VEDLEGG I LISTE OVER NAVN, LEGEMIDDELFORMER, LEGEMIDDELSTYRKER, ADMINISTRASJONSMÅTE, INNEHAVERE AV MARKEDSFØRINGSTILLATELSEN I MEDLEMSLANDENE 1
Østerrike Østerrike Østerrike Østerrike Østerrike Østerrike Østerrike Gynial GmbH Gablenzgasse 11/III 1150 Wien Austria Ratiopharm Arzneimittel Vertriebs-GmbH Albert-Schweitzer-Gasse 3 1140 Wien Austria Dermapharma GmbH, Türkenstraße 25/12 A-1090 Wien, Austria Bayer Austria GmbH Herbststrasse 6-10 1160 Wien Austria Dermapharm AG Lil-Dagover-Ring 7 82031 Grünwald Pelpharma Handels GmbH Stammhausstraße 31 1140 Wien Austria Bayer Austria GmbH Herbststrasse 6-10 1160 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
Østerrike Belgia Belgia Belgia Belgia Belgia Belgia Austria Sandoz GmbH Biochemiestrase 10 6250 Kundl Austria Mithra Pharmaceuticals S.A. Rue Saint Georges 5 4000 Liège Belgium Sandoz N.V. Telecom Gardens Medialaan 40 1800 Vilvoorde Belgium Mithra Pharmaceuticals S.A. Rue Saint Georges 5 4000 Liège Belgium Bayer N.V. Jan Emiel Mommaertslaan 14 1831 Machelen Belgium Mylan BVBA/SPRL Terhulpsesteenweg 6A 1560 Hoeilaart Belgium 3 DDD Pharma N.V. Diestersteenweg 349 3510 Hasselt Belgium Xylia - Dragées Chloe Claudia-35 Daphne Diane-35 Elisamylan Gratiella 35 3
Bulgaria Bulgaria Bulgaria Tsjekkia Tsjekkia Tsjekkia Tsjekkia Danmark Medico Uno Worldwide Ltd. 2 Grigori Afxentiou Street Larnaca 6023 Cyprus Zentiva, k.s. U kabelovny 130 102 37 Praha 10 Dolní Měcholupy Czech Republic Zentiva, k.s. U kabelovny 130 102 37 Praha 10 Dolní Měcholupy Czech Republic Heaton k.s. Na Pankráci 332/14 14000 Praha 4Czech Republic Mithra Pharmaceuticals S.A. Rue Saint Georges 5 Diane 35 Melleva Chloe CHLOE VREYA MINERVA DIANE-35 Chloe 4
Danmark Danmark Danmark Danmark Danmark Danmark Estland 4000 Liège Belgium Teva A/S Parallelvej 10-12 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-13342 Berlin Cypretyl Diane Mite Dianova Mite Feminil mite Vreya Zyrona Diane 5
Estland Estland Finland Finland Finland Finland Frankrike Frankrike Nycomed Sefa AS Jaama 55B 63308 Põlva Estonia Ratiopharm GmbH Graf-Arco-Strasse 3 DE-89079 Ulm Bayer Oy Pansiontie 47 FI-20210 Turku Finland Ratiopharm GmbH Graf-Arco-Strasse 3 DE-89079 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 59120 Loos Bayer Santé 220, avenue de la Recherche 59120 Loos Femina Cypretil DIANE NOVA CYPRETYL FEMINIL VREYA DIANE 35 µg, coated tablet MINERVA 35 µg Tablett Tablett Tablett Tablett 6
Frankrike Bayer Santé CYPROTERONE/ETHINYLESTRADIOL 220, avenue de la Recherche 59120 Loos BAYER 35 µg Frankrike Laboratoires Majorelle 80-82 rue Gallieni 92100 Boulogne Billancourt CYPROPHARM 2 mg/ Frankrike DCI Pharma CYPROTERONE/ETHINYLESTRADIOL 180 Rue Eugene Avinee 59120 Loos DCI PHARMA 2 mg/ Frankrike EG LABO - LABORATOIRES CYPROTERONE/ETHINYLESTRADIOL EUROGENERICS 12 rue Danjou le Quintet bâtiment A 92517 Boulogne Billancourt Cedex EG 2 mg/ Frankrike Ranbaxy Pharmacie Generiques CYPROTERONE/ETHINYLESTRADIOL 11-15 quai de Dion Bouton 92800 Puteaux RANBAXY 2 mg/ Frankrike Teva Sante CYPROTERONE/ETHINYLESTRADIOL 110 Esplanade du Général de Gaulle 92931 Paris la Defence RATIOPHARM 2 mg/ Frankrike SANDOZ CYPROTERONE/ETHINYLESTRADIOL 7
Frankrike Frankrike Frankrike Frankrike Frankrike Frankrike 49 avenue Georges Pompidou 92593 Levallois Perret Cedex Teva Sante 110 Esplanade du Général de Gaulle 92931 Paris la Defence Sanofi Aventis 1-13 Boulevard Romain Rolland 75014 Paris ZYDUS Parc d'activités des Peupliers 25 rue des Peupliers 92000 Nanterre CHEMICAL FARMA 19-23 rue d'hautpoul 75019 Paris MYLAN SAS 117 allée des Parcs 69800 Saint Priest EFFIK bâtiment ''le Newton'' 9-11 rue Jeanne Braconnier 92366 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
Frankrike Tyskland Tyskland Tyskland Tyskland Tyskland Tyskland Tyskland Pierre Fabre Dermatologie 45, place Abel Gance F-92100 Boulogne Dermapharm AG Lil-Dagover-Ring 7 82031 Grünwald Aristo Pharma GmbH Wallenroder Str. 8-10 13435 Berlin Bayer Vital GmbH Kaiser-Wilhelm-Allee 51373 Leverkusen Dermapharm AG Lil-Dagover-Ring 7 82031 Grünwald Hexal Aktiengesellschaft Industriestr. 25 83607 Holzkirchen Mylan dura GmbH Wittichstr. 6 64295 Darmstadt Ratiopharm GmbH Graf-Arco-Strasse 3 DE-89079 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
Tyskland Tyskland Hellas Ungarn Ungarn Ungarn Island Taurus Pharma GmbH Benzstr. 11 61352 Bad Homburg UCB Pharma GmbH Alfred-Nobel-Str. 10 40789 Monheim Bayer Hellas ABEE Sorou 18-20 Maroussi Athens GR-15125 Greece Pliva Hungária Kereskedelmi és Szolgáltató Kft. Rákóczi út 70-72 Budapest 1074 Hungary D-13342 Berlin Ergalea 2,00/ Filmtabletten Moea Sanol 2 mg/ überzogene Tabletten GYNOFEN 35 Bellune Pliva Diane Minerva Diane mite Tablett 10
Island Irland Irland Italia Italia Ratiopharm GmbH Graf-Arco-Strasse 3 DE-89079 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, 130 20156 Milano (MI) Italy FIDIA Farmaceutici S.p.A. Via Ponte della Fabbrica 3/A 35031 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 130 102 37 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
Latvia Litauen Litauen Litauen Litauen Luxembourg Luxembourg 63308 Põlva Estonia Nycomed Sefa AS Jaama 55B 63308 Põlva Estonia Zentiva, k.s. U kabelovny 130 102 37 Praha 10 Dolní Měcholupy Czech Republic Ratiopharm GmbH Graf-Arco-Strasse 3 DE-89079 Ulm Bayer SA/NV 14 J.E. Mommaertslaan B-1831 Diegem Belgium Mithra Pharmaceuticals S.A. Rue Saint Georges 5 4000 Liège Belgium Diane 2000 micrograms/35 micrograms film-coated tablets Diane Femina CHLOE Cypretil Diane-35 Chloe 12
Luxembourg Luxembourg Malta Malta Norge Norge Norge Mithra Pharmaceuticals S.A. Rue Saint Georges 5 4000 Liège Belgium Pierre Fabre Dermatologie 45, place Abel Gance F-92100 Boulogne Stragen UK Limited Castle Court 41 London Road Reigate, Surrey RH2 PRJ Sandoz d.d Verovskova 57 1000 Ljubljana Slovenia Sandoz Edvard Thomsens Vej 14 2300 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
Polen Polen Polen Polen Polen Polen Polen Acis Arzneimittel GmbH Lil-Dagover-Ring 7 82031 Grünwald Zentiva, k.s. U kabelovny 130 102 37 Praha 10 Dolní Měcholupy Czech Republic Pabianickie Zakłady Farmaceutyczne Polfa S.A. ul. Marszałka J. Piłsudskiego 5 95-200 Pabianice Poland Polfarmex S.A. Józefów 9 99-300 Kutno Poland SymPhar Sp. z o.o. ul. Włoska 1 00-777 Warszawa Poland Sun-Farm Sp. z o.o. Człekówka 75 05-340 Kołbiel Poland Acnemine Diane-35 Chloe Cyprest OC-35 Syndi-35 Cyprodiol 14
Portugal Portugal Portugal Portugal Romania Romania Slovakia Berlifarma - Especialidades Farmaceuticas, Lda. Rua Quinta Pinheiro, 5, Outurela 2794-003 Carnaxide Portugal Mylan, Lda. Rua Alfredo da Silva, 3 C-4º 1300-040 Lisboa Portugal Generis Farmaceutica, S.A. Rua Joao de Deus, 19 2700-487 Amadora Portugal Generis Farmaceutica, S.A. Rua Joao de Deus, 19 2700-487 Amadora Portugal Ladeepharma Pharmaceutical Limited Lajos u. 48-66 E ép. 5. em. H-1036 Budapest Hungary Heaton a.s. Na Pankráci 14 14000 Praha 4 Czech Republic Diane 35 Acetato Ciproterona/ Etinilestradiol 2 mg/ Comprimidos Ciproterona + Etinilestradiol Generis Ciproterona + Etinilestradiol Inventis DIANE- 35 MELLEVA 2mg/ Vreya 15
Slovakia Slovakia Slovakia Slovenia Spania Spania Spania Zentiva, k.s. U kabelovny 130 102 37 Praha 10 Dolní Měcholupy Czech Republic BAYER HISPANIA, S.L. Avda. Baix Llobregat 3 y 5 08970 Sant Joan Despi Barcelona Spain BAYER HISPANIA, S.L. Avda. Baix Llobregat 3 y 5 08970 Sant Joan Despi Barcelona Spain Laboratorios EFFIK, S.A. San Rafael, 3 28108 Alcobendas Madrid Minerva CHLOE Diane-35 Diane /2 mg obložene tablete DIANE 35 DIANE 35 DIARIO ETINILESTRADIOL/CIPROTERONA GINESERVICE /2 mg comprimidos EFG 16
Spania Spania Spania Spania Sverige Sverige Spain Sandoz Farmaceutica, S.A. Avda. Osa Mayor, 4 28023 Aravaca Madrid Spain Laboratorios EFFIK, S.A. San Rafael, 3 28108 Alcobendas Madrid Spain Farmalider S.A. Calle Aragoneses, 15 28108 Alcobendas Madrid Spain Teva Pharma, SLU Anabel Segura 11 Edificio Albatros B 1ª planta 28108 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
DK-5260 Odense S. Actavis B.V. Baarnsche Dijk 1 3741 LN Baarn The Netherlands Apotex Europe B.V. Darwinweg 20 2333 CR Leiden The Netherlands Centrafarm B.V. Nieuwe Donk 3 4879 AC Etten-Leur The Netherlands Mylan B.V. Dieselweg 25 3752 LB Bunschoten The Netherlands Mylan B.V. Dieselweg 25 3752 LB Bunschoten The Netherlands ratiopharm B.V. Swensweg 5 2031 GA Haarlem The Netherlands Sandoz B.V. Veluwezoom 22 1327 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
Mylan B.V. Dieselweg 25 3752 LB Bunschoten The Netherlands Pharmachemie B.V. Swensweg 5 2031 GA Haarlem The Netherlands Stragen Nordic A/S Helsingørsgade 8C DK-3400 Hillerød Bayer B.V. Energieweg 1 3641 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
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
Fannin (UK) Limited 42-46 Booth Drive Park Farm South Wellingborough Kent NN8 6GT Farmalider SA Calle Aragoneses 15 Alcobendas Madrid E-28108 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