Amlodipine, valsartan
Sold as Exforge, Dafiro, Copalia, Valgamez, Tensoforj, Duoforge, Hiperval, Valdou, Amvadran, Amlodipine/valsartan adco, Valduo
Combination product
This product contains more than one active ingredient, so it has no single molecular structure.
Background
Registration
- Applicants
- 7
- Registrations
- 28
- Schedule source
- Consolidated Schedules 06 July 2026
Applicants and registrations
| Applicant | Brands | Dosages | Registrations | Schedule | Leaflets |
|---|---|---|---|---|---|
| Novartis South Africa (Pty) Ltd | Exforge, Copalia | 5/160 mg, 5/320 mg, 10/160 mg, 10/320 mg | 410291, 410292, 410770, 410771, 450850, 450851, 451013, 451014 | S3 | None |
| Sandoz South Africa (Pty) Ltd2 of 4 cancelled | Dafiro | 5/160 mg, 5/320 mg, 10/160 mg, 10/320 mg | 450706, 450707, 451011, 451012 | S3 | None |
| Ranbaxy Pharmaceutical (Pty) Ltd | Valgamez | 5/160, 10/160 | 490169.167, 490170.168 | S3 | None |
| Cipla Medpro (Pty) Ltd | Tensoforj | 5/160, 10/160 | 500518, 500519 | S3 | None |
| Innovata pharmaceuticals2 of 4 cancelled | Duoforge, Hiperval | 5/160, 10/160 | 500520, 500521, 500522, 500523 | S3 | None |
| Forrester Pharma (Pty) Ltd | Valdou, Valduo | 5/80, 5/160, 5/320, 10/160, 10/320 | 510067, 510068, 510069, 530179, 530180 | S3 | PIPIL |
| Adcock ingram limited | Amvadran, Amlodipine/valsartan adco | 5/160, 5 mg/ 10 mg | 520086, 520088.086, 520089.087 | S3 | PIPIL |
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Exforge 5/160 MG EACH TABLET CONTAINS AMLODIPINE BESYLATE EQUIVALENT TO AMLODIPINE 5,0 mg VALSARTAN 160,0 mg | 5/160 mg | 41029141/7.1.3/0291 | Registered | S3 | None |
| Exforge 10/160 MG EACH TABLET CONTAINS AMLODIPINE BESYLATE EQUIVALENT TO AMLODIPINE 10,0 mg VALSARTAN 160,0 mg | 10/160 mg | 41029241/7.1.3/0292 | Registered | S3 | None |
| Exforge 5/320 MG EACH TABLET CONTAINS AMLODIPINE BESYLATE EQUIVALENT TO AMLODIPINE 5,0 mg VALSARTAN 320,0 mg | 5/320 mg | 41077041/7.1.3/0770 | Registered | S3 | None |
| Exforge 10/320 MG EACH TABLET CONTAINS AMLODIPINE BESYLATE EQUIVALENT TO AMLODIPINE 10,0 mg VALSARTAN 320,0 mg | 10/320 mg | 41077141/7.1.3/0771 | Registered | S3 | None |
| Dafiro 5/160 MG EACH TABLET CONTAINS AMLODIPINE BESYLATE EQUIVALENT TO AMLODIPINE 5,0 mg VALSARTAN 160,0 mg | 5/160 mg | 45070645/7.1.3/0706 | Registered | S3 | None |
| Dafiro 10/160 MG EACH TABLET CONTAINS AMLODIPINE BESYLATE EQUIVALENT TO AMLODIPINE 10,0 mg VALSARTAN 160,0 mg | 10/160 mg | 45070745/7.1.3/0707 | Registered | S3 | None |
| Copalia 5/160 MG EACH TABLET CONTAINS AMLODIPINE BESYLATE EQUIVALENT TO AMLODIPINE 5,0 mg VALSARTAN 160,0 mg | 5/160 mg | 45085045/7.1.3/0850 | Registered | S3 | None |
| Copalia 10/160 MG EACH TABLET CONTAINS AMLODIPINE BESYLATE EQUIVALENT TO AMLODIPINE 10,0 mg VALSARTAN 160,0 mg | 10/160 mg | 45085145/7.1.3/0851 | Registered | S3 | None |
| Dafiro 5/320 MG EACH TABLET CONTAINS :AMLODIPINE BESYLATE EQUIVALENT TO AMLODIPINE 5,0 mgVALSARTAN 320,0 mg | 5/320 mg | 45101145/7.1.3/1011 | Cancelled | S3 | None |
| Dafiro 10/320 MG EACH TABLET CONTAINS AMLODIPINE BESYLATE EQUIVALENT TO AMLODIPINE 10,0 mgVALSARTAN 320,0 mg | 10/320 mg | 45101245/7.1.3/1012 | Cancelled | S3 | None |
| Copalia 5/320 MG EACH TABLET CONTAINS AMLODIPINE BESYLATE EQUIVALENT TO AMLODIPINE 5,0 mg VALSARTAN 320,0 mg | 5/320 mg | 45101345/7.1.3/1013 | Registered | S3 | None |
| Copalia 10/320 MG EACH TABLET CONTAINS AMLODIPINE BESYLATE EQUIVALENT TO AMLODIPINE 10,0 mg VALSARTAN 320,0 mg | 10/320 mg | 45101445/7.1.3/1014 | Registered | S3 | None |
| Valgamez 5/160 EACH TABLET CONTAINS: AMLODIPINE BESILATE 5,0 mg VALSARTAN 160,0 mg | 5/160 | 490169.16749/7.1.3/0169.167 | Registered | S3 | None |
| Valgamez 10/160 EACH TABLET CONTAINS: AMLODIPINE BESILATE 10,0 mg VALSARTAN 160,0 mg | 10/160 | 490170.16849/7.1.3/0170.168 | Registered | S3 | None |
| Tensoforj 5/160 EACH TABLET CONTAINS AMLODIPINE BESYLATE EQUIVALENT TO AMLODIPINE 5,0 mg VALSARTAN 160,0 mg | 5/160 | 50051850/7.1.3/0518 | Registered | S3 | None |
| Tensoforj 10/160 EACH TABLET CONTAINS AMLODIPINE BESYLATE EQUIVALENT TO AMLODIPINE 10,0 mg VALSARTAN 160,0 mg | 10/160 | 50051950/7.1.3/0519 | Registered | S3 | None |
| Duoforge 5/160 EACH TABLET CONTAINS AMLODIPINE BESYLATE EQUIVALENT TO AMLODIPINE 5,0 mg VALSARTAN 160,0 mg | 5/160 | 50052050/7.1.3/0520 | Registered | S3 | None |
| Duoforge 10/160 EACH TABLET CONTAINS AMLODIPINE BESYLATE EQUIVALENT TO AMLODIPINE 10,0 mg VALSARTAN 160,0 mg | 10/160 | 50052150/7.1.3/0521 | Registered | S3 | None |
| Hiperval 5/160 EACH TABLET CONTAINS AMLODIPINE BESYLATE EQUIVALENT TO AMLODIPINE 5,0 mg VALSARTAN 160,0 mg | 5/160 | 50052250/7.1.3/0522 | Cancelled | S3 | None |
| Hiperval 10/160 EACH TABLET CONTAINS AMLODIPINE BESYLATE EQUIVALENT TO AMLODIPINE 10,0 mg VALSARTAN 160,0 mg | 10/160 | 50052350/7.1.3/0523 | Cancelled | S3 | None |
| Valdou 5/80 EACH TABLET CONTAINS AMLODIPINE BESYLATE EQUIVALENT TO AMLODIPINE 5,0 mg VALSARTAN 80,0 mg | 5/80 | 51006751/7.1.3/0067 | Registered | S3 | None |
| Valdou 5/160 EACH TABLET CONTAINS AMLODIPINE BESYLATE EQUIVALENT TO AMLODIPINE 5,0 mg VALSARTAN 160,0 mg | 5/160 | 51006851/7.1.3/0068 | Registered | S3 | None |
| Valdou 10/160 EACH TABLET CONTAINS AMLODIPINE BESYLATE EQUIVALENT TO AMLODIPINE 10,0 mg VALSARTAN 160,0 mg | 10/160 | 51006951/7.1.3/0069 | Registered | S3 | None |
| Amvadran 5/160 Each film-coated tablet contains AMLODIPINE BESYLATE EQUIVALENT TO AMLODIPINE 5,0 mg and VALSARTAN 160,0 mg | 5/160 | 52008652/7.1.3/0086 | Registered | S3 | None |
| Amlodipine/valsartan 5/160 adco Each film-coated tablet contains AMLODIPINE BESYLATE EQUIVALENT TO AMLODIPINE 5,0 mg and VALSARTAN 160,0 mg | 5 mg/ 10 mgFilm-coated tablets | 520088.08652/7.1.3/0088.086Approved 8 June 2023 | Registered | S3 | PIPIL |
| Amlodipine/valsartan 10/160 adco Each film-coated tablet contains AMLODIPINE BESYLATE EQUIVALENT TO AMLODIPINE 10,0 mg and VALSARTAN 160,0 mg | 5 mg/ 10 mgFilm-coated tablets | 520089.08752/7.1.3/0089.087Approved 8 June 2023 | Registered | S3 | PIPIL |
| Valduo 5/320 EACH TABLET CONTAINS AMLODIPINE BESYLATE EQUIVALENT TO AMLODIPINE 5,0 mg and VALSARTAN 320,0 mg | 5/320Film-coated tablets | 53017953/7.1.3/0179Approved 22 July 2025 | Registered | S3 | PIPIL |
| Valduo 10/320 EACH TABLET CONTAINS AMLODIPINE BESYLATE EQUIVALENT TO AMLODIPINE 10,0 mgVALSARTAN 320,0 mg | 10/320Film-coated tablets | 53018053/7.1.3/0180Approved 22 July 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, 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 Amlodipine besylate equivalent to amlodipine, valsartan
S3: Amlodipine
Consolidated Schedules 06 July 2026, line 3138
S3: Valsartan
Consolidated Schedules 06 July 2026, line 4376
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
These documents are provided by SAHPRA for informational purposes. Always consult with a healthcare professional for medical advice.