Oestradiol
Sold as Climara, Estrofem, Divigel, Estradot, Vagifem
(8R,9S,13S,14S,17S)-13-Methyl-6,7,8,9,11,12,14,15,16,17-decahydrocyclopenta[a]phenanthrene-3,17-diol
Drag to rotate. Structure from PubChem CID 5757.
Background
Registration
- Applicants
- 4
- Registrations
- 9
Applicants and registrations
| Applicant | Brands | Dosages | Registrations | Schedule | Leaflets |
|---|---|---|---|---|---|
| Bayer (Pty) Ltd û IsandoCancelled | Climara | 50 | 290610 | Not determined | None |
| Novo Nordisk (Pty) Ltd û (Rivonia) | Estrofem, Vagifem | 1 mg, 10 ug | 340159, 470166 | Not determined | None |
| Pharmacare limited û woodmeadCancelled | Divigel | 0,1 % | 340289 | Not determined | None |
| Sandoz South Africa (Pty) Ltd | Estradot | 25, 37,5, 50, 75, 100 | 370215, 370216, 370217, 370218, 370493 | Not determined | None |
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Climara -50 EACH 12,5 cm PATCH CONTAINS : OESTRADIOL HEMIHYDRATE EQUIVALENT TO OESTRADIOL, 3,9 mg | -50 | 29061029/21.8.1/0610 | Cancelled | Not determined | None |
| Estrofem 1 MG EACH TABLET CONTAINS OESTRADIOL HEMIHYDRATE EQUIVALENT TO OESTRADIOL 1,0 mg | 1 mg | 34015934/21.8.1/0159 | Registered | Not determined | None |
| Divigel 0,1 % EACH 1,0 g GEL CONTAINS OESTRADIOL HEMIHYDRATE EQUIVALENT TO OESTRADIOL 1,0 mg | 0,1 % | 34028934/21.8.1/0289 | Cancelled | Not determined | None |
| Estradot 37,5 EACH PATCH CONTAINS OESTRADIOL HEMIHYDRATE 0,585 mg | 37,5 | 37021537/21.8.1/0215 | Registered | Not determined | None |
| Estradot 50 EACH PATCH CONTAINS OESTRADIOL HEMIHYDRATE 0,78 mg | 50 | 37021637/21.8.1/0216 | Registered | Not determined | None |
| Estradot 75 EACH PATCH CONTAINS OESTRADIOL HEMIHYDRATE 1,17 mg | 75 | 37021737/21.8.1/0217 | Registered | Not determined | None |
| Estradot 100 EACH PATCH CONTAINS OESTRADIOL HEMIHYDRATE 1,56 mg | 100 | 37021837/21.8.1/0218 | Registered | Not determined | None |
| Estradot 25 EACH PATCH CONTAINS OESTRADIOL HEMIHYDRATE 0,39 mg | 25 | 37049337/21.8.1/0493 | Registered | Not determined | None |
| Vagifem 10 ug EACH VAGINAL TABLET CONTAINS OESTRADIOL HEMIHYDRATE EQUIVALENT TO OESTRADIOL 10,0 ug | 10 ug | 47016647/21.8.1/0166 | Registered | Not determined | None |
Regulatory status
This product is still scheduled by law even when this site could not determine which tier it falls under. The label carries the S number in a square border; ask a pharmacist if you need to know its schedule.
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
SAHPRA has not published a professional information or patient information leaflet for this product.