Dolutegravir (Dolutegravir Cipla, Dalimune)
Dolutegravir
Cipla Medpro Manufacturing (Pty) Ltd
Registration
- Applicant
- Cipla Medpro Manufacturing (Pty) Ltd
- Certificate holder
- Cipla Medpro (Pty) Ltd.
- Registrations
- 2
- Schedule source
- Consolidated Schedules 06 July 2026
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Dolutegravir cipla 50 EACH TABLET CONTAINS DOLUTEGRAVIR SODIUM 50,0 mg | 50 mgFilm-coated tablets | 51103151/20.2.8/1031Approved 18 November 2021 | Registered | S4 | PIPIL |
| Dalimune EACH TABLET CONTAINS DOLUTEGRAVIR SODIUM 50,0 mg | 50 mgFilm-coated tablets | 511032.103151/20.2.8/1032.1031Approved 20 February 2024 | Registered | S4 | PIPIL |
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 Dolutegravir sodium
S4: Dolutegravir
Consolidated Schedules 06 July 2026, line 6100
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.
(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. Structure from PubChem CID 54726191.
SAHPRA documents
These documents are provided by SAHPRA for informational purposes. Always consult with a healthcare professional for medical advice.