Dutasteride, tamsulosin (Duodart, Dutasteride /Tamsulosin Gsk)
Dutasteride, tamsulosin
Glaxosmithkline South Africa (Pty) Limited
Registration
- Applicant
- Glaxosmithkline South Africa (Pty) Limited
- Certificate holder
- Glaxosmithkline South Africa (Pty) Ltd
- Registrations
- 2
- Schedule source
- SAHPRA documentation
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Duodart EACH CAPSULE CONTAINS DUTASTERIDE 0,5 mg TAMSULOSIN HYDROCHLORIDE 0,4 mg | 0,5 mgCapsules | 44085044/21.12/0850Approved 17 August 2022 | Registered | S4 | PIPIL |
| Dutasteride 0,5 mg/tamsulosin 0,4 MG gsk EACH CAPSULE CONTAINS DUTASTERIDE 0,5 mg TAMSULOSIN HYDROCHLORIDE 0,4 mg | 0,5 mg 0,4 mg | 45080445/21.12/0804 | Registered | S4 | None |
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, tamsulosin hydrochloride
S4: Dutasteride
Consolidated Schedules 06 July 2026, line 6141
S4: Tamsulosin
Consolidated Schedules 06 July 2026, line 8100
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.
Combination product
This product contains more than one active ingredient, so it has no single molecular structure.
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.