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Aspen Dolutegravir

Dolutegravir

S4Read from the PI-PIL document and verified
Loading the molecular structure
C20H19F2N3O5419.40 g/mol

(3S,7R)-N-[(2,4-Difluorophenyl)methyl]-11-hydroxy-7-methyl-9,12-dioxo-4-oxa-1,8-diazatricyclo[8.4.0.03,8]tetradeca-10,13-diene-13-carboxamide

Drag to rotate; arrow keys step through the atoms. Structure from PubChem CID 54726191.

Registration

Applicants
1
Registrations
1
Schedule source
SAHPRA documentation

Applicants and registrations

ApplicantBrandsDosagesRegistrationsScheduleLeaflets
Pharmacare limited û woodmeadCertificate held by Pharmacare limitedAspen dolutegravir50 mg521004S4PIPIL

Variants

ProductStrength and formRegistrationStatusScheduleLeaflets
Aspen dolutegravir

EACH TABLET CONTAINS DOLUTEGRAVIR SODIUM EQUIVALENT TO DOLUTEGRAVIR 50, 0 mg

50 mgFilm-coated tablets52100452/20.2.8/1004Approved 17 January 2022RegisteredS4PIPIL

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 Dolutegravir sodium equivalent to dolutegravir

  • S4: Dolutegravir

    Consolidated Schedules 06 July 2026, line 6100

  • S4: Lamivudine

    Consolidated Schedules 06 July 2026, line 6850

Pharmacological class: Antiviral agents. (class 20.2.8)

Matched through the component Lamivudine.

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.

Background

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SAHPRA documents

Schedule verified from official documents

Schedule Verification

Aspen dolutegravir, Pharmacare limited û woodmead is scheduled S4 in its official SAHPRA documents, read with 90% confidence.

These documents come from SAHPRA's PI-PIL repository unless the line under a document says otherwise. Always consult with a healthcare professional for medical advice.

Research articles

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