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Baclofen

Sold as Spastigon, Baclofen teva, Aspen baclofen, Bacentra intrathecal, *Baclofen unicorn, Spasifen, Fenozyd, Baclofen activo, Lioresal, * fenolacob, Bio baclofen

S4
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C10H12ClNO2213.66 g/mol

4-Amino-3-(4-chlorophenyl)butanoic acid

Drag to rotate. Structure from PubChem CID 2284.

Background

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Registration

Applicants
9
Registrations
17
Schedule source
Consolidated Schedules 06 July 2026

Applicants and registrations

ApplicantBrandsDosagesRegistrationsScheduleLeaflets
Pharmacare limited û woodmead2 of 4 cancelledSpastigon, Aspen baclofen10 mg, 25 mg270182, 270183, 430722, 430723S4None
Teva Pharmaceuticals (Pty) LtdBaclofen teva50 mg300392S4PIPIL
Umsebe healthcareBacentra intrathecal0,05 mg/ml, 0,5 mg/ml, 2 mg/ml540366, 540367, 540368S4None
Unichem SA (Pty) Ltd*Baclofen unicorn10 mg560132S4None
Trinity Pharma (Pty) LtdSpasifenNot stated561154S4None
Zydus Healthcare (Pty) LtdFenozydNot stated570182S4None
Activo Health (Pty) LtdBaclofen activo10 mg580090S4PIPIL
Novartis South Africa (Pty) LtdLioresal10 mg/ 25 mgE0227, E0228S4PIPIL
Biotech Laboratories (Pty) Ltd* fenolacob, Bio baclofen10, 25W0236, W0237, W0433S4None

Variants

ProductStrength and formRegistrationStatusScheduleLeaflets
Spastigon - 10

EACH TABLET CONTAINS BACLOFEN 10 mg

- 1027018227/2.10/0182CancelledS4None
Spastigon - 25

EACH TABLET CONTAINS BACLOFEN 25 mg

- 2527018327/2.10/0183CancelledS4None
Baclofen 10 teva

EACH TABLET CONTAINS BACLOFEN 10,0 mg

50 mgTablets.30039230/2.10/0392Approved 13 September 2024RegisteredS4PIPIL
Aspen baclofen 10 MG

EACH TABLET CONTAINS BACLOFEN 10,0 mg

10 mg43072243/2.10/0722RegisteredS4None
Aspen baclofen 25 MG

EACH TABLET CONTAINS BACLOFEN 25,0 mg

25 mg43072343/2.10/0723RegisteredS4None
Bacentra intrathecal 0,05 mg/ml

EACH 1,0 ml SOLUTION CONTAINS :BACLOFEN 0,05 mg

0,05 mg/ml54036654/2.10/0366RegisteredS4None
Bacentra intrathecal 0,5 mg/ml

EACH 1,0 ml SOLUTION CONTAINS: BACLOFEN 0,5 mg

0,5 mg/ml54036754/2.10/0367RegisteredS4None
Bacentra intrathecal 2 mg/ml

EACH 1,0 ml SOLUTION CONTAINS BACLOFEN 2,0 mg

2 mg/ml54036854/2.10/0368RegisteredS4None
*Baclofen 10 MG unicorn

EACH TABLET CONTAINS BACLOFEN 10,0 mg

10 mg56013256/2.10/0132RegisteredS4None
Spasifen

EACH TABLET CONTAINS BACLOFEN 10,0 mg

Not listed56115456/2.10/1154RegisteredS4None
Fenozyd

EACH TABLET CONTAINS BACLOFEN 10,0 mg

Not listed57018257/2.10/0182RegisteredS4None
Baclofen activo

Each Tablet contains: Baclofen 10,0 mg

10 mgTablet58009058/2.10/0090Approved 22 July 2025RegisteredS4PIPIL
Lioresal 10

EACH TABLET CONTAINS BACLOFEN 10 mg

10 mg/ 25 mgTablet.E0227E/2.10/227Approved 27 November 2025RegisteredS4PIPIL
Lioresal 25

EACH TABLET CONTAINS BACLOFEN 25 mg

10 mg/ 25 mgTablet.E0228E/2.10/228Approved 27 November 2025RegisteredS4PIPIL
* fenolacob 10

EACH TABLET CONTAINS :BACLOFEN 10 mg

10W0236W/2.10/236RegisteredS4None
* fenolacob 25

EACH TABLET CONTAINS: BACLOFEN 25 mg

25W0237W/2.10/237RegisteredS4None
Bio baclofen

EACH TABLET CONTAINS BACLOFEN 10 mg

Not listedW0433W/2.10/433RegisteredS4None

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 verified from official 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.

Research articles

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