Baclofen (Lioresal)
Baclofen
Novartis South Africa (Pty) Ltd
Registration
- Applicant
- Novartis South Africa (Pty) Ltd
- Certificate holder
- Novartis South Africa (Pty) Ltd
- Registrations
- 2
- Schedule source
- Consolidated Schedules 06 July 2026
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Lioresal 10 EACH TABLET CONTAINS BACLOFEN 10 mg | 10 mg/ 25 mgTablet. | E0227E/2.10/227Approved 27 November 2025 | Registered | S4 | PIPIL |
| Lioresal 25 EACH TABLET CONTAINS BACLOFEN 25 mg | 10 mg/ 25 mgTablet. | E0228E/2.10/228Approved 27 November 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, 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 Baclofen
S4: Baclofen
Consolidated Schedules 06 July 2026, line 5425
Pharmacological class: Centrally acting muscle relaxants. (class 2.10)
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.
4-Amino-3-(4-chlorophenyl)butanoic acid
Drag to rotate. Structure from PubChem CID 2284.
SAHPRA documents
These documents are provided by SAHPRA for informational purposes. Always consult with a healthcare professional for medical advice.