Cyproterone, ethinylestradiol
Sold as Minerva, Ginette, Cyprene ed, Diva, Adco-fem, Diane
Combination product
This product contains more than one active ingredient, so it has no single molecular structure.
Background
Registration
- Applicants
- 5
- Registrations
- 6
- Schedule source
- SAHPRA documentation
Applicants and registrations
| Applicant | Brands | Dosages | Registrations | Schedule | Leaflets |
|---|---|---|---|---|---|
| Bayer (Pty) Ltd û IsandoCertificate held by Bayer (Pty) Ltd | Minerva, Diane | 0,035 mg/2,0 mg | 290685, V0300 | S4 | PIPIL |
| Cipla Medpro (Pty) LtdCertificate held by Cipla Medpro (Pty) Ltd. | Ginette | 2,0 mg/ 0,035 mg | 330185 | Not determined | PIPIL |
| Pharmaplan (Pty) LtdCancelled | Cyprene ed | 35 | 360454 | Not determined | None |
| Unicorn Pharmaceuticals (Pty) Ltd | Diva | 35 | 380055 | S4 | PIPIL |
| Adcock ingram limitedCancelled | Adco-fem | 35 | 380248 | Not determined | None |
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Minerva-35 EACH TABLET CONTAINS CYPROTERONE 2,0 mg ETHINYLESTRADIOL 0,035 mg | 0,035 mg/2,0 mgCoated tablets | 29068529/21.8.2/0685Approved 21 July 2022 | Registered | S4 | PIPIL |
| Ginette EACH TABLET CONTAINS CYPROTERONE ACETATE 2,0 mg ETHINYLESTRADIOL 0,035 mg | 2,0 mg/ 0,035 mgFilm-coated tablets | 33018533/21.8.2/0185Approved 10 November 2022 | Registered | Not determined | PIPIL |
| Cyprene-35 ed EACH TABLET CONTAINS CYPROTERONE ACETATE 2,0 mgETHINYLESTRADIOL 0,035 mg | 35 | 36045436/21.8.2/0454 | Cancelled | Not determined | None |
| Diva 35 EACH TABLET CONTAINS CYPROTERONE ACETATE 2,0 mg ETHINYLESTRADIOL 35,0 ug | 35Tablets | 38005538/21.8.2/0055Approved 23 August 2020 | Registered | S4 | PIPIL |
| Adco-fem 35 EACH TABLET CONTAINS: CYPROTERONE ACETATE 2,0 mg, ETHINYLESTRADIOL 0,035 mg | 35 | 38024838/21.8.2/0248 | Cancelled | Not determined | None |
| Diane-35 EACH TABLET CONTAINS CYPROTERONE ACETATE 2 mg ETHINYLESTRADIOL 0,035 mg | 0,035 mg/2,0 mgCoated tablets | V0300V/21.8.2/300Approved 25 July 2022 | Registered | S4 | PIPIL |
Regulatory status
Where S4 sits on the scale
Prescription-only medicine.
Schedule 4 covers most ordinary prescription medicines. You need a prescription from an authorised prescriber, such as a doctor or dentist, and a pharmacist dispenses it. Its price, name, pack size and strength can still be told to the public, as long as nothing links it to what it treats.
Schedule S4, read from the product's PI-PIL leaflet.
Who may supply: A pharmacist dispensing against a written or verbal prescription from an authorised prescriber; a veterinarian, who may also prescribe, compound or dispense it directly; a medical practitioner or dentist, who may prescribe it and may compound or dispense it directly only if licensed under section 22C(1)(a); manufacturers and wholesalers may supply people who may lawfully possess it; and, for animal treatment, a person practising a para-veterinary profession, on a veterinarian's written or verbal instruction.
This is an informational summary of the Medicines and Related Substances Act 101 of 1965 and its 2017 General Regulations. It is not medical advice and not legal advice. Always check the medicine's label, which carries the schedule number inside a square border, or ask a pharmacist if you are unsure.
SAHPRA documents
Schedule Verification
Minerva-35, Bayer (Pty) Ltd û Isando is scheduled S4 in its official SAHPRA documents, read with 90% confidence.
These documents are provided by SAHPRA for informational purposes. Always consult with a healthcare professional for medical advice.