Perindopril tert-butylamine
Sold as Vectoryl, Perdotor, Perindopril unicorn, Acti-prex, Pearinda, Spec-perindopril, Rindlo, Ran-perindopril, Reprex, * perindopril unimed, *Perindopril unimed, Zyace
(2S,3AS,7aS)-1-[(2S)-2-[[(2S)-1-ethoxy-1-oxopentan-2-yl]amino]propanoyl]-2,3,3a,4,5,6,7,7a-octahydroindole-2-carboxylic acid
Drag to rotate. Structure from PubChem CID 107807.
Background
Registration
- Applicants
- 9
- Registrations
- 18
- Schedule source
- SAHPRA documentation
Applicants and registrations
| Applicant | Brands | Dosages | Registrations | Schedule | Leaflets |
|---|---|---|---|---|---|
| Servier Laboratories South Africa (Pty) Ltd | Vectoryl, Perdotor, Perindopril unicorn | 8 mg | 380116, 380118, 380121 | Not determined | None |
| Activo Health (Pty) Ltd | Acti-prex | Not stated | 410175 | Not determined | None |
| Pharma Dynamics (Pty) Ltd | Pearinda | 4, 8 | 410649, 410650 | Not determined | None |
| Specpharm (Pty) Ltd | Spec-perindopril | 2, 4, 8 | 410651, 410652, 410653 | Not determined | None |
| Ranbaxy (SA) (Pty) LtdCancelled | Rindlo | 4 | 420106 | Not determined | None |
| Ranbaxy Pharmaceutical (Pty) LtdCertificate held by Ranbaxy Pharmaceuticals (Pty) Ltd | Ran-perindopril | 4 mg | 420107 | S3 | PIPIL |
| Aurogen South Africa (Pty) Ltd | Reprex | 2 mg, 4 mg, 8 mg | 431032, 431033, 431034 | Not determined | None |
| Unimed Healthcare (Pty) Ltd | * perindopril unimed, *Perindopril unimed | 2, 4, 8 | 431039, 431040, 431041 | Not determined | None |
| Zydus Healthcare (Pty) Ltd | Zyace | Not stated | 440504 | Not determined | None |
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Vectoryl 8 MG EACH TABLET CONTAINS PERINDOPRIL TERT-BUTYLAMINE 8,0 mg | 8 mg | 38011638/7.1.3/0116 | Registered | Not determined | None |
| Perdotor 8 MG EACH TABLET CONTAINS PERINDOPRIL TERT-BUTYLAMINE 8,0 mg | 8 mg | 38011838/7.1.3/0118 | Registered | Not determined | None |
| Perindopril unicorn 8 EACH TABLET CONTAINS PERINDOPRIL TERT-BUTYLAMINE 8,0 mg | 8 | 38012138/7.1.3/0121 | Registered | Not determined | None |
| Acti-prex EACH TABLET CONTAINS PERINDOPRIL TERT-BUTYLAMINE 4,0 mg | Not listed | 41017541/7.1.3/0175 | Registered | Not determined | None |
| Pearinda 4 EACH TABLET CONTAINS PERINDOPRIL TERT-BUTYLAMINE 4,0 mg | 4 | 41064941/7.1.3/0649 | Registered | Not determined | None |
| Pearinda 8 EACH TABLET CONTAINS PERINDOPRIL TERT-BUTYLAMINE 8,0 mg | 8 | 41065041/7.1.3/0650 | Registered | Not determined | None |
| Spec-perindopril 2 EACH TABLET CONTAINS PERINDOPRIL TERT-BUTYLAMINE 2,0 mg | 2 | 41065141/7.1.3/0651 | Registered | Not determined | None |
| Spec-perindopril 4 EACH TABLET CONTAINS PERINDOPRIL TERT-BUTYLAMINE 4,0 mg | 4 | 41065241/7.1.3/0652 | Registered | Not determined | None |
| Spec-perindopril 8 EACH TABLET CONTAINS PERINDOPRIL TERT-BUTYLAMINE 8,0 mg | 8 | 41065341/7.1.3/0653 | Registered | Not determined | None |
| Rindlo 4 EACH TABLET CONTAINS PERINDOPRIL TERT-BUTYLAMINE 4,0 mg | 4 | 42010642/7.1.3/0106 | Cancelled | Not determined | None |
| Ran-perindopril 4 EACH TABLET CONTAIN: PERINDOPRIL TERT-BUTYLAMINE 4,0 mg | 4 mgTablets | 42010742/7.1.3/0107Approved 25 February 2022 | Registered | S3 | PIPIL |
| Reprex 2 MG EACH TABLET CONTAINS PERINDOPRIL TERT-BUTYLAMINE 2,0 mg | 2 mg | 43103243/7.1.3/1032 | Registered | Not determined | None |
| Reprex 4 MG EACH TABLET CONTAINS PERINDOPRIL TERT-BUTYLAMINE 4,0 mg | 4 mg | 43103343/7.1.3/1033 | Registered | Not determined | None |
| Reprex 8 MG EACH TABLET CONTAINS PERINDOPRIL TERT-BUTYLAMINE 8,0 mg | 8 mg | 43103443/7.1.3/1034 | Registered | Not determined | None |
| * perindopril 2 unimed EACH TABLET CONTAINS PERINDOPRIL TERT-BUTYLAMINE 2,0 mg | 2 | 43103943/7.1.3/1039 | Registered | Not determined | None |
| *Perindopril 4 unimed EACH TABLET CONTAINS PERINDOPRIL TERT-BUTYLAMINE 4,0 mg | 4 | 43104043/7.1.3/1040 | Registered | Not determined | None |
| *Perindopril 8 unimed EACH TABLET CONTAINS PERINDOPRIL TERT-BUTYLAMINE 8,0 mg | 8 | 43104143/7.1.3/1041 | Registered | Not determined | None |
| Zyace EACH TABLET CONTAINS PERINDOPRIL TERT-BUTYLAMINE 4,0 mg | Not listed | 44050444/7.1.3/0504 | 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.
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
Ran-perindopril 4, Ranbaxy Pharmaceutical (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.