Dutasteride
Sold as Avodart, Actasvo, Zedrast
(1S,3AS,3bS,5aR,9aR,9bS,11aS)-N-[2,5-bis(trifluoromethyl)phenyl]-9a,11a-dimethyl-7-oxo-1,2,3,3a,3b,4,5,5a,6,9b,10,11-dodecahydroindeno[5,4-f]quinoline-1-carboxamide
Drag to rotate. Structure from PubChem CID 6918296.
Background
Registration
- Applicants
- 3
- Registrations
- 3
- Schedule source
- SAHPRA documentation
Applicants and registrations
| Applicant | Brands | Dosages | Registrations | Schedule | Leaflets |
|---|---|---|---|---|---|
| Glaxosmithkline South Africa (Pty) Limited | Avodart | 0.5mg | 370282 | S4 | PIPIL |
| Activo Health (Pty) LtdCertificate held by Activo Health (Pty) Ltd. | Actasvo | 0,5 mg | 540010 | S4 | PIPIL |
| Zydus Healthcare (Pty) LtdCertificate held by Zydus Healthcare SA (Pty) Ltd | Zedrast | 0.5 mg | 540491 | S4 | PIPIL |
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Avodart EACH CAPSULE CONTAINS DUTASTERIDE 0,5 mg | 0.5mgSoft capsule | 37028237/21.12/0282Approved 28 February 2021 | Registered | S4 | PIPIL |
| Actasvo Each Capsule contains: Dutasteride 0,5 mg | 0,5 mgSoft capsules | 54001054/21.12/0010Approved 8 April 2025 | Registered | S4 | PIPIL |
| Zedrast EACH CAPSULE CONTAINS DUTASTERIDE 0,5 mg | 0.5 mgCapsules | 54049154/21.12/0491Approved 15 June 2021 | 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 Dutasteride
S4: Dutasteride
Consolidated Schedules 06 July 2026, line 6141
Pharmacological class: Hormone inhibitors. (class 21.12)
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
Avodart, Glaxosmithkline South Africa (Pty) Limited 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.