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List of referrals for human medicinal products

Cyproterone acetate/ethinylestradiol (2mg/0.035mg)

Product name: Cyproterone acetate/ethinylestradiol (2mg/0.035mg)
Also marketed in the EU under the name(s): Acetato Ciproterona / Etinilestradiol, Acnemine, Acnocin 2000, Alisma, Attempta-ratiopharm 35, Bella HEXAL 35, Bellgyn "ratiopharm", Bellune Pliva, Camilette Co-Cyprindiol 2000, Chloe, Chloe 35, Ciproterona + Etinilestradiol Generis, Ciproterona + Etinilestradiol Inventis, Clairette, Clairette 2000, Claudia-35, Co-Cyprindiol 2000/35, Cyprest, Cypretil, Cypretyl, CYPRINETTE DIARIO, Cyprodiol, Cyproethinyl acis, CYPROPHARM, Cyproteronacetaat/Ethinylestradiol, Cyproteronacetaat/ethinylestradiol Actavis, Cyproteronacetaat/ethinylestradiol Apotex, Cyproteronacetaat/Ethinylestradiol CF, Cyproteronacetaat/Ethinylestradiol Mylan, Cyproteronacetaat/ethinylestradiol ratiopharm, Cyproteronacetaat/Ethinylestradiol Sandoz, Cyproteronacetat/Ethinylestradiol Dermapharm, Cyproterone Acetate 2.0 mg Ethinylestradiol 0.035 mg, Cyproterone Acetate/Ethinylestradiol, CYPROTERONE/ETHINYLESTRADIOL BAYER, CYPROTERONE/ETHINYLESTRADIOL DCI PHARMA, CYPROTERONE/ETHINYLESTRADIOL EG, CYPROTERONE/ETHINYLESTRADIOL RANBAXY, CYPROTERONE/ETHINYLESTRADIOL RATIOPHARM, CYPROTERONE/ETHINYLESTRADIOL SANDOZ, CYPROTERONE/ETHINYLESTRADIOL TEVA, CYPROTERONE/ETHINYLESTRADIOL ZENTIVA, CYPROTERONE/ETHINYLESTRADIOL ZYDUS, Cyprotomin, Daphne, Dialider, Diane, Diane 35, Diane Mite, DIANE NOVA, Dianette, Dianova Mite, Elisamylan, ELLEACNELLE, Ergalea, Ethinylestradiol 0,035 mg /Cyproteronacetaat 2 mg, ETINILESTRADIOL/CIPROTERONA GINESERVICE, EVEPAR, Fannin UK Co-Cyprindiol 2000/35, Femina, Feminil, Feminil mite, Femogyn 2 mg/0,035 mg, Generics UK Cyproterone Acetate and Ethinylestradiol, Gratiella 35, GYNEPLEN, GYNOFEN 35, HOLGYEME 2 mg/0,035 mg, Jennifer 35 2 mg/0,035 mg Filmtabletten, Juliette, Lumalia, LUMALIA 2 mg/0,035 mg, Melleva, MELLEVA 2mg/0,035mg, Midane - Dragees, Minerva, MINERVA, Minerva - Dragees, MINERVA 35 µg, Moea Sanol 2 mg/0,035 mg überzogene Tabletten, OC-35, Strandhaven Co-Cyprindiol 2000/35 Tablets, Syndi-35, VISOFID, Vreya, VREYA, Xylia - Dragées, Zyrona
Active substance: cyproterone acetate/ethinylestradiol (2mg/0.035mg)
Indication: Treatment of moderate to severe acne related to androgen-sensitivity (with or without seborrhoea) and/or hirsutism, in women of reproductive age.
For the treatment of acne, should only be used after topical therapy or systemic antibiotic treatments have failed.
Since is also a hormonal contraceptive, it should not be used in combination with other hormonal contraceptives
Marketing Authorisation Holder: Not applicable

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
29/07/2013 Referral EMEA/H/A-107i/1357 (2013)4967 of 25/07/2013