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Dolutegravir, lamivudine, tenofovir disoproxil (Rarudine)

Dolutegravir, lamivudine, tenofovir disoproxil

Pharma Dynamics (Pty) Ltd

S4Read from the PI-PIL document and verified

Registration

Applicant
Pharma Dynamics (Pty) Ltd
Certificate holder
Pharma Dynamics (Pty) Ltd
Registrations
1
Schedule source
SAHPRA documentation

Variants

ProductStrength and formRegistrationStatusScheduleLeaflets
Rarudine

EACH TABLET CONTAINS DOLOTEGRAVIR SODIUM EQUIVALENT TO DOLUTEGRAVIR 50,0 mg LAMIVUDINE 300,0 mg TENOFOVIR DISOPROXIL FUMARATE 300,0 mg

50 mg, 300 mg, 300 mgTablet54034354/20.2.8/0343Approved 28 March 2023RegisteredS4PIPIL

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 Dolotegravir sodium equivalent to dolutegravir, lamivudine, tenofovir disoproxil fumarate

  • S4: Dolutegravir

    Consolidated Schedules 06 July 2026, line 6100

  • S4: Lamivudine

    Consolidated Schedules 06 July 2026, line 6850

  • S4: Tenofovir

    Consolidated Schedules 06 July 2026, line 8130

Pharmacological class: Antiviral agents. (class 20.2.8)

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.

Combination product

This product contains more than one active ingredient, so it has no single molecular structure.

SAHPRA documents

Schedule verified from official documents

Schedule Verification

This medication's schedule (S4) has been verified from official SAHPRA documents with 90% confidence.

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

Background

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Research articles

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