Desogestrel, ethinylestradiol
Sold as Novynette, Regulon, Desimar, Merdeza, Marvelon, Mercilon
Combination product
This product contains more than one active ingredient, so it has no single molecular structure.
Background
Registration
- Applicants
- 3
- Registrations
- 6
- Schedule source
- SAHPRA documentation
Applicants and registrations
| Applicant | Brands | Dosages | Registrations | Schedule | Leaflets |
|---|---|---|---|---|---|
| Acino Pharma (Pty) Ltd1 of 2 cancelled | Novynette, Regulon | Not stated | 430071, 430072 | Not determined | None |
| Cipla Medpro (Pty) Ltd | Desimar, Merdeza | 0,15 mg | 481041, 490711 | S3 | PIPIL |
| Organon South Africa (Pty) Ltd | Marvelon, Mercilon | 0,15 mg and 0,02 mg, 150 / 30MG | Q0324, Y0078 | Not determined | PIPIL |
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Novynette EACH TABLET CONTAINS DESOGESTREL 0,15 mg ETHINYLESTRADIOL 0,02 mg | Not listed | 43007143/18.8/0071 | Registered | Not determined | None |
| Regulon EACH FILM-COATED TABLETS CONTAINS: DESOGESTREL 150,0 mcg ETHINYLESTRADIOL 30,0 mcg | Not listed | 43007243/18.8/0072 | Cancelled | Not determined | None |
| Desimar Each active tablet contains DESOGESTREL 0,15 mg and ETHINYLESTRADIOL 0,03 mg | 0,15 mgFilm-coated tablets | 48104148/18.8/1041Approved 17 July 2022 | Registered | S3 | PIPIL |
| Merdeza Each tablet contains DESOGESTREL 0,15 mg ETHINYLESTRADIOL 0,02 mg | Not listed | 49071149/18.8/0711 | Registered | Not determined | None |
| Marvelon 150/30* EACH TABLET CONTAINS DESOGESTREL 0,15 mg ETHINYLESTRADIOL 0,03 mg | 150 / 30MGTablet | Q0324Q/18.1/324Approved 14 October 2022 | Registered | Not determined | PIPIL |
| Mercilon EACH TABLET CONTAINS DESOGESTREL 0,15 mg ETHINYLESTRADIOL 0,02 mg | 0,15 mg and 0,02 mgTablets | Y0078Y/18.8/78Approved 14 October 2022 | Registered | Not determined | PIPIL |
Regulatory status
Where S3 sits on the scale
Needs a doctor's prescription, dispensed by a pharmacist.
Schedule 3 medicines can only be sold on a prescription from an authorised prescriber, such as a doctor or dentist. A pharmacist dispenses the medicine once they have the written prescription, or a verbal instruction from a prescriber they know. 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 S3, 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
Desimar, Cipla Medpro (Pty) Ltd is scheduled S3 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.