Irbesartan
Sold as Aprovel, Irbelo, Ran-irbesartan, Isart, Dynarb, Vaspec, Apresar, Irbevel, Adco-irbesartan, Arotan, Irbesartan BGM, Kirbex, Kartilyn, Sotan, Jubitan, Arbin, Irbecard, Irbewin
2-Butyl-3-[[4-[2-(2H-tetrazol-5-yl)phenyl]phenyl]methyl]-1,3-diazaspiro[4.4]non-1-en-4-one
Drag to rotate. Structure from PubChem CID 3749.
Background
Registration
- Applicants
- 13
- Registrations
- 47
- Schedule source
- Consolidated Schedules 06 July 2026
Applicants and registrations
| Applicant | Brands | Dosages | Registrations | Schedule | Leaflets |
|---|---|---|---|---|---|
| Sanofi-aventis South Africa (Pty) Ltd2 of 4 cancelled | Aprovel, Irbewin | 150 mg, 300 mg | 310633, 310634, A400288, A400289 | S3 | None |
| Unimed Healthcare (Pty) Ltd | Irbelo | 75, 150, 300 | 420947, 420948, 420949 | S3 | None |
| MSQ Pharma (Pty) Ltd | Ran-irbesartan | 75, 150, 300 | 420950, 420951, 420952 | S3 | None |
| Zydus Healthcare (Pty) LtdCancelled | Isart | 75, 150, 300 | 430269, 430283, 430291 | S3 | None |
| Pharma Dynamics (Pty) Ltd | Dynarb | 150 mg, 300 mg | 430720, 430721 | S3 | None |
| Dr Reddyæs Laboratories (Pty) LtdCancelled | Vaspec | 300 | 440057 | S3 | None |
| Adcock ingram limitedCancelled | Apresar, Irbevel, Adco-irbesartan | 75, 150, 300 | 440511, 440512, 440513, 440526, 440527, 440528, 440529, 440530, 440531 | S3 | None |
| Arrow Pharma South Africa (Pty) Ltd | Arotan | 75, 150, 300 | 450621, 450622, 450623 | S3 | None |
| BGM Pharmaceuticals (Pty) Ltd | Irbesartan BGM | 75, 150, 300 | 450624, 450625, 450626 | S3 | None |
| Aurogen South Africa (Pty) Ltd3 of 9 cancelled | Kirbex, Kartilyn, Sotan | 75 mg, 150 mg, 300 mg | 450996, 450997, 450998, 450999, 451000, 451001, 451051, 451052, 451053 | S3 | None |
| Jubilant Pharma SA (Pty) Ltd | Jubitan | 150 mg, 300 mg | 460124, 460125 | S3 | None |
| Austell Pharmaceuticals (Pty) LtdCancelled | Arbin | 150 mg, 300 mg | 460656, 460657 | S3 | None |
| Smart Pharmaceuticals (Pty) Ltd | Irbecard | 75 mg, 150 mg, 300 mg | 470732, 470733, 470734 | S3 | None |
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Aprovel 150 MG EACH TABLET CONTAINS IRBESARTAN 150 mg | 150 mg | 31063331/7.1.3/0633 | Cancelled | S3 | None |
| Aprovel 300 MG EACH TABLET CONTAINS IRBESARTAN 300 mg | 300 mg | 31063431/7.1.3/0634 | Cancelled | S3 | None |
| Irbelo 75 EACH TABLET CONTAINS: IRBESARTAN 75,0 mg | 75 | 42094742/7.1.3/0947 | Registered | S3 | None |
| Irbelo 150 EACH TABLET CONTAINS :IRBESARTAN 150,0 mg | 150 | 42094842/7.1.3/0948 | Registered | S3 | None |
| Irbelo 300 EACH TABLET CONTAINS: IRBESARTAN 300,0 mg | 300 | 42094942/7.1.3/0949 | Registered | S3 | None |
| Ran-irbesartan 75 EACH TABLET CONTAINS IRBESARTAN 75,0 mg | 75 | 42095042/7.1.3/0950 | Registered | S3 | None |
| Ran-irbesartan 150 EACH TABLET CONTAINS IRBESARTAN 150,0 mg | 150 | 42095142/7.1.3/0951 | Registered | S3 | None |
| Ran-irbesartan 300 EACH TABLET CONTAINS IRBESARTAN 300,0 mg | 300 | 42095242/7.1.3/0952 | Registered | S3 | None |
| Isart 75 tablets EACH TABLET CONTAINS IRBESARTAN 75,0 mg | 75Tablets | 43026943/7.1.3/0269 | Cancelled | S3 | None |
| Isart 150 tablets EACH TABLET CONTAINS IRBESARTAN 150,0 mg | 150Tablets | 43028343/7.1.3/0283 | Cancelled | S3 | None |
| Isart 300 tablets EACH TABLET CONTAINS IRBESARTAN 300,0 mg | 300Tablets | 43029143/7.1.3/0291 | Cancelled | S3 | None |
| Dynarb 150 MG EACH TABLET CONTAINS IRBESARTAN 150,0 mg | 150 mg | 43072043/7.1.3/0720 | Registered | S3 | None |
| Dynarb 300 MG EACH TABLET CONTAINS IRBESARTAN 300,0 mg | 300 mg | 43072143/7.1.3/0721 | Registered | S3 | None |
| Vaspec 300 EACH TABLET CONTAINS IRBESARTAN A 300,0 mg | 300 | 44005744/7.1.3/0057 | Cancelled | S3 | None |
| Apresar 75 EACH TABLET CONTAINS IRBESARTAN 75,0 mg | 75 | 44051144/7.1.3/0511 | Cancelled | S3 | None |
| Apresar 150 EACH TABLET CONTAINS IRBESARTAN 150,0 mg | 150 | 44051244/7.1.3/0512 | Cancelled | S3 | None |
| Apresar 300 EACH TABLET CONTAINS IRBESARTAN 300,0 mg | 300 | 44051344/7.1.3/0513 | Cancelled | S3 | None |
| Irbevel 75 EACH TABLET CONTAINS IRBESARTAN 75,0 mg | 75 | 44052644/7.1.3/0526 | Cancelled | S3 | None |
| Irbevel 150 EACH TABLET CONTAINS IRBESARTAN 150,0 mg | 150 | 44052744/7.1.3/0527 | Cancelled | S3 | None |
| Irbevel 300 EACH TABLET CONTAINS IRBESARTAN 300,0 mg | 300 | 44052844/7.1.3/0528 | Cancelled | S3 | None |
| Adco-irbesartan 75 EACH TABLET CONTAINS IRBESARTAN 75,0 mg | 75 | 44052944/7.1.3/0529 | Cancelled | S3 | None |
| Adco-irbesartan 150 EACH TABLET CONTAINS IRBESARTAN 150,0 mg | 150 | 44053044/7.1.3/0530 | Cancelled | S3 | None |
| Adco-irbesartan 300 EACH TABLET CONTAINS IRBESARTAN 300,0 mg | 300 | 44053144/7.1.3/0531 | Cancelled | S3 | None |
| Arotan 75 EACH TABLET CONTAINS IRBESARTAN 75,0 mg | 75 | 45062145/7.1.3/0621 | Registered | S3 | None |
| Arotan 150 EACH TABLET CONTAINS IRBESARTAN 150,0 mg | 150 | 45062245/7.1.3/0622 | Registered | S3 | None |
| Arotan 300 EACH TABLET CONTAINS IRBESARTAN 300,0 mg | 300 | 45062345/7.1.3/0623 | Registered | S3 | None |
| Irbesartan 75 BGM EACH TABLET CONTAINS IRBESARTAN 75,0 mg | 75 | 45062445/7.1.3/0624 | Registered | S3 | None |
| Irbesartan 150 BGM EACH TABLET CONTAINS IRBESARTAN 150,0 mg | 150 | 45062545/7.1.3/0625 | Registered | S3 | None |
| Irbesartan 300 BGM EACH TABLET CONTAINS IRBESARTAN 300,0 mg | 300 | 45062645/7.1.3/0626 | Registered | S3 | None |
| Kirbex 75 MG tablets EACH TABLET CONTAINS IRBESARTAN 75,0 mg | 75 mgTablets | 45099645/7.1.3/0996 | Registered | S3 | None |
| Kirbex 150 MG tablets EACH TABLET CONTAINS IRBESARTAN 150,0 mg | 150 mgTablets | 45099745/7.1.3/0997 | Registered | S3 | None |
| Kirbex 300 MG tablets EACH TABLET CONTAINS IRBESARTAN 300,0 mg | 300 mgTablets | 45099845/7.1.3/0998 | Registered | S3 | None |
| Kartilyn 75 MG tablets EACH TABLET CONTAINS: IRBESARTAN 75,0 mg | 75 mgTablets | 45099945/7.1.3/0999 | Cancelled | S3 | None |
| Kartilyn 150 MG tablets EACH TABLET CONTAINS: IRBESARTAN 150,0 mg | 150 mgTablets | 45100045/7.1.3/1000 | Cancelled | S3 | None |
| Kartilyn 300 MG tablets EACH TABLET CONTAINS: IRBESARTAN 300,0 mg | 300 mgTablets | 45100145/7.1.3/1001 | Cancelled | S3 | None |
| Sotan 75 MG tablets EACH TABLET CONTAINS IRBESARTAN 75,0 mg | 75 mgTablets | 45105145/7.1.3/1051 | Registered | S3 | None |
| Sotan 150 MG tablets EACH TABLET CONTAINS IRBESARTAN 150,0 mg | 150 mgTablets | 45105245/7.1.3/1052 | Registered | S3 | None |
| Sotan 300 MG tablets EACH TABLET CONTAINS IRBESARTAN 300,0 mg | 300 mgTablets | 45105345/7.1.3/1053 | Registered | S3 | None |
| Jubitan 150 MG EACH TABLET CONTAINS IRBESARTAN 150,0 mg | 150 mg | 46012446/7.1.3/0124 | Registered | S3 | None |
| Jubitan 300 MG EACH TABLET CONTAINS IRBESARTAN 300,0 mg | 300 mg | 46012546/7.1.3/0125 | Registered | S3 | None |
| Arbin 150 MG EACH TABLET CONTAINS: IRBESARTAN 150,0 mg | 150 mg | 46065646/7.1.3/0656 | Cancelled | S3 | None |
| Arbin 300 MG EACH TABLET CONTAINS: IRBESARTAN 300,0 mg | 300 mg | 46065746/7.1.3/0657 | Cancelled | S3 | None |
| Irbecard 75 MG Each tablet contains: Irbesartan 75,0 mg | 75 mg | 47073247/7.1.3/0732 | Registered | S3 | None |
| Irbecard 150 MG Each tablet contains: Irbesartan 150,0 mg | 150 mg | 47073347/7.1.3/0733 | Registered | S3 | None |
| Irbecard 300 MG Each tablet contains: Irbesartan 300,0 mg | 300 mg | 47073447/7.1.3/0734 | Registered | S3 | None |
| Irbewin 150 EACH TABLET CONTAINS IRBESARTAN 150,0 mg | 150 | A400288A40/7.1.3/0288 | Registered | S3 | None |
| Irbewin 300 EACH TABLET CONTAINS IRBESARTAN 300,0 mg | 300 | A400289A40/7.1.3/0289 | 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 high.
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 Irbesartan
S3: Irbesartan
Consolidated Schedules 06 July 2026, line 3806
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
SAHPRA has not published a professional information or patient information leaflet for this product.