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Fulvestrant

Sold as *Fulvestrant viatris, Eranfu, Fastelev, Fulvedex, Fuvistra, Desofal, Vesota, Fulvestrant sandoz, Frexivo, Actifulve for and actifulve diluent for, Fasatrant, Faslodex

S4
Loading the molecular structure
C32H47F5O3S606.80 g/mol

(7R,8R,9S,13S,14S,17S)-13-Methyl-7-[9-(4,4,5,5,5-pentafluoropentylsulfinyl)nonyl]-6,7,8,9,11,12,14,15,16,17-decahydrocyclopenta[a]phenanthrene-3,17-diol

Drag to rotate. Structure from PubChem CID 104741.

Background

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Registration

Applicants
10
Registrations
12
Schedule source
Consolidated Schedules 06 July 2026

Applicants and registrations

ApplicantBrandsDosagesRegistrationsScheduleLeaflets
Viatris South Africa (Pty) Ltd*Fulvestrant viatrisNot stated501066S4None
Dr Reddyæs Laboratories (Pty) LtdCertificate held by Dr. Reddy’s Laboratories (Pty) Ltd.Eranfu250 mg / 5 mL510740S4PIPIL
Teva Pharmaceuticals (Pty) LtdFastelev250 mg/5 ml520472S4PIPIL
Juno Pharma SA (Pty) LtdCertificate held by Kahma Biotech (Pty) LtdFulvedex250 mg550531S4PIPIL
Ranbaxy Pharmaceutical (Pty) LtdFuvistraNot stated560245S4None
Aurogen South Africa (Pty) LtdCertificate held by Aurogen SA (Pty) LtdDesofal, Vesota250 mg560405, 560406.405S4PIPIL
Sandoz South Africa (Pty) LtdFulvestrant sandozNot stated560415S4None
Astrazeneca Pharmaceuticals (Pty) LtdCertificate held by Astrazeneca Pharmaceuticals (Pty) Limited, AstrazenecaFrexivo, Faslodex250mg, 250mg / 5ml560606, A380656S4PIPIL
Activo Health (Pty) LtdActifulve for and actifulve diluent forpowder solution injection solution injection560716S4None
Abex Pharmaceutica (Pty) LtdFasatrantNot stated570365S4None

Variants

ProductStrength and formRegistrationStatusScheduleLeaflets
*Fulvestrant viatris

EACH 5,0 ml SOLUTION CONTAINS: FULVESTRANT 250,0 mg

Not listed50106650/21.12/1066RegisteredS4None
Eranfu 250

EACH PRE-FILLED SYRINGE CONTAINS: FULVESTRANT 250.0 mg

250 mg / 5 mLSolution for injection51074051/21.12/0740Approved 24 February 2025RegisteredS4PIPIL
Fastelev

EACH 1,0 ml SOLUTION CONTAINS: FULVESTRANT 50,0 mg

250 mg/5 mlSolution for injection in pre-filled syringe.52047252/26/0472Approved 3 March 2020RegisteredS4PIPIL
Fulvedex 250 mg/5 ML

FULVESTRANT

250 mgInjection55053155/21.12/0531Approved 8 November 2022RegisteredS4PIPIL
Fuvistra

EACH 5,0 ml SOLUTION CONTAINS FULVESTRANT 500,0 mg

Not listed56024556/21.12/0245RegisteredS4None
Desofal

EACH 5,0 ml SOLUTION CONTAINS FULVESTRANT 250,0 mg

250 mgSolution for injection56040556/26/0405Approved 3 October 2023RegisteredS4PIPIL
Vesota

EACH 5,0 ml SOLUTION CONTAINS FULVESTRANT 250,0 mg

250 mgSolution for injection560406.40556/26/0406.405Approved 3 October 2023RegisteredS4PIPIL
Fulvestrant sandoz

EACH 5,0 ml SOLUTION CONTAINS FULVESTRANT 250,0 mg

Not listed56041556/21.12/0415RegisteredS4None
Frexivo

EACH 5,0 ml SOLUTION CONTAINS FULVESTRANT 250,0 mg

250mgSolution for injection56060656/21.12/0606Approved 15 March 2022RegisteredS4PIPIL
Actifulve powder for solution for injection and actifulve diluent for solution for injection

EACH 10,0 ml VIAL CONTAINS FULVESTRANT 250,0 mg

Powder solution injection solution injection56071656/21.12/0716RegisteredS4None
Fasatrant

Each 5,0 ml Solution contains: Fulvestrant 250,0 mg

Not listed57036557/21.12/0365RegisteredS4None
Faslodex

EACH PRE-FILLED SYRINGE CONTAINS FULVESTRANT 250,0 mg

250mg / 5mlInjectionA380656A38/21.12/0656Approved 7 June 2019RegisteredS4PIPIL

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 Fulvestrant

  • S4: Fulvestrant

    Consolidated Schedules 06 July 2026, line 6472

Pharmacological class: Hormone inhibitors. (class 21.12)

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

Professional information (PI)For healthcare professionalsEranfu 250, Dr Reddyæs Laboratories (Pty) LtdPatient information leaflet (PIL)For patients and carersEranfu 250, Dr Reddyæs Laboratories (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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