Sacubitril valsartan sodium hydrate (Entresto, Vymada)
Sacubitril valsartan sodium hydrate
Novartis South Africa (Pty) Ltd
Registration
- Applicant
- Novartis South Africa (Pty) Ltd
- Registrations
- 6
- Schedule source
- Consolidated Schedules 06 July 2026
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Entresto 50 MG EACH TABLET CONTAINS SACUBITRIL VALSARTAN SODIUM HYDRATE 50,0 mg | 50 mg | 50101650/7.6/1016 | Registered | S3 | None |
| Entresto 100 MG EACH TABLET CONTAINS SACUBITRIL VALSARTAN SODIUM HYDRATE 100,0 mg | 100 mg | 50101750/7.6/1017 | Registered | S3 | None |
| Entresto 200 MG EACH TABLET CONTAINS SACUBITRIL VALSARTAN SODIUM HYDRATE 200,0 mg | 200 mg | 50101850/7.6/1018 | Registered | S3 | None |
| Vymada 50 MG EACH TABLET CONTAINS SACUBITRIL VALSARTAN SODIUM HYDRATE 50,0 mg | 50 mg | 50101950/7.6/1019 | Registered | S3 | None |
| Vymada 100 MG EACH TABLET CONTAINS SACUBITRIL VALSARTAN SODIUM HYDRATE 100,0 mg | 100 mg | 50102050/7.6/1020 | Registered | S3 | None |
| Vymada 200 MG EACH TABLET CONTAINS SACUBITRIL VALSARTAN SODIUM HYDRATE 200,0 mg | 200 mg | 50102150/7.6/1021 | 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 medium.
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 Sacubitril valsartan sodium hydrate
S3: Sacubitril
Consolidated Schedules 06 July 2026, line 4236
S3: Valsartan
Consolidated Schedules 06 July 2026, line 4376
Pharmacological class: Others. (class 7.6)
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.
(2S)-3-Methyl-2-[pentanoyl-[[4-[2-(2H-tetrazol-5-yl)phenyl]phenyl]methyl]amino]butanoic acid
Drag to rotate. Structure from PubChem CID 60846.
SAHPRA documents
SAHPRA has not published a professional information or patient information leaflet for this product.