Dolutegravir (Syromak Odt, Kovasyp Odt, Maktegir, Syromak)
Dolutegravir
Macleods Pharmaceuticals SA (Pty) Ltd
Registration
- Applicant
- Macleods Pharmaceuticals SA (Pty) Ltd
- Registrations
- 4
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Syromak 10 odt EACH DISPERSIBLE TABLET CONTAINS : Dolutegravir Sodium equivalent to Dolutegravir 10,0 mg | 10 | 56071956/20.2.8/0719 | Registered | Not determined | None |
| Kovasyp 10 odt EACH DISPERSIBLE TABLET CONTAINS: DOLUTEGRAVIR SODIUM EQUIVALENT TO DOLUTEGRAVIR 10,0 mg | 10 | 560720.71956/20.2.8/0720.719 | Registered | Not determined | None |
| Maktegir 50 MG EACH TABLET CONTAINS DOLUTEGRAVIR SODIUM EQUIVALENT TO DOLUTEGRAVIR 50,0 mg | 50 mg | 56111056/20.2.8/1110 | Registered | Not determined | None |
| Syromak 50 MG EACH TABLET CONTAINS DOLUTEGRAVIR SODIUM EQUIVALENT TO DOLUTEGRAVIR 50,0 mg | 50 mg | 561111.111056/20.2.8/1111.1110 | Registered | Not determined | None |
Regulatory status
This product is still scheduled by law even when this site could not determine which tier it falls under. The label carries the S number in a square border; ask a pharmacist if you need to know its schedule.
Listings for this ingredient that could not be applied to this product
S4: Dolutegravir
Consolidated Schedules 06 July 2026, line 6100
S4: Lamivudine
Consolidated Schedules 06 July 2026, line 6850
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
SAHPRA has not published a professional information or patient information leaflet for this product.