Bedaquiline (Sirturo)
Bedaquiline
Janssen Pharmaceutica (Pty) Ltd
Registration
- Applicant
- Janssen Pharmaceutica (Pty) Ltd
- Certificate holder
- Janssen Pharmaceutica (Pty) Ltd
- Registrations
- 2
- Schedule source
- Consolidated Schedules 06 July 2026
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Sirturo EACH TABLET CONTAINS BEDAQUILINE FUMARATE EQUIVALENT TO BEDAQUILINE 100,0 mg | 100 mgTablets | 47118247/20.2.3/1182Approved 18 May 2021 | Registered | S4 | PIPIL |
| Sirturo 20 MG EACH TABLET CONTAINS BEDAQUILINE FUMARATE EQUIVALENT TO BEDAQUILINE 20,0 mg | 20 mgTablet | 56079956/20.2.3/0799Approved 4 July 2023 | 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, matched to the Consolidated Schedules by ingredient, confidence high.
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 Bedaquiline fumarate equivalent to bedaquiline
S4: Bedaquiline
Consolidated Schedules 06 July 2026, line 5443
Pharmacological class: Tuberculostatics. (class 20.2.3)
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.
(1R,2S)-1-(6-Bromo-2-methoxyquinolin-3-yl)-4-(dimethylamino)-2-naphthalen-1-yl-1-phenylbutan-2-ol
Drag to rotate. Structure from PubChem CID 5388906.
SAHPRA documents
These documents are provided by SAHPRA for informational purposes. Always consult with a healthcare professional for medical advice.