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Ambrisentan

Sold as Volibris, Ampulm, Ambrisentan cipla, Volmaro, Ambera, Pulerttan, Mabraten

S4
Loading the molecular structure
C22H22N2O4378.40 g/mol

(2S)-2-(4,6-Dimethylpyrimidin-2-yl)oxy-3-methoxy-3,3-diphenylpropanoic acid

Drag to rotate. Structure from PubChem CID 6918493.

Background

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Registration

Applicants
3
Registrations
14
Schedule source
Consolidated Schedules 06 July 2026

Applicants and registrations

ApplicantBrandsDosagesRegistrationsScheduleLeaflets
Glaxosmithkline South Africa (Pty) LimitedVolibris5 mg, 10 mg450106, 450107S4None
Lebasi Pharmaceuticals (Pty) LtdAmpulm, Ambera, Pulerttan, Mabraten5, 10490713.709, 590708, 590709, 590710.708, 590711.709, 590712.708, 590714.708, 590715.709S4PIPIL
Cipla Medpro (Pty) LtdAmbrisentan cipla, Volmaro5, 10520602, 520603, 520604.602, 520605.603S4PIPIL

Variants

ProductStrength and formRegistrationStatusScheduleLeaflets
Volibris 5 MG

EACH TABLET CONTAINS AMBRISENTAN 5,0 mg

5 mg45010645/7.1.3/0106RegisteredS4None
Volibris 10 MG

EACH TABLET CONTAINS AMBRISENTAN 10,0 mg

10 mg45010745/7.1.3/0107RegisteredS4None
Ampulm 10

EACH TABLET CONTAINS: AMBRISENTAN 10,0 mg

10Film-coated tablets490713.70959/7.1.3/0713.709Approved 22 May 2026RegisteredS4PIPIL
Ambrisentan cipla 55Film-coated tablets52060252/7.1.3/0602Approved 30 March 2022RegisteredS4PIPIL
Ambrisentan cipla 1010Film-coated tablets52060352/7.1.3/0603Approved 30 March 2022RegisteredS4PIPIL
Volmaro 55Film-coated tablets520604.60252/7.1.3/0604.602Approved 30 March 2022RegisteredS4PIPIL
Volmaro 1010Film-coated tablets520605.60352/7.1.3/0605.603Approved 30 March 2022RegisteredS4PIPIL
Ambera 5

EACH TABLET CONTAINS: AMBRISENTAN 5,0 mg

5Film-coated tablets59070859/7.1.3/0708Approved 22 May 2026RegisteredS4PIPIL
Ambera 10

EACH TABLET CONTAINS: AMBRISENTAN 10,0 mg

10Film-coated tablets59070959/7.1.3/0709Approved 22 May 2026RegisteredS4PIPIL
Pulerttan 5

EACH TABLET CONTAINS: AMBRISENTAN 5,0 mg

5Film-coated tablets590710.70859/7.1.3/0710.708Approved 22 May 2026RegisteredS4PIPIL
Pulerttan 10

EACH TABLET CONTAINS: AMBRISENTAN 10,0 mg

10Film-coated tablets590711.70959/7.1.3/0711.709Approved 22 May 2026RegisteredS4PIPIL
Ampulm 5

EACH TABLET CONTAINS: AMBRISENTAN 5,0 mg

5Film-coated tablets590712.70859/7.1.3/0712.708Approved 22 May 2026RegisteredS4PIPIL
Mabraten 5

EACH TABLET CONTAINS: AMBRISENTAN 5,0 mg

5Film-coated tablets590714.70859/7.1.3/0714.708Approved 22 May 2026RegisteredS4PIPIL
Mabraten 10

EACH TABLET CONTAINS: AMBRISENTAN 10,0 mg

10Film-coated tablets590715.70959/7.1.3/0715.709Approved 22 May 2026RegisteredS4PIPIL

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 Ambrisentan

  • S4: Ambrisentan

    Consolidated Schedules 06 July 2026, line 5210

Pharmacological class: Other hypotensives. (class 7.1.3)

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.

SAHPRA documents

Schedule verified from official documents

Schedule Verification

Ampulm 10, Lebasi Pharmaceuticals (Pty) Ltd is scheduled S4 in its official SAHPRA documents, read with 90% confidence.

Professional information (PI)For healthcare professionalsAmpulm 10, Lebasi Pharmaceuticals (Pty) LtdPatient information leaflet (PIL)For patients and carersAmpulm 10, Lebasi Pharmaceuticals (Pty) Ltd

These documents are provided by SAHPRA for informational purposes. Always consult with a healthcare professional for medical advice.

Research articles

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