VEDLEGG I LISTE OVER NAVN, LEGEMIDDELFORMER, LEGEMIDDELSTYRKER, ADMINISTRASJONSMÅTE, INNEHAVERE AV MARKEDSFØRINGSTILLATELSEN I MEDLEMSLANDENE

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1 VEDLEGG I LISTE OVER NAVN, LEGEMIDDELFORMER, LEGEMIDDELSTYRKER, ADMINISTRASJONSMÅTE, INNEHAVERE AV MARKEDSFØRINGSTILLATELSEN I MEDLEMSLANDENE 1

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

3 Østerrike Belgia Belgia Belgia Belgia Belgia Belgia Austria Sandoz GmbH Biochemiestrase Kundl Austria 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 Mylan BVBA/SPRL Terhulpsesteenweg 6A 1560 Hoeilaart Belgium 3 DDD Pharma N.V. Diestersteenweg Hasselt Belgium Xylia - Dragées Chloe Claudia-35 Daphne Diane-35 Elisamylan Gratiella 35 3

4 Bulgaria Bulgaria Bulgaria Tsjekkia Tsjekkia Tsjekkia Tsjekkia Danmark 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 Heaton k.s. Na Pankráci 332/ Praha 4Czech Republic Mithra Pharmaceuticals S.A. Rue Saint Georges 5 Diane 35 Melleva Chloe CHLOE VREYA MINERVA DIANE-35 Chloe 4

5 Danmark Danmark Danmark Danmark Danmark Danmark Estland 4000 Liège Belgium Teva A/S Parallelvej DK-2800 Kongens Lyngby Alternova A/S Lodshusvej 11 DK-4230 Skælskør Sandoz A/S Edvard Thomsens Vej 14 DK-2300 København S Stragen Nordic A/S Helsingørsgade 8C DK-3400 Hillerød Orifarm Generics A/S Postbox 69 Energivej 15 DK-5260 Odense S. D Berlin Cypretyl Diane Mite Dianova Mite Feminil mite Vreya Zyrona Diane 5

6 Estland Estland Finland Finland Finland Finland Frankrike Frankrike Nycomed Sefa AS Jaama 55B Põlva Estonia Ratiopharm GmbH Graf-Arco-Strasse 3 DE Ulm Bayer Oy Pansiontie 47 FI Turku Finland Ratiopharm GmbH Graf-Arco-Strasse 3 DE Ulm Sandoz A/S Edvard Thomsens Vej 14 DK-2300 København S Stragen Nordic A/S Helsingørsgade 8C DK-3400 Hillerød Bayer Santé 220, avenue de la Recherche Loos Bayer Santé 220, avenue de la Recherche Loos Femina Cypretil DIANE NOVA CYPRETYL FEMINIL VREYA DIANE 35 µg, coated tablet MINERVA 35 µg Tablett Tablett Tablett Tablett 6

7 Frankrike Bayer Santé CYPROTERONE/ETHINYLESTRADIOL 220, avenue de la Recherche Loos BAYER 35 µg Frankrike Laboratoires Majorelle rue Gallieni Boulogne Billancourt CYPROPHARM 2 mg/ Frankrike DCI Pharma CYPROTERONE/ETHINYLESTRADIOL 180 Rue Eugene Avinee Loos DCI PHARMA 2 mg/ Frankrike EG LABO - LABORATOIRES CYPROTERONE/ETHINYLESTRADIOL EUROGENERICS 12 rue Danjou le Quintet bâtiment A Boulogne Billancourt Cedex EG 2 mg/ Frankrike Ranbaxy Pharmacie Generiques CYPROTERONE/ETHINYLESTRADIOL quai de Dion Bouton Puteaux RANBAXY 2 mg/ Frankrike Teva Sante CYPROTERONE/ETHINYLESTRADIOL 110 Esplanade du Général de Gaulle Paris la Defence RATIOPHARM 2 mg/ Frankrike SANDOZ CYPROTERONE/ETHINYLESTRADIOL 7

8 Frankrike Frankrike Frankrike Frankrike Frankrike Frankrike 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 MYLAN SAS 117 allée des Parcs Saint Priest EFFIK bâtiment ''le Newton'' 9-11 rue Jeanne Braconnier Meudon la Foret SANDOZ 2 mg/ CYPROTERONE/ETHINYLESTRADIOL TEVA 2 mg/ CYPROTERONE/ETHINYLESTRADIOL ZENTIVA 2 mg/ CYPROTERONE/ETHINYLESTRADIOL ZYDUS 2 mg/ ELLEACNELLE 2 mg/ EVEPAR 2 mg/ HOLGYEME 2 mg/ 8

9 Frankrike Tyskland Tyskland Tyskland Tyskland Tyskland Tyskland Tyskland Pierre Fabre Dermatologie 45, place Abel Gance F Boulogne Dermapharm AG Lil-Dagover-Ring Grünwald Aristo Pharma GmbH Wallenroder Str Berlin Bayer Vital GmbH Kaiser-Wilhelm-Allee Leverkusen Dermapharm AG Lil-Dagover-Ring Grünwald Hexal Aktiengesellschaft Industriestr Holzkirchen Mylan dura GmbH Wittichstr Darmstadt Ratiopharm GmbH Graf-Arco-Strasse 3 DE Ulm LUMALIA 2 mg/ Cyproethinyl acis Jennifer 35 2 mg/ Filmtabletten Diane-35 /2mg überzogene Tablette Cyproteronacetat/Ethinylestradiol Dermapharm 2 mg/ überzogene Tablette Bella HEXAL 35 2 mg/ überzogene Tablette Juliette Attempta-ratiopharm 35 2 mg/ überzogene Tablette 9

10 Tyskland Tyskland Hellas Ungarn Ungarn Ungarn Island Taurus Pharma GmbH Benzstr Bad Homburg UCB Pharma GmbH Alfred-Nobel-Str Monheim Bayer Hellas ABEE Sorou Maroussi Athens GR Greece Pliva Hungária Kereskedelmi és Szolgáltató Kft. Rákóczi út Budapest 1074 Hungary D Berlin Ergalea 2,00/ Filmtabletten Moea Sanol 2 mg/ überzogene Tabletten GYNOFEN 35 Bellune Pliva Diane Minerva Diane mite Tablett 10

11 Island Irland Irland Italia Italia Ratiopharm GmbH Graf-Arco-Strasse 3 DE Ulm Generics (UK) Limited Station Close Potters Bar Hertfordshire EN6 1TL Bayer Limited The Atrium Blackthorn Road Sandyford Dublin 18 Ireland Bayer S.p.A. Viale Certosa, Milano (MI) Italy FIDIA Farmaceutici S.p.A. Via Ponte della Fabbrica 3/A Abano Terme (PD) Italy Cypretyl Cyproterone Acetate/Ethinylestradiol Tablets 2mg/0.035mg Dianette 2mg/35 microgram coated tablets. DIANE VISOFID Tablett Latvia Latvia Zentiva, k.s. U kabelovny Praha 10 Dolní Měcholupy Czech Republic Takeda Pharma AS Jaama 55B Chloe 35 micrograms/2 mg film-coated tablets Femina 2 mg/35 micrograms coated tablets 11

12 Latvia Litauen Litauen Litauen Litauen Luxembourg Luxembourg Põlva Estonia Nycomed Sefa AS Jaama 55B Põlva Estonia Zentiva, k.s. U kabelovny Praha 10 Dolní Měcholupy Czech Republic Ratiopharm GmbH Graf-Arco-Strasse 3 DE Ulm Bayer SA/NV 14 J.E. Mommaertslaan B-1831 Diegem Belgium Mithra Pharmaceuticals S.A. Rue Saint Georges Liège Belgium Diane 2000 micrograms/35 micrograms film-coated tablets Diane Femina CHLOE Cypretil Diane-35 Chloe 12

13 Luxembourg Luxembourg Malta Malta Norge Norge Norge 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 Sandoz Edvard Thomsens Vej KØBENHAVN S Orifarm Generics A/S Postbox 69 Energivej 15 DK-5260 Odense S. Daphne Lumalia Clairette 2000/35 Tablets Acnocin 2000/35 Tablets Diane Feminil Zyrona 13

14 Polen Polen Polen Polen Polen Polen Polen 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 Polfarmex S.A. Józefów Kutno Poland SymPhar Sp. z o.o. ul. Włoska Warszawa Poland Sun-Farm Sp. z o.o. Człekówka Kołbiel Poland Acnemine Diane-35 Chloe Cyprest OC-35 Syndi-35 Cyprodiol 14

15 Portugal Portugal Portugal Portugal Romania Romania Slovakia Berlifarma - Especialidades Farmaceuticas, Lda. Rua Quinta Pinheiro, 5, Outurela Carnaxide Portugal Mylan, Lda. Rua Alfredo da Silva, 3 C-4º Lisboa Portugal Generis Farmaceutica, S.A. Rua Joao de Deus, Amadora Portugal Generis Farmaceutica, S.A. Rua Joao de Deus, Amadora Portugal Ladeepharma Pharmaceutical Limited Lajos u E ép. 5. em. H-1036 Budapest Hungary Heaton a.s. Na Pankráci Praha 4 Czech Republic Diane 35 Acetato Ciproterona/ Etinilestradiol 2 mg/ Comprimidos Ciproterona + Etinilestradiol Generis Ciproterona + Etinilestradiol Inventis DIANE- 35 MELLEVA 2mg/ Vreya 15

16 Slovakia Slovakia Slovakia Slovenia Spania Spania Spania Zentiva, k.s. U kabelovny Praha 10 Dolní Měcholupy Czech Republic 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 Minerva CHLOE Diane-35 Diane /2 mg obložene tablete DIANE 35 DIANE 35 DIARIO ETINILESTRADIOL/CIPROTERONA GINESERVICE /2 mg comprimidos EFG 16

17 Spania Spania Spania Spania Sverige Sverige Spain 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 Orifarm Generics A/S Postbox 69 Energivej 15 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 Zyrona Tablett 17

18 DK-5260 Odense S. Actavis B.V. Baarnsche Dijk LN Baarn The Netherlands Apotex Europe B.V. Darwinweg CR Leiden The Netherlands Centrafarm B.V. Nieuwe Donk AC Etten-Leur The Netherlands Mylan B.V. Dieselweg LB Bunschoten The Netherlands Mylan B.V. Dieselweg LB Bunschoten The Netherlands ratiopharm B.V. Swensweg GA Haarlem The Netherlands Sandoz B.V. Veluwezoom AH Almere The Netherlands Cyproteronacetaat/ethinylestradiol Actavis 2/, filmomhulde tabletten 2 mg/ Cyproteronacetaat/ethinylestradiol Apotex 2/, omhulde tabletten Cyproteronacetaat/Ethinylestradiol CF 2/, omhulde tablet Cyproteronacetaat/Ethinylestradiol Mylan 2 mg/, omhulde tabletten Cyproteronacetaat/Ethinylestradiol Mylan 2 mg/, omhulde tabletten Cyproteronacetaat/ethinylestradiol ratiopharm 2 mg/, omhulde tabletten Cyproteronacetaat/Ethinylestradiol Sandoz 2/0,035, omhulde tabletten 18

19 Mylan B.V. Dieselweg LB Bunschoten The Netherlands Pharmachemie B.V. Swensweg GA Haarlem The Netherlands Stragen Nordic A/S Helsingørsgade 8C DK-3400 Hillerød Bayer B.V. Energieweg RT Mijdrecht The Netherlands 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 Cyproteronacetaat/Ethinylestradiol 2 mg/, omhulde tabletten Cyproteronacetaat/Ethinylestradiol 2/0,035 PCH, omhulde tabletten 2 mg/ Ethinylestradiol /Cyproteronacetaat 2 mg, omhulde tabletten Diane-35, omhulde tabletten Dianette Tablets Co-Cyprindiol Tablets 2000/35 Clairette Tablets 2000/35 19

20 Reigate, Surrey RH2 PRJ Chatfield Pharmaceuticals Limited Kramer Mews London SW5 9JL Sandoz Limited Frimley Business Park Frimley, Camberley Surrey GU16 7SR 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 Camilette Co-Cyprindiol 2000/35 Tablets Acnocin 2000/35 Tablets 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 Tablett 20

21 Fannin (UK) Limited Booth Drive Park Farm South Wellingborough Kent NN8 6GT Farmalider SA Calle Aragoneses 15 Alcobendas Madrid E Spain Cipla (EU) Limited Hillbrow House Hillbrow Road Esher Surrey KT10 9NW Fannin UK Co-Cyprindiol 2000/35 Tablets Dialider Tablets Co-Cyprindiol 2000/35 Tablets 21