Berlin Chlormadinon acetate Chlormadinon acetate Chlormadinon acetate Chlormadinon acetate Chlormadinon acetate Chlormadinon acetate Chlormadinon acetate eufem /0,0 Filmtabletten LaBibiane Lilia 0,0/ Filmtabletten Lisa Lisette 0,0/ Filmtabletten Madinette 30 Minette /0,0 Filmtabletten 0,0 0,0 0,0 0,0 0,0 0,0 0,0 EMA/713187/2012 Page 93/253

94 Hexal Aktiengesellschaft Industriestr Holzkirchen Stadapharm GmbH Stadastr Bad Vilbel Hormosan Pharma GmbH Wilhelmshoeher Str Frankfurt Madaus GmbH Colonia Allee Köln Ratiopharm GmbH Graf-Arco-Strasse 3 DE Ulm Mithra Pharmaceuticals S.A. Rue Saint Georges Liège Chlormadinon acetate Chlormadinon acetate Chlormadinon acetate Chlormadinon acetate Chlormadinon acetate Chlormadinon acetate Chlormadinon acetate Mona HEXAL /0,03 mg Filmtabletten Neo-Eunomin Pink Luna 0,0/ Filmtabletten Solera /0,0 Filmtabletten Triamica Verana-ratiopharm 2 mg/0,0 Filmtabletten Zetdinone 0,0 0,05 mg / 0,05 mg 1 mg / 0,0 0,0 0,0 0,0 0,0 EMA/713187/2012 Page 94/253

95 betapharm Arzneimittel GmbH Kobelweg Augsburg Aliud Pharma GmbH Gottlieb-Daimler-Str Laichingen Aliud Pharma GmbH Gottlieb-Daimler-Str Laichingen MSD Sharp & Dohme Gesellschaft mit beschränkter Haftung Lindenplatz Haar Aristo Pharma GmbH Wallenroder Straße Berlin Chlormadinonacetat Belara Ametist Filmtabletten Aricia beta Belinda AL /0,02 mg ten Belinda AL /0,03 mg ten Biviol Cedia µg/150 µg ten 0,0 0,035 mg / 0,0 / 0,0 0,05 mg / 0,1 mg / 0,0 0,04 mg 0,025 mg EMA/713187/2012 Page 95/253

96 Aristo Pharma GmbH Wallenroder Straße Berlin mibe GmbH Arzneimittel Münchener Str Brehna mibe GmbH Arzneimittel Münchener Str Brehna Ratiopharm GmbH Graf-Arco-Strasse 3 DE Ulm Ratiopharm GmbH Graf-Arco-Strasse 3 DE Ulm Mylan dura gmbh Wittstichstr Darmstadt Cedia µg/150 µg ten Desmin 20 Desmin 30 Desofemine 20 Nova Desofemine 30 Famina-ratiopharm 20 Famina-ratiopharm 30 Gabrielle-20 /0,02 mg ten 0,0 0,0 0,0 0,0 EMA/713187/2012 Page 96/253

97 Mylan dura gmbh Wittstichstr Darmstadt Zentiva Pharma GmbH Industriepark Frankfurt-Höchst, Gebäude K Frankfurt am Main Zentiva Pharma GmbH Industriepark Frankfurt-Höchst, Gebäude K Frankfurt am Main Stadapharm GmbH Stadastr Bad Vilbel Stadapharm GmbH Stadastr Bad Vilbel Hexal Aktiengesellschaft Industriestr Holzkirchen Hexal Aktiengesellschaft Industriestr Holzkirchen Gabrielle-30 /0,03 mg ten Juliane 20 Juliane 30 Kosima STADA 0,15 mg/ ten Kosima STADA 0,15 mg/0,0 ten Lamuna 20 Lamuna 30 0,0 0,0 0,0 0,0 EMA/713187/2012 Page 97/253

98 betapharm Arzneimittel GmbH Kobelweg Augsburg MSD Sharp & Dohme Gesellschaft mit beschränkter Haftung Lindenplatz Haar MSD Sharp & Dohme Gesellschaft mit beschränkter Haftung Lindenplatz Haar MSD Sharp & Dohme Gesellschaft mit beschränkter Haftung Lindenplatz Haar MSD Sharp & Dohme Gesellschaft mit beschränkter Haftung Lindenplatz Haar UCB Pharma GmbH Alfred-Nobel-Str Monheim Lonicera beta Lovelle Lovelle Marvelon Novial previva sanol 20 ten 0,0 0,0 0,035 mg /0,0 / 0,0 0,05 mg / 0,1 mg / EMA/713187/2012 Page 98/253

99 UCB Pharma GmbH Alfred-Nobel-Str Monheim 1 A Pharma GmbH Keltenring Oberhaching Aristo Pharma GmbH Wallenroder Straße Berlin Zentiva Pharma GmbH Industriepark Frankfurt-Höchst, Gebäude K Frankfurt am Main Jenapharm GmbH & Co. KG Otto-Schott-Straße Jena Deutschland Bayer Pharma AG Müllerstraße 178 D Berlin Helm AG Nordkanalstrasse Hamburg Dienogest Dienogest Dienogest Dienogest Dienogest Dienogest previva sanol 30 ten Amelie - 1 A Pharma 0,03 mg/0, Filmtabletten Aristelle 0,0/ Filmtabletten BonaDea Celimona Celimone Deltanogest 0,0/2 mg Filmtabletten 0,0 0,0 0,0 0,0 0,0 0,0 0,0 EMA/713187/2012 Page 99/253

100 Pharbil Waltrop GmbH Im Wirrigen Waltrop Helm AG Nordkanalstrasse Hamburg mibe GmbH Arzneimittel Münchener Str Brehna Pharbil Waltrop GmbH Im Wirrigen Waltrop Dr. Kade Pharmazeutische Fabrik GmbH Rigistr Berlin Helm AG Nordkanalstrasse Hamburg Helm AG Nordkanalstrasse Hamburg UCB Pharma GmbH Alfred-Nobel-Str Monheim Dienogest Dienogest Dienogest Dienogest Dienogest Dienogest Dienogest Dienogest Diena Pharbil Dienestra 0,0/ Filmtabletten Dienovel /Dienogest Pharbil Waltrop 0,03/2,0mg Filmtabletten Finic Gamonogest 0,0/2 mg Filmtabletten Kappanogest 0,0/2 mg Filmtabletten ladonna sanol /0,03 mg Filmtabletten 0,0 0,0 0,0 0,0 0,0 0,0 0,0 0,0 EMA/713187/2012 Page 100/253

101 Helm AG Nordkanalstrasse Hamburg TEVA GmbH Graf-Arco-Str Ulm Jenapharm GmbH & Co. KG Otto-Schott-Straße Jena Deutschland Madaus GmbH Colonia Allee Köln Hexal Aktiengesellschaft Industriestr Holzkirchen Stadapharm GmbH Stadastr Bad Vilbel Aliud Pharma GmbH Gottlieb-Daimler-Str Laichingen Dienogest Dienogest Dienogest Dienogest Dienogest Dienogest Dienogest Dienogest Lamdanogest 0,0/2 mg Filmtabletten LaViola 0,0/ Filmtabletten maxim Mayra 0,0/ Filmtabletten Sibilla /0,0 Filmtabletten Starletta HEXAL 2 mg/0,0 Filmtabletten Stella STADA 0,0/2,0 mg Filmtabletten Susette AL 0,0/2,0 mg Filmtabletten 0,0 0,0 0,0 0,0 0,0 0,0 0,0 EMA/713187/2012 Page 101/253

102 "ARAC" At Regulatory Affairs Consulting GmbH Kichengasse 48/ Wien Jenapharm GmbH & Co. KG Otto-Schott-Straße Jena Deutschland Pfizer Pharma GmbH Linkstr Berlin Velvian GmbH Carl-Zeiss-Ring Ismaning Ratiopharm GmbH Graf-Arco-Strasse 3 DE Ulm Mylan dura gmbh Wittstichstr Darmstadt Jenapharm GmbH & Co. KG Otto-Schott-Straße Jena Deutschland Dienogest Dienogest Dienogest Dienogest Dienogest Dienogest Drospirenon Tessa 0,0/ Filmtabletten Valette vatrice 0,0/ Filmtabletten Velafee 0,0/ Filmtabletten Velvet-ratiopharm 0,03 mg/ Filmtabletten Violette 0,0/ Filmtabletten aida 0,0 0,0 0,0 0,0 0,0 0,0 EMA/713187/2012 Page 102/253

103 Ivowen Limited 3, Anglesea Street Clonmel Co. Tipperary Ireland Hexal Aktiengesellschaft Industriestr Holzkirchen Jenapharm GmbH & Co. KG Otto-Schott-Straße Jena Deutschland Laboratorios Leon Farma SA Poligono Industrial Navatejera, La Vallina s/n, Villaquilambre,Leon Drospirenon Drospirenon Drospirenon Drospirenon Drospirenon Drospirenon Drospirenon ARTADAL 0,0/ Filmtablette BERTELLE unterbrechungsfreie Einnahme /0,0 Filmtabletten Daylette / Eliza HEXAL Eloine / Filmtabletten Epir / Filmtabletten ESLARILA / Filmtabletten 0,0 0,0 EMA/713187/2012 Page 103/253

104 Mylan dura gmbh Wittstichstr Darmstadt Laboratorios Leon Farma SA Poligono Industrial Navatejera, La Vallina s/n, Villaquilambre,Leon Ivowen Limited 3, Anglesea Street Clonmel Co. Tipperary Ireland TEVA GmbH Graf-Arco-Str Ulm TEVA GmbH Graf-Arco-Str Ulm TEVA GmbH Graf-Arco-Str Ulm Drospirenon Drospirenon Drospirenon Drospirenon Drospirenon Drospirenon Drospirenon ESLARILA unterbrechungsfreie Einnahme / Filmtabletten Iren / Filmtabletten Iren 28 / Filmtabletten KYLNETTA 0,0/ Filmtablette LaYaisa LaYanina LaYnes 0,0 0,0 EMA/713187/2012 Page 104/253

105 TEVA GmbH Graf-Arco-Str Ulm Jenapharm GmbH & Co. KG Otto-Schott-Straße Jena Deutschland Drospirenon Drospirenon Drospirenon Drospirenon Drospirenon Drospirenon Drospirenon Drospirenon LaYva LILADROS / Filmtabletten LILADROS unterbrechungsfreie Einnnahme / Filmtabletten Liofora MAITALON 20 /3 mg Filmtabletten MAITALON 20/21+7 0,02 mg/ Filmtabletten MAITALON 30 0,0/3 mg Filmtabletten MAITALON 30/21+7 0,03 mg/ Filmtabletten 0,0 0,0 0,0 EMA/713187/2012 Page 105/253

106 Laboratorios Leon Farma SA Poligono Industrial Navatejera, La Vallina s/n, Villaquilambre,Leon Jenapharm GmbH & Co. KG Otto-Schott-Straße Jena Deutschland Jenapharm GmbH & Co. KG Otto-Schott-Straße Jena Deutschland Mylan dura gmbh Wittstichstr Darmstadt Laboratorios Leon Farma SA Poligono Industrial Navatejera, La Vallina s/n, Villaquilambre,Leon Drospirenon Drospirenon Drospirenon Drospirenon Drospirenon Drospirenon MESILARA / Filmtabletten Ospen 0,0/ Filmtabletten Palandra Petibelle 0,0/ Filmtabletten Rosal 0,0/ Filmtabletten Rosal 28 0,0/ Filmtabletten 0,0 0,0 0,0 0,0 0,0 EMA/713187/2012 Page 106/253

107 Hexal Aktiengesellschaft Industriestr Holzkirchen Hexal Aktiengesellschaft Industriestr Holzkirchen Hexal Aktiengesellschaft Industriestr Holzkirchen Hexal Aktiengesellschaft Industriestr Holzkirchen Bayer Vital GmbH Kaiser-Wilhelm-Allee Leverkusen Bayer Vital GmbH Kaiser-Wilhelm-Allee Leverkusen Drospirenon Drospirenon Drospirenon Drospirenon Drospirenon Drospirenon SELIKYNE / Filmtabletten YARA HEXAL 20 YARA HEXAL 20 und Placebo YARA HEXAL 30 YARA HEXAL 30 und Placebo Yasmin 0,0/ Filmtabletten Yasminelle / Filmtabletten 0,0 0,0 0,0 EMA/713187/2012 Page 107/253

108 Bayer Vital GmbH Kaiser-Wilhelm-Allee Leverkusen Hexal Aktiengesellschaft Industriestr Holzkirchen Bayer Vital GmbH Kaiser-Wilhelm-Allee Leverkusen Velvian GmbH Carl-Zeiss-Ring Ismaning 1 A Pharma GmbH Keltenring Oberhaching Pfizer Pharma GmbH Linkstr Berlin Janssen-Cilag GmbH Johnson & Johnson Platz Neuss Gestoden Gestoden Gestoden Gestoden Gestoden Norgestimat YAZ / Filmtabletten Alessia HEXAL 0,06 mg/ 0,015 mg Filmtabletten Femovan 0,0/0,075 mg überzogene ten Jamyle 0,060 mg / 0,015 mg Filmtabletten Lenisagyn - 1 A Pharma Minulet Cilest 0,015 mg 0,06 mg 0,0 0,015 mg 0,06 mg 0,015 mg 0,06 mg 0,0 0,035 mg 0,25 mg EMA/713187/2012 Page 108/253

109 Greece Greece Greece Greece Janssen-Cilag GmbH Johnson & Johnson Platz Neuss MSD Sharp & Dohme Gesellschaft mit beschränkter Haftung Lindenplatz Haar Varipharm Arzneimittel GmbH Lindenplatz Haar N.V. Organon Kloosterstraat AB, Oss N.V. Organon Kloosterstraat AB, Oss Teva Pharma BV Computerweg DR Utrecht Teva Pharma BV Computerweg DR Utrecht Norgestimat Etonogestrel Etonogestrel Pramino NuvaRing vaginales Freisetzungssystem Circlet 0,120 mg/0,015 mg pro 24 Stunden vaginales Freisetzungssystem 0,035 mg /0,035 mg / 0,035 mg 0,18 mg / 0,215 mg / 0,25 mg 2,7 mg 11,7 mg 2,7 mg 11,7 mg GRACIAL (0.125/0.030)mg, (0.025/0.040)mg LAURINA (0.100/0.030)mg, (0.150/0.030)mg, (0.050/0.035)mg Vaginal insert Vaginal insert Vaginal use Vaginal use GISSELINA (3/0.02)mg GISSELINA 28 (3/0.02) mg, EMA/713187/2012 Page 109/253

110 Greece Greece Greece Greece Greece Greece Greece Greece Teva Pharma BV Computerweg DR Utrecht Teva Pharma BV Computerweg DR Utrecht N.V. Organon Kloosterstraat AB, Oss BAYER HELLAS AG Sorou Maroussi Athens Greece BAYER HELLAS AG Sorou Maroussi Athens Greece BAYER HELLAS AG Sorou Maroussi Athens Greece Estradiol Valeriate Dienogest GISSELLE (3/0.03)mg GISSELLE 28 (3/0.02)mg MERCILON (0.150/0.020)mg VILUZOR (3/0.3)mg YASMIN (3/0.03)mg YASMINELLE (3.0/0.02) mg QLAIRA 3mg (2/2)mg (2/3)mg 1mg HUNOGIDON (0.02/0.15)mg EMA/713187/2012 Page 110/253

111 Greece Greece Greece BAYER HELLAS AG Sorou Maroussi Athens Greece N.V. Organon Kloosterstraat AB, Oss BAYER HELLAS AG Sorou Maroussi Athens Greece Stragen Nordic A/S, Helsingørgade 8C, DK-3400 Hillerød, Stragen Nordic A/S, Helsingørgade 8C, DK-3400 Hillerød, N.V. Organon Kloosterstraat AB, Oss Etonogestrel desogestrel ethinylestradiol desogestrel ethinylestradiol desogestrel ethinylestradiol desogestrel ethinylestradiol desogestrel ethinylestradiol YAZ ( )mg, PLACEBO NUVARING (11.7/2.7)mg Vaginal delivery system TRIGYNERA AMETIST CARICIA CONTROVUL CONTROVUL GRACIAL ( )mg/T AB (yellow), ( )mg/ta b (brown), ( )mg/T AB (white) 0,05mg/0,035mg 0,10mg/0,03mg 0,15mg/0,03mg 0,05mg/0,035mg 0,10mg/0,03mg 0,15mg/0,03mg 0,15mg 0,02mg 0,15mg 0,03mg 0,025mg/0.04mg 0,125mg/0,03mg Vaginal use EMA/713187/2012 Page 111/253

112 N.V. Organon Kloosterstraat AB, Oss N.V. Organon Kloosterstraat AB, Oss Bayer Hungaria ltd Alkotás street 50. Budapest 1123 desogestrel ethinylestradiol desogestrel ethinylestradiol desogestrel ethinylestradiol desogestrel ethinylestradiol desogestrel ethinylestradiol desogestrel ethinylestradiol drospirenone ethinylestradiol drospirenone ethinylestradiol LAURINA MERCILON NOVYNETTE NOVYNETTE CONTINUOUS REGULON SAMBA ALIANE AMAROSA 0,05mg/0,035mg 0,10mg/0,03mg 0,15mg/0,03mg 0,15mg 0,02mg 0,15mg 0,02mg 0,15mg 0,02mg 0,15mg 0,03mg 0,05mg/0,035mg 0,10mg/0,03mg 0,15mg/0,03mg EMA/713187/2012 Page 112/253

113 Bayer Hungaria ltd Alkotás street 50. Budapest 1123 Teva PLC Pallagi street 13., Debrecen 4042 Teva PLC Pallagi street 13., Debrecen 4042 drospirenone ethinylestradiol drospirenone ethinylestradiol drospirenone ethinylestradiol drospirenone ethinylestradiol drospirenone ethinylestradiol drospirenone ethinylestradiol drospirenone ethinylestradiol drospirenone ethinylestradiol AMAROSA CONTINUOUS ANAESTELL ANEEA ARANKA BELUSHA BERTELLE CORENELLE CORENELLE 0,0 0,0 0,0 0,0 EMA/713187/2012 Page 113/253

114 Sandoz LTD Bartók Béla street Budapest 1114 Sandoz LTD Bartók Béla street Budapest 1114 drospirenone ethinylestradiol drospirenone ethinylestradiol drospirenone ethinylestradiol drospirenone ethinylestradiol drospirenone ethinylestradiol drospirenone ethinylestradiol drospirenone ethinylestradiol drospirenone ethinylestradiol DECIORA DECIORA DEREN DEREN CONTINUOUS DROSINETTA DROSINETTA CONTINUOUS DROSPIRENONE/ETHINYL ESTRADIOL RICHTER ESLARILA 0,0 0,0 0,0 0,0 EMA/713187/2012 Page 114/253

115 Bayer Hungaria ltd Alkotás street 50. Budapest 1123 Laboratorios Leon Farma SA Calle La Vallina S/N Poligono Industrial Navatejera Navatejera, Leon E drospirenone ethinylestradiol drospirenone ethinylestradiol drospirenone ethinylestradiol drospirenone ethinylestradiol drospirenone ethinylestradiol drospirenone ethinylestradiol drospirenone ethinylestradiol ESLARILA CONTINUOUS ESTRIENNE EVERISSA FEDERIA FEDERIA CONTINUOUS FERRANELLES GYNDORA 0,0 EMA/713187/2012 Page 115/253

116 LadeePharma LTD. Lajos street E Budapest 1036 LadeePharma LTD. Lajos street E Budapest 1036 Laboratorios Leon Farma SA Calle La Vallina S/N Poligono Industrial Navatejera Navatejera, Leon E drospirenone ethinylestradiol drospirenone ethinylestradiol drospirenone ethinylestradiol drospirenone ethinylestradiol drospirenone ethinylestradiol drospirenone ethinylestradiol GYNDORA CONTINUOUS INKODESS INKODESS CONTINUOUS JANGEE /0.0 JANGEE /0.0 JANGEE NAPONTA 3 mg/0.0 0,0 EMA/713187/2012 Page 116/253

117 Laboratorios Leon Farma SA Calle La Vallina S/N Poligono Industrial Navatejera Navatejera, Leon E drospirenone ethinylestradiol drospirenone ethinylestradiol drospirenone ethinylestradiol drospirenone ethinylestradiol drospirenone ethinylestradiol drospirenone ethinylestradiol drospirenone ethinylestradiol JANGEE NAPONTA 3 mg/0.0 KATUL KATUL CONTINUOUS KLEODINA KYLIXA KYLNETTA KYLNETTA CONTINUOUS 0,0 0,0 0,0 0,0 0,0 0,0 EMA/713187/2012 Page 117/253

118 drospirenone ethinylestradiol drospirenone ethinylestradiol drospirenone ethinylestradiol drospirenone ethinylestradiol drospirenone ethinylestradiol drospirenone ethinylestradiol drospirenone ethinylestradiol drospirenone ethinylestradiol LILAS LULINA MINKIAN PERLITA PYRLA PYRLA CONTINUOUS REZIA SEELAR 0,0 0,0 0,0 EMA/713187/2012 Page 118/253

119 LadeePharma LTD. Lajos street E Budapest 1036 drospirenone ethinylestradiol drospirenone ethinylestradiol drospirenone ethinylestradiol drospirenone ethinylestradiol drospirenone ethinylestradiol drospirenone ethinylestradiol drospirenone ethinylestradiol drospirenone ethinylestradiol SELIKYNE SVELTA SYMICIA TENTACIA TOLUKIM VELGYN VESPIREA VIVIENNE 0.02mg 0,0 0,0 EMA/713187/2012 Page 119/253

120 Bayer Hungaria ltd Alkotás street 50. Budapest 1123 Bayer Hungaria ltd Alkotás street 50. Budapest 1123 Sanofi Aventis PLC Tó street 1-5. Budapest 1045 Hunagry drospirenone ethinylestradiol drospirenone ethinylestradiol drospirenone ethinylestradiol drospirenone ethinylestradiol drospirenone ethinylestradiol drospirenone ethinylestradiol drospirenone ethinylestradiol gestodene ethinylestradiol VOLINA XINDEA YADINE YASMINELLE ZEELAR CONTINUOUS ZEPHIRENE ZOA DALIA 0,0 0,0 0,0 0,0 0,0 0,075mg 0,02mg EMA/713187/2012 Page 120/253

121 Bayer Hungaria ltd Alkotás street 50. Budapest 1123 Aramis Pharma Kft. Mester u. 28B III/ Budapest Aramis Pharma Kft. Mester u. 28B III/ Budapest Pfizer LTD. Alkotás street 53 MOM Park F, Budapest 1123 Hunagry Sandoz LTD Bartók Béla street Budapest 1114 Sandoz LTD Bartók Béla street Budapest 1114 gestodene ethinylestradiol gestodene ethinylestradiol gestodene ethinylestradiol gestodene ethinylestradiol gestodene ethinylestradiol gestodene ethinylestradiol gestodene ethinylestradiol gestodene ethinylestradiol FEMODEN GESTOMIX GESTOMIX HARMONET IAMNA IAMNA LINDYNETTE LINDYNETTE 0,075mg 0,03mg 0,075mg 0,02mg 0,075mg 0,03mg 0,075mg 0,02mg 0,075mg 0,02mg 0,075mg 0,03mg 0,075mg 0,02mg 0,075mg 0,03mg EMA/713187/2012 Page 121/253

122 Bayer Hungaria ltd Alkotás street 50. Budapest 1123 Pfizer LTD. Alkotás street 53 MOM Park F, Budapest 1123 Hunagry SOLDRA International Kft. Ady Endre u. 22. Budapest 1024 SOLDRA International Kft. Ady Endre u. 22. Budapest 1024 Teva PLC Pallagi street 13., Debrecen 4042 Teva PLC Pallagi street 13., Debrecen 4042 gestodene ethinylestradiol gestodene ethinylestradiol gestodene ethinylestradiol gestodene ethinylestradiol gestodene ethinylestradiol gestodene ethinylestradiol gestodene ethinylestradiol MELIANE MILLIGEST MINULET MIRABELLA MIRABELLA SENSONETTE SENSONETTE 0,075mg 0,02mg 0,05mg/0,03mg 0,07mg/0,04mg 0,01mg/0,03mg 0,075mg 0,03mg 0,075mg 0,02mg 0,075mg 0,03mg 0,075mg 0,02mg 0,075mg 0,03mg EMA/713187/2012 Page 122/253

123 Medico Uno Pharma Kft. Viadukt u. 12 Biatorbágy 2051 Bayer Hungaria ltd Alkotás street 50. Budapest 1123 LadeePharma LTD. Lajos street E Budapest 1036 Sanofi Aventis PLC Tó street 1-5. Budapest 1045 Hunagry gestodene ethinylestradiol gestodene ethinylestradiol gestodene ethinylestradiol gestodene ethinylestradiol gestodene ethinylestradiol Dienogest Dienogest Dienogest SOLDANELLE 0,06mg/0,015mg STODETTE TRIODENA ZULFIJA ZULFIJA MISTRAL DIENILLE BONADEA 0,075mg 0,02mg 0,05mg/0,03mg 0,07mg/0,04mg 0,1mg/0,03mg 0,075mg 0,02mg 0,075mg 0,03mg 2mg 0,03mg 2mg 0,03mg 2mg 0,03mg EMA/713187/2012 Page 123/253

124 Bayer Hungaria ltd Alkotás street 50. Budapest 1123 N.V. Organon Kloosterstraat AB, Oss N.V. Organon Kloosterstraat AB, Oss Zentiva, k.s. U kabelovny Praha 10 Dolní Měcholupy Zentiva, k.s. U kabelovny Praha 10 Dolní Měcholupy N.V. Organon Kloosterstraat AB, Oss Bayer Pharma AG Müllerstraße 178 D Berlin Dienogest etonogestrel ethinylestradiol etonogestrel ethinylestradiol desogestrel ethinylestradiol desogestrel ethinylestradiol desogestrel ethinylestradiol drospirenone ethinylestradiol QLAIRA NUVARING CIRCLET Estmar Estmar Marvelon Angeliq 2mg 0,03mg 0,12mg 0,015mg 0,12mg 0,015mg 0.15mg 0.02mg 0.15mg 0.03mg 0.15mg 0.03mg 3mg 0,02mg Vaginal delivery system Vaginal delivery system Vaginal use Vaginal use EMA/713187/2012 Page 124/253

125 Laboratorios Leon Farma SA Calle La Vallina S/N Poligono Industrial Navatejera Navatejera, Leon E Laboratorios Leon Farma SA Calle La Vallina S/N Poligono Industrial Navatejera Navatejera, Leon E Bayer Pharma AG Müllerstraße 178 D Berlin Gyömrői út Ratiopharm GmbH Graf-Arco-Strasse 3 DE Ulm Zentiva HU Kft. Tó u Budapest drospirenone ethinylestradiol drospirenone ethinylestradiol drospirenone ethinylestradiol Chlormadinone acetate Chlormadinone Chlormadinone Drosetil NAPONTA / 0,02mg filmtabletta Drosetil NAPONTA / 0,0 filmtabletta Flexyess Belara Claranette-ratiopharm Clomet 3mg 0,02mg 3mg 0,03mg 3mg 0,02mg 0,03mg 2mg 2mg 0.03mg 2mg 0.03mg EMA/713187/2012 Page 125/253

126 Iceland Iceland Iceland Iceland Iceland Iceland Laboratorios Leon Farma SA Calle La Vallina S/N Poligono Industrial Navatejera Navatejera, Leon E Bayer Pharma AG Müllerstraße 178 D Berlin Bayer Pharma AG Müllerstraße 178 D Berlin Bayer Pharma AG Müllerstraße 178 D Berlin N.V. Organon Kloosterstraat AB, Oss N.V. Organon Kloosterstraat AB, Oss N.V. Organon Kloosterstraat AB, Oss Chlormadinone Estradiol Drospirenon betadex-clatrat Drospirenon betadex-clatrat Drospirenon Deogestrel Deogestrel Deogestrel Clormetin Angemin Yasminelle YAZ Gracial Marvelon 2mg 0.03mg 1mg 2mg 0,02mg 0,02mg 0.030mg mg mg Mercilon 0.020mg mg EMA/713187/2012 Page 126/253

127 Iceland Iceland Iceland Iceland Iceland Iceland Iceland Bayer AB Postbox 606 Gustav III's Boulevard 56 SE Solna Sweden Bayer AB Postbox 606 Gustav III's Boulevard 56 SE Solna Sweden Bayer Pharma AG Müllerstraße 178 D Berlin Bayer Pharma AG Müllerstraße 178 D Berlin Pfizer ApS, Lautrupvang 8, DK-2750 Ballerup, Actavis Group PTC ehf Reykjavikurvegi Hafnarfjordur Iceland Actavis Group PTC ehf Reykjavikurvegi Hafnarfjordur Iceland Drospirenon Drospirenon Drospirenon Drospirenon gestoden /ethinyle stradiol /ethinyle stradiol Eloine Palandra Yasmin Yasmin 28 0,02mg 0,03mg 0,03mg 0,03mg Harmonet 0.020mg mg Benidette Benifema 0,15 m 0,0 EMA/713187/2012 Page 127/253

128 Iceland Iceland Iceland Ireland Ireland Ireland Bayer AB Postbox 606 Gustav III's Boulevard 56 SE Solna Sweden N.V. Organon Kloosterstraat AB, Oss Bayer AB Postbox 606 Gustav III's Boulevard 56 SE Solna Sweden Organon (Ireland) Ltd, PO Box 2857, Drynam Road, Swords, Co.Dublin, Ireland Organon (Ireland) Ltd, PO Box 2857, Drynam Road, Swords, Co.Dublin, Ireland Dropsirenone/ethinyl estradiol etonogestrelum um Dienogestum um Flexyess NuvaRing 3mg 11,7 mg 2,7 mg Qlaira 0/3mg - 2mg/ - 3mg/2mg - 0/1mg Gracial Leticia Marviol 0.025mg 0.040mg 0.125mg 0.030mg 0.150mg 0.030mg 0.150mg 0.030mg Vaginal delivery system Vaginal use EMA/713187/2012 Page 128/253

129 Ireland Ireland Ireland Ireland Ireland Ireland Ireland Organon (Ireland) Ltd, PO Box 2857, Drynam Road, Swords, Co.Dublin, Ireland Bayer Limited The Atrium, Blackthorn Road, Dublin 18, Ireland Teva Pharma BV Computerweg DR Utrecht Bayer Limited The Atrium, Blackthorn Road, Dublin 18, Ireland Teva Pharma BV Computerweg DR Utrecht Estradiol Dienogest as betadex Clathate Mercilon Vivides Qlaira Dretine Yaz Dretinelle Enador 0.150mg 0.020mg 0.150mg 0.020mg 3mg/2mg/1mg 2mg/3mg 0.3mg 3mg 0.02mg 3mg 0.02mg 3mg 0.02mg 3mg EMA/713187/2012 Page 129/253

130 Ireland Ireland Ireland Ireland Ireland Ireland Laboratorios Leon Farma SA Calle La Vallina S/N Poligono Industrial Navatejera Navatejera, Leon E Laboratorios Leon Farma SA Calle La Vallina S/N Poligono Industrial Navatejera Navatejera, Leon E Laboratorios Leon Farma SA Calle La Vallina S/N Poligono Industrial Navatejera Navatejera, Leon E Rowex Ltd Bantry Co. Cork Ireland Enador&Placebo / Leon Farma / Leon Farma & Placebo / Leon Farma & Placebo /Drospiren one Gedeon Richter Freedo 0.02mg 3mg 0.02mg 3mg 0.02mg 3mg 0.03mg 3mg 0.03mg 3mg 0.03mg 3mg EMA/713187/2012 Page 130/253

131 Ireland Ireland Ireland Ireland Ireland Ireland Ireland Ireland Rowex Ltd Bantry Co. Cork Ireland Rowex Ltd Bantry Co. Cork Ireland Rowex Ltd Bantry Co. Cork Ireland Bayer Limited The Atrium, Blackthorn Road, Dublin 18, Ireland Teva Pharma BV Computerweg DR Utrecht Bayer Limited The Atrium, Blackthorn Road, Dublin 18, Ireland Bayer Limited The Atrium, Blackthorn Road, Dublin 18, Ireland Freedo&Placebo Freedonel Freedonel&Placebo Palandra Svelta Veyann Yasmin Yasminelle 0.03mg 3.0mg 0.02mg 3mg 0.02mg 3.0mg 0.03mg 3mg 0.02mg 3mg 0.02mg 3mg 0.03mg 3mg 0.02mg 3mg EMA/713187/2012 Page 131/253

132 Ireland Ireland Ireland Ireland Ireland Bayer Limited The Atrium, Blackthorn Road, Dublin 18, Ireland Organon (Ireland) Ltd, PO Box 2857, Drynam Road, Swords, Co.Dublin, Ireland Organon (Ireland) Ltd, PO Box 2857, Drynam Road, Swords, Co.Dublin, Ireland Pfizer Healthcare Ireland 9 Riverwalk National Digital Park Citywest Business Campus Dublin 24 Ireland Clonmel Healthcare Ltd Waterford Road Clonmel Co Tipperary Ireland (as betadex Clathate) Etonogestrel Etonogestrel Liofora Circlet Nuvaring Tri-minulet Estelle 0.02mg 3mg 11.7mg 2.7mg 11.7mg 2.7mg 0.050mg/0.070mg/0.100mg 0.030mg/0.040mg/0.030mg 0.075mg 0.020mg Vaginal delivery system Vaginal delivery system Vaginal use Vaginal use EMA/713187/2012 Page 132/253

133 Ireland Ireland Ireland Ireland Clonmel Healthcare Ltd Waterford Road Clonmel Co Tipperary Ireland Pfizer Healthcare Ireland 9 Riverwalk National Digital Park Citywest Business Campus Dublin 24 Ireland Pfizer Healthcare Ireland 9 Riverwalk National Digital Park Citywest Business Campus Dublin 24 Ireland Pfizer Healthcare Ireland 9 Riverwalk National Digital Park Citywest Business Campus Dublin 24 Ireland Estelle Harmonet Minesse Minulet 0.075mg 0.030mg 0.075mg 0.020mg 0.060mg 0.015mg 0.075mg 0.030mg EMA/713187/2012 Page 133/253

134 Ireland Ireland Italy Italy Italy Italy Janssen-Cilag Limited Holmers Farm Way High Wycombe Buckinghamshire HP12 4EG United Kingdom Laboratorios Leon Farma SA C/Roa de la Vega Leon Teva Italia S.r.l. via Messina Milano Italy MYLAN S.P.A. Viale dell'innovazione, 3, Milano Italy MYLAN S.P.A. Viale dell'innovazione, 3, Milano Italy A. Menarini Industrie Farmaceutiche Riunite s.r.l., via Sette Santi, Florence Italy Norgestimate Etinylestradiol Cilest / Leon Farma DENISELLE DESOGESTREL E ETINILESTRADIOLO MYLAN GENERICS DESOGESTREL E ETINILESTRADIOLO MYLAN GENERICS DUEVA 0.250mg 0.035mg 0.03mg 3mg 0,150 mg 0,0 0,025mg/ 0,040mg ; 0,125mg/ 0,030mg EMA/713187/2012 Page 134/253

135 Italy Italy Italy Italy Italy Italy Farmitalia Industrie Chimico Farmaceutiche Via Alcide De Gasperi, 165 B Catania Italy Farmitalia Industrie Chimico Farmaceutiche Via Alcide De Gasperi, 165 B Catania Italy N.V. Organon Kloosterstraat AB, Oss N.V. Organon Kloosterstraat AB, Oss N.V. Organon Kloosterstraat AB, Oss Farmitalia Industria chimico farmaceutica S.R.L Via Alcide De Gasperi 165/B Catania Italy ANTELA ANTELA GRACIAL LUCILLE MERCILON NOVYNETTE 0,0 0,025mg/ 0,040mg ; 0,125mg/ 0,030mg 0,05mg/0,035mg; 0,100mg/0,030mg; 0,150mg/0,030 mg EMA/713187/2012 Page 135/253

136 Italy Italy Italy Italy Italy Italy A. Menarini Industrie Farmaceutiche Riunite s.r.l., via Sette Santi, Florence Italy N.V. Organon Kloosterstraat AB, Oss A. Menarini Industrie Farmaceutiche Riunite s.r.l., via Sette Santi, Florence Italy EG S.P.A. Via Pavia, Milano Italy EG S.P.A. Via Pavia, Milano Italy Cyndea Pharma S.L. Polígono Industrial Emiliano Revilla Sanz Av. De Ágreda Ólvega (Soria) PLANUM PRACTIL SECURGIN ZAKIRA ZAKIRA ZYNTHIA 0,150 mg 0,0 0,150 mg 0,0 0,150 mg 0, mg 0.03mg EMA/713187/2012 Page 136/253

137 Italy Italy Italy Italy Italy Italy Italy Italy Effik Italia S.p.A. Via Lincoln 7/A, Cinisello Balsamo (MI) Italy Bayer S.p.A. Viale Certosa, Milano (MI) Italy Sandoz Spa Largo U. Boccioni, Origgio (VA) Italy Effik Italia S.p.A. Via Lincoln 7/A, Cinisello Balsamo (MI) Italy Effik Italia S.p.A. Via Lincoln 7/A, Cinisello Balsamo (MI) Italy Doc Generici S.R.L. Via Manuzio Milano Italy Dienogest Dienogest EFFIPREV SIBILLA ALIANE CALINDIR CREDIGYNE CREDIGYNETTE DAYLETTE DOCGYN 0,00 0,00 0,0 0,0 0,0 0,0 EMA/713187/2012 Page 137/253

138 Italy Italy Italy Italy Italy Italy Italy Italy Doc Generici S.R.L. Via Manuzio Milano Italy Effik Italia S.p.A. Via Lincoln 7/A, Cinisello Balsamo (MI) Italy Effik Italia S.p.A. Via Lincoln 7/A, Cinisello Balsamo (MI) Italy Effik Italia S.p.A. Via Lincoln 7/A, Cinisello Balsamo (MI) Italy Bayer S.p.A. Viale Certosa, Milano (MI) Italy Doc Generici S.R.L. Via Manuzio Milano Italy Doc Generici S.R.L. Via Manuzio Milano Italy Doc Generici S.R.L. Via Manuzio Milano Italy DOCTYNE DROSPIL DROSURE DROSURELLE ELOINE ETINILESTRADIOLO E DROSPIRENONE DOC ETINILESTRADIOLO E DROSPIRENONE DOC GENERICI ETINILESTRADIOLO E DROSPIRENONE DOCGEN 0,0 0,0 0,0 0,0 0,0 EMA/713187/2012 Page 138/253

139 Italy Farmitalia Industria chimico farmaceutica S.R.L Via Alcide De Gasperi 165/B Catania Italy LERNA Italy Italy Italy Italy Italy Italy Teva Italia S.r.l. via Messina Milano Italy Teva Italia S.r.l. via Messina Milano Italy Sandoz Spa Largo U. Boccioni, Origgio (VA) Italy Bayer S.p.A. Viale Certosa, Milano (MI) Italy LILADROS LUSINE LUSINELLE MIDIANA RUBIRA YASMIN 0,0 0,0 0,0 EMA/713187/2012 Page 139/253

140 Italy Italy Italy Bayer S.p.A. Viale Certosa, Milano (MI) Italy Bayer S.p.A. Viale Certosa, Milano (MI) Italy Farmitalia Industria chimico farmaceutica S.R.L Via Alcide De Gasperi 165/B Catania Italy YASMINELLE YAZ ALCMENA 0,0 0,06 mg 0,015 mg Italy Italy Italy Italy Bayer S.p.A. Viale Certosa, Milano (MI) Italy Effik Italia S.p.A. Via Lincoln 7/A, Cinisello Balsamo (MI) Italy ARIANNA EDESIA EDESIA ESTINETTE 0,06 mg 0,015 mg 0,0 EMA/713187/2012 Page 140/253

141 Italy Italy Italy Italy Italy Alfra di anselmo leonarda & C. SNC, viale Manzoni, Roma, Italy Mylan S.p.A. Via Aquileia, Cinisello Balsamo (MI) Italy Mylan S.p.A. Via Aquileia, Cinisello Balsamo (MI) Italy Bayer S.p.A. Viale Certosa, Milano (MI) Italy Farmitalia Industria chimico farmaceutica S.R.L Via Alcide De Gasperi 165/B Catania Italy ETINILESTRADIOLO E GESTODENE ALFRA ETINILESTRADIOLO E GESTODENE MYLAN GENERICS ETINILESTRADIOLO E GESTODENE MYLAN GENERICS FEDRA GESTODIOL 0,06 mg 0,015 mg 0,0 EMA/713187/2012 Page 141/253

142 Italy Farmitalia Industria chimico farmaceutica S.R.L Via Alcide De Gasperi 165/B Catania Italy GESTODIOL 0,0 Italy Italy Italy Italy Italy Italy Bayer S.p.A. Viale Certosa, Milano (MI) Italy WYETH MEDICA IRELAND Newbridge Ireland Effik Italia S.p.A. Via Lincoln 7/A, Cinisello Balsamo (MI) Italy Teva Italia S.r.l. via Messina Milano Italy Teva Italia S.r.l. via Messina Milano Italy Bayer S.p.A. Viale Certosa, Milano (MI) Italy GINODEN HARMONET KIPLING LIUDA LIUDA MILVANE 0,0 0,0 0,0 0,05mg/0,030mg; 0,070mg/0,040mg; 0,100mg/0,030 mg EMA/713187/2012 Page 142/253

143 Italy Italy Italy Italy Italy Italy Latvia Latvia Pfizer Italia S.r.l., via Isonzo, Latina Italy WYETH MEDICA IRELAND Newbridge Ireland WYETH MEDICA IRELAND Newbridge Ireland Sandoz Spa Largo U. Boccioni, Origgio (VA) Italy Actavis Group PTC ehf Reykjavikurvegi Hafnarfjordur Iceland Actavis Group PTC ehf Reykjavikurvegi Hafnarfjordur Iceland UAB Ladee Pharma Baltics Zemaitijos g.13/siauliu g.10 Vilnius LT Lithuania Zentiva, k.s. U kabelovny Praha 10 Dolní Měcholupy Chlormadinoni acetas um um um MINESSE MINULET TRIMINULET YVETTE ZOE ZOE Clormetin /0,0 film-coated tablets Estmar 150/20 micrograms tablets 0,06 mg 0,015 mg 0,0 0,05mg/0,030mg; 0,070mg/0,040mg; 0,100mg/0,030 mg 0,06 mg 0,015 mg 0,0 0,0 EMA/713187/2012 Page 143/253

144 Latvia Latvia Latvia Latvia Latvia Latvia Latvia Latvia Zentiva, k.s. U kabelovny Praha 10 Dolní Měcholupy N.V. Organon Kloosterstraat AB, Oss N.V. Organon Kloosterstraat AB, Oss Organon (Ireland) Ltd, PO Box 2857, Drynam Road, Swords, Co.Dublin, Ireland Orivas UAB J.Jasinskio 16B LT Vilinius Lithuania um um um um um um um um um um um um um um Dienogestum um Estmar 150/30 micrograms tablets Gracial tablets Marvelon 150/30 micrograms tablets Mercilon 150/20 micrograms tablets Novynette 150/20 microgram film-coated tablets Novynette Plus 150 micrograms/ 20 micrograms film-coated tablets Regulon 150/30 micrograms film-coated tablets Ammily /0,0 film-coated tablets 0,030 mg mg/0.040 mg mg /0.030 mg 0,030 mg 0,030 mg 0,0 EMA/713187/2012 Page 144/253

145 Latvia Latvia Latvia Latvia Latvia Latvia Latvia Latvia Jenapharm GmbH & Co. KG Otto-Schott-Straße Jena Deutschland Zentiva, k.s. U kabelovny Praha 10 Dolní Měcholupy Ivowen Limited 3, Anglesea Street Clonmel Co. Tipperary Ireland Bayer Pharma AG Müllerstraße 178 D Berlin Bayer Pharma AG Müllerstraße 178 D Berlin Dienogestum um Dienogestum um Dienogestum um Drospirenonum um Drospirenonum um Drospirenonum um Estradioli valeras Dienogestum Chlormadinon acetate Jeanine 2000/30 micrograms film-coated tablets Sibilla /0,0 filmcoated tablets Zenadea /0,0 film-coated tablets Lulina /0,0 filmcoated tablets Midiana 3mg/0,0 film-coated tablets Yarina 3000/30 micrograms film-coated tablets Qlaira film-coated tablets Belara 0,0/ filmcoated tablets 0,0 0,0 0,0 0,0 0,0 0,0 / / 1 mg 0,0 EMA/713187/2012 Page 145/253

146 Latvia Latvia Latvia Latvia Latvia Latvia Laboratorios Leon Farma SA Poligono Industrial Navatejera, La Vallina s/n, Villaquilambre,Leon Laboratorios Leon Farma SA Poligono Industrial Navatejera, La Vallina s/n, Villaquilambre,Leon Laboratorios Leon Farma SA Poligono Industrial Navatejera, La Vallina s/n, Villaquilambre,Leon um Drospirenonum um Drospirenonum um Drospirenonum um Drospirenonum um Drospirenonum um Drospirenonum Aneea / filmcoated tablets Belusha / film-coated tablets Daylette / film-coated tablets Drosetil / 28 film-coated tablets Drosetil 0,0/ 28 film-coated tablets Etindros / 28 film-coated tablets 0,0 EMA/713187/2012 Page 146/253

147 Latvia Latvia Latvia Latvia Latvia UAB Ladee Pharma Baltics Zemaitijos g.13/siauliu g.10 Vilnius LT Lithuania UAB Ladee Pharma Baltics Zemaitijos g.13/siauliu g.10 Vilnius LT Lithuania Laboratorios Leon Farma SA Poligono Industrial Navatejera, La Vallina s/n, Villaquilambre,Leon Laboratorios Leon Farma SA Poligono Industrial Navatejera, La Vallina s/n, Villaquilambre,Leon Zentiva, k.s. U kabelovny Praha 10 Dolní Měcholupy um Drospirenonum um Drospirenonum um Drospirenonum um Drospirenonum um Drospirenonum Etindros / film-coated tablets Etindros 0,0/ film-coated tablets Etindros 0,0/ 28 film-coated tablets Ferranelles / film-coated tablets Sidretella / film-coated tablets 0,0 0,0 EMA/713187/2012 Page 147/253

148 Latvia Latvia Latvia Latvia Latvia Latvia Latvia Zentiva, k.s. U kabelovny Praha 10 Dolní Měcholupy UAB Ladee Pharma Baltics Zemaitijos g.13/siauliu g.10 Vilnius LT Lithuania Bayer Pharma AG Müllerstraße 178 D Berlin Bayer Pharma AG Müllerstraße 178 D Berlin Bayer Pharma AG Müllerstraße 178 D Berlin N.V. Organon Kloosterstraat AB, Oss um Drospirenonum um Drospirenonum um Drospirenonum um Drospirenonum um Drospirenonum um Drospirenonum Etonogestrelum um Sidretella 0,0/ film-coated tablets Teenia / film-coated tablets Velgyn / film-coated tablets Yasminelle / film-coated tablets YAZ / filmcoated tablets Yvidually / film-coated tablets NuvaRing 120/15 micrograms/24 hours vaginal delivery system 0,0 120mg mg Vaginal delivery system Vaginal use EMA/713187/2012 Page 148/253

149 Latvia Latvia Latvia Latvia Latvia Latvia Latvia Latvia Zentiva, k.s. U kabelovny Praha 10 Dolní Měcholupy Bayer Pharma AG Müllerstraße 178 D Berlin Ratiopharm GmbH Graf-Arco-Strasse 3 DE Ulm Ratiopharm GmbH Graf-Arco-Strasse 3 DE Ulm Pfizer Europe MA EEIG Ramsgate Road, Sandwich, Kent CT 13 9NJ United Kingdom Gestodenum um Gestodenum um Gestodenum um Gestodenum um Gestodenum um Gestodenum um Gestodenum um Gestodenum um ARTIZIA 75 micrograms/20 micrograms coated tablets Edesia 75 micrograms/20 micrograms coated tablets Femoden 75/30 micrograms film-coated tablets Gesytil 75/20 micrograms coated tablets Gesytil 75/30 micrograms coated tablets Harmonet 75 micrograms/20 micrograms film-coated tablets Lindynette 75/20 micrograms coated tablets Lindynette 75/30 micrograms coated tablets 0,0 0,0 0,0 EMA/713187/2012 Page 149/253

150 Latvia Latvia Latvia Latvia Latvia Latvia Latvia Bayer Pharma AG Müllerstraße 178 D Berlin Pfizer Europe MA EEIG Ramsgate Road, Sandwich, Kent CT 13 9NJ United Kingdom Bayer Pharma AG Müllerstraße 178 D Berlin UAB Ladee Pharma Baltics Zemaitijos g.13/siauliu g.10 Vilnius LT Lithuania UAB Johnson & Johnson Geležinio Vilko g. 18A LT Vilnius Lithuania Gestodenum um Gestodenum um Gestodenum um Gestodenum um Gestodenum um Gestodenum um Norgestimatum um Logest 75 micrograms/20 micrograms film-coated tablets Minulet 75 micrograms/30 micrograms coated tablets Mirelle 60/15 micrograms film-coated tablets Violetta 60 micrograms/15 micrograms film-coated tablets VONILLE 60 micrograms/15 micrograms film-coated tablets Zulfija 75 micrograms/30 micrograms coated tablets Cilest 250/35 micrograms tablets 0,0 0,06 mg 0,015 mg 0,06 mg 0,015 mg 0,06 mg 0,015 mg 0,0 0,25 mg 0,035 mg EMA/713187/2012 Page 150/253

151 Lithuania Lithuania Lithuania Lithuania Lithuania Lithuania Lithuania UAB Orivas J.Jasinskio 16B, LT Vilnius Lithuania Jenapharm GmbH & Co. KG Otto-Schott-Straße Jena Deutschland Zentiva, k.s. U kabelovny Praha 10 Dolní Měcholupy Laboratorios Leon Farma SA Poligono Industrial Navatejera, La Vallina s/n, Villaquilambre,Leon Ivowen Limited 3, Anglesea Street Clonmel Co. Tipperary Ireland Dienogest Dienogest Dienogest Dienogest Ammily Jeanine SIBILLA Zenadea Espirol LULINA MIDIANA 0,0 0,0 0,0 0,0 0,0 0,0 0,0 EMA/713187/2012 Page 151/253

152 Lithuania Lithuania Lithuania Lithuania Lithuania Lithuania Lithuania Laboratorios Leon Farma SA Poligono Industrial Navatejera, La Vallina s/n, Villaquilambre,Leon Zentiva, k.s. U kabelovny Praha 10 Dolní Měcholupy Bayer Pharma AG Müllerstraße 178 D Berlin Bayer Pharma AG Müllerstraße 178 D Berlin Bayer Pharma AG Müllerstraße 178 D Berlin Estradiol Estradiol Estradiol+Dienogest Estradiol+Dienogest Estradiol Chlormadinone Pirestrol Sidretella Yarina Angeliq Qlaira Belara ANEEA 0,0 0,0 0,0 1mg 2mg 0mg/ 2mg/2mg 2mg/3mg 1mg 0,0 EMA/713187/2012 Page 152/253

153 Lithuania Lithuania Lithuania Lithuania Lithuania Lithuania Laboratorios Leon Farma SA Poligono Industrial Navatejera, La Vallina s/n, Villaquilambre,Leon UAB Ladee Pharma Baltics Zemaitijos g.13/siauliu g.10 Vilnius LT Lithuania UAB Ladee Pharma Baltics Zemaitijos g.13/siauliu g.10 Vilnius LT Lithuania Zentiva, k.s. U kabelovny Praha 10 Dolní Měcholupy BELUSHA DAYLETTE Espirol Etindros Etindros Ferranelles 0,0 EMA/713187/2012 Page 153/253

154 Lithuania Lithuania Lithuania Lithuania Lithuania Lithuania Laboratorios Leon Farma SA Poligono Industrial Navatejera, La Vallina s/n, Villaquilambre,Leon Zentiva, k.s. U kabelovny Praha 10 Dolní Měcholupy UAB Ladee Pharma Baltics Zemaitijos g.13/siauliu g.10 Vilnius LT Lithuania Bayer Pharma AG Müllerstraße 178 D Berlin Bayer Pharma AG Müllerstraße 178 D Berlin Pirestrol Sidretella TEENIA Velgyn Yasminelle YAZ EMA/713187/2012 Page 154/253

155 Lithuania Lithuania Lithuania Lithuania Lithuania Lithuania Lithuania Pfizer Europe MA EEIG Ramsgate Road, Sandwich, Kent CT 13 9NJ United Kingdom Pfizer Europe MA EEIG Ramsgate Road, Sandwich, Kent CT 13 9NJ United Kingdom Zentiva, k.s. U kabelovny Praha 10 Dolní Měcholupy Bayer Pharma AG Müllerstraße 178 D Berlin Ratiopharm GmbH Graf-Arco-Strasse 3 DE Ulm Ratiopharm GmbH Graf-Arco-Strasse 3 DE Ulm Harmonet Minulet ARTIZIA Femoden Gesytil Gesytil Lindynette mg 0,0 0,0 0,0 EMA/713187/2012 Page 155/253

156 Lithuania Lithuania Lithuania Lithuania Lithuania Lithuania Lithuania Lithuania Bayer Pharma AG Müllerstraße 178 D Berlin Bayer Pharma AG Müllerstraße 178 D Berlin UAB Ladee Pharma Baltics Zemaitijos g.13/siauliu g.10 Vilnius LT Lithuania UAB Johnson & Johnson Geležinio Vilko g. 18A LT Vilnius Lithuania Norgestimate Lindynette Logest Mirelle VIOLETTA VONILLE ZULFIJA ZULFIJA Cilest 0,06 mg 0,015 mg 0,06 mg 0,015 mg 0,06 mg 0,015 mg 0,0 0,25 mg 0,035 mg EMA/713187/2012 Page 156/253

157 Lithuania Lithuania Lithuania Lithuania Lithuania Lithuania Lithuania Lithuania Zentiva, k.s. U kabelovny Praha 10 Dolní Měcholupy Zentiva, k.s. U kabelovny Praha 10 Dolní Měcholupy N.V. Organon Kloosterstraat AB, Oss N.V. Organon Kloosterstraat AB, Oss N.V. Organon Kloosterstraat AB, Oss +Ehtinyl estradiol;desogestre l+etinilestradiolis ESTMAR ESTMAR 0,15m 0,03mg Gracial Marvelon 0,15m 0,03mg Mercilon 0,15m 0,02mg NOVYNETTE 0,15m 0,02mg REGULON 0,15m 0,03mg NOVYNETTE CONTINUOUS 0,15m 0,02mg 0,025mg+0,04m 0,125mg+0,03mg EMA/713187/2012 Page 157/253

158 Lithuania Lithuania Lithuania Luxembourg Luxembourg Luxembourg Luxembourg Luxembourg N.V. Organon Kloosterstraat AB, Oss N.V. Organon Kloosterstraat AB, Oss UAB Johnson & Johnson Geležinio Vilko g. 18A LT Vilnius Lithuania BAYER N.V. J.E. Mommaertslaan Diegem Madaus GmbH Colonia Allee Köln Mithra Pharmaceuticals S.A. Rue Saint Georges Liège Ratiopharm GmbH Graf-Arco-Strasse 3 DE Ulm Etonogestrel+Ethinyl estradiol Etonogestrel+Ethinyl estradiol Norgestimate+Ethin ylestradiol Estradiol Valerate Dienogest Chlormadinone Acetate Chlormadinone Acetate Chlormadinone Acetate Chlormadinone Acetate Circlet NuvaRing Cilest Qlaira Bellina Bellissima Helen Verana-ratiopharm 0,12mg 0,015mg 0,12mg 0,015mg 0,25mg 0,035mg / / / 1 mg 0,0 0,0 0,0 0,0 Vaginal delivery system Vaginal delivery system Vaginal use Vaginal use EMA/713187/2012 Page 158/253

159 Luxembourg Luxembourg Luxembourg Luxembourg Luxembourg Luxembourg Luxembourg Luxembourg N.V. Organon Kloosterstraat AB, Oss N.V. Organon Kloosterstraat AB, Oss N.V. Organon Kloosterstraat AB, Oss Mithra Pharmaceuticals S.A. Rue Saint Georges Liège Dienogest Deso 20 Gracial Marvelon Mercilon Regulon Louise Annabelle Annais 0.04 mg /0,025 mg 0.0 /0,125 mg 0,0 0,0 0,0 0,0 EMA/713187/2012 Page 159/253

160 Luxembourg Luxembourg Luxembourg Luxembourg Luxembourg Luxembourg Luxembourg Teva Pharma N.V. Laarstraat Wilrijk Teva Pharma N.V. Laarstraat Wilrijk Teva Pharma N.V. Laarstraat Wilrijk Teva Pharma N.V. Laarstraat Wilrijk Bayer Sante 220 avenue de la Recherche Loos BAYER N.V. J.E. Mommaertslaan Diegem BAYER N.V. J.E. Mommaertslaan Diegem LaYaisa LaYanina LaYnes LaYva Palandra Yasmin Yasminelle 0,0 0,0 0,0 0,0 EMA/713187/2012 Page 160/253

161 Luxembourg Luxembourg Luxembourg Luxembourg Luxembourg Luxembourg Luxembourg BAYER N.V. J.E. Mommaertslaan Diegem N.V. Organon Kloosterstraat AB, Oss N.V. Organon Kloosterstraat AB, Oss BAYER N.V. J.E. Mommaertslaan Diegem Medimpex S.A. 1-3 rue Caumartin Paris Medimpex S.A. 1-3 rue Caumartin Paris PFIZER S.A. 17 Boulevard de la Plaine 1050 Brussels Etonogestrel Etonogestrel Yaz Circlet NuvaRing Femodene Gestodelle 20 Gestofeme 30 Harmonet 2,7 mg 11,7 mg 2,7 mg 11,7 mg 0,0 0,0 Vaginal delivery system Vaginal delivery system Vaginal use Vaginal use EMA/713187/2012 Page 161/253

162 Luxembourg Luxembourg Luxembourg Luxembourg Luxembourg Luxembourg Bayer Sante 220 avenue de la Recherche Loos PFIZER S.A. 17 Boulevard de la Plaine 1050 Brussels BAYER N.V. J.E. Mommaertslaan Diegem PFIZER S.A. 17 Boulevard de la Plaine 1050 Brussels BAYER N.V. J.E. Mommaertslaan Diegem JANSSEN-CILAG N.V. Antwerpseweg Beerse Norgestimate Meliane Minulet Mirelle Tri-Minulet Triodene Cilest 0,0 0,015 mg 0,06 mg 0,0 / 0,05 mg 0,04 mg / 0,07 mg 0,0 / 0,1 mg 0,0 /0,05 mg 0,04 mg / 0,07 mg 0,0 / 0,1 mg 0,035 mg 0,25 mg EMA/713187/2012 Page 162/253

163 Malta Malta Malta Malta Organon Laboratories Limited, Cambridge Science Park, Milton Road, Cambridge CB4 0FL, United Kingdom Bayer PLC Pharma Division, Bayer House, Strawberry Hill, Newbury, Berkshire RG14 1JA, United Kingdom Bayer PLC Pharma Division, Bayer House, Strawberry Hill, Newbury, Berkshire RG14 1JA, United Kingdom Bayer PLC Pharma Division, Bayer House, Strawberry Hill, Newbury, Berkshire RG14 1JA, United Kingdom Estradiol dienogest ethinylestradiol drospirenone Mercilon Qlaira, film-coated tablets ELOINE 0.0 / film coated tablets Palandra 0.0 / film-coated tablets 0.150mg; 0.020mg / / 1 mg mg/ 0.030mg 3mg EMA/713187/2012 Page 163/253

164 Malta Malta Malta Malta Malta Bayer PLC Pharma Division, Bayer House, Strawberry Hill, Newbury, Berkshire RG14 1JA, United Kingdom Bayer PLC Pharma Division, Bayer House, Strawberry Hill, Newbury, Berkshire RG14 1JA, United Kingdom Bayer PLC Pharma Division, Bayer House, Strawberry Hill, Newbury, Berkshire RG14 1JA, United Kingdom Bayer Limited The Atrium, Blackthorn Road, Dublin 18, Ireland Pfizer Hellas S.A. 243 Messoghion Avenue, N. Psychiko, Greece ethinylestradiol drospirenone (as betadex clathrate), (as betadex clathrate), Yasmin film-coated tablets 0.0/ Yaz 0.02mg/3mg filmcoated tablets Aliane Yasminelle 0.0/ film-coated tablets Minesse 0.030mg 3mg mg/ 0.0 3mg 0.0 3mg mg mg EMA/713187/2012 Page 164/253

165 Malta Malta Malta Malta Malta Malta Janssen-Cilag International N.V. Turnhoutseweg 30 B 2340 Beerse Stragen UK Limited, Castle Court, 41 London Road, Reigate, Surrey RH2 9RJ United Kingdom Stragen UK Limited, Castle Court, 41 London Road, Reigate, Surrey RH2 9RJ United Kingdom Organon Laboratories Limited, Cambridge Science Park, Milton Road, Cambridge CB4 0FL, United Kingdom N.V. Organon Kloosterstraat AB, Oss Bayer PLC Pharma Division Bayer House, Strawberry Hill Newbury RG14 1JA, Berkshire United Kingdom Norgestimate 20mcg, gestodene 75mcg 30mcg, gestodene 75mcg Etonogestrel Oestradiol (as estradiol hemihydrate) CILEST 250/35 microgram Oral Contraceptive s Sunya 20/75 Katya 30/75 Marvelon NuvaRing Angeliq 1 mg/ filmcoated tablets 0.250mg mg 20mcg, gestodene 75mcg 30mcg, gestodene 75mcg 0.15mg 0.03mg 11.7mg 2.7mg 1mg 2mg Vaginal delivery system Vaginal use EMA/713187/2012 Page 165/253

166 Norway Norway Norway Norway Norway Norway Norway Norway Medimpex UK Ltd, 127 Shirland Road, London W9 2EP United Kingdom Mylan AB, Postbox 23033, Ynglingagatan 14, SE Stockholm, Sweden Mylan AB, Postbox 23033, Ynglingagatan 14, SE Stockholm, Sweden N.V. Organon Kloosterstraat AB, Oss N.V. Organon Kloosterstraat AB, Oss N.V. Organon Kloosterstraat AB, Oss Medimpex UK Ltd, 127 Shirland Road, London W9 2EP United Kingdom Desodiolcont Igixon Lestramyl Lestramyl Marvelon Marvelon 28 Mercilon 28 Regulon mg mg mg mg EMA/713187/2012 Page 166/253

167 Norway Norway Norway Norway Norway Bayer AB Postbox 606 Gustav III's Boulevard 56 SE Solna Sweden Laboratorios Leon Farma SA Poligono Industrial Navatejera, La Vallina s/n, Villaquilambre,Leon Laboratorios Leon Farma SA Poligono Industrial Navatejera, La Vallina s/n, Villaquilambre,Leon Teva Sweden AB Järnvägsgatan 11 Box Helsingborg Sweden Teva Sweden AB Järnvägsgatan 11 Box Helsingborg Sweden Estradiol valerate Dienogest Qlaira Calima Calima 28 Dretine Dretine 28 / / 1 mg 0,0 0,0 EMA/713187/2012 Page 167/253

168 Norway Norway Norway Norway Norway Norway Teva Sweden AB Järnvägsgatan 11 Box Helsingborg Sweden Teva Sweden AB Järnvägsgatan 11 Box Helsingborg Sweden Laboratorios Leon Farma SA Poligono Industrial Navatejera, La Vallina s/n, Villaquilambre,Leon Laboratorios Leon Farma SA Poligono Industrial Navatejera, La Vallina s/n, Villaquilambre,Leon Dretinelle Dretinelle 28 Drosetil 28 Drosetil 28 Drosinetta Drosinetta 28 0,0 EMA/713187/2012 Page 168/253

169 Norway Norway Norway Norway Norway Norway Norway Bayer AB Postbox 606 Gustav III's Boulevard 56 SE Solna Sweden Sandoz A/S Edward Thomsens Vej 14 DK-2300 København S Sandoz A/S Edward Thomsens Vej 14 DK-2300 København S Ratiopharm GmbH Graf-Arco-Strasse 3 DE Ulm Sandoz A/S Edward Thomsens Vej 14 DK-2300 København S Sandoz A/S Edward Thomsens Vej 14 DK-2300 København S /Ethinylestra diol Richter Eloine Elyra Elyra 28 Estez Finminette Finminette 0,0 0,0 0,0 0,0 EMA/713187/2012 Page 169/253

170 Norway Norway Norway Norway Norway Laboratorios Leon Farma SA Poligono Industrial Navatejera, La Vallina s/n, Villaquilambre,Leon Laboratorios Leon Farma SA Poligono Industrial Navatejera, La Vallina s/n, Villaquilambre,Leon Laboratorios Leon Farma SA Poligono Industrial Navatejera, La Vallina s/n, Villaquilambre,Leon BAYER SCHERING PHARMA AG Müllerstrasse 178 D Berlin BAYER SCHERING PHARMA AG Müllerstrasse 178 D Berlin Iradier Iren Iren 28 Liofora Liofora 28 EMA/713187/2012 Page 170/253

171 Norway Norway Norway Norway Norway Norway Orifarm Generics A/S Postbox 69 Energivej 15 DK-5260 Odense S Orifarm Generics A/S Postbox 69 Energivej 15 DK-5260 Odense S Orifarm Generics A/S Postbox 69 Energivej 15 DK-5260 Odense S Orifarm Generics A/S Postbox 69 Energivej 15 DK-5260 Odense S Laboratorios Leon Farma SA Poligono Industrial Navatejera, La Vallina s/n, Villaquilambre,Leon Laboratorios Leon Farma SA Poligono Industrial Navatejera, La Vallina s/n, Villaquilambre,Leon Movinella 21 Movinella 21 Movinella 28 Movinella 28 Naiwanel Naiwanel 28 0,0 0,0 EMA/713187/2012 Page 171/253

172 Norway Norway Norway Norway Norway Laboratorios Leon Farma SA Poligono Industrial Navatejera, La Vallina s/n, Villaquilambre,Leon Laboratorios Leon Farma SA Poligono Industrial Navatejera, La Vallina s/n, Villaquilambre,Leon Bayer AB Postbox 606 Gustav III's Boulevard 56 SE Solna Sweden Laboratorios Leon Farma SA Poligono Industrial Navatejera, La Vallina s/n, Villaquilambre,Leon Ospen Ospen 28 Palandra Perlita Rosal 0,0 0,0 0,0 0,0 EMA/713187/2012 Page 172/253

173 Norway Norway Norway Norway Norway Norway Laboratorios Leon Farma SA Poligono Industrial Navatejera, La Vallina s/n, Villaquilambre,Leon Sandoz A/S Edward Thomsens Vej 14 DK-2300 København S Sandoz A/S Edward Thomsens Vej 14 DK-2300 København S Zentiva, k.s. U kabelovny Praha 10 Dolní Měcholupy Zentiva, k.s. U kabelovny Praha 10 Dolní Měcholupy Teva Sweden AB Järnvägsgatan 11 Box Helsingborg Sweden Rosal 28 Rubira Rubira Sidreta Sidretella Varena 0,0 0,0 0,0 0,0 EMA/713187/2012 Page 173/253

174 Norway Norway Norway Norway Norway Norway Norway Teva Sweden AB Järnvägsgatan 11 Box Helsingborg Sweden Teva Sweden AB Järnvägsgatan 11 Box Helsingborg Sweden Teva Sweden AB Järnvägsgatan 11 Box Helsingborg Sweden Bayer AB Postbox 606 Gustav III's Boulevard 56 SE Solna Sweden BAYER SCHERING PHARMA AG Müllerstrasse 178 D Berlin BAYER SCHERING PHARMA AG Müllerstrasse 178 D Berlin BAYER SCHERING PHARMA AG Müllerstrasse 178 D Berlin Varena 28 Varenelle Varenelle 28 Yalisca Yasmin Yasmin 28 Yasminelle 0,0 0,0 0,0 EMA/713187/2012 Page 174/253

175 Norway Norway Norway Norway Norway Poland Poland BAYER SCHERING PHARMA AG Müllerstrasse 178 D Berlin Bayer AB Postbox 606 Gustav III's Boulevard 56 SE Solna Sweden N.V. Organon Kloosterstraat AB, Oss N.V. Organon Kloosterstraat AB, Oss Janssen-Cilag AB, Box 7073, Sollentuna, Sweden Actavis Group PTC ehf Reykjavikurvegi Hafnarfjordur Iceland Organon (Ireland) Ltd, PO Box 2857, Drynam Road, Swords, Co.Dublin, Ireland Etonogestrel Etonogestrel Norgestimate Chlormadinoni acetas um um um Yasminelle 28 Yaz Circlet 0.1/0.015 mg Vaginal delivery system Nuvaring 0.1/0.015 mg Vaginal delivery system Cilest Dinostrine Gracial 0,25 mg 0,035 mg 0,0 0,025 mg 0,040 mg 0,125 mg/0,030 mg Vaginal use Vaginal use EMA/713187/2012 Page 175/253

176 Poland Poland Poland Poland Poland Poland N.V. Organon Kloosterstraat AB, Oss N.V. Organon Kloosterstraat AB, Oss Organon (Ireland) Ltd, PO Box 2857, Drynam Road, Swords, Co.Dublin, Ireland Pabianickie Zakłady Farmaceutyczne Polfa S.A. ul. Marszałka J. Piłsudskiego Pabianice Poland Pabianickie Zakłady Farmaceutyczne Polfa S.A. ul. Marszałka J. Piłsudskiego Pabianice Poland um um um um um um um um um um um um Laurina Marvelon Mercilon Novynette Ovulastan Ovulastan Forte 0,05 mg/0,035 mg 0,100 mg/0,030 mg 0,150 mg/0,030 mg 0,0 0,0 EMA/713187/2012 Page 176/253

177 Poland Poland Poland Poland Poland Poland Poland Gedeon Richter Polska Sp. z o.o. ul. Graniczna Grodzisk Mazowiecki Poland Temapharm Sp. z o.o. ul. Żwirki i Wigury Warszawa Poland Teva Pharmaceuticals Polska Sp. z o.o. ul. Emilii Plater Warszawa Poland Teva Pharmaceuticals Polska Sp. z o.o. ul. Emilii Plater Warszawa Poland Ivowen Limited 3, Anglesea Street Clonmel Co. Tipperary Ireland Gedeon Richter Polska Sp. z o.o. ul. Graniczna Grodzisk Mazowiecki Poland Bayer Pharma AG Müllerstraße 178 D Berlin um um Drospirenonum um Drospirenonum um Drospirenonum um Drospirenonum um Drospirenonum um Drospirenonum um Samba tabletka powlekana Asubtela Cortelle Lesine Lulina Midiana Palandra 0,05 mg/0,035 mg 0,1 mg/0,0 /0,0 0,0 0,0 0,0 0,0 0,0 0,0 EMA/713187/2012 Page 177/253

178 Poland Poland Poland Poland Poland Poland Poland Zentiva, k.s. U kabelovny Praha 10 Dolní Měcholupy Zakłady Farmaceutyczne POLPHARMA S.A. ul. Pelplińska Starogard Gdański Poland Bayer Pharma AG Müllerstraße 178 D Berlin Bayer Pharma AG Müllerstraße 178 D Berlin Sun-Farm Sp. z o.o. Człekówka Kołbiel, Poland Cyndea Pharma S.L. Polígono Industrial Emiliano Revilla Sanz Av. De Ágreda Ólvega (Soria) Drospirenonum um Drospirenonum um Estradioli valeras Dienogestum Estradiolum Drospirenonum um Chlormadinon acetate um um um Dienogestum Sidretella 30 Vibin Qlaira Angeliq Madinette Regulon Aidee 0,0 0,0 / / 1 mg 1mg 2mg 0,0 0,0 0,0 EMA/713187/2012 Page 178/253

179 Poland Poland Poland Poland Poland Poland Poland Poland Temapharm Sp. z o.o. ul. Żwirki i Wigury Warszawa Poland Zentiva, k.s. U kabelovny Praha 10 Dolní Měcholupy Regiomedica GmbH Teichstrasse 66 D Loerrach Sun-Farm Sp. z o.o. Człekówka Kołbiel, Poland Pharbil Waltrop GmbH Im Wirrigen Waltrop Bayer Pharma AG Müllerstraße 178 D Berlin Gedeon Richter Polska Sp. z o.o. ul. Graniczna Grodzisk Mazowiecki Poland Bayer Pharma AG Müllerstraße 178 D Berlin um Dienogestum um Dienogestum um Dienogestum um Dienogestum um Dienogestum um Dienogestum um Dienogestum um Drospirenonum Atywia Bonadea Dionelle Dorin /Dienogest Pharbil Jeanine Sibilla Aliane 0,0 0,0 0,0 0,0 0,0 0,0 0,0 EMA/713187/2012 Page 179/253

180 Poland Poland Poland Poland Poland Poland Poland Gedeon Richter Polska Sp. z o.o. ul. Graniczna Grodzisk Mazowiecki Poland Gedeon Richter Polska Sp. z o.o. ul. Graniczna Grodzisk Mazowiecki Poland Teva Pharmaceuticals Polska Sp. z o.o. ul. Emilii Plater Warszawa Poland Bayer Pharma AG Müllerstraße 178 D Berlin Temapharm Sp. z o.o. ul. Żwirki i Wigury Warszawa Poland Temapharm Sp. z o.o. ul. Żwirki i Wigury Warszawa Poland um Drospirenonum um Drospirenonum um Drospirenonum um Drospirenonum um Drospirenonum um Drospirenonum um Drospirenonum Aneea Belusha Daylette Lesinelle Linatera Naraya Naraya Plus EMA/713187/2012 Page 180/253

181 Poland Poland Poland Poland Poland Poland Poland Zentiva, k.s. U kabelovny Praha 10 Dolní Měcholupy Gedeon Richter Polska Sp. z o.o. ul. Graniczna Grodzisk Mazowiecki Poland Teva Pharmaceuticals Polska Sp. z o.o. ul. Emilii Plater Warszawa Poland Teva Pharmaceuticals Polska Sp. z o.o. ul. Emilii Plater Warszawa Poland Zakłady Farmaceutyczne POLPHARMA S.A. ul. Pelplińska Starogard Gdański Poland Bayer Pharma AG Müllerstraße 178 D Berlin Bayer Pharma AG Müllerstraße 178 D Berlin um Drospirenonum um Drospirenonum um Drospirenonum um Drospirenonum um Drospirenonum um Drospirenonum um Drospirenonum Sidretella 20 Teenia Varenelle Veyann Vibin mini Yasmin Yasminelle 0,0 EMA/713187/2012 Page 181/253

182 Poland Poland Poland Poland Poland Poland Bayer Pharma AG Müllerstraße 178 D Berlin Pabianickie Zakłady Farmaceutyczne Polfa S.A. ul. Marszałka J. Piłsudskiego Pabianice Poland Bayer Pharma AG Müllerstraße 178 D Berlin Pfizer Europe MA EEIG Ramsgate Road, Sandwich, Kent CT 13 9NJ United Kingdom Pabianickie Zakłady Farmaceutyczne Polfa S.A. ul. Marszałka J. Piłsudskiego Pabianice Poland SymPhar Sp. z o.o. ul. Włoska Warszawa Poland um Drospirenonum um Gestodenum um Gestodenum um Gestodenum um Gestodenum um Gestodenum Yaz Femipol 0,0 Femoden 30 mcg + 75 mcg Harmonet Kontracept Sylvie 20 0,02 m 0,02 m 0,02 m EMA/713187/2012 Page 182/253

183 Poland Poland Poland Poland Poland Poland Poland SymPhar Sp. z o.o. ul. Włoska Warszawa Poland Zentiva, k.s. U kabelovny Praha 10 Dolní Měcholupy Temapharm Sp. z o.o. ul. Żwirki i Wigury Warszawa Poland Actavis Group PTC ehf Reykjavikurvegi Hafnarfjordur Iceland Actavis Group PTC ehf Reykjavikurvegi Hafnarfjordur Iceland Gedeon Richter Polska Sp. z o.o. ul. Graniczna Grodzisk Mazowiecki Poland Gedeon Richter Polska Sp. z o.o. ul. Graniczna Grodzisk Mazowiecki Poland um Gestodenum Gestodenum um Gestodenum um Gestodenum um Gestodenum um Gestodenum um Gestodenum um Sylvie mcg + 75 mcg Artizia Gefemin / Actavis / Actavis Kostya Lindynette 0,06 mg 0,015 mg 0,0 0,0 EMA/713187/2012 Page 183/253

184 Poland Poland Poland Poland Poland Poland Poland Bayer Pharma AG Müllerstraße 178 D Berlin Bayer Pharma AG Müllerstraße 178 D Berlin Pfizer Europe MA EEIG Ramsgate Road, Sandwich, Kent CT 13 9NJ United Kingdom Gedeon Richter Polska Sp. z o.o. ul. Graniczna Grodzisk Mazowiecki Poland Janssen-Cilag International N.V. Turnhoutseweg 30 B 2340 Beerse N.V. Organon Kloosterstraat AB, Oss Gestodenum um Gestodenum um Gestodenum um Gestodenum um Gestodenum um Norgestimatum um Etonogestrelum um Logest Milvane Minulet Vendiol Zulfija Cilest NuvaRing 0,05 mg/0,0 0,07 mg/ 0,04 mg 0,10 mg + 0,0 0,0 0,06 mg 0,015 mg 0,0 0,25 mg 0,035 mg 0,1 0,015 mg Vaginal ring Vaginal use EMA/713187/2012 Page 184/253

185 Poland Portugal Portugal Portugal Portugal Portugal N.V. Organon Kloosterstraat AB, Oss Laboratorios Leon Farma SA Poligono Industrial Navatejera, La Vallina s/n, Villaquilambre,Leon Italfarmaco - Produtos Farmacêuticos, Lda. Rua Consiglieri Pedroso, Queluz de Baixo Barcarena Portugal Actavis Group PTC ehf Reykjavikurvegi Hafnarfjordur Iceland Etonogestrelum um Chlormadinone Chlormadinone Chlormadinone Chlormadinone Chlormadinone Circlet Belara Bonae Clarissa Cloromadinona + Etinilestradiol Actavis Libeli 0,1 0,015 mg Vaginal ring Vaginal use EMA/713187/2012 Page 185/253

186 Portugal Portugal Portugal Portugal Portugal Portugal Merck Sharp & Dohme, Lda. Quinta da Fonte 19 Edificio Vasco da Gama Paço d' Arcos Portugal Actavis Group PTC ehf Reykjavikurvegi Hafnarfjordur Iceland Actavis Group PTC ehf Reykjavikurvegi Hafnarfjordur Iceland Stragen Nordic A/S, Helsingørgade 8C, DK-3400 Hillerød, Stragen Nordic A/S, Helsingørgade 8C, DK-3400 Hillerød, Mylan, Lda. Rua Doutor António Loureiro Borges, Edificio Arquiparque 1, R/C Esq Algés Portugal Gracial Benidette Benifema + Etinilestradiol Generis + Etinilestradiol Generis + Etinilestradiol Mylan 0,025 mg + 0,04 mg 0,125 mg + 0, mg mg mg mg mg 0.0 EMA/713187/2012 Page 186/253

187 Portugal Portugal Portugal Portugal Mylan, Lda. Rua Doutor António Loureiro Borges, Edificio Arquiparque 1, R/C Esq Algés Portugal Merck Sharp & Dohme, Lda. Quinta da Fonte 19 Edificio Vasco da Gama Paço d' Arcos Portugal Merck Sharp & Dohme, Lda. Quinta da Fonte 19 Edificio Vasco da Gama Paço d' Arcos Portugal Merck Sharp & Dohme, Lda. Quinta da Fonte 19 Edificio Vasco da Gama Paço d' Arcos Portugal + Etinilestradiol Mylan Laurina Laurina 28 Marvelon 0.15 mg 0.0 0,05mg + 0,035 mg + 0,0 0,1 mg + 0,0 0,05mg + 0,035 mg + 0,0 0,1 mg + 0, mg 0.0 EMA/713187/2012 Page 187/253

188 Portugal Portugal Portugal Portugal Portugal Portugal Merck Sharp & Dohme, Lda. Quinta da Fonte 19 Edificio Vasco da Gama Paço d' Arcos Portugal Stragen Nordic A/S, Helsingørgade 8C, DK-3400 Hillerød, Stragen Nordic A/S, Helsingørgade 8C, DK-3400 Hillerød, Bayer Portugal, S.A. Rua Quinta do Pinheiro Carnaxide Portugal Dienogest Estradiol Valerate Mercilon Novynette Regulon Ydeza Ydeza Climodien 0.15 mg mg mg mg mg 0.0 EMA/713187/2012 Page 188/253

189 Portugal Berlifarma - Especialidades Farmacêuticas, Lda. Rua Quinta Pinheiro, 5, Outurela Carnaxide Portugal Portugal Laboratorios EFFIK, Sociedade Unipessoal, Lda. Rua Consiglieri Pedroso, 123 Barcarena Portugal Portugal Portugal Berlifarma - Especialidades Farmacêuticas, Lda. Rua Quinta Pinheiro, 5, Outurela Carnaxide Portugal Portugal Lusal - Producao Quimico-Farmaceutica Luso-Alema, Lda. Rua Quinta Pinheiro, 5, Outurela - Carnaxide Portugal Dienogest Estradiol Valerate Dienogest Dienogest Dienogest Qlaira Denille Mistral Valette Aliane / / 1 g EMA/713187/2012 Page 189/253

190 Portugal Portugal Portugal Portugal Portugal Sandoz Farmaceutica, Lda. Alameda da Beloura, Edificio 1, 2º Escritorio 15 Sintra Portugal Portugal Teva Pharma - Produtos Farmaceuticos, Lda Edifício Cyprium, Av. 25 de Abril, 15, 2º F Linda-a- Velha Portugal Aranka Arankelle Arankitelle Daylette Dioz Dretine EMA/713187/2012 Page 190/253

191 Portugal Teva Pharma - Produtos Farmaceuticos, Lda Edifício Cyprium, Av. 25 de Abril, 15, 2º F Linda-a- Velha Portugal Portugal Laboratorios EFFIK, Sociedade Unipessoal, Lda. Rua Consiglieri Pedroso, 123 Barcarena Portugal Portugal Sandoz Farmaceutica, Lda. Alameda da Beloura Edificio 1, 2º Escritorio Sintra Portugal Portugal Sandoz Farmaceutica, Lda. Alameda da Beloura Edificio 1, 2º Escritorio Sintra Portugal Dretinelle Droseffik Drosianelle Drosianelle EMA/713187/2012 Page 191/253

192 Portugal Portugal Portugal Portugal Portugal Sandoz Farmaceutica, Lda. Alameda da Beloura Edificio 1, 2º Escritorio Sintra Portugal Sandoz Farmaceutica, Lda. Alameda da Beloura Edificio 1, 2º Escritorio Sintra Portugal Laboratorios EFFIK, Sociedade Unipessoal, Lda. Rua Consiglieri Pedroso, 123 Barcarena Portugal Laboratorios EFFIK, Sociedade Unipessoal, Lda. Rua Consiglieri Pedroso, 123 Barcarena Portugal Drospirenona + Etinilestradiol Sandoz Drospirenona + Etinilestradiol Sandoz Drosurall Drosure Liladros EMA/713187/2012 Page 192/253

193 Portugal Portugal Portugal Portugal Berlex - Especialidades Farmaceuticas, Lda. Rua Quinta Pinheiro, 5, Outurela Carnaxide Portugal Laboratorios Leon Farma SA Poligono Industrial Navatejera, La Vallina s/n, Villaquilambre,Leon Lusal - Producao Quimico-Farmaceutica Luso-Alema, Lda. Rua Quinta Pinheiro, 5, Outurela - Carnaxide Portugal Lusal - Producao Quimico-Farmaceutica Luso-Alema, Lda. Rua Quinta Pinheiro, 5, Outurela - Carnaxide Portugal Linatera Nelecta Palandra Petibelle EMA/713187/2012 Page 193/253

194 Portugal Sanofi-Aventis - Produtos Farmaceuticos, Lda. Empreendimento Lagoas Park, Edifício 7-3º Piso - Porto Salvo Portugal Portugal Sanofi-Aventis - Produtos Farmaceuticos, Lda. Empreendimento Lagoas Park, Edifício 7-3º Piso - Porto Salvo Portugal Portugal Laboratorios Leon Farma SA Poligono Industrial Navatejera, La Vallina s/n, Villaquilambre,Leon Portugal Bayer Portugal, S.A. Rua Quinta do Pinheiro Carnaxide Portugal Portugal Berlex - Especialidades Farmaceuticas, Lda. Rua Quinta Pinheiro, 5, Outurela Carnaxide Portugal Sidreta Sidretella Tunile Yasmin Yasminelle EMA/713187/2012 Page 194/253

195 Portugal Portugal Portugal Portugal Portugal Portugal Berlex - Especialidades Farmaceuticas, Lda. Rua Quinta Pinheiro, 5, Outurela Carnaxide Portugal Laboratórios EFFIK, Sociedade Unipessoal, Lda. Rua Consiglieri Pedroso, Barcarena Portugal Laboratórios EFFIK, Sociedade Unipessoal, Lda. Rua Consiglieri Pedroso, Barcarena Portugal Actavis Group PTC ehf Reykjavikurvegi Hafnarfjordur Iceland Actavis Group PTC ehf Reykjavikurvegi Hafnarfjordur Iceland Medimpex, S.A 1-3, Rue Caumartin F Paris Yaz Effiplen Estinette Etinilestradiol + Gestodeno Actavis Etinilestradiol + Gestodeno Actavis Etinilestradiol + Gestodeno Dorinette mg mg mg mg mg EMA/713187/2012 Page 195/253

196 Portugal Portugal Portugal Portugal Portugal Portugal Portugal Generis Farmacêutica, S.A. Rua João de Deus, Amadora Portugal Generis Farmacêutica, S.A. Rua João de Deus, Amadora Portugal Medimpex, S.A 1-3, Rue Caumartin F Paris Stragen Nordic A/S, Helsingørgade 8C, DK-3400 Hillerød, Bayer Portugal, S.A. Rua Quinta do Pinheiro Carnaxide Portugal Laboratórios Pfizer, Lda. Lagoas Park, Edificio Porto Salvo Portugal Bayer Portugal, S.A. Rua Quinta do Pinheiro Carnaxide Portugal Etinilestradiol + Gestodeno Generis Etinilestradiol + Gestodeno Generis Etinilestradiol + Gestodeno Gestilla Etinilestradiol + Gestodeno Phagecon Gynera Harmonet Microgeste mg mg mg mg 0.06 mg mg mg mg 0.06 mg EMA/713187/2012 Page 196/253

197 Portugal Portugal Portugal Portugal Portugal Portugal Laboratórios Pfizer, Lda. Lagoas Park, Edificio Porto Salvo Portugal Bayer Portugal, S.A. Rua Quinta do Pinheiro Carnaxide Portugal Laboratórios Pfizer, Lda. Lagoas Park, Edificio Porto Salvo Portugal Bayer Portugal, S.A. Rua Quinta do Pinheiro Carnaxide Portugal Laboratórios Pfizer, Lda. Lagoas Park, Edificio Porto Salvo Portugal Minesse Minigeste Minulet Tri-Gynera Tri-Minulet Varianta mg 0.06 mg mg mg 0,0 / 0,05 mg 0,04 mg / 0,07 mg 0,0 / 0,1 mg 0,0 / 0,05 mg 0,04 mg / 0,07 mg 0,0 / 0,1 mg mg 0.06 mg EMA/713187/2012 Page 197/253

198 Portugal Portugal Portugal Romania Romania Aristo Pharma GmbH Wallenroder Straße Berlin Merck Sharp & Dohme, Lda. Quinta da Fonte 19 Edificio Vasco da Gama Paço d' Arcos Portugal Merck Sharp & Dohme, Lda. Quinta da Fonte 19 Edificio Vasco da Gama Paço d' Arcos Portugal Gedeon Richter România S.A. Str. Cuza-Vodă, nr Târgu Mureş România Gedeon Richter România S.A. Str. Cuza-Vodă, nr Târgu Mureş România Norgestimate Etonogestrel Etonogestrel Chlormadinone Amicette Circlet NuvaRing BELARA NOVYNETTE CONTINUU 0,25 mg 0,035 mg mg mg 0.1 0,0 Vaginal delivery system Vaginal delivery system Vaginal use Vaginal use EMA/713187/2012 Page 198/253

199 Romania Romania Romania Romania Romania Romania Romania Gedeon Richter România S.A. Str. Cuza-Vodă, nr Târgu Mureş România LadeePharma LTD. Lajos street E Budapest 1036 Jenapharm GmbH & Co. KG Otto-Schott-Straße Jena Deutschland Zentiva, k.s. U kabelovny Praha 10 Dolní Měcholupy Medico Uno Pharma Kft. Viadukt u. 12 Biatorbágy 2051 Ivowen Limited 3, Anglesea Street Clonmel Co. Tipperary Ireland Dienogest Dienogest Dienogest SAMBA SIBILLA DIENILLE JEANINE ZENADEA JOLINA LULINA 0,05mg/0,035mg 0,1mg/0,03mg 0,15mg/0,03mg 0,0 0,0 0,0 0,0 0,0 0,0 EMA/713187/2012 Page 199/253

200 Romania Romania Romania Romania Romania Romania Gedeon Richter România S.A. Str. Cuza-Vodă, nr Târgu Mureş România BAYER SCHERING PHARMA AG Müllerstrasse 178 D Berlin BAYER SCHERING PHARMA AG Müllerstrasse 178 D Berlin Gedeon Richter România S.A. Str. Cuza-Vodă, nr Târgu Mureş România Gedeon Richter România S.A. Str. Cuza-Vodă, nr Târgu Mureş România Gedeon Richter România S.A. Str. Cuza-Vodă, nr Târgu Mureş România Estradiol Dienogest MIDIANA YASMIN QLAIRA ANEEA BELUSHA DAYLETTE 0,0 0,0 3mg/2mg/2mg/ 2mg/3mg/1mg EMA/713187/2012 Page 200/253

201 Romania Romania Romania Romania Romania Laboratorios Leon Farma SA Poligono Industrial Navatejera, La Vallina s/n, Villaquilambre,Leon Teva Pharmaceuticals S.R.L. Str. Domniţa Ruxandra nr. 12, parter, Sector 2 Bucureşti România S.C. SANDOZ S.R.L. Str. Livezeni nr. 7A, Târgu Mureş, România. Laboratorios Leon Farma SA Poligono Industrial Navatejera, La Vallina s/n, Villaquilambre,Leon Laboratorios Leon Farma SA Poligono Industrial Navatejera, La Vallina s/n, Villaquilambre,Leon DROSETIL DROSPIR 0,0/ FELICITY 0,0/ JANGEE MYWY EMA/713187/2012 Page 201/253

202 Romania Romania Romania Romania Romania Romania Romania BAYER SCHERING PHARMA AG Müllerstrasse 178 D Berlin Zentiva, k.s. U kabelovny Praha 10 Dolní Měcholupy Medico Uno Pharma Kft. Viadukt u. 12 Biatorbágy 2051 LadeePharma LTD. Lajos street E Budapest 1036 BAYER SCHERING PHARMA AG Müllerstrasse 178 D Berlin N.V. Organon Kloosterstraat AB, Oss N.V. Organon Kloosterstraat AB, Oss Etonogestrel Etonogestrel PALANDRA SIDRETELLA TAISA VELGYN YAZ CIRCLET NUVARING 0,0 0,0 0,120 mg 0,015 mg 0,120 mg 0,015 mg Vaginal delivery system Vaginal delivery system Vaginal use Vaginal use EMA/713187/2012 Page 202/253

203 Romania Romania Romania Romania Romania Romania Romania Zentiva, k.s. U kabelovny Praha 10 Dolní Měcholupy Medico Uno Pharma Kft. Viadukt u. 12 Biatorbágy 2051 Pfizer Europe MA EEIG Ramsgate Road, Sandwich, Kent CT 13 9NJ United Kingdom Gedeon Richter România S.A. Str. Cuza-Vodă, nr Târgu Mureş România Bayer Pharma AG Müllerstraße 178 D Berlin Gestoden Gestoden ARTIZIA STODETTE HARMONET KARISSA KOSTYA LOGEST MILLIGEST 0,03mg/0,05mg 0,04mg/0,07mg 0,03mg/0,10mg EMA/713187/2012 Page 203/253

204 Romania Romania Romania Slovak Republic Slovak Republic Slovak Republic Slovak Republic Gedeon Richter România S.A. Str. Cuza-Vodă, nr Târgu Mureş România Johnson & Johnson d.o.o. Šmartinska cesta Ljubljana Slovenija Actavis Group PTC ehf Reykjavikurvegi Hafnarfjordur Iceland Stada Arzneimittel AG, Stadastrasse 2-8, DE Bad Vibel, Ratiopharm GmbH Graf-Arco-Strasse 3 DE Ulm Norgestimate Chlormadinone acetate Chlormadinone acetate Chlormadinone acetate Chlormadinone acetate VENDIOL ZULFIJA CILEST Angiletta / 0,0 Belara Belissa Egretta /0,0 0,06 mg 0,015 mg 0,0 0,25 mg 0,035 mg 0,0 0,0 0,0 0,0 EMA/713187/2012 Page 204/253

205 Slovak Republic Slovak Republic Slovak Republic Slovak Republic Slovak Republic Slovak Republic Slovak Republic Slovak Republic mibe GmbH Arzneimittel Münchener Str Brehna Heaton a.s. Na Pankráci Praha 4 N.V. Organon Kloosterstraat AB, Oss N.V. Organon Kloosterstraat AB, Oss N.V. Organon Kloosterstraat AB, Oss Heaton a.s. Na Pankráci Praha 4 Zentiva, k.s. U kabelovny Praha 10 Dolní Měcholupy Chlormadinone acetate Etinylestradiol 0,0/ Chlormadinoniumacetat 2 mg mibe filmom obalene tablety Adele Laurina Marvelon Mercilon Natalya Novynette Regisha 0,150 mg/0,02 mg 0,0 0,0 0,05 mg 0,035 mg/0,100 mg 0,030 mg / 0,150 mg 0,030 mg 0,0 EMA/713187/2012 Page 205/253

206 Slovak Republic Slovak Republic Slovak Republic Slovak Republic Slovak Republic Slovak Republic Slovak Republic Zentiva, k.s. U kabelovny Praha 10 Dolní Měcholupy VIVAX EuroAsia s.r.o. Karloveske rameno Bratislava Slovensko LADEEPHARMA Slovakia s.r.o. Prievozská 4D Bratislava Slovak Republic Bayer Pharma AG Müllerstraße 178 D Berlin Sandoz Pharmaceuticals d.d. Verovškova Ľubľana Slovenia Dienogest Dienogest Dienogest Dienogest Dienogest Regisha 0,150 mg/0,03 mg REGULON AIDEE /0,0 filmom obalene tablety Dienorette filmom obalene tablety Jeanine Mistra SEEGEE /0,0 0,0 0,0 0,0 0,0 0,0 0,0 0,0 EMA/713187/2012 Page 206/253

207 Slovak Republic Slovak Republic Slovak Republic Slovak Republic Slovak Republic Slovak Republic Slovak Republic Zentiva, k.s. U kabelovny Praha 10 Dolní Měcholupy LADEEPHARMA Slovakia s.r.o. Prievozská 4D Bratislava Slovak Republic LADEEPHARMA Slovakia s.r.o. Prievozská 4D Bratislava Slovak Republic Bayer, spol. s r.o. Digital Park II Einsteinova Bratislava Slovak republic Sandoz Pharmaceuticals d.d. Verovškova Ľubľana Slovenia Dienogest ZENADEA KarHla KarHleight MAITALON / 0,0 filmom obalene tablety Narayeight Palandra Phaenya 21 0,0 0,0 0,0 0,0 0,0 0,0 0,0 EMA/713187/2012 Page 207/253

208 Slovak Republic Slovak Republic Slovak Republic Slovak Republic Slovak Republic Slovak Republic Slovak Republic Sandoz Pharmaceuticals d.d. Verovškova Ľubľana Slovenia Zentiva, k.s. U kabelovny Praha 10 Dolní Měcholupy Teva Pharmaceuticals Slovakia s.r.o. Teslova Bratislava Slovak republic Ivowen Limited 3, Anglesea Street Clonmel Co. Tipperary Ireland BAYER SCHERING PHARMA AG Müllerstrasse 178 D Berlin Bayer, spol. s r.o. Digital Park II Einsteinova Bratislava Slovak republic Bayer Pharma AG Müllerstraße 178 D Berlin estradiol valerate dienogest Phaenya 28 Sidreta Softine 0,0/ filmom obalené tablety WERRCA Yadine Qlaira Aliane 0,0 0,0 0,0 0,0 0,0 / / 1 mg EMA/713187/2012 Page 208/253

209 Slovak Republic Slovak Republic Slovak Republic Slovak Republic Slovak Republic Slovak Republic Slovak Republic Bayer, spol. s r.o. Digital Park II Einsteinova Bratislava Slovak republic Laboratorios Leon Farma SA Poligono Industrial Navatejera, La Vallina s/n, Villaquilambre,Leon LADEEPHARMA Slovakia s.r.o. Prievozská 4D Bratislava Slovak Republic BELUSHA DAYLETTE DAYLLA KIRGA Linatera LluviEight Lunytta EMA/713187/2012 Page 209/253

210 Slovak Republic Slovak Republic Slovak Republic Slovak Republic Slovak Republic Slovak Republic Slovak Republic LADEEPHARMA Slovakia s.r.o. Prievozská 4D Bratislava Slovak Republic Sandoz Pharmaceuticals d.d. Verovškova Ľubľana Slovenia Sandoz Pharmaceuticals d.d. Verovškova Ľubľana Slovenia Zentiva, k.s. U kabelovny Praha 10 Dolní Měcholupy Teva Pharmaceuticals Slovakia s.r.o. Teslova Bratislava Slovak republic Bayer Pharma AG Müllerstraße 178 D Berlin Bayer, spol. s r.o. Digital Park II Einsteinova Bratislava Slovak republic Lunytteight Phaenyela 21 Phaenyela 28 Sidretella Softinelle / filmom obalené tablety Yasminelle YAZ EMA/713187/2012 Page 210/253

211 Slovak Republic Slovak Republic Slovak Republic Slovak Republic Slovak Republic Slovak Republic Slovak Republic Slovak Republic N.V. Organon Kloosterstraat AB, Oss N.V. Organon Kloosterstraat AB, Oss Zentiva, k.s. U kabelovny Praha 10 Dolní Měcholupy Bayer Pharma AG Müllerstraße 178 D Berlin LADEEPHARMA Slovakia s.r.o. Prievozská 4D Bratislava Slovak Republic Medico Uno Pharma Kft. Viadukt u. 12 Biatorbágy 2051 Heaton a.s. Na Pankráci Praha 4 Etonogestrel Etonogestrel Circlet NuvaRing ARTIZIA / 0,020 mg obalene tablety Femoden Gefemin 0,060 mg/0,015 mg Gestodette Katya KOSTYA /0,075 mg obalene tablety 0,1 0,015 mg 0,1 0,015 mg 0,0 0,06 mg 0,015 mg 0,0 Vaginal insert Vaginal insert Vaginal use Vaginal use EMA/713187/2012 Page 211/253

212 Slovak Republic Slovak Republic Slovak Republic Bayer Pharma AG Müllerstraße 178 D Berlin Slovak Republic Bayer Pharma AG Müllerstraße 178 D Berlin Slovak Republic Heaton a.s. Na Pankráci Praha 4 Slovak Republic Slovak Republic Slovak Republic Johnson & Johnson, s. r. o. Karadžičova Bratislava Slovak republic Norgestimate LINDYNETTE 20 Lindynette 30 Logest Mirelle Sunya Violetta ZULFIJA 0,0/0,075 mg obalené tablety Cilest 0,0 0,06 mg 0,015 mg 0,06 mg 0,015 mg 0,0 0,25 mg 0,035 mg EMA/713187/2012 Page 212/253

213 Slovenia Slovenia Slovenia Slovenia Slovenia Slovenia Slovenia Slovenia Bayer d.o.o., Bravničarjeva 13, Ljubljana, Slovenia Bayer Pharma AG Müllerstraße 178 D Berlin Bayer Pharma AG Müllerstraße 178 D Berlin Bayer Pharma AG Müllerstraße 178 D Berlin Bayer d.o.o., Bravničarjeva 13, Ljubljana, Slovenia N.V. Organon Kloosterstraat AB, Oss Bayer Pharma AG Müllerstraße 178 D Berlin Chlormadinon Etonogestrel Belara 0,0/ filmsko obložene tablete Linatera / filmsko obložene tablete Liofora / filmsko obložene tablete Yarina 0,0/ filmsko obložene tablete Yasminelle / filmsko obložene tablete YAZ / filmsko obložene tablete NuvaRing 0,120 mg/0,015 mg na 24 ur vaginalni dostavni sistem Femoden 0,0/0,075 mg obložene tablete 0, mg/0.015 mg Vaginal delivery system 0,0 Vaginal use EMA/713187/2012 Page 213/253

214 Slovenia Slovenia Slovenia Slovenia Slovenia Slovenia Pfizer Europe MA EEIG Ramsgate Road, Sandwich, Kent CT 13 9NJ United Kingdom Chemical Works of, Gyömrői ut 19-21, H-1103 Budapest, Chemical Works of, Gyömrői ut 19-21, H-1103 Budapest, Bayer Pharma AG Müllerstraße 178 D Berlin Pfizer Europe MA EEIG Ramsgate Road, Sandwich, Kent CT 13 9NJ United Kingdom Johnson & Johnson d.o.o. Šmartinska cesta Ljubljana Slovenija Actavis Group PTC ehf Reykjavikurvegi Hafnarfjordur Iceland Norgestimate Chlormadinone acetate Harmonet 75 mikrogramov/20 mikrogramov obložene tablete LINDYNETTE 0,075 mg/ obložene tablete LINDYNETTE 0,075 mg/0,0 obložene tablete Logest / obložene tablete MINULET 75 mikrogramov/30 mikrogramov obložene tablete Cilest 0,25 mg/0,035 mg tablete ANGILETTA 0,0 /2 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG 0,0 0,0 0,25 mg 0,035 mg 0,0 EMA/713187/2012 Page 214/253

215 FAES FARMA, S.A. Maximo Aguirre, Lamiaco-Lejona (Vizcaya) FAES FARMA, S.A. Maximo Aguirre, Lamiaco-Lejona (Vizcaya) BRILL PHARMA, S.L. Mandri 66 Escalera A despacho Barcelona QUALITEC EUROPA, S.L Paseo Pintor Rosales, Madrid Chlormadinone acetate Chlormadinone acetate Chlormadinone acetate Chlormadinone acetate Chlormadinone acetate Chlormadinone acetate BALIANCA 0,0/2mg COMPRIMIDOS RECUBIERTOS CON PELICULA BALIANCA DIARIO 0,03 mg/ COMPRIMIDOS RECUBIERTOS CON PELICULA BELARA 0,0/ COMPRIMIDOS RECUBIERTOS CON PELICULA BELARA DIARIO 0,03 mg/ COMPRIMIDOS RECUBIERTOS CON PELICULA ELYNOR 0.0/ COMPRIMIDOS RECUBIERTOS CON PELICULA EFG ETINILESTRADIOL / CLORMADINONA QUASSET 0,0/ COMPRIMIDOS RECUBIERTOS CON PELICULA EFG 0,0 0,0 0,0 0,0 0,0 0,0 EMA/713187/2012 Page 215/253

216 LABORATORIO STADA, S.L. Frederic Mompou, Sant Just Desvern Barcelona TEVA PHARMA S.L.U. C/ Anabel Segura, 11 Edificio Albatros B 1ª planta Alcobendas Madrid Merck Sharp and Dohme de España, S.A Josefa Valcárcel, Madrid GYNEA LABORATORIOS, S.L. Colón, Palau-Solitá i Plegamans Barcelona Actavis Group PTC ehf Reykjavikurvegi Hafnarfjordur Iceland Actavis Group PTC ehf Reykjavikurvegi Hafnarfjordur Iceland Chlormadinone acetate Chlormadinone acetate Ethinyl estradiol Ethinyl estradiol Ethinyl estradiol ETINILESTRADIOL/CLORM ADINONA STADA 0,03 mg/ COMPRIMIDOS RECUBIERTOS CON PELICULA EFG TYARENA 0,0/ COMPRIMIDOS RECUBIERTOS CON PELICULA EFG GRACIAL comprimido BEMASIVE 150 microgramos/20 microgramos comprimidos recubiertos BENIDETTE / comprimidos EFG BENIFEMA /0,0 comprimidos EFG 0,0 0,0 0,025 mg/0,04 mg 0,125 mg/0,0 0,0 EMA/713187/2012 Page 216/253

217 Famy Care Europe Ltd. One Wood Street EC2V 7WS London United Kingdom Famy Care Europe Ltd. One Wood Street EC2V 7WS London United Kingdom MYLAN PHARMACEUTICALS S.L. Plom, 2-4, 5ª planta Barcelona MYLAN PHARMACEUTICALS S.L. Plom, 2-4, 5ª planta Barcelona Merck Sharp and Dohme de España, S.A Josefa Valcárcel, Madrid Merck Sharp and Dohme de España, S.A Josefa Valcárcel, Madrid Ethinyl estradiol Ethinyl estradiol Ethinyl estradiol Ethinyl estradiol Ethinyl estradiol Ethinyl estradiol Ethinyl estradiol DESOGESTREL/ETINILEST RADIOL FAMYCARE / comprimidos EFG DESOGESTREL/ETINILEST RADIOL FAMYCARE /0,0 comprimidos EFG DESOGESTREL/ETINILEST RADIOL MYLAN / comprimidos EFG DESOGESTREL/ETINILEST RADIOL MYLAN /0,0 comprimidos EFG MICRODIOL comprimidos REGULON 150 microgramos/30 microgramos comprimidos recubiertos SUAVURET comprimidos 0,0 0,0 0,0 0,0 EMA/713187/2012 Page 217/253

218 BAYER HISPANIA, S.L Avda. Baix Llobregat 3 y Sant Joan Despi Barcelona JUSTE, S.A.Q.F. Juan Ignacio Luca de Tena, Madrid BAYER HISPANIA, S.L Avda. Baix Llobregat 3 y Sant Joan Despi Barcelona BIAL INDUSTRIAL FARMACEUTICA, S.A. Parque Científico y Tecnológico de Bizkaia, Edificio Zamudio Vizcaya GYNEA LABORATORIOS, S.L. Colón, Palau-Solitá i Plegamans Barcelona Dienogest Estradiol Dienogest Estradiol Dienogest Estradiol valerate Dienogest Dienogest CLIMODIEN 2/ comprimidos recubiertos MEVAREN 2/ comprimidos recubiertos QLAIRA comprimidos recubiertos con película AILYN /0,0 comprimidos recubiertos con película EFG DANIELLE /0,0 comprimidos recubiertos con película / 0 mg/ / / 0 mg/1 mg 0,0 0,0 EMA/713187/2012 Page 218/253

219 LABORATORIOS EFFIK, S.A. San Rafael, Alcobendas Madrid BAYER HISPANIA, S.L Avda. Baix Llobregat 3 y Sant Joan Despi Barcelona KERN PHARMA, S.L. Venus, 72 Polígono Industrial Colón II Tarrasa Barcelona KERN PHARMA, S.L. Venus, 72 Polígono Industrial Colón II Tarrasa Barcelona Dienogest hemihydrate DONABEL comprimidos recubiertos con película ANGELIQ 1 mg/ comprimidos recubiertos con película ANTIN 0,0/ comprimidos recubiertos con película EFG ANTIN DIARIO 0,0/ comprimidos recubiertos con película EFG ARANKA 0,0/ comprimidos recubiertos con película EFG 0,0 1mg 0,0 0,0 0,0 EMA/713187/2012 Page 219/253

220 TEVA PHARMA S.L.U. C/ Anabel Segura, 11 Edificio Albatros B 1ª planta Alcobendas Madrid TEVA PHARMA S.L.U. C/ Anabel Segura, 11 Edificio Albatros B 1ª planta Alcobendas Madrid Laboratorios Leon Farma S.A. Poligono Industrial Navatejera, La Vallina s/n, Villaquilambre, Leon SANDOZ FARMACEUTICA, S.A. Avda. Osa Mayor, Aravaca Madrid SANDOZ FARMACEUTICA, S.A. Avda. Osa Mayor, Aravaca Madrid DRETINE 0,0/ comprimidos recubiertos con película EFG DRETINE 0,0/ 28 comprimidos recubiertos con película EFG DROSETIL DIARIO 0,0/ comprimidos recubiertos con película EFG DROSIANE / comprimido recubiertos con película DROSIANE DIARIO 0,0/ comprimidos recubiertos con película EFG 0,0 0,0 0,0 0,0 EMA/713187/2012 Page 220/253

221 LABORATORIOS EFFIK, S.A. San Rafael, Alcobendas Madrid LABORATORIOS EFFIK, S.A. San Rafael, Alcobendas Madrid ACTAVIS SPAIN, S.A. Avda. de Burgos, 16-D Madrid ACTAVIS SPAIN, S.A. Avda. de Burgos, 16-D Madrid LABORATORIO STADA, S.L. Frederic Mompou, Sant Just Desvern Barcelona LABORATORIO STADA, S.L. Frederic Mompou, Sant Just Desvern DROSURE 0,0/ comprimidos recubiertos con película EFG DROSURE DIARIO 0,03 mg/ comprimidos recubiertos con película EFG ESTINILESTRADIOL/DROS PIRENONA DIARIO ACTAVIS 0,0/ comprimidos recubiertos con película EFG ESTINILESTRADIOL/DROS PIRENONA ACTAVIS 0,03 mg/ comprimidos recubiertos con película EFG ESTINILESTRADIOL/DROS PIRENONA DIARIO STADA 0,0/ comprimidos recubiertos con película EFG ESTINILESTRADIOL/DROS PIRENONA STADA 0,03 mg/ comprimidos recubiertos con película EFG 0,0 0,0 0,0 0,0 0,0 0,0 EMA/713187/2012 Page 221/253

222 Zentiva, k.s. U kabelovny Praha 10 Dolní Měcholupy BAYER HISPANIA, S.L Avda. Baix Llobregat 3 y Sant Joan Despi Barcelona BAYER HISPANIA, S.L Avda. Baix Llobregat 3 y Sant Joan Despi Barcelona BAYER HISPANIA, S.L Avda. Baix Llobregat 3 y Sant Joan Despi Barcelona BAYER HISPANIA, S.L Avda. Baix Llobregat 3 y Sant Joan Despi Barcelona KERN PHARMA, S.L. Venus, 72 Polígono Industrial Colón II Tarrasa Barcelona ESTINILESTRADIOL/DROS PIRENONA ZENTIVA 0,03 mg/ comprimidos recubiertos con película EFG PALANDRA 0,0/ comprimidos recubiertos con película YASMIN 0,0/ comprimidos recubiertos con película YASMIN DIARIO 0,03 mg/ comprimidos recubiertos con película YIRA 0,0/ comprimidos recubiertos con película ANTINELLE / comprimidos recubiertos con película EFG 0,0 0,0 0,0 0,0 0,0 EMA/713187/2012 Page 222/253

223 KERN PHARMA, S.L. Venus, 72 Polígono Industrial Colón II Tarrasa Barcelona SANDOZ FARMACEUTICA, S.A. Avda. Osa Mayor, Aravaca Madrid TEVA PHARMA S.L.U. C/ Anabel Segura, 11 Edificio Albatros B 1ª planta Alcobendas Madrid ANTINELLE DIARIO 0,02 mg/ comprimidos recubiertos con película EFG ARANKELLE / comprimidos recubiertos con película EFG ARANKELLE DIARIO / comprimidos recubiertos con película EFG DAYLETTE / comprimidos recubiertos con película EFG DRELLE / comprimidos recubiertos con película EFG DRETINELLE / 28 comprimidos recubiertos con película EFG EMA/713187/2012 Page 223/253

224 TEVA PHARMA S.L.U. C/ Anabel Segura, 11 Edificio Albatros B 1ª planta Alcobendas Madrid Laboratorios Leon Farma SA Poligono Industrial Navatejera, La Vallina s/n, Villaquilambre,Leon SANDOZ FARMACEUTICA, S.A. Avda. Osa Mayor, Aravaca Madrid SANDOZ FARMACEUTICA, S.A. Avda. Osa Mayor, Aravaca Madrid LABORATORIOS EFFIK, S.A. San Rafael, Alcobendas Madrid DRETINELLE / comprimidos recubiertos con película EFG DROSETIL DIARIO 0,02 mg/ comprimidos recubiertos con película EFG DROSIANELLE 0,0/ comprimidos recubiertos con película EFG DROSIANELLE DIARIO / comprimido recubiertos con película EFG DROSPIL / comprimidos recubiertos con película EFG EMA/713187/2012 Page 224/253

225 LABORATORIOS EFFIK, S.A. San Rafael, Alcobendas Madrid LABORATORIOS EFFIK, S.A. San Rafael, Alcobendas Madrid BAYER HISPANIA, S.L Avda. Baix Llobregat 3 y Sant Joan Despi Barcelona ACTAVIS SPAIN, S.A. Avda. de Burgos, 16-D Madrid ACTAVIS SPAIN, S.A. Avda. de Burgos, 16-D Madrid Zentiva, k.s. U kabelovny Praha 10 Dolní Měcholupy DROSURELLE /3 mg comprimido recubiertos con película EFG DROSURELLE DIARIO 0,02 mg/ comprimidos recubiertos con película EFG ELOINE / comprimidos recubiertos con película ESTINILESTRADIOL/DROS PIRENONA DIARIO ACTAVIS / comprimidos recubiertos con película EFG ESTINILESTRADIOL/DROS PIRENONA ACTAVIS 0,02 mg/ comprimidos recubiertos con película EFG ESTINILESTRADIOL/DROS PERINONA ZENTIVA 0,02 mg/ comprimidos recubiertos con película EFG EMA/713187/2012 Page 225/253

226 LABORATORIO STADA, S.L. Frederic Mompou, Sant Just Desvern Barcelona LABORATORIO STADA, S.L. Frederic Mompou, Sant Just Desvern Barcelona BAYER HISPANIA, S.L Avda. Baix Llobregat 3 y Sant Joan Despi Barcelona BAYER HISPANIA, S.L Avda. Baix Llobregat 3 y Sant Joan Despi Barcelona BAYER HISPANIA, S.L Avda. Baix Llobregat 3 y Sant Joan Despi Barcelona ESTINILESTRADIOL/DROS PIRENONA DIARIO STADA / comprimidos recubiertos con película EFG ESTINILESTRADIOL/DROS PIRENONA STADA 0,02 mg/ comprimidos recubiertos con película EFG LIOFORA / comprimidos recubiertos con película LIOFORA DIARIO 0,02 mg/ comprimidos recubiertos con película YASMINELLE /3 mg comprimidos recubiertos con película EMA/713187/2012 Page 226/253

227 BAYER HISPANIA, S.L Avda. Baix Llobregat 3 y Sant Joan Despi Barcelona BAYER HISPANIA, S.L Avda. Baix Llobregat 3 y Sant Joan Despi Barcelona N.V. Organon Kloosterstraat AB, Oss Merck Sharp and Dohme de España, S.A Josefa Valcárcel, Madrid SANDOZ FARMACEUTICA, S.A. Avda. Osa Mayor, Aravaca Madrid LABORATORIOS EFFIK, S.A. San Rafael, Alcobendas Madrid Etonogestrel Etonogestrel YASMINELLE DIARIO 0,02 mg/ comprimidos recubiertos con película YAZ / comprimidos recubiertos con película CIRCLET 0,120 mg/0,015 mg CADA 24 HORAS, SISTEMA DE LIBERACION VAGINAL NUVARING 0,120 mg/0,015 mg CADA 24 HORAS, SISTEMA DE LIBERACION VAGINAL ETINILESTRADIOL/G ESTODENO SANDOZ 0,02 mg/ comprimidos recubiertos GESTINYL 20/75 microgramos comprimidos recubiertos 11,7 mg 2,7 mg 11,7 mg 2,7 mg Vaginal delivery system Vaginal delivery system Vaginal use Vaginal use EMA/713187/2012 Page 227/253

228 BAYER HISPANIA, S.L Avda. Baix Llobregat 3 y Sant Joan Despi Barcelona WYETH FARMA, S.A. Ctra. de Burgos, Km 23. Desvio Algete, Km San Sebastián de los Reyes - Madrid Actavis Group PTC ehf Reykjavikurvegi Hafnarfjordur Iceland BAYER HISPANIA, S.L Avda. Baix Llobregat 3 y Sant Joan Despi Barcelona BAYER HISPANIA, S.L Avda. Baix Llobregat 3 y Sant Joan Despi Barcelona BAYER HISPANIA, S.L Avda. Baix Llobregat 3 y Sant Joan Despi Barcelona GYNOVIN comprimidos recubiertos HARMONET 75/20 microgramos comprimidos recubiertos JULIPERLA /0,075 mg comprimidos recubiertos con película MELIANE comprimidos recubiertos MELIANE DIARIO comprimidos recubiertos MELODENE microgramos/15 microgramos comprimidos recubiertos con película 0,0 0,0618 mg 0,0154 mg EMA/713187/2012 Page 228/253

229 TEVA PHARMA S.L.U. C/ Anabel Segura, 11 Edificio Albatros B 1ª planta Alcobendas Madrid WYETH FARMA, S.A. Ctra. de Burgos, Km 23. Desvio Algete, Km San Sebastián de los Reyes - Madrid WYETH FARMA, S.A. Ctra. de Burgos, Km 23. Desvio Algete, Km San Sebastián de los Reyes - Madrid Actavis Group PTC ehf Reykjavikurvegi Hafnarfjordur Iceland TEVA PHARMA S.L.U. C/ Anabel Segura, 11 Edificio Albatros B 1ª planta Alcobendas Madrid MELTEVA /0,075 mg comprimidos recubiertos con película MINESSE 60 microgramos/15 microgramos comprimidos recubiertos MINULET 75/30 microgramos comprimidos recubiertos SOFIPERLA 0,0/0,075 mg comprimidos recubiertos con película TEVALET 0,0/0,075 mg comprimidos recubiertos 0,0618 mg 0,0154 mg 0,0 0,0 EMA/713187/2012 Page 229/253

230 Sweden Sweden BAYER HISPANIA, S.L Avda. Baix Llobregat 3 y Sant Joan Despi Barcelona WYETH FARMA, S.A. Ctra. de Burgos, Km 23. Desvio Algete, Km San Sebastián de los Reyes - Madrid LABORATORIOS EFFIK, S.A. San Rafael, Alcobendas Madrid Bayer AB Postbox 606 Gustav III's Boulevard 56 SE Solna Sweden Norgestimate Estradiol valerate Dienogest TRIGYNOVIN comprimidos recubiertos TRI-MINULET comprimidos recubiertos VARIANTA 60 microgramos/15 microgramos comprimidos recubiertos con película EDELSIN comprimidos Qlaira Aroletta 28 0,05 mg/0,0 0,07 mg/ 0,04 mg 0,10 mg/0,0 0,05 mg/0,0 0,07 mg/0,04 mg 0,10 mg/0,0 0,06 mg 0,015 mg 0,25 mg 0,035 mg / / 1 mg 0,0 EMA/713187/2012 Page 230/253

231 Sweden Sweden Sweden Sweden Sweden Sweden Sweden Sweden N.V. Organon Kloosterstraat AB, Oss N.V. Organon Kloosterstraat AB, Oss Stada Arzneimittel AG, Stadastrasse 2-8, DE Bad Vibel, Asphalia Caricia Desodiol Desodiolcont Desolett Desolett 28 Docrelen 28 Femistad 0,0 0,0 0,0 0,0 0,0 EMA/713187/2012 Page 231/253

232 Sweden Sweden Sweden Sweden Sweden Sweden Sweden Sweden Stada Arzneimittel AG, Stadastrasse 2-8, DE Bad Vibel, Mylan AB, Postbox 23033, Ynglingagatan 14, SE Stockholm, Sweden N.V. Organon Kloosterstraat AB, Oss N.V. Organon Kloosterstraat AB, Oss Ivowen Limited 3, Anglesea Street Clonmel Co. Tipperary Ireland Teva Sweden AB Järnvägsgatan 11 Box Helsingborg Sweden Femistad Lestramyl Mercilon 28 Mercilon Sablona 28 Artadal Artadal 28 Dretine 0,0 0,0 0,0 0,0 0,0 EMA/713187/2012 Page 232/253

233 Sweden Sweden Sweden Sweden Sweden Sweden Teva Sweden AB Järnvägsgatan 11 Box Helsingborg Sweden Teva Sweden AB Järnvägsgatan 11 Box Helsingborg Sweden Teva Sweden AB Järnvägsgatan 11 Box Helsingborg Sweden Bayer AB Postbox 606 Gustav III's Boulevard 56 SE Solna Sweden Teva Sweden AB Järnvägsgatan 11 Box Helsingborg Sweden Bayer AB Postbox 606 Gustav III's Boulevard 56 SE Solna Sweden Dretine 28 Dretinelle Dretinelle 28 Eloine / Teva Flexyess 0,0 EMA/713187/2012 Page 233/253

234 Sweden Sweden Sweden Sweden Sweden Sweden Sweden Laboratorios Leon Farma SA Poligono Industrial Navatejera, La Vallina s/n, Villaquilambre,Leon Bayer Pharma AG Müllerstraße 178 D Berlin Bayer AB Postbox 606 Gustav III's Boulevard 56 SE Solna Sweden Sandoz A/S Edward Thomsens Vej 14 DK-2300 København S Iradier Liofora Mesilara Palandra Stefaminelle Valdorin Valdorin 28 0,0 EMA/713187/2012 Page 234/253

235 Sweden Sweden Sweden Sweden Sweden Sweden Sweden Sweden Bayer Pharma AG Müllerstraße 178 D Berlin Bayer Pharma AG Müllerstraße 178 D Berlin Bayer Pharma AG Müllerstraße 178 D Berlin Bayer Pharma AG Müllerstraße 178 D Berlin Bayer AB Postbox 606 Gustav III's Boulevard 56 SE Solna Sweden N.V. Organon Kloosterstraat AB, Oss N.V. Organon Kloosterstraat AB, Oss Janssen-Cilag AB, Box 7073, Sollentuna, Sweden Etonogestrel Etonogestrel Norgestimate Yasmin Yasmin 28 Yasminelle Yasminelle 28 Yaz Circlet NuvaRing Cilest 0,0 0,0 0,1 0,015 mg 0,120 mg 0,015 mg 0,035 mg 0,25 mg Vaginal delivery system Vaginal delivery system Vaginal use Vaginal use EMA/713187/2012 Page 235/253

236 Sweden The Netherlands The Netherlands The Netherlands The Netherlands The Netherlands The Netherlands The Netherlands Janssen-Cilag AB, Box 7073, Sollentuna, Sweden betapharm Arzneimittel GmbH Kobelweg Augsburg Actavis Group PTC ehf Reykjavikurvegi Hafnarfjordur Iceland Actavis Group PTC ehf Reykjavikurvegi Hafnarfjordur Iceland Centrafarm B.V. Nieuwe Donk AC Etten-Leur Centrafarm B.V. Nieuwe Donk AC Etten-Leur Stada Arzneimittel AG, Stadastrasse 2-8, DE Bad Vibel, Stada Arzneimittel AG, Stadastrasse 2-8, DE Bad Vibel, Norgestimate Cilest microgram en 20 microgram betapharm tabletten /Ethinylestradi ol Actavis 150/20 microgram tabletten /Ethinylestradi ol Actavis 150/30 microgram tabletten /Ethinylestradi ol CF 0,15/, tabletten /Ethinylestradi ol CF 0,15/0,0, tabletten /Ethinylestradi ol STADA 0,15/, tabletten /Ethinylestradi ol STADA 0,15/0,0, tabletten 0,035 mg 0,25 mg 0,0 0,0 0,0 EMA/713187/2012 Page 236/253

237 The Netherlands The Netherlands The Netherlands The Netherlands The Netherlands The Netherlands The Netherlands The Netherlands Teva Nederland B.V. Swensweg GA Haarlem WeCare, Lagedijk 1-3; 1541 KA Koog aan de Zaan, Teva Nederland B.V. Swensweg GA Haarlem WeCare, Lagedijk 1-3; 1541 KA Koog aan de Zaan, Mylan B.V. Dieselweg LB BUNSCHOTEN Mylan B.V. Dieselweg LB BUNSCHOTEN /Desogestr el 0,02/ Teva, tabletten /desogestr el 0,020 mg/0,150 mg WEC tabletten /Desogestr el 0,03/ Teva, tabletten /desogestr el 0,030 mg/0,150 mg WEC tabletten /Desogestr el Mylan 0,02/, tabletten /Desogestr el Mylan 0,03/, tabletten /desogestr el Richter /0,15 mg filmomhulde tabletten /desogestr el Richter 0,0/0,15 mg filmomhulde tabletten 0,0 0,0 0,0 0,0 EMA/713187/2012 Page 237/253

238 The Netherlands The Netherlands The Netherlands The Netherlands The Netherlands The Netherlands The Netherlands The Netherlands Zentiva, k.s. U kabelovny Praha 10 Dolní Měcholupy Zentiva, k.s. U kabelovny Praha 10 Dolní Měcholupy N.V. Organon Kloosterstraat AB, Oss betapharm Arzneimittel GmbH Kobelweg Augsburg N.V. Organon Kloosterstraat AB, Oss N.V. Organon Kloosterstraat AB, Oss /Desogestr el Richter 0.02 mg/0.15mg -28 filmomhulde tabletten /Desogestr el Richter 150 microgram/30 microgram -28 filmomhulde tabletten Juliane 150/20 microgram tabletten Juliane 150/30 microgram tabletten Laurina, tabletten Lonicera 150/30 microgram tabletten Marvelon, tabletten Mercilon, tabletten 0,0 0,0 0,05 mg/0,035 mg 0,1 mg/0,0 /0,0 0,0 0,0 EMA/713187/2012 Page 238/253

239 The Netherlands The Netherlands The Netherlands The Netherlands The Netherlands The Netherlands The Netherlands Sandoz B.V. Veluwezoom AH Almere Berlipharm B.V. Energieweg RT Mijdrecht Teva B.V GA Haarlem Swensweg 5 Sandoz B.V. Veluwezoom AH Almere Bayer B.V. Energieweg RT Mijdrecht Mylan B.V. Dieselweg LB BUNSCHOTEN Armarrok 28, filmomhulde tabletten 0,0/ / Drospirenon 0,0/ 3 mg Berlipharm, filmomhulde tabletten 0,03/ /Drospiren on 0,0/ Teva, filmomhulde tabletten /Drospiren on Richter 0,0/ filmomhulde tabletten 28x /Drospiren on Sandoz 0,03/, filmomhulde tabletten Palandra, filmomhulde tabletten 0,0/ Rosal 0,0/, filmomhulde tabletten 0,0 0,0 0,0 0,0 0,0 0,0 0,0 EMA/713187/2012 Page 239/253

240 The Netherlands The Netherlands The Netherlands The Netherlands The Netherlands The Netherlands The Netherlands Laboratorios Leon Farma SA Poligono Industrial Navatejera, La Vallina s/n, Villaquilambre,Leon Bayer B.V. Energieweg RT Mijdrecht Bayer B.V. Energieweg RT Mijdrecht Bayer B.V. Energieweg RT Mijdrecht Sandoz B.V. Veluwezoom AH Almere Sandoz B.V. Veluwezoom AH Almere estradiol valerate dienogest Rosal 28, filmomhulde tabletten Volina 0,0 / filmomhulde tabletten Yasmin 28, filmomhulde tabletten 0,03/ Yasmin, omhulde tabletten 0,03/ Qlaira filmomhulde tabletten Filmomhulde tablet Armunia 28, filmomhulde tabletten / Armunia, filmomhulde tabletten / 0,0 0,0 0,0 0,0 /0 mg / / 1 mg/0 mg EMA/713187/2012 Page 240/253

241 The Netherlands The Netherlands The Netherlands The Netherlands The Netherlands The Netherlands Bayer B.V. Energieweg RT Mijdrecht Bayer B.V. Energieweg RT Mijdrecht Berlipharm B.V. Energieweg RT Mijdrecht Bayer B.V. Energieweg RT Mijdrecht Laboratorios Leon Farma SA Poligono Industrial Navatejera, La Vallina s/n, Villaquilambre,Leon Belanette 28, filmomhulde tabletten / Belanette, filmomhulde tabletten / /Drospiren on 24+4 / Berlipharm filmomhulde tabletten /Drospiren on Richter / filmomhulde tabletten Liofora, filmomhulde tabletten / Vallclara /, filmomhulde tabletten EMA/713187/2012 Page 241/253

242 The Netherlands The Netherlands The Netherlands The Netherlands The Netherlands The Netherlands Laboratorios Leon Farma SA Poligono Industrial Navatejera, La Vallina s/n, Villaquilambre,Leon Bayer B.V. Energieweg RT Mijdrecht Bayer B.V. Energieweg RT Mijdrecht Bayer B.V. Energieweg RT Mijdrecht Bayer B.V. Energieweg RT Mijdrecht Vallclara 28 /3 mg, filmomhulde tabletten Volina / filmomhulde tabletten Yasminelle 28, filmomhulde tabletten / Yasminelle, filmomhulde tabletten / Yaz 24+4 / filmomhulde tabletten Yvidually /, filmomhulde tabletten EMA/713187/2012 Page 242/253

243 The Netherlands The Netherlands The Netherlands The Netherlands The Netherlands The Netherlands The Netherlands Laboratorios Leon Farma SA Poligono Industrial Navatejera, La Vallina s/n, Villaquilambre,Leon Apothecon B.V. Nijverheidsweg ME Barneveld Apothecon B.V. Nijverheidsweg ME Barneveld Apothecon B.V. Nijverheidsweg ME Barneveld Mylan B.V. Dieselweg LB BUNSCHOTEN Mylan B.V. Dieselweg LB BUNSCHOTEN Sandoz B.V. Veluwezoom AH Almere Annantah 0,060 mg/0,015 mg, filmomhulde tabletten /gestodeen 0,015/0,060 A filmomhulde tabletten 0,015/0,060 mg /gestodeen 0,02/0,075 A, omhulde tabletten /0,075 mg /gestodeen 0,03/0,075 A, omhulde tabletten 0,0/0,075 mg /Gestodeen Mylan 0,02/, omhulde tabletten /Gestodeen Mylan 0,03/, omhulde tabletten /Gestodeen Sandoz 0,020/, omhulde tabletten 0,015 mg 0,06 mg 0,015 mg 0,06 mg 0,0 0,0 EMA/713187/2012 Page 243/253

244 The Netherlands The Netherlands The Netherlands The Netherlands The Netherlands The Netherlands The Netherlands The Netherlands Sandoz B.V. Veluwezoom AH Almere Bayer B.V. Energieweg RT Mijdrecht Pharmachemie B.V. Swensweg GA Haarlem Pharmachemie B.V. Swensweg GA Haarlem Velvian GmbH Carl-Zeiss-Ring Ismaning Pfizer B.V. Rivium Westlaan LD Capelle a/d IJssel N.V. Organon Kloosterstraat AB, Oss N.V. Organon Kloosterstraat AB, Oss Etonogestrel Etonogestrel /Gestodeen Sandoz 0,030/, omhulde tabletten Femodeen / 0,030 mg omhulde tabletten Gestodeen/ /0,020 mg PCH, omhulde tabletten Gestodeen/ /0,030 mg PCH, omhulde tabletten Jamyle 0,060 mg / 0,015 mg, filmomhulde tabletten Minulet, dragees Circlet 0,120 mg/0,015 mg per 24 uur, hulpmiddel voor vaginaal gebruik NuvaRing 0,120 mg/0,015 mg per 24 uur, hulpmiddel voor vaginaal gebruik 0,0 0,0 0,0 0,015 mg 0,06 mg 0,0 11,7 mg 2,7 mg 11,7 mg 2,7 mg Vaginal delivery system Vaginal delivery system Vaginal use Vaginal use EMA/713187/2012 Page 244/253

245 The Netherlands United Kingdom United Kingdom United Kingdom United Kingdom United Kingdom Janssen-Cilag B.V. Dr. Paul Janssenweg RH TILBURG Bayer PLC Pharma Division, Bayer House, Strawberry Hill, Newbury, Berkshire RG14 1JA, United Kingdom Norgestimate Estradiol valerate Dienogest Cilest, tabletten Gedarel 150/20 Micrograms Film-Coated s Gedarel 150/30 Micrograms Film-Coated s Gedarel ED 20 micrograms/150 micrograms Gedarel ED 30 micrograms/150 micrograms Qlaira 0,25 mg 0,035 mg 0,0 0,0 1mg/ 2mg / 3mg / 3mg EMA/713187/2012 Page 245/253

246 United Kingdom United Kingdom United Kingdom United Kingdom United Kingdom Organon Laboratories Limited, Cambridge Science Park, Milton Road, Cambridge CB4 0FL, United Kingdom Morningside Healthcare Limited, 115 Narborough Road, Leicester LE3 0PA United Kingdom Famy Care Europe Ltd. One Wood Street EC2V 7WS London United Kingdom Famy Care Europe Ltd. One Wood Street EC2V 7WS London United Kingdom Organon Laboratories Limited, Cambridge Science Park, Milton Road, Cambridge CB4 0FL, United Kingdom Ethinyestradiol Etonogestrel NuvaRing Cimizt s 150 mg/30 mg Lestramyl s 150 microgram/20 microgram Lestramyl s 150 microgram/30 microgram Marvelon 150/30 s 2.7mg 11.7mg 0,0 0,0 0,0 Vaginal delivery system Vaginal use EMA/713187/2012 Page 246/253

247 United Kingdom United Kingdom United Kingdom United Kingdom United Kingdom Organon Laboratories Limited, Cambridge Science Park, Milton Road, Cambridge CB4 0FL, United Kingdom Laboratorios Leon Farma SA Poligono Industrial Navatejera, La Vallina s/n, Villaquilambre,Leon Laboratorios Leon Farma SA Poligono Industrial Navatejera, La Vallina s/n, Villaquilambre,Leon Laboratorios Leon Farma SA Poligono Industrial Navatejera, La Vallina s/n, Villaquilambre,Leon Mercilon s Armentinar s 0.02 mg/ Bellmunt 28 Film-coated s 0.0/ Bellmunt Film-coated s 0.0/ Daylette film-coated tablets 0.02mg/3mg mg 0,0 0,0 EMA/713187/2012 Page 247/253

248 United Kingdom United Kingdom United Kingdom United Kingdom United Kingdom Teva UK Limited, Brampton Road, Hampden Park, Eastbourne, East Sussex BN22 9AG, United Kingdom Teva UK Limited, Brampton Road, Hampden Park, Eastbourne, East Sussex BN22 9AG, United Kingdom Bayer PLC Pharma Division, Bayer House, Strawberry Hill, Newbury, Berkshire RG14 1JA, United Kingdom Dretine 28 s 0.03mg/3.0mg Dretine s 0.03mg/3.0mg Eloine film coated tablets 0.02mg/3mg Eslarilla ED Film-coated tablets 0.02mg/3mg Eslarilla Film-coated tablets 0.02mg/3mg 0,0 0,0 EMA/713187/2012 Page 248/253

249 United Kingdom United Kingdom United Kingdom United Kingdom United Kingdom United Kingdom United Kingdom Bayer PLC Pharma Division, Bayer House, Strawberry Hill, Newbury, Berkshire RG14 1JA, United Kingdom Flexyess s 0.02mg/3mg Kylnetta ED film-coated tablets 0.03mg/3mg Kylnetta film-coated tablets 0.03mg/3mg Lovette ED film-coated tablets 0.02mg/3mg Lovette film-coated tablets 0.02mg/3mg Lucette ED film-coated tablets 0.03mg/3mg Lucette Film-coated tablets 0.03mg/3mg 0,0 0,0 0,0 0,0 EMA/713187/2012 Page 249/253

250 United Kingdom United Kingdom United Kingdom United Kingdom United Kingdom Bayer PLC Pharma Division, Bayer House, Strawberry Hill, Newbury, Berkshire RG14 1JA, United Kingdom Laboratorios Leon Farma SA Poligono Industrial Navatejera, La Vallina s/n, Villaquilambre,Leon Laboratorios Leon Farma SA Poligono Industrial Navatejera, La Vallina s/n, Villaquilambre,Leon Bayer PLC Pharma Division, Bayer House, Strawberry Hill, Newbury, Berkshire RG14 1JA, United Kingdom Minkian film-coated tablets 0.02mg/3mg Palandra s 0.03mg/3mg Vallclara 28 Film-coated s 0.0/ Vallclara Film-coated s 0.0/ Yasmin ED s 0,0 0,0 EMA/713187/2012 Page 250/253

251 United Kingdom United Kingdom United Kingdom United Kingdom United Kingdom Bayer PLC Pharma Division, Bayer House, Strawberry Hill, Newbury, Berkshire RG14 1JA, United Kingdom Bayer PLC Pharma Division, Bayer House, Strawberry Hill, Newbury, Berkshire RG14 1JA, United Kingdom Bayer PLC Pharma Division, Bayer House, Strawberry Hill, Newbury, Berkshire RG14 1JA, United Kingdom Yasmin s Yasminelle s Yaz film coated tablets 0.02mg/3mg Edesia Coated s 75 micrograms / 20 micrograms Edesia Coated s 75 micrograms / 30 micrograms 0, mg EMA/713187/2012 Page 251/253

252 United Kingdom United Kingdom United Kingdom United Kingdom United Kingdom Bayer PLC Pharma Division, Bayer House, Strawberry Hill, Newbury, Berkshire RG14 1JA, United Kingdom Bayer PLC Pharma Division, Bayer House, Strawberry Hill, Newbury, Berkshire RG14 1JA, United Kingdom Bayer PLC Pharma Division, Bayer House, Strawberry Hill, Newbury, Berkshire RG14 1JA, United Kingdom Gedeon Richter, 1-3 Ruse Caumartin, Paris 75009, Stragen UK Limited, Castle Court, 41 London Road, Reigate, Surrey RH2 9RJ United Kingdom Femodene ED s Femodene s Femodette Gestilla Coated s 75 micrograms / 30 micrograms Katya Coated s 30/ mg mg mg mg EMA/713187/2012 Page 252/253

253 United Kingdom United Kingdom United Kingdom United Kingdom United Kingdom United Kingdom Gedeon Richter, 1-3 Ruse Caumartin, Paris 75009, Stragen UK Limited, Castle Court, 41 London Road, Reigate, Surrey RH2 9RJ United Kingdom Bayer PLC Pharma Division, Bayer House, Strawberry Hill, Newbury, Berkshire RG14 1JA, United Kingdom Morningside Healthcare Limited, 115 Narborough Road, Leicester LE3 0PA United Kingdom Janssen-Cilag Limited Holmers Farm Way High Wycombe Buckinghamshire HP12 4EG United Kingdom Norgestimate Norgestimate Millinette Coated s 75 micrograms / 30 micrograms Millinette ED Micrograms Film-Coated s 15 / 60 Sunya 20/75 Coated s Triadene Lizinna s 250/35mcg Cilest s mg 0,015 mg 0,06 mg 0.0 / 0.04 mg 0.01mg / 0.05mg / 0.07mg 35mg 0,25 mg 0,25 mg 0,035 mg EMA/713187/2012 Page 253/253