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Montelukast (Montelukast Accord, Astelair)

Montelukast

Accord Healthcare (Pty) Ltd

S3

Registration

Applicant
Accord Healthcare (Pty) Ltd
Registrations
5
Schedule source
Consolidated Schedules 06 July 2026

Variants

ProductStrength and formRegistrationStatusScheduleLeaflets
Montelukast 4 accord

EACH TABLET CONTAINS MONTELUKAST 4,0 mg

447031247/10.3/0312RegisteredS3None
Montelukast 5 accord

EACH TABLET CONTAINS MONTELUKAST 5,0 mg

547031347/10.3/0313RegisteredS3None
Astelair 4

EACH TABLET CONTAINS MONTELUKAST 4,0 mg

447031447/10.3/0315RegisteredS3None
Montelukast 10 MG accord

Each tablet contains MONTELUKAST (AS MONTELUKAST SODIUM) 10,0 mg

10 MG47031447/10.2.2/0314RegisteredS3None
Astelair 5

EACH TABLET CONTAINS: MONTELUKAST 5,0 mg

547031547/10.3/0316RegisteredS3None

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 Montelukast

  • S3: Montelukast

    Consolidated Schedules 06 July 2026, line 3967

Pharmacological class: Others. (class 10.3)

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.

C35H36ClNO3S586.20 g/mol

2-[1-[[(1R)-1-[3-[(E)-2-(7-Chloroquinolin-2-yl)ethenyl]phenyl]-3-[2-(2-hydroxypropan-2-yl)phenyl]propyl]sulfanylmethyl]cyclopropyl]acetic acid

Drag to rotate. Structure from PubChem CID 5281040.

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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