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

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Annex I List of the Names, Pharmaceutical Forms, Strengths Of Annex I List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, marketing authorisation holders in the member states 1 Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA) Austria Janssen - Cilag Pharma GmbH Norgestimate Cileste - Tabletten 0,25 mg Tablet Oral use Vorgartenstraße 206b Ethinylestradiol 0,035 mg A-1020 Wien Austria Austria N.V. Organon Desogestrel Gracial - Tabletten 0,03 mg/0,125 mg Tablet Oral use Kloosterstraat 6 Ethinylestradiol 0,04 mg/0,025 mg 5349 AB, Oss The Netherlands Austria Bayer Austria GmbH Estradiol valerate Qlaira Filmtabletten 3 mg Film-coated tablet Oral use Herbststrasse 6-10 Dienogest 2 mg/2 mg 1160 Wien 2 mg/3 mg Austria 1 mg Austria Gynial GmbH Chlormadinone Bilinda 0,03 mg/2 mg 0,03 mg Film-coated tablet Oral use Gablenzgasse 11/III Ethinylestradiol Filmtabletten 2 mg 1150 Wien Austria Austria Kwizda Pharma GmbH Chlormadinone Delia 0,03 mg/2 mg 0,03 mg Film-coated tablet Oral use Effingergasse 21 Ethinylestradiol Filmtabletten 2 mg 1160 Wien Austria Austria Dermapharm GmbH Chlormadinone Madinette 0,03 mg/2 0,03 mg Film-coated tablet Oral use Türkenstraße 25/12 Ethinylestradiol mg Filmtabletten 2 mg 1090 Wien Austria Austria Teva Pharma BV Chlormadinone Mellow ratiopharm 0,03 mg Film-coated tablet Oral use Computerweg 10 Ethinylestradiol 0,03 mg/2 mg 2 mg 3542 DR Utrecht Filmtabletten The Netherlands 2 Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA) Austria Actavis Group PTC ehf Chlormadinone Angiletta 0,03 mg/2 0,03 mg Film-coated tablet Oral use Reykjavikurvegi 76-78 Ethinylestradiol mg Filmtabletten 2 mg 220 Hafnarfjordur Iceland Austria Gedeon Richter Plc. Chlormadinone Balanca 0,03 mg/2 0,03 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol mg - Filmtabletten 2 mg HU-1103 Budapest Hungary Austria Pfizer Corporation Austria GmbH Chlormadinone Beatrice 0,03 mg/2 0,03 mg Film-coated tablet Oral use Floridsdorfer Hauptstraße 1 Ethinylestradiol mg Filmtabletten 2 mg 1210 Wien Austria Austria Gedeon Richter Plc. Chlormadinone Belara 0,03 mg/2 mg 0,03 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol - Filmtabletten 2 mg HU-1103 Budapest Hungary Austria Madaus GmbH Chlormadinone Bellissima 0,03 mg/2 0,03 mg Film-coated tablet Oral use Colonia Allee 15 Ethinylestradiol mg Filmtabletten 2 mg 51067 Köln Germany Austria Hexal GmbH Chlormadinone Ethinylestradiol/Chlor 0,03 mg Film-coated tablet Oral use Stella-Klein-Löw-Weg 17 Ethinylestradiol madinon Hexal 0,03 2 mg 1020 Wien mg/2 mg - Austria Filmtabletten Austria Dermapharm GmbH Desogestrel Desofemine 20 0,02 mg Film-coated tablet Oral use Türkenstraße 25/12 Ethinylestradiol Mikrogramm/150 0,15 mg 1090 Wien Mikrogramm Austria Filmtabletten 3 Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA) Austria Dermapharm GmbH Desogestrel Desofemine 30 0,03 mg Film-coated tablet Oral use Türkenstraße 25/12 Ethinylestradiol Mikrogramm/150 0,15 mg 1090 Wien Mikrogramm Austria Filmtabletten Austria Gedeon Richter Plc. Desogestrel Desorelle 30 0,03 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol Mikrogramm/150 0,15 mg HU-1103 Budapest Mikrogramm 21+7 Hungary Filmtabletten Austria Gedeon Richter Plc. Desogestrel Desorelle Mite 20 0,02 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol Mikrogramm/150 0,15 mg HU-1103 Budapest Mikrogramm 21+7 Hungary Filmtabletten Austria Kwizda Pharma GmbH Desogestrel Liberel - Filmtabletten 0,03 mg Film-coated tablet Oral use Effingergasse 21 Ethinylestradiol 0,15 mg 1160 Wien Austria Austria Kwizda Pharma GmbH Desogestrel Liberel mite - 0,02 mg Film-coated tablet Oral use Effingergasse 21 Ethinylestradiol Filmtabletten 0,15 mg 1160 Wien Austria Austria N.V. Organon Desogestrel Marvelon - Tabletten 0,03 mg Tablet Oral use Kloosterstraat 6 Ethinylestradiol 0,15 mg 5349 AB, Oss The Netherlands Austria N.V. Organon Desogestrel Mercilon - Tabletten 0,02 mg Tablet Oral use Kloosterstraat 6 Ethinylestradiol 0,15 mg 5349 AB, Oss The Netherlands 4 Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA) Austria Pfizer Corporation Austria GmbH Dienogest Bonisara 0,03 mg/2 0,03 mg Film-coated tablet Oral use Floridsdorfer Hauptstraße 1 Ethinylestradiol mg Filmtabletten 2 mg 1210 Wien Austria Austria Aristo Pharma GmbH Dienogest Cara 0,03 mg/2 mg 0,03 mg Film-coated tablet Oral use Wallenroder Straße 8-10 Ethinylestradiol Filmtabletten 2 mg 13435 Berlin Germany Austria Dermapharm GmbH Dienogest Dienovel 0,03 mg/2,0 0,03 mg Film-coated tablet Oral use Türkenstraße 25/12 Ethinylestradiol mg Filmtabletten 2 mg 1090 Wien Austria Austria Pelpharma Handels GmbH Dienogest Peliette 0,03 mg/2 mg 0,03 mg Film-coated tablet Oral use Stammhaustraße Ethinylestradiol Filmtabletten 2 mg 1210 Wien Austria Austria Helm AG Dienogest Kappanogest 0,03 0,03 mg Film-coated tablet Oral use Nordkanalstrasse 28 Ethinylestradiol mg/2 mg 2 mg 20097 Hamburg Filmtabletten Germany Austria Velvian Germany GmbH Dienogest Dienorette 0,03 mg/2 0,03 mg Film-coated tablet Oral use Carl-Zeiss-Ring 9 Ethinylestradiol mg Filmtabletten 2 mg 85737 Ismaning Germany Austria Gynial GmbH Dienogest Larissa 0,03 mg/2 mg 0,03 mg Film-coated tablet Oral use Gablenzgasse 11/III Ethinylestradiol Filmtabletten 2 mg 1150 Wien Austria 5 Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA) Austria Madaus GmbH Dienogest Mayra 0,03 mg/2 mg 0,03 mg Film-coated tablet Oral use Colonia Allee 15 Ethinylestradiol Filmtabletten 2 mg 51067 Köln Germany Austria Ratiopharm Arzneimittel Dienogest Motion ratiopharm 2 0,03 mg Film-coated tablet Oral use Vertriebs-GmbH Ethinylestradiol mg/0,03 mg 2 mg Albert-Schweitzer-Gasse 3 Filmtabletten 1140 Wien Austria Austria Gedeon Richter Plc. Dienogest Sibilla 0,03 mg/2 mg 0,03 mg Film-coated tablet Oral use Gyömröí út 19-21 Ethinylestradiol Filmtabletten 2 mg HU-1103 Budapest Hungary Austria Stada Arzneimittel GmbH Dienogest Stella 0,03 mg/2,0 0,03 mg Film-coated tablet Oral use Muthgasse 36/2 Ethinylestradiol mg Filmtabletten 2 mg 1190 Wien Austria Austria Bayer Austria GmbH Dienogest Valette Dragees 0,03 mg Coated tablet Oral use Herbststrasse 6-10 Ethinylestradiol 2 mg 1160 Wien Austria Austria Velvian Germany GmbH Dienogest Viola 0,03 mg/2 mg 0,03 mg Film-coated tablet Oral use Carl-Zeiss-Ring 9 Ethinylestradiol Filmtabletten 2 mg 85737 Ismaning Germany 6 Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA) Austria Bayer Austria GmbH Drospirenone Aliane 0,02 mg/3 mg 0,02 mg Film-coated tablet Oral use Herbststrasse 6-10 Ethinylestradiol Filmtabletten 3 mg 1160 Wien Austria Austria Ratiopharm Arzneimittel Drospirenone Balancette 0,02 mg/3 0,02 mg Film-coated tablet Oral use Vertriebs-GmbH Ethinylestradiol mg Filmtabletten 3 mg Albert-Schweitzer-Gasse 3 1140 Wien Austria Austria Ratiopharm Arzneimittel Drospirenone Danselle 0,02 mg/3 0,02 mg Film-coated tablet Oral use Vertriebs-GmbH Ethinylestradiol mg 21 + 7 3 mg Albert-Schweitzer-Gasse 3 Filmtabletten 1140 Wien Austria Austria Ratiopharm Arzneimittel Drospirenone Danselle 0,02 mg/3 0,02 mg Film-coated tablet Oral use Vertriebs-GmbH Ethinylestradiol mg 21 Filmtabletten 3 mg Albert-Schweitzer-Gasse 3 1140 Wien Austria Austria Ratiopharm Arzneimittel Drospirenone Danseo 0,03 mg/3 mg 0,03 mg Film-coated tablet Oral use Vertriebs-GmbH Ethinylestradiol 21 + 7 Filmtabletten 3 mg Albert-Schweitzer-Gasse 3 1140 Wien Austria 7 Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA) Austria Ratiopharm Arzneimittel Drospirenone Danseo 0,03 mg/3 mg 0,03 mg Film-coated tablet Oral use Vertriebs-GmbH Ethinylestradiol 21 Filmtabletten 3 mg Albert-Schweitzer-Gasse 3 1140 Wien Austria Austria Bayer Austria GmbH Drospirenone Eloine 0,02 mg/3 mg 0,02 mg Film-coated tablet Oral use Herbststrasse 6-10 Ethinylestradiol Filmtabletten 3 mg 1160 Wien Austria Austria Bayer Austria GmbH Drospirenone Ethinylestradiol/Drospi 0,03 mg Film-coated tablet Oral use Herbststrasse 6-10 Ethinylestradiol renon Bayer 0,03 3 mg 1160 Wien mg/3 mg Austria Filmtabletten Austria Sandoz GmbH Drospirenone Ethinylestradiol/Drospi 0,02 mg Film-coated tablet Oral use Biochemiestrase 10 Ethinylestradiol renon Sandoz 0,02 3 mg 6250 Kundl mg/3 mg 21 Austria Filmtabletten Austria Sandoz GmbH Drospirenone Ethinylestradiol/Drospi 0,02 mg Film-coated tablet Oral use Biochemiestrase 10 Ethinylestradiol renon Sandoz 0,02 3 mg 6250 Kundl mg/3 mg 21+7 Austria Filmtabletten Austria Sandoz GmbH Drospirenone Ethinylestradiol/Drospi 0,03 mg Film-coated tablet Oral use Biochemiestrase 10 Ethinylestradiol renon Sandoz 0,03 3 mg 6250 Kundl mg/3 mg 21 Austria Filmtabletten 8 Member Marketing Authorisation INN Invented name Strength Pharmaceutical Route of State (in Holder form administration EEA) Austria Sandoz GmbH Drospirenone Ethinylestradiol/Drospi 0,03 mg Film-coated tablet Oral use Biochemiestrase 10 Ethinylestradiol renon Sandoz 0,03 3 mg 6250 Kundl mg/3 mg 21+7 Austria Filmtabletten Austria Laboratorios Leon Farma SA Drospirenone Etindros 0,02 mg/3 0,02 mg Film-coated tablet Oral use Calle La Vallina S/N Ethinylestradiol mg Filmtabletten 3 mg Poligono Industrial Navatejera
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