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Clofazamine

Sold as Lamprene, Clofazimine macleods

S4Read from the PI-PIL document

No structure available

This product's active ingredient could not be matched to a single known compound.

Background

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Registration

Applicants
2
Registrations
4
Schedule source
SAHPRA documentation

Applicants and registrations

ApplicantBrandsDosagesRegistrationsScheduleLeaflets
Novartis South Africa (Pty) LtdCertificate held by NovartisLamprene50, 100530472, B0108Not determinedPIPIL
Macleods Pharmaceuticals SA (Pty) LtdClofazimine macleods50 mg, 100 mg540236, 540237S4PIPIL

Variants

ProductStrength and formRegistrationStatusScheduleLeaflets
Lamprene 50

EACH CAPSULE CONTAINS :CLOFAZIMINE 50,0 mg

50Gelatine capsules53047253/20.2.4/0472Approved 22 August 2024RegisteredNot determinedPIPIL
Clofazimine tablets 50 MG macleods

EACH TABLET CONTAINS:CLOFAZIMINE 50,0 mg

50 mgTablet54023654/20.2.3/0236Approved 25 April 2023RegisteredS4PIPIL
Clofazimine tablets 100 MG macleods

EACH TABLET CONTAINS CLOFAZIMINE 100,0 mg

100 mgTablet54023754/20.2.3/0237Approved 25 April 2023RegisteredS4PIPIL
Lamprene 100

EACH CAPSULE CONTAINS: CLOFAZIMINE 100 mg

100Gelatine capsulesB0108B/20.2.4/108Approved 22 August 2024RegisteredNot determinedPIPIL

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, read from the product's PI-PIL leaflet.

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.

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

Research articles

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