DIANE-35

This brand name is authorized in Brazil, Canada, Ecuador, Estonia, Spain, France, Hong Kong, Croatia, Lithuania, Nigeria, Netherlands, New Zealand, Poland, Romania, Singapore, Tunisia, South Africa

Active ingredients

The drug DIANE-35 contains a combination of these active pharmaceutical ingredients (APIs):

1 Cyproterone UNII 4KM2BN5JHF - CYPROTERONE ACETATE

Cyproterone acetate acts as an antiandrogen by blocking androgen receptors. It also has progestogenic activity, which exerts a negative feedback effect on hypothalamic receptors, so leading to a reduction in gonadotrophin release, and hence to diminished production of testicular androgens. Sexual drive and potency are reduced and gonadal function is inhibited. Read about Cyproterone

2 17 alpha-Ethinylestradiol UNII 423D2T571U - ETHINYL ESTRADIOL

Ethinylestradiol is chemically and biologically identical to endogenous human oestradiol. It substitutes for the loss of estrogen production in menopausal women, and alleviates menopausal symptoms. Estrogens prevent bone loss following menopause or ovariectomy. Read about 17 alpha-Ethinylestradiol

Medication package inserts

Below package inserts are available for further reading:

Title	Information Source	Document Type
DIANE-35 Coated tablet	Health Products Regulatory Authority (ZA)	MPI, Generic

Medicine classification

This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:

ATC code	Group title	Classification
G03HB01	Cyproterone and estrogen	G Genito urinary system and sex hormones → G03 Sex hormones and modulators of the genital system → G03H Antiandrogens → G03HB Antiandrogens and estrogens
Discover more medicines within G03HB01

Authorization and marketing

This drug has been assigned below unique identifiers within the countries it is being marketed:

Country	Identification scheme	Identifier(s)
Country: BR	Câmara de Regulação do Mercado de Medicamentos	Identifier(s): 538912080018214, 538912080018304
Country: CA	Health Products and Food Branch	Identifier(s): 02233542
Country: EC	Agencia Nacional de Regulación, Control y Vigilancia Sanitaria	Identifier(s): 26.600-09-05
Country: EE	Ravimiamet	Identifier(s): 1818165
Country: ES	Centro de información online de medicamentos de la AEMPS	Identifier(s): BE114572
Country: FR	Base de données publique des médicaments	Identifier(s): 64066269, 65148623
Country: HK	Department of Health Drug Office	Identifier(s): 43330
Country: HR	Agencija za lijekove i medicinske proizvode	Identifier(s): HR-H-931753518
Country: LT	Valstybinė vaistų kontrolės tarnyba	Identifier(s): 1085206, 1085246, 1085352, 1088453
Country: NG	Registered Drug Product Database	Identifier(s): 04-1192
Country: NL	Z-Index G-Standaard, PRK	Identifier(s): 25836
Country: NZ	Medicines and Medical Devices Safety Authority	Identifier(s): 3071
Country: PL	Rejestru Produktów Leczniczych	Identifier(s): 100018600
Country: RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	Identifier(s): W64045001
Country: SG	Health Sciences Authority	Identifier(s): 04784P
Country: TN	Direction de la Pharmacie et du Médicament	Identifier(s): 17463011
Country: ZA	Health Products Regulatory Authority	Identifier(s): V/21.8.2/300