DIANE-35

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

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 more 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 more about 17 alpha-Ethinylestradiol

Medication package inserts

Below package inserts are available for further reading:

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

Medicine classification

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

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