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Pirfenidone

Sold as Esbriet, Pirofibra, Pirfenidone cipla, Fibrotev

S4Read from the PI-PIL document and verified
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C12H11NO185.22 g/mol

5-Methyl-1-phenylpyridin-2-one

Drag to rotate. Structure from PubChem CID 40632.

Background

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Registration

Applicants
3
Registrations
9
Schedule source
SAHPRA documentation

Applicants and registrations

ApplicantBrandsDosagesRegistrationsScheduleLeaflets
Roche Products (Pty) LtdEsbriet267 mg, 801501168, 560186, 560187S4PIPIL
Cipla Medpro (Pty) LtdPirofibra, Pirfenidone cipla267, 801570693, 570694, 570695.693, 570696.694S4None
Teva Pharmaceuticals (Pty) LtdFibrotev267, 801570910, 570911S4None

Variants

ProductStrength and formRegistrationStatusScheduleLeaflets
Esbriet

EACH CAPSULE CONTAINS PIRFENIDONE 267,0 mg

267 mgCapsules50116850/32.16/1168Approved 21 September 2022RegisteredS4PIPIL
Esbriet 267

EACH TABLET CONTAINS PIRFENIDONE 267,0 mg

26756018656/32.16/0186RegisteredS4None
Esbriet 801

EACH TABLET CONTAINS PIRFENIDONE 801,0 mg

80156018756/32.16/0187RegisteredS4None
Pirofibra 267

EACH TABLET CONTAINS PIRFENIDONE 267,0 mg

26757069357/32.16/0693RegisteredS4None
Pirofibra 801

EACH TABLET CONTAINS PIRFENIDONE 801,0 mg

80157069457/32.16/0694RegisteredS4None
Pirfenidone 267 cipla

EACH TABLET CONTAINS PIRFENIDONE 267,0 mg

267570695.69357/32.16/0695.693RegisteredS4None
Pirfenidone 801 cipla

EACH TABLET CONTAINS PIRFENIDONE 801,0 mg

801570696.69457/32.16/0696.694RegisteredS4None
Fibrotev 267

EACH TABLET CONTAINS: PIRFENIDONE 267,0 mg

26757091057/32.16/0910RegisteredS4None
Fibrotev 801

EACH TABLET CONTAINS: PIRFENIDONE 801,0 mg

80157091157/32.16/0911RegisteredS4None

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.

Consolidated Schedules listings for Pirfenidone

  • S4: Pirfenidone

    Consolidated Schedules 06 July 2026, line 7574

Pharmacological class: Others. (class 32.16)

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

Esbriet, Roche Products (Pty) Ltd is scheduled S4 in its official SAHPRA documents, read with 90% confidence.

Professional information (PI)For healthcare professionalsEsbriet, Roche Products (Pty) LtdPatient information leaflet (PIL)For patients and carersEsbriet, Roche Products (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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