Omeprazole (Altosec)
Omeprazole
Acino Pharma (Pty) Ltd
Registration
- Applicant
- Acino Pharma (Pty) Ltd
- Certificate holder
- Acino Pharma (Pty) Ltd
- Registrations
- 3
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Altosec 20 EACH CAPSULE CONTAINS OMEPRAZOLE 20,0 mg | 20 mgCapsules | 32008732/11.4.3/0087Approved 25 February 2023 | Registered | Not determined | PIPIL |
| Altosec 10 EACH CAPSULE CONTAINS OMEPRAZOLE 10,0 mg | 10 | 32070332/11.4.3/0703 | Cancelled | Not determined | None |
| Altosec 40 mg/10 ML EACH VIAL CONTAINS OMEPRAZOLE 40,0 mg | 40 mg/10 ml | A400192A40/11.4.3/0192 | Cancelled | 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: Omeprazole
- except when intended for the temporary, short-term relief of heartburn ans hyperacidity, subject to:
- a maximum daily dose of 20 milligrams
- a maximum treatment period of 14 days. (S2)
Consolidated Schedules 06 July 2026, lines 7392 to 7395
S2: Omeprazole
- when intended for the temporary, short-term relief of heartburn and hyperacidity, subject to:
- a maximum daily dose of 20 milligrams
- a maximum treatment period of 14 days. (S4)
Consolidated Schedules 06 July 2026, lines 2457 to 2461
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.
6-Methoxy-2-[(4-methoxy-3,5-dimethyl-2-pyridinyl)methylsulfinyl]-1H-benzimidazole
Drag to rotate. Structure from PubChem CID 4594.
SAHPRA documents
These documents are provided by SAHPRA for informational purposes. Always consult with a healthcare professional for medical advice.