Amlodipine
Sold as Norcard, Amlodipine oethmaan, Amlodipine biotech, Amlodipine PD, Amloc, Lomanor, Adco-norpene, Besyloc, Amtas, Amlodipine unicorn, Keysal, Aparate, Amlodipine unimed, Amlodipine GDC, Amlodipine dezzo, Vascolok, Amlodipine hetero, Innovasc, Ascivasc, Amlov ar, Amlodipine PHARMC, Amlosyn, Calbloc, Ciplavasc, Almadin, Apex-amlodipine, Amlopress, Amlodac, Austell amlodipine, Pendine, Klodip, Amlodipine ascendis, Amlate, Amlobloc, Norvasc
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.
Background
Registration
- Applicants
- 28
- Registrations
- 68
- Schedule source
- SAHPRA documentation
Applicants and registrations
| Applicant | Brands | Dosages | Registrations | Schedule | Leaflets |
|---|---|---|---|---|---|
| Pharma-q Holdings (Pty) Ltd | Norcard | 5 mg, 10 mg | 360480, 360481 | Not determined | None |
| Oethmaan Biosims (Pty) Ltd | Amlodipine oethmaan | 5, 10 | 370376, 370377 | Not determined | None |
| Biotech Laboratories (Pty) LtdCertificate held by Biotech Laboratories (Pty) Ltd. | Amlodipine biotech | 5 or 10 mg | 370378, 370379 | Not determined | PIPIL |
| Pharma Dynamics (Pty) Ltd | Amlodipine PD, Amloc, Besyloc | 5 mg, 10 mg | 380146, 380147, 380183, 380184, 410560, 410561 | Not determined | None |
| Viatris South Africa (Pty) Ltd | Lomanor | 5 mg, 10 mg | 380271, 380272 | Not determined | None |
| Adcock ingram limited | Adco-norpene, Almadin | 5 mg, 10 mg | 410172, 410173, A390119, A390121 | Not determined | None |
| Accord Healthcare (Pty) Ltd | Amtas, Amlodipine unicorn | 5, 10 | 410659, 410660, 410661, 410662 | Not determined | PIPIL |
| Novagen Pharma (Pty) Ltd | Keysal | 5 mg, 10 mg | 410749, 410750 | Not determined | None |
| Aurogen South Africa (Pty) Ltd | Aparate | 5 mg, 10 mg | 410754, 410755 | Not determined | None |
| Unimed Healthcare (Pty) Ltd | Amlodipine unimed | 5, 10 | 410782, 410783 | Not determined | None |
| Gulf Drug Company (Pty) Ltd | Amlodipine GDC | 5, 10 | 410812, 410813 | Not determined | None |
| Dezzo Trading 392 (Pty) Ltd | Amlodipine dezzo, Vascolok, Amlodipine ascendis | 5, 10 | 480037, 480038, 480039, 480040, A400284 | Not determined | None |
| Hetero Drugs South Africa (Pty) Ltd | Amlodipine hetero | 5, 10 | 480584, 480585 | Not determined | None |
| Innovata pharmaceuticalsCertificate held by Innovata Pharmaceuticals (Pty) Ltd | Innovasc | 5, 10 | 490165, 490166 | Not determined | PIPIL |
| Ascendis Pharma (Pty) Ltd | Ascivasc | 5, 10 | 500557, 500558 | S3 | PIPIL |
| Lebasi Pharmaceuticals (Pty) Ltd | Amlov ar | 5, 10 | 510070, 510071 | Not determined | None |
| Pharmacorp (Pty) Ltd | Amlodipine PHARMC | 5, 10 | 570786, 570787 | Not determined | None |
| Acino Pharma (Pty) Ltd | Amlosyn | 5 mg, 10 mg | A380355, A380356 | Not determined | None |
| Ranbaxy Pharmaceutical (Pty) LtdCertificate held by Ranbaxy Pharmaceuticals (Pty) Ltd.Cancelled | Calbloc | 5 mg/ 10mg | A380652, A380653 | S3 | PIPIL |
| Cipla Medpro (Pty) LtdCertificate held by Cipla Medpro (Pty) Ltd. | Ciplavasc | 5, 10 | A390117, A390120 | Not determined | PIPIL |
| Camox Pharmaceuticals (Pty) LtdCancelled | Apex-amlodipine, Amlopress | 5 mg, 10 mg | A390368, A390369, A390370, A390371 | Not determined | None |
| Zydus Healthcare (Pty) Ltd | Amlodac | 5, 10 | A390532, A390533 | Not determined | None |
| Austell Pharmaceuticals (Pty) Ltd | Austell amlodipine | 5 mg, 10 mg | A390545, A390546 | Not determined | None |
| Unichem SA (Pty) Ltd | Pendine | 5, 10 | A400057, A400058 | S3 | PIPIL |
| Teva Pharmaceuticals (Pty) LtdCancelled | Klodip | 5 | A400283 | Not determined | None |
| Dr Reddyæs Laboratories (Pty) Ltd | Amlate | 5, 10 | A400312, A400313 | Not determined | None |
| Sandoz South Africa (Pty) LtdCertificate held by Sandoz SA (Pty) Ltd | Amlobloc | 5, 10 | A400435, A400436 | S3 | PIPIL |
| Viatris Healthcare (Pty) Ltd | Norvasc | 5 mg, 10 mg | Y0026, Y0027 | Not determined | None |
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Norcard 5 MG EACH TABLET CONTAINS AMLODIPINE BESYLATE EQUIVALENT TO AMLODIPINE 5,0 mg | 5 mg | 36048036/7.1/0480 | Registered | Not determined | None |
| Norcard 10 MG EACH TABLET CONTAINS AMLODIPINE BESYLATE EQUIVALENT TO AMLODIPINE 10,0 mg | 10 mg | 36048136/7.1/0481 | Registered | Not determined | None |
| Amlodipine 5 oethmaan EACH TABLET CONTAINS AMLODIPINE 5,0 mg | 5 | 37037637/7.1/0376 | Registered | Not determined | None |
| Amlodipine 10 oethmaan EACH TABLET CONTAINS AMLODIPINE 10,0 mg | 10 | 37037737/7.1/0377 | Registered | Not determined | None |
| 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 |
| Amlodipine 5 MG PD EACH TABLET CONTAINS AMLODIPINE 10,0 mg | 5 mg | 38014638/7.1/0146 | Registered | Not determined | None |
| Amloc 10 MG EACH TABLET CONTAINS AMLODIPINE 10,0 mg | 10 mg | 38014738/7.1/0147 | Registered | Not determined | None |
| Amloc 5 MG EACH TABLET CONTAINS AMLODIPINE 5,0 mg | 5 mg | 38018338/7.1/0183 | Registered | Not determined | None |
| Amlodipine 10 MG PD EACH TABLET CONTAINS AMLODIPINE 10,0 mg | 10 mg | 38018438/7.1/0184 | Registered | Not determined | None |
| Lomanor 5 MG EACH TABLET CONTAINS AMLODIPINE BESYLATE EQUIVALENT TO AMLODIPINE 5,0 mg | 5 mg | 38027138/7.1/0271 | Registered | Not determined | None |
| Lomanor 10 MG EACH TABLET CONTAINS AMLODIPINE BESYLATE EQUIVALENT TO AMLODIPINE 10,0 mg | 10 mg | 38027238/7.2/0272 | Registered | Not determined | None |
| Adco-norpene 5 MG EACH TABLET CONTAINS AMLODIPINE BESYLATE EQUIVALENT TO AMLODIPINE 5,0 mg | 5 mg | 41017241/7.1/0172 | Registered | Not determined | None |
| Adco-norpene 10 MG EACH TABLET CONTAINS AMLODIPINE BESYLATE EQUIVALENT TO AMLODIPINE 10,0 mg | 10 mg | 41017341/7.1/0173 | Registered | Not determined | None |
| Besyloc 5 MG EACH TABLET CONTAINS AMLODIPINE BESYLATE EQUIVALENT TO AMLODIPINE 5,0 mg | 5 mg | 41056041/7.1/0560 | Registered | Not determined | None |
| Besyloc 10 MG EACH TABLET CONTAINS AMLODIPINE BESYLATE EQUIVALENT TO AMLODIPINE 10,0 mg | 10 mg | 41056141/7.1/0561 | Registered | Not determined | None |
| Amtas 5 EACH TABLET CONTAINS AMLODIPINE BESYLATE EQUIVALENT TO AMLODIPINE 5,0 mg | 5Tablets | 41065941/7.1/0659Approved 16 August 2024 | Registered | Not determined | PIPIL |
| Amtas 10 EACH TABLET CONTAINS :AMLODIPINE BESYLATE EQUIVALENT TO AMLODIPINE 10,0 mg | 10Tablets | 41066041/7.1/0660Approved 16 August 2024 | Registered | Not determined | PIPIL |
| Amlodipine unicorn 5 EACH TABLET CONTAINS AMLODIPINE BESYLATE EQUIVALENT TO AMLODIPINE 5,0 mg | 5 | 41066141/7.1/0661 | Registered | Not determined | None |
| Amlodipine unicorn 10 EACH TABLET CONTAINS AMLODIPINE BESYLATE EQUIVALENT TO AMLODIPINE 10,0 mg | 10 | 41066241/7.1/0662 | Registered | Not determined | None |
| Keysal 5 MG EACH TABLET CONTAINS AMLODIPINE BESYLATE EQUIVALENT TO AMLODIPINE 5,0 mg | 5 mg | 41074941/7.1/0749 | Registered | Not determined | None |
| Keysal 10 MG EACH TABLET CONTAINS AMLODIPINE BESYLATE EQUIVALENT TO AMLODIPINE 10,0 mg | 10 mg | 41075041/7.1/0750 | Registered | Not determined | None |
| Aparate 5 MG EACH TABLET CONTAINS AMLODIPINE BESYLATE EQUIVALENT TO AMLODIPINE 5,0 mg | 5 mg | 41075441/7.1/0754 | Registered | Not determined | None |
| Aparate 10 MG EACH TABLET CONTAINS AMLODIPINE BESYLATE EQUIVALENT TO AMLODIPINE 10,0 mg | 10 mg | 41075541/7.1/0755 | Registered | Not determined | None |
| Amlodipine 5 unimed EACH TABLET CONTAINS AMLODIPINE BESYLATE EQUIVALENT TO AMLODIPINE 5,0 mg | 5 | 41078241/7.1/0782 | Registered | Not determined | None |
| Amlodipine 10 unimed EACH TABLET CONTAINS AMLODIPINE BESYLATE EQUIVALENT TO AMLODIPINE 10,0 mg | 10 | 41078341/7.1/0783 | Registered | Not determined | None |
| Amlodipine 5 GDC EACH TABLET CONTAINS :AMLODIPINE BESYLATE EQUIVALENT TO AMLODIPINE 5,0 mg | 5 | 41081241/7.1/0812 | Registered | Not determined | None |
| Amlodipine 10 GDC EACH TABLET CONTAINS :AMLODIPINE BESYLATE EQUIVALENT TO AMLODIPINE 10,0 mg | 10 | 41081341/7.1/0813 | Registered | Not determined | None |
| Amlodipine dezzo 5 EACH TABLET CONTAINS : AMLODIPINE BESYLATE EQUIVALENT TO AMLODIPINE 5,0 mg | 5 | 48003748/7.1/0037 | Registered | Not determined | None |
| Amlodipine dezzo 10 EACH TABLET CONTAINS : AMLODIPINE BESYLATE EQUIVALENT TO AMLODIPINE 10,0 mg | 10 | 48003848/7.1/0038 | Registered | Not determined | None |
| Vascolok 5 EACH TABLET CONTAINS : AMLODIPINE BESYLATE EQUIVALENT TO AMLODIPINE 5,0 mg | 5 | 48003948/7.1/0039 | Registered | Not determined | None |
| Vascolok 10 EACH TABLET CONTAINS : AMLODIPINE BESYLATE EQUIVALENT TO AMLODIPINE 10,0 mg | 10 | 48004048/7.1/0040 | Registered | Not determined | None |
| Amlodipine hetero 5 EACH TABLET CONTAINS AMLODIPINE BESYLATE EQUIVALENT TO AMLODIPINE 5,0 mg | 5 | 48058448/7.1/0584 | Registered | Not determined | None |
| Amlodipine hetero 10 EACH TABLET CONTAINS AMLODIPINE BESYLATE EQUIVALENT TO AMLODIPINE 10,0 mg | 10 | 48058548/7.1/0585 | Registered | Not determined | None |
| Innovasc 5 | 5Tablets | 49016549/7.1/0165Approved 30 April 2024 | Registered | Not determined | PIPIL |
| Innovasc 10 | 10Tablets | 49016649/7.1/0166Approved 30 April 2024 | Registered | Not determined | PIPIL |
| Ascivasc 5 EACH TABLET CONTAINS: AMLODIPINE 5,0 mg | 5Tablets | 50055750/7.1/0557Approved 27 November 2023 | Registered | S3 | PIPIL |
| Ascivasc 10 EACH TABLET CONTAINS AMLODIPINE 10,0 mg | 10Tablets | 50055850/7.1/0558Approved 27 November 2023 | Registered | S3 | PIPIL |
| Amlov ar 5 Each tablet contains AMLODIPINE (AS AMLODIPINE BESILATE) 5,0 mg | 5 | 51007051/7.1/0070 | Registered | Not determined | None |
| Amlov ar 10 Each tablet contains AMLODIPINE (AS AMLODIPINE BESILATE) 10,0 mg | 10 | 51007151/7.1/0071 | Registered | Not determined | None |
| Amlodipine 5 PHARMC EACH TABLET CONTAINS: AMLODIPINE BESILATE EQUIVALENT TO AMLODIPINE 5,0 mg | 5 | 57078657/7.1/0786 | Registered | Not determined | None |
| Amlodipine 10 PHARMC EACH TABLET CONTAINS: AMLODIPINE BESILATE EQUIVALENT TO AMLODIPINE 10,0 mg | 10 | 57078757/7.1/0787 | Registered | Not determined | None |
| Amlosyn 5 MG EACH TABLET CONTAINS AMLODIPINE BESYLATE EQUIVALENT TO AMLODIPINE 5,0 mg | 5 mg | A380355A38/7.1/0355 | Registered | Not determined | None |
| Amlosyn 10 MG EACH TABLET CONTAINS AMLODIPINE BESYLATE EQUIVALENT TO AMLODIPINE 10,0 mg | 10 mg | A380356A38/7.1/0356 | Registered | Not determined | None |
| Calbloc 5 EACH TABLET CONTAINS AMLODIPINE BESYLATE EQUIVALENT TO AMLODIPINE 5,0 mg | 5 mg/ 10mgFilm coated tablets | A380652A38/7.1/0652Approved 3 August 2023 | Cancelled | S3 | PIPIL |
| Calbloc 10 EACH TABLET CONTAINS AMLODIPINE BESYLATE EQUIVALENT TO AMLODIPINE 10,0 mg | 5 mg/ 10mgFilm coated tablets | A380653A38/7.1/0653Approved 3 August 2023 | Cancelled | S3 | PIPIL |
| Ciplavasc 5 EACH TABLET CONTAINS AMLODIPINE BESYLATE EQUIVALENT TO AMLODIPINE 5,0 mg | 5Tablets | A390117A39/7.1/0117Approved 17 December 2025 | Registered | Not determined | PIPIL |
| Almadin 10 EACH TABLET CONTAINS AMLODIPINE BESYLATE EQUIVALENT TO AMLODIPINE 10,0 mg | 10 | A390119A39/7.1/0119 | Registered | Not determined | None |
| Ciplavasc 10 EACH TABLET CONTAINS AMLODIPINE BESYLATE EQUIVALENT TO AMLODIPINE 10,0 mg | 10Tablets | A390120A39/7.1/0120Approved 17 December 2025 | Registered | Not determined | PIPIL |
| Almadin 5 EACH TABLET CONTAINS AMLODIPINE BESYLATE EQUIVALENT TO AMLODIPINE 5,0 mg | 5 | A390121A39/7.1/0121 | Registered | Not determined | None |
| Apex-amlodipine 5 MG EACH TABLET CONTAINS AMLODIPINE BESYLATE EQUIVALENT TO AMLODIPINE 5,0 mg | 5 mg | A390368A39/7.1/0368 | Cancelled | Not determined | None |
| Apex-amlodipine 10 MG EACH TABLET CONTAINS AMLODIPINE BESYLATE EQUIVALENT TO AMLODIPINE 10,0 mg | 10 mg | A390369A39/7.1/0369 | Cancelled | Not determined | None |
| Amlopress 5 MG EACH TABLET CONTAINS AMLODIPINE BESYLATE EQUIVALENT TO AMLODIPINE 5,0 mg | 5 mg | A390370A39/7.1/0370 | Cancelled | Not determined | None |
| Amlopress 10 MG EACH TABLET CONTAINS AMLODIPINE BESYLATE EQUIVALENT TO AMLODIPINE 10,0 mg | 10 mg | A390371A39/7.1/0371 | Cancelled | Not determined | None |
| Amlodac 5 EACH TABLET CONTAINS AMLODIPINE BESYLATE EQUIVALENT TO AMLODIPINE 5,0 mg | 5 | A390532A39/7.1/0532 | Registered | Not determined | None |
| Amlodac 10 EACH TABLET CONTAINS AMLODIPINE BESYLATE EQUIVALENT TO AMLODIPINE 10,0 mg | 10 | A390533A39/7.1/0533 | Registered | Not determined | None |
| Austell amlodipine 5 MG EACH TABLET CONTAINS :AMLODIPINE BESYLATE EQUIVALENT TO AMLODIPINE 5,0 mg | 5 mg | A390545A39/7.1/0545 | Registered | Not determined | None |
| Austell amlodipine 10 MG EACH TABLET CONTAINS :AMLODIPINE BESYLATE EQUIVALENT TO AMLODIPINE 10,0 mg | 10 mg | A390546A39/7.1/0546 | Registered | Not determined | None |
| Pendine 5 EACH TABLET CONTAINS AMLODIPINE BESYLATE EQUIVALENT TO AMLODIPINE 5,0 mg | 5Tablets. | A400057A40/7.1/0057Approved 4 August 2023 | Registered | S3 | PIPIL |
| Pendine 10 EACH TABLET CONTAINS AMLODIPINE BESYLATE EQUIVALENT TO AMLODIPINE 10,0 mg | 10Tablets. | A400058A40/7.1/0058Approved 4 August 2023 | Registered | S3 | PIPIL |
| Klodip-5 EACH TABLET CONTAINS AMLODIPINE BESYLATE EQUIVALENT TO AMLODIPINE 5,0 mg | 5 | A400283A40/7.1/0283 | Cancelled | Not determined | None |
| Amlodipine ascendis 5 EACH TABLET CONTAINS AMLODIPINE BESYLATE EQUIVALENT TO AMLODIPINE 5,0 mg | 5 | A400284A40/7.1/0284 | Registered | Not determined | None |
| Amlate 5 EACH TABLET CONTAINS AMLODIPINE MALEATE EQUIVALENT TO AMLODIPINE 5,0 mg | 5 | A400312A40/7.1/0312 | Registered | Not determined | None |
| Amlate 10 EACH TABLET CONTAINS AMLODIPINE MALEATE EQUIVALENT TO AMLODIPINE 10,0 mg | 10 | A400313A40/7.1/0313 | Registered | Not determined | None |
| Amlobloc 5 EACH TABLET CONTAINS AMLODIPINE BESYLATE EQUIVALENT TO AMLODIPINE 5,0 mg | 5Tablet. | A400435A40/7.1/0435Approved 28 March 2023 | Registered | S3 | PIPIL |
| Amlobloc 10 EACH TABLET CONTAINS AMLODIPINE BESYLATE EQUIVALENT TO AMLODIPINE 10,0 mg | 10Tablet. | A400436A40/7.1/0436Approved 28 March 2023 | Registered | S3 | PIPIL |
| Norvasc tablets 5 MG EACH TABLET CONTAINS AMLODIPINE BESYLATE EQUIVALENT TO 5 mg AMLODIPINE | 5 mgTablets | Y0026Y/7.1/26 | Registered | Not determined | None |
| Norvasc tablets 10 MG EACH TABLET CONTAINS AMLODIPINE BESYLATE EQUIVALENT TO 10 mg AMLODIPINE | 10 mgTablets | Y0027Y/7.1/27 | Registered | Not determined | 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, 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
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
Pharmacological class: Vasodilators, hypotensive, antihypertensive medicines include other antihypertensive medicines e.g. ACE-inhibitors, ARBs, RAAS, etc] (class 7.1)
Matched through the components Irbesartan, Indapamide, Telmisartan.
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.