Ethinylestradiol, gestodene
Sold as Melodene, Nessifem, Actordene, Carmadene, Dyolafem, Gestodene/ethinylestradiol forrester, Minulette, Femodene ed
Combination product
This product contains more than one active ingredient, so it has no single molecular structure.
Background
Registration
- Applicants
- 4
- Registrations
- 8
- Schedule source
- SAHPRA documentation
Applicants and registrations
| Applicant | Brands | Dosages | Registrations | Schedule | Leaflets |
|---|---|---|---|---|---|
| Bayer (Pty) Ltd û IsandoCertificate held by Bayer (Pty) Ltd | Melodene, Femodene ed | 0.02 mg/0.075 mg, 0,03 mg/0,075 mg | 310462, W0098 | S3 | PIPIL |
| Cipla Medpro (Pty) Ltd | Nessifem, Actordene, Carmadene | Not stated | 470344, 481352, 481353 | Not determined | None |
| Forrester Pharma (Pty) Ltd | Dyolafem, Gestodene/ethinylestradiol forrester | 0,075/0,02 MG | 521019, 521020 | Not determined | None |
| Pfizer Laboratories (Pty) Ltd | Minulette | 30ug, 75ug | W0011 | Not determined | PIPIL |
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Melodene EACH TABLET CONTAINS ETHINYLESTRADIOL 0,02 mg GESTODENE 0,075 mg | 0.02 mg/0.075 mgCoated tablets | 31046231/18.8/0462Approved 20 May 2022 | Registered | S3 | PIPIL |
| Nessifem Each active tablet contains GESTODENE 60,0 mcg and ETHINYLESTRADIOL 15,0 mcg | Not listed | 47034447/18.8/0344 | Registered | Not determined | None |
| Actordene Each active tablet contains GESTODENE 0,075 mg and ETHINYLESTRADIOL 0,02 mg | Not listed | 48135248/18.8/1352 | Registered | Not determined | None |
| Carmadene Each active tablet contains GESTODENE 0,075 mg and ETHINYLESTRADIOL 0,03 mg | Not listed | 48135348/18.8/1353 | Registered | Not determined | None |
| Dyolafem Each active tablet contains GESTODENE 0,075 mg and ETHINYLESTRADIOL 0,030 mg | Not listed | 52101952/18.8/1019 | Registered | Not determined | None |
| Gestodene/ethinylestradiol 0,075/0,02 MG forrester Each active tablet contains GESTODENE 0,075 mg and ETHINYLESTRADIOL 0,020 mg | 0,075/0,02 MG | 52102052/18.8/1020 | Registered | Not determined | None |
| Minulette EACH TABLET CONTAINS ETHINYLESTRADIOL 0,030 mg GESTODENE 0,75 mg | 30ug. 75ugTablet | W0011W/18.8/11Approved 4 October 2021 | Registered | Not determined | PIPIL |
| Femodene ed EACH TABLET CONTAINS ETHINYLESTRADIOL 0,030 mg GESTODENE 0,75 mg | 0,03 mg/0,075 mgCoated tablets. | W0098W/21.8.2/98Approved 20 May 2022 | Registered | S3 | 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
Melodene, Bayer (Pty) Ltd û Isando 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.