Regulatory PathRegulatory requirements compared

Active substance

Cyproterone

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
ANDROCUR 50MG TAB50 mgTablet · Oral use20 BlisterSAR 63.55NCE · PrescriptionBAYER PHARMA AGInvalid · Not Marketed
ANDROCUR 50MG TAB.50 mgTablet · Oral use20 BottleSAR 94.00NCE · PrescriptionBAYER SANTE FAMILIALEWithdrawn by MAH · Not Marketed

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
ANDROCUR0070443150 MGTABLET · ORALAMDIPHARM LIMITED
CYPROTERONE0224589850 MGTABLET · ORALAA PHARMA INC
MED-CYPROTERONE0239076050 MGTABLET · ORALGENERIC MEDICAL PARTNERS INC
RIVA-CYPROTERONE0239579750 MGTABLET · ORALLABORATOIRE RIVA INC.

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
NHS Drug TariffCyproterone 100mg tablets£132.5784 tablet1 Oct 2026
NHS Drug TariffCyproterone 50mg tablets£98.7556 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.

Safety signals and safety-related labeling changes

  • MHRA 29 Jun 2020 Cyproterone acetate: new advice to minimise risk of meningioma
    Risk of meningioma with cyproterone acetate increases with increasing cumulative dose. Use of cyproterone is contraindicated in patients with previous or current meningioma (for all indications) and should only be considered for control of libido in severe hypersexuality or paraphilias in adult men when other interventions are inappropriate.

All safety entries for cyproterone →

Combinations containing Cyproterone

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.