Amlodipine (Amlodipine Biotech)
Amlodipine
Biotech Laboratories (Pty) Ltd
Registration
- Applicant
- Biotech Laboratories (Pty) Ltd
- Certificate holder
- Biotech Laboratories (Pty) Ltd.
- Registrations
- 2
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Amlodipine 5 biotech EACH TABLET CONTAINS AMLODIPINE MALEATE EQUIVALENT TO AMLODIPINE 5,0 mg | 5 or 10 mgTablets | 37037837/7.1/0378Approved 5 July 2021 | Registered | Not determined | PIPIL |
| Amlodipine 10 biotech EACH TABLET CONTAINS AMLODIPINE 10,0 mg | 5 or 10 mgTablets | 37037937/7.1/0379Approved 5 July 2021 | Registered | Not determined | PIPIL |
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
S3: Amlodipine
Consolidated Schedules 06 July 2026, line 3138
S3: Indapamide
Consolidated Schedules 06 July 2026, line 3780
S3: Irbesartan
Consolidated Schedules 06 July 2026, line 3806
S3: Telmisartan
Consolidated Schedules 06 July 2026, line 4286
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.
3-O-Ethyl 5-O-methyl 2-(2-aminoethoxymethyl)-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate
Drag to rotate. Structure from PubChem CID 2162.
SAHPRA documents
These documents are provided by SAHPRA for informational purposes. Always consult with a healthcare professional for medical advice.