Estradiol (Novofem, Estrofem)
Estradiol
Novo Nordisk (Pty) Ltd û (Rivonia)
Registration
- Applicant
- Novo Nordisk (Pty) Ltd û (Rivonia)
- Certificate holder
- Novo Nordisk (Pty) Ltd.
- Registrations
- 2
- Schedule source
- SAHPRA documentation
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Novofem EACH TABLET CONTAINS NORETHISTERONE ACETATE A OESTRADIOL HEMIHYDRATE A | 1 mg.Film-coated tablet. | 37029737/21.8.2/0297Approved 26 August 2025 | Registered | S4 | PIPIL |
| Estrofem EACH TABLET CONTAINS ESTRADIOL 2 mg | 1 mg & 2 mgFilm-coated tablets. | J0214J/21.8.1/214Approved 17 February 2025 | 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.
Consolidated Schedules listings for Estradiol hemihydrate
S4: Estradiol
- when intended for hormone replacement therapy;
- except when intended for human vaginal use; (S2)
- except when intended for oral contraception. (S3)
Consolidated Schedules 06 July 2026, lines 6246 to 6251
S3: Estradiol
- when intended for oral contraception;
- except when intended for human vaginal use; (S2)
- except when intended for hormone replacement therapy. (S4)
Consolidated Schedules 06 July 2026, lines 3514 to 3524
S2: Estradiol
- when intended for human vaginal use;
- except when intended for oral contraception; (S3)
- except when intended for hormone replacement therapy. (S4)
Consolidated Schedules 06 July 2026, lines 1927 to 1933
Pharmacological class: Progesterones with or without oestrogens. (class 21.8.2)
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.
(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.
SAHPRA documents
Schedule Verification
This medication's schedule (S4) has been verified from official SAHPRA documents with 90% confidence.
These documents are provided by SAHPRA for informational purposes. Always consult with a healthcare professional for medical advice.