Amlodipine, losartan
Sold as Amzaar
Combination product
This product contains more than one active ingredient, so it has no single molecular structure.
Background
Registration
- Applicants
- 1
- Registrations
- 2
- Schedule source
- SAHPRA documentation
Applicants and registrations
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Amzaar 5/50 EACH TABLET CONTAINS:AMLODIPINE CAMSYLATE EQUIVALENT TO AMLODIPINE 5,0 mg, LOSARTAN POTASSIUM 50,0 mg | 5/50Tablets | 46055946/7.1.3/0559Approved 30 November 2025 | Registered | S3 | PIPIL |
| Amzaar 5/100 EACH TABLET CONTAINS AMLODIPINE CAMSYLATE EQUIVALENT TO AMLODIPINE 5,0 mgLOSARTAN POTASSIUM 100,0 mg | 5/100Tablets | 46056046/7.1.3/0560Approved 30 November 2025 | Registered | S3 | PIPIL |
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, read from the product's PI-PIL leaflet.
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 Amlodipine camsylate equivalent to amlodipine, losartan potassium
S3: Amlodipine
Consolidated Schedules 06 July 2026, line 3138
S3: Losartan
Consolidated Schedules 06 July 2026, line 3908
S3: Potassium
- when intended for intravenous infusion or for injection;
- except when contained in oral rehydration preparations; (S0)
- except in oral preparations or mixtures containing more than 20 millimoles (1500mg) of potassium per 24 hours. (S2)
Consolidated Schedules 06 July 2026, lines 4148 to 4153
S2: Potassium
- in oral preparations or mixtures containing more than 20 millimoles (1500mg) of potassium per 24 hours;
- except when intended for intravenous infusion or for injection; (S3) and
- except when contained in oral rehydration preparations. (S0)
Consolidated Schedules 06 July 2026, lines 2563 to 2569
Pharmacological class: Other hypotensives. (class 7.1.3)
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
Schedule Verification
Amzaar 5/50, Organon South Africa (Pty) Ltd is scheduled S3 in its official SAHPRA documents, read with 90% confidence.
These documents are provided by SAHPRA for informational purposes. Always consult with a healthcare professional for medical advice.