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Amlodipine (Irbeam)

Amlodipine

Sanofi-aventis South Africa (Pty) Ltd

Every registration of this product has been cancelled.

Registration

Applicant
Sanofi-aventis South Africa (Pty) Ltd
Registrations
4

Variants

ProductStrength and formRegistrationStatusScheduleLeaflets
Irbeam 150/5

Each Tablet Contains: Irbesartan 150 mg Amlodipine Besilate equivalent to Amlodipine 5 mg

150/546054646/7.1.3/0546CancelledNot determinedNone
Irbeam 150/10

Each Tablet Contains: Irbesartan 150 mg Amlodipine Besilate equivalent to Amlodipine 10 mg

150/1046054746/7.1.3/0547CancelledNot determinedNone
Irbeam 300/5

Each Tablet Contains: Irbesartan 300 mg Amlodipine Besilate equivalent to Amlodipine 5 mg

300/546054846/7.1.3/0548CancelledNot determinedNone
Irbeam 300/10

Each Tablet Contains: Irbesartan 300 mg Amlodipine Besilate equivalent to Amlodipine 10 mg

300/1046054946/7.1.3/0549CancelledNot determinedNone

Regulatory status

This product is still scheduled by law even when this site could not determine which tier it falls under. The label carries the S number in a square border; ask a pharmacist if you need to know its schedule.

Listings for this ingredient that could not be applied to this product

  • 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

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.

C20H25ClN2O5408.90 g/mol

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.

SAHPRA documents

SAHPRA has not published a professional information or patient information leaflet for this product.

Background

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Research articles

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