Baclofen
Sold as Spastigon, Baclofen teva, Aspen baclofen, Bacentra intrathecal, *Baclofen unicorn, Spasifen, Fenozyd, Baclofen activo, Lioresal, * fenolacob, Bio baclofen
4-Amino-3-(4-chlorophenyl)butanoic acid
Drag to rotate. Structure from PubChem CID 2284.
Background
Registration
- Applicants
- 9
- Registrations
- 17
- Schedule source
- Consolidated Schedules 06 July 2026
Applicants and registrations
| Applicant | Brands | Dosages | Registrations | Schedule | Leaflets |
|---|---|---|---|---|---|
| Pharmacare limited û woodmead2 of 4 cancelled | Spastigon, Aspen baclofen | 10 mg, 25 mg | 270182, 270183, 430722, 430723 | S4 | None |
| Teva Pharmaceuticals (Pty) Ltd | Baclofen teva | 50 mg | 300392 | S4 | PIPIL |
| Umsebe healthcare | Bacentra intrathecal | 0,05 mg/ml, 0,5 mg/ml, 2 mg/ml | 540366, 540367, 540368 | S4 | None |
| Unichem SA (Pty) Ltd | *Baclofen unicorn | 10 mg | 560132 | S4 | None |
| Trinity Pharma (Pty) Ltd | Spasifen | Not stated | 561154 | S4 | None |
| Zydus Healthcare (Pty) Ltd | Fenozyd | Not stated | 570182 | S4 | None |
| Activo Health (Pty) Ltd | Baclofen activo | 10 mg | 580090 | S4 | PIPIL |
| Novartis South Africa (Pty) Ltd | Lioresal | 10 mg/ 25 mg | E0227, E0228 | S4 | PIPIL |
| Biotech Laboratories (Pty) Ltd | * fenolacob, Bio baclofen | 10, 25 | W0236, W0237, W0433 | S4 | None |
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Spastigon - 10 EACH TABLET CONTAINS BACLOFEN 10 mg | - 10 | 27018227/2.10/0182 | Cancelled | S4 | None |
| Spastigon - 25 EACH TABLET CONTAINS BACLOFEN 25 mg | - 25 | 27018327/2.10/0183 | Cancelled | S4 | None |
| Baclofen 10 teva EACH TABLET CONTAINS BACLOFEN 10,0 mg | 50 mgTablets. | 30039230/2.10/0392Approved 13 September 2024 | Registered | S4 | PIPIL |
| Aspen baclofen 10 MG EACH TABLET CONTAINS BACLOFEN 10,0 mg | 10 mg | 43072243/2.10/0722 | Registered | S4 | None |
| Aspen baclofen 25 MG EACH TABLET CONTAINS BACLOFEN 25,0 mg | 25 mg | 43072343/2.10/0723 | Registered | S4 | None |
| Bacentra intrathecal 0,05 mg/ml EACH 1,0 ml SOLUTION CONTAINS :BACLOFEN 0,05 mg | 0,05 mg/ml | 54036654/2.10/0366 | Registered | S4 | None |
| Bacentra intrathecal 0,5 mg/ml EACH 1,0 ml SOLUTION CONTAINS: BACLOFEN 0,5 mg | 0,5 mg/ml | 54036754/2.10/0367 | Registered | S4 | None |
| Bacentra intrathecal 2 mg/ml EACH 1,0 ml SOLUTION CONTAINS BACLOFEN 2,0 mg | 2 mg/ml | 54036854/2.10/0368 | Registered | S4 | None |
| *Baclofen 10 MG unicorn EACH TABLET CONTAINS BACLOFEN 10,0 mg | 10 mg | 56013256/2.10/0132 | Registered | S4 | None |
| Spasifen EACH TABLET CONTAINS BACLOFEN 10,0 mg | Not listed | 56115456/2.10/1154 | Registered | S4 | None |
| Fenozyd EACH TABLET CONTAINS BACLOFEN 10,0 mg | Not listed | 57018257/2.10/0182 | Registered | S4 | None |
| Baclofen activo Each Tablet contains: Baclofen 10,0 mg | 10 mgTablet | 58009058/2.10/0090Approved 22 July 2025 | Registered | S4 | PIPIL |
| 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 |
| * fenolacob 10 EACH TABLET CONTAINS :BACLOFEN 10 mg | 10 | W0236W/2.10/236 | Registered | S4 | None |
| * fenolacob 25 EACH TABLET CONTAINS: BACLOFEN 25 mg | 25 | W0237W/2.10/237 | Registered | S4 | None |
| Bio baclofen EACH TABLET CONTAINS BACLOFEN 10 mg | Not listed | W0433W/2.10/433 | 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, 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.
SAHPRA documents
Schedule Verification
Baclofen 10 teva, Teva Pharmaceuticals (Pty) Ltd 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.