Raltegravir
Sold as Isentress, Isentress tabltes
N-[2-[4-[(4-Fluorophenyl)methylcarbamoyl]-5-hydroxy-1-methyl-6-oxopyrimidin-2-yl]propan-2-yl]-5-methyl-1,3,4-oxadiazole-2-carboxamide
Drag to rotate. Structure from PubChem CID 54671008.
Background
Registration
- Applicants
- 1
- Registrations
- 3
- Schedule source
- Consolidated Schedules 06 July 2026
Applicants and registrations
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Isentress EACH TABLET CONTAINS RALTEGRAVIR POTASSIUM EQUIVALENT TO RALTEGRAVIR 400,0 mg | 400 mg, 25 mg and 100 mgFilm-coated tablet, chewable tablet | 42068742/20.2.8/0687Approved 21 November 2023 | Registered | S4 | PIPIL |
| Isentress chewable tablets 25 MG EACH TABLET CONTAINS RALTEGRAVIR POTASSIUM EQUIVALENT TO RALTEGRAVIR 25,0 mg | 25 mgChewable tablets | 46086346/20.2.8/0863 | Registered | S4 | None |
| Isentress chewable tabltes 100 MG EACH TABLET CONTAINS RALTEGRAVIR POTASSIUM EQUIVALENT TO RALTEGRAVIR 100,0 mg | 100 mgChewable | 46086446/20.2.8/0864 | Registered | S4 | None |
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 Raltegravir potassium equivalent to raltegravir
S4: Raltegravir
Consolidated Schedules 06 July 2026, line 7758
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.
SAHPRA documents
These documents are provided by SAHPRA for informational purposes. Always consult with a healthcare professional for medical advice.