Regulatory PathRegulatory requirements compared

Active substances

Cyproterone + Ethinylestradiol

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
DIANE-35 TAB2`,0.035 mg,mgCoated tablet · Oral use21 BlisterSAR 21.90NCE · PrescriptionBAYER AGValid
DIANE-35 TAB0.035, 2 mgCoated tablet · Oral use21 BlisterSAR 21.90NCE · PrescriptionBAYER PHARMA AGWithdrawn by MAH · Not Marketed
Indications — CHI Daman Drug Formulary

ENDOMETRIOSIS; HYPERPROLACTINEMIA; MENOPAUSE

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
AMB-CYPROTERONE ACETATE / ETHINYL ESTRADIOL025644240.035 MG; 2 MGTABLET · ORALAMBICARE PHARMACEUTICALS INC.
CLÉO -35024367360.035 MG; 2 MGTABLET · ORALALTIUS HEALTHCARE INC
CYESTRA-35022903080.035 MG; 2 MGTABLET · ORALKNIGHT THERAPEUTICS INC.
DIANE-35022335422 MG; 35 MCGTABLET · ORALBAYER INC
TARO-CYPROTERONE/ETHINYL ESTRADIOL024250170.035 MG; 2 MGTABLET · ORALSUN PHARMA CANADA INC
TEVA-CYPROTERONE / ETHINYL ESTRADIOL023095560.035 MG; 2 MGTABLET · ORALTEVA CANADA LIMITED

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
NHS Drug TariffCo-cyprindiol 2000microgram/35microgram tablets£7.0263 tablet1 Oct 2026

NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.

Components

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.