Nifedipine (Nifedalat, Nifedalat Sr, Biotech Nifedipine Xl, Fidocare Xl30, Fidocare Xl, Dapinelat, Bio-nifedipine)
Nifedipine
Biotech Laboratories (Pty) Ltd
Registration
- Applicant
- Biotech Laboratories (Pty) Ltd
- Registrations
- 10
- Schedule source
- Consolidated Schedules 06 July 2026
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Nifedalat 10 MG EACH CAPSULE CONTAINS NIFEDIPINE 10 mg | 10 mg | 27021027/7.1.4/0210 | Registered | S3 | None |
| Nifedalat 20 sr EACH TABLET CONTAINS :NIFEDIPINE 20,0 mg | 20 mgFilm-coated tablets | 28001428/7.1/0014 | Registered | S3 | PIPIL |
| Biotech nifedipine xl 30 EACH TABLET CONTAINS NIFEDIPINE 30,0 mg | 30 | 43055843/7.1/0558 | Registered | S3 | None |
| Biotech nifedipine xl 60 EACH TABLET CONTAINS NIFEDIPINE 60,0 mg | 60 | 43055943/7.1/0559 | Registered | S3 | None |
| Fidocare xl30 EACH EXTENDED RELEASE TABLET CONTAINS: NIFEDIPINE 30,0 mg | 30 mg or 60 mgProlonged-release tablets. | 500504.50250/7.1/0504.502Approved 22 July 2025 | Registered | S3 | PIPIL |
| Fidocare xl 60 EACH EXTENDED RELEASE TABLET CONTAINS: NIFEDIPINE 60,0 mg | 60Prolonged-release tablets. | 500505.50350/7.1/0505.503Approved 22 July 2025 | Registered | S3 | PIPIL |
| Dapinelat 30 EACH TABLET CONTAINS NIFEDIPINE 30,0 mg | 30Tablet | 53052153/7.1/0521Approved 29 March 2022 | Registered | S3 | PIPIL |
| Dapinelat 60 EACH TABLET CONTAINS NIFEDIPINE 60,0 mg | 60Tablet | 53052253/7.1/0522Approved 29 March 2022 | Registered | S3 | PIPIL |
| Bio-nifedipine 5 EACH CAPSULE CONTAINS NIFEDIPINE 5 mg | 5 | X0102X/7.1/102 | Registered | S3 | None |
| Bio-nifedipine 10 EACH CAPSULE CONTAINS NIFEDIPINE 10 mg | 10 | X0103X/7.1/103 | Registered | S3 | None |
Regulatory status
Where S3 sits on the scale
Needs a doctor's prescription, dispensed by a pharmacist.
Schedule 3 medicines can only be sold on a prescription from an authorised prescriber, such as a doctor or dentist. A pharmacist dispenses the medicine once they have the written prescription, or a verbal instruction from a prescriber they know. 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 S3, 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 Nifedipine
S3: Nifedipine
Consolidated Schedules 06 July 2026, line 4029
Pharmacological class: Vasodilators - coronary and other medicines used in angina pectoris. (class 7.1.4)
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.
Dimethyl 2,6-dimethyl-4-(2-nitrophenyl)-1,4-dihydropyridine-3,5-dicarboxylate
Drag to rotate. Structure from PubChem CID 4485.
SAHPRA documents
These documents are provided by SAHPRA for informational purposes. Always consult with a healthcare professional for medical advice.