VIÐAUKI I LISTI YFIR HEITI, LYFJAFORM, STYRKLEIKA LYFJANNA, ÍKOMULEIÐ, MARKAÐSLEYFISHAFA Í AÐILDARLÖNDUNUM

Átírás

1 VIÐAUKI I LISTI YFIR HEITI, LYFJAFORM, STYRKLEIKA LYFJANNA, ÍKOMULEIÐ, MARKAÐSLEYFISHAFA Í AÐILDARLÖNDUNUM 1

2 Austurríki Gynial GmbH Gablenzgasse 11/III 1150 Wien Austria Alisma 2mg/35µg Filmtablette Austurríki Austurríki Ratiopharm Arzneimittel Vertriebs-GmbH Albert-Schweitzer-Gasse Wien Austria Dermapharma GmbH, Türkenstraße 25/12 A-1090 Wien, Austria Bellgyn "ratiopharm" 2 mg/ - überzogene Tabletten Cyprotomin 2 mg/ Filmtabletten Austurríki Bayer Austria GmbH Herbststrasse Wien Austria Diane mite - Dragees Austurríki Dermapharm AG Lil-Dagover-Ring Grünwald Femogyn 2 mg/ überzogene Tabletten Austurríki Pelpharma Handels GmbH Stammhausstraße Wien Austria Midane - Dragees

3 Austurríki Bayer Austria GmbH Herbststrasse Wien Austria Minerva - Dragees Austurríki Sandoz GmbH Biochemiestrase Kundl Austria Xylia - Dragées Belgía Belgía Belgía Belgía Mithra Pharmaceuticals S.A. Rue Saint Georges Liège Belgium Sandoz N.V. Telecom Gardens Medialaan Vilvoorde Belgium Mithra Pharmaceuticals S.A. Rue Saint Georges Liège Belgium Bayer N.V. Jan Emiel Mommaertslaan Machelen Belgium Chloe Claudia-35 Daphne Diane-35

4 Belgía Mylan BVBA/SPRL Terhulpsesteenweg 6A 1560 Hoeilaart Belgium Elisamylan Belgía Búlgaría Búlgaría Búlgaría Tékkland 3 DDD Pharma N.V. Diestersteenweg Hasselt Belgium Medico Uno Worldwide Ltd. 2 Grigori Afxentiou Street Larnaca 6023 Cyprus Zentiva, k.s. U kabelovny Praha 10 Dolní Měcholupy Czech Republic Zentiva, k.s. U kabelovny Praha 10 Dolní Měcholupy Czech Republic Gratiella 35 Diane 35 Melleva Chloe CHLOE

5 Tékkland Heaton k.s. Na Pankráci 332/ Praha 4Czech Republic VREYA Tékkland MINERVA Tékkland DIANE-35 Danmörk Danmörk Danmörk Mithra Pharmaceuticals S.A. Rue Saint Georges Liège Belgium Teva Denmark A/S Parallelvej DK-2800 Kongens Lyngby Denmark Chloe Cypretyl Diane Mite

6 Danmörk Alternova A/S Lodshusvej 11 DK-4230 Skælskør Denmark Dianova Mite Danmörk Sandoz A/S Edvard Thomsens Vej 14 DK-2300 København S Denmark Feminil mite Danmörk Stragen Nordic A/S Helsingørsgade 8C DK-3400 Hillerød Denmark Vreya Danmörk Eistland Orifarm Generics A/S Postbox 69 Energivej 15 DK-5260 Odense S. Denmark D Berlin Zyrona Diane Eistland Nycomed Sefa AS Jaama 55B Põlva Estonia Femina Eistland Ratiopharm GmbH Graf-Arco-Strasse 3 DE Ulm Cypretil

7 Finnland Bayer Oy Pansiontie 47 FI Turku Finland DIANE NOVA Tafla Finnland Ratiopharm GmbH Graf-Arco-Strasse 3 DE Ulm CYPRETYL Tafla Finnland Sandoz A/S Edvard Thomsens Vej 14 DK-2300 København S Denmark FEMINIL Tafla Finnland Stragen Nordic A/S Helsingørsgade 8C DK-3400 Hillerød Denmark VREYA Tafla Bayer Santé 220, avenue de la Recherche Loos Bayer Santé 220, avenue de la Recherche Loos DIANE 35 µg, coated tablet MINERVA 35 µg

8 Bayer Santé 220, avenue de la Recherche Loos Laboratoires Majorelle rue Gallieni Boulogne Billancourt DCI Pharma 180 Rue Eugene Avinee Loos CYPROTERONE/ETHINYLESTRADIOL BAYER 35 µg CYPROPHARM 2 mg/ CYPROTERONE/ETHINYLESTRADIOL DCI PHARMA 2 mg/ EG LABO - LABORATOIRES EUROGENERICS 12 rue Danjou le Quintet bâtiment A Boulogne Billancourt Cedex Ranbaxy Pharmacie Generiques quai de Dion Bouton Puteaux CYPROTERONE/ETHINYLESTRADIOL EG 2 mg/ CYPROTERONE/ETHINYLESTRADIOL RANBAXY 2 mg/

9 Teva Sante 110 Esplanade du Général de Gaulle Paris la Defence SANDOZ 49 avenue Georges Pompidou Levallois Perret Cedex Teva Sante 110 Esplanade du Général de Gaulle Paris la Defence Sanofi Aventis 1-13 Boulevard Romain Rolland Paris ZYDUS Parc d'activités des Peupliers 25 rue des Peupliers Nanterre CHEMICAL FARMA rue d'hautpoul Paris CYPROTERONE/ETHINYLESTRADIOL RATIOPHARM 2 mg/ CYPROTERONE/ETHINYLESTRADIOL SANDOZ 2 mg/ CYPROTERONE/ETHINYLESTRADIOL TEVA 2 mg/ CYPROTERONE/ETHINYLESTRADIOL ZENTIVA 2 mg/ CYPROTERONE/ETHINYLESTRADIOL ZYDUS 2 mg/ ELLEACNELLE 2 mg/

10 MYLAN SAS 117 allée des Parcs Saint Priest EVEPAR 2 mg/ Þýskaland EFFIK bâtiment ''le Newton'' 9-11 rue Jeanne Braconnier Meudon la Foret Pierre Fabre Dermatologie 45, place Abel Gance F Boulogne Dermapharm AG Lil-Dagover-Ring Grünwald HOLGYEME 2 mg/ LUMALIA 2 mg/ Cyproethinyl acis Þýskaland Aristo Pharma GmbH Wallenroder Str Berlin Jennifer 35 2 mg/ Filmtabletten Þýskaland Bayer Vital GmbH Kaiser-Wilhelm-Allee Leverkusen Diane-35 /2mg überzogene Tablette

11 Þýskaland Dermapharm AG Lil-Dagover-Ring Grünwald Cyproteronacetat/Ethinylestradiol Dermapharm 2 mg/ überzogene Tablette Þýskaland Hexal Aktiengesellschaft Industriestr Holzkirchen Bella HEXAL 35 2 mg/ überzogene Tablette Þýskaland Mylan dura GmbH Wittichstr Darmstadt Juliette Þýskaland Ratiopharm GmbH Graf-Arco-Strasse 3 DE Ulm Attempta-ratiopharm 35 2 mg/ überzogene Tablette Þýskaland Taurus Pharma GmbH Benzstr Bad Homburg Ergalea 2,00/ Filmtabletten Þýskaland UCB Pharma GmbH Alfred-Nobel-Str Monheim Moea Sanol 2 mg/ überzogene Tabletten Grikkland Bayer Hellas ABEE Sorou Maroussi Athens GR Greece GYNOFEN 35

12 Ungverjaland Ungverjaland Pliva Hungária Kereskedelmi és Szolgáltató Kft. Rákóczi út Budapest 1074 Hungary Bellune Pliva Diane Ungverjaland Minerva Ísland D Berlin Diane mite Tafla Ísland Ratiopharm GmbH Graf-Arco-Strasse 3 DE Ulm Cypretyl Írland Generics (UK) Limited Station Close Potters Bar Hertfordshire EN6 1TL Cyproterone Acetate/Ethinylestradiol Tablets 2mg/0.035mg Tafla

13 Írland Ítalía Bayer Limited The Atrium Blackthorn Road Sandyford Dublin 18 Ireland Bayer S.p.A. Viale Certosa, Milano (MI) Italy Dianette 2mg/35 microgram coated tablets. DIANE Ítalía FIDIA Farmaceutici S.p.A. Via Ponte della Fabbrica 3/A Abano Terme (PD) Italy VISOFID Lettland Lettland Zentiva, k.s. U kabelovny Praha 10 Dolní Měcholupy Czech Republic Takeda Pharma AS Jaama 55B Põlva Estonia Chloe 35 micrograms/2 mg film-coated tablets Femina 2 mg/35 micrograms coated tablets Film-coated tablet

14 Lettland Diane 2000 micrograms/35 micrograms film-coated tablets Litháen Diane Litháen Nycomed Sefa AS Jaama 55B Põlva Estonia Femina Litháen Litháen Zentiva, k.s. U kabelovny Praha 10 Dolní Měcholupy Czech Republic Ratiopharm GmbH Graf-Arco-Strasse 3 DE Ulm CHLOE Cypretil Lúxemborg Bayer SA/NV 14 J.E. Mommaertslaan B-1831 Diegem Belgium Diane-35

15 Lúxemborg Lúxemborg Lúxemborg Malta Malta Noregur Mithra Pharmaceuticals S.A. Rue Saint Georges Liège Belgium Mithra Pharmaceuticals S.A. Rue Saint Georges Liège Belgium Pierre Fabre Dermatologie 45, place Abel Gance F Boulogne Stragen UK Limited Castle Court 41 London Road Reigate, Surrey RH2 PRJ Sandoz d.d Verovskova Ljubljana Slovenia Chloe Daphne Lumalia Clairette 2000/35 Tablets Acnocin 2000/35 Tablets Diane

16 Noregur Sandoz Edvard Thomsens Vej KØBENHAVN S Denmark Feminil Noregur Pólland Pólland Pólland Pólland Orifarm Generics A/S Postbox 69 Energivej 15 DK-5260 Odense S. Denmark Acis Arzneimittel GmbH Lil-Dagover-Ring Grünwald Zentiva, k.s. U kabelovny Praha 10 Dolní Měcholupy Czech Republic Pabianickie Zakłady Farmaceutyczne Polfa S.A. ul. Marszałka J. Piłsudskiego Pabianice Poland Zyrona Acnemine Diane-35 Chloe Cyprest

17 Pólland Pólland Polfarmex S.A. Józefów Kutno Poland SymPhar Sp. z o.o. ul. Włoska Warszawa Poland OC-35 Syndi-35 Pólland Sun-Farm Sp. z o.o. Człekówka Kołbiel Poland Cyprodiol Portúgal Berlifarma - Especialidades Farmaceuticas, Lda. Rua Quinta Pinheiro, 5, Outurela Carnaxide Portugal Portúgal Mylan, Lda. Rua Alfredo da Silva, 3 C-4º Lisboa Portugal Portúgal Generis Farmaceutica, S.A. Rua Joao de Deus, Amadora Portugal Diane 35 Acetato Ciproterona/ Etinilestradiol 2 mg/ Comprimidos Ciproterona + Etinilestradiol Generis

18 Portúgal Rúmenía Generis Farmaceutica, S.A. Rua Joao de Deus, Amadora Portugal Ciproterona + Etinilestradiol Inventis DIANE- 35 Rúmenía Slóvakía Ladeepharma Pharmaceutical Limited Lajos u E ép. 5. em. H-1036 Budapest Hungary Heaton a.s. Na Pankráci Praha 4 Czech Republic MELLEVA 2mg/ Vreya Slóvakía Minerva Slóvakía Zentiva, k.s. U kabelovny Praha 10 Dolní Měcholupy Czech Republic CHLOE

19 Slóvakía Diane-35 Slóvenía Diane /2 mg obložene tablete Spánn Spánn Spánn BAYER HISPANIA, S.L. Avda. Baix Llobregat 3 y Sant Joan Despi Barcelona Spain BAYER HISPANIA, S.L. Avda. Baix Llobregat 3 y Sant Joan Despi Barcelona Spain Laboratorios EFFIK, S.A. San Rafael, Alcobendas Madrid Spain DIANE 35 DIANE 35 DIARIO ETINILESTRADIOL/CIPROTERONA GINESERVICE /2 mg comprimidos EFG

20 Spánn Spánn Spánn Spánn Svíþjóð Sandoz Farmaceutica, S.A. Avda. Osa Mayor, Aravaca Madrid Spain Laboratorios EFFIK, S.A. San Rafael, Alcobendas Madrid Spain Farmalider S.A. Calle Aragoneses, Alcobendas Madrid Spain Teva Pharma, SLU Anabel Segura 11 Edificio Albatros B 1ª planta Alcobendas Madrid Spain ACETATO DE CIPROTERONA/ETINILESTRADIOL SANDOZ 2 mg/ comprimidos recubiertos EFG GYNEPLEN /2 mg comprimidos recubiertos DIALIDER 2/ comprimidos recubiertos con película CYPRINETTE DIARIO /2 mg comprimidos recubiertos EFG Diane Tafla Oral use

21 Svíþjóð Holland Orifarm Generics A/S Postbox 69 Energivej 15 DK-5260 Odense S. Denmark Actavis B.V. Baarnsche Dijk LN Baarn The Netherlands Zyrona Cyproteronacetaat/ethinylestradiol Actavis 2/, filmomhulde tabletten 2 mg/ Holland Apotex Europe B.V. Darwinweg CR Leiden The Netherlands Cyproteronacetaat/ethinylestradiol Apotex 2/, omhulde tabletten Holland Centrafarm B.V. Nieuwe Donk AC Etten-Leur The Netherlands Cyproteronacetaat/Ethinylestradiol CF 2/, omhulde tablet Holland Mylan B.V. Dieselweg LB Bunschoten The Netherlands Cyproteronacetaat/Ethinylestradiol Mylan 2 mg/, omhulde tabletten Holland Mylan B.V. Dieselweg LB Bunschoten The Netherlands Cyproteronacetaat/Ethinylestradiol Mylan 2 mg/, omhulde tabletten

22 Holland Holland ratiopharm Nederland B.V. Swensweg GA Haarlem The Netherlands Sandoz B.V. Veluwezoom AH Almere The Netherlands Cyproteronacetaat/ethinylestradiol ratiopharm 2 mg/, omhulde tabletten Cyproteronacetaat/Ethinylestradiol Sandoz 2/0,035, omhulde tabletten Holland Mylan B.V. Dieselweg LB Bunschoten The Netherlands Cyproteronacetaat/Ethinylestradiol 2 mg/, omhulde tabletten Holland Holland Holland Pharmachemie B.V. Swensweg GA Haarlem The Netherlands Stragen Nordic A/S Helsingørsgade 8C DK-3400 Hillerød Denmark Bayer B.V. Energieweg RT Mijdrecht The Netherlands Cyproteronacetaat/Ethinylestradiol 2/0,035 PCH, omhulde tabletten 2 mg/ Ethinylestradiol /Cyproteronacetaat 2 mg, omhulde tabletten Diane-35, omhulde tabletten

23 Bretland Bretland Bretland Bretland Bretland Bayer plc Bayer House Strawberry Hill Newbury, Berkshire RG14 1JA, Teva UK Limited Brampton Road Hampden Park Eastbourne East Sussex BN22 9AG Stragen UK Limited Castle Court 41 London Road Reigate, Surrey RH2 PRJ Chatfield Pharmaceuticals Limited Kramer Mews London SW5 9JL Sandoz Limited Frimley Business Park Frimley, Camberley Surrey GU16 7SR Dianette Tablets Co-Cyprindiol Tablets 2000/35 Clairette Tablets 2000/35 Camilette Co-Cyprindiol 2000/35 Tablets Acnocin 2000/35 Tablets Tafla

24 Bretland Bretland Bretland Bretland Bretland Bretland Sandoz Limited Frimley Business Park Frimley, Camberley Surrey GU16 7SR Generics (UK) Limited Station Close Potters Bar Hertfordshire EN6 1TL Generics (UK) Limited Station Close Potters Bar Hertfordshire EN6 1TL Strandhaven Limited 600 High Road Seven Kings, Ilford Essex IG3 8BS Fannin (UK) Limited Booth Drive Park Farm South Wellingborough Kent NN8 6GT Farmalider SA Calle Aragoneses 15 Alcobendas Madrid E Spain Cyproterone Acetate 2.0mg Ethinylestradiol 0.035mg Tablets Co-Cyprindiol Tablets 2mg/0.035mg Generics UK Cyproterone Acetate and Ethinylestradiol Tablets Strandhaven Co-Cyprindiol 2000/35 Tablets Fannin UK Co-Cyprindiol 2000/35 Tablets Dialider Tablets

25 Bretland Cipla (EU) Limited Hillbrow House Hillbrow Road Esher Surrey KT10 9NW Co-Cyprindiol 2000/35 Tablets