Montelukast (Singulair, Monte-air, Monte-air Sprinkles, Airathon, Airathon Sprinkles, Singulair Sprinkles)
Montelukast
Organon South Africa (Pty) Ltd
Registration
- Applicant
- Organon South Africa (Pty) Ltd
- Registrations
- 12
- Schedule source
- Consolidated Schedules 06 July 2026
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Singulair 5 MG EACH CHEW TABLET CONTAINS MONTELUKAST SODIUM EQUIVALENT TO MONTELUKAST 5,0 mg | 5 mg | 32032132/10.2.2/0321 | Registered | S3 | None |
| Singulair 10 MG EACH TABLET CONTAINS MONTELUKAST SODIUM EQUIVALENT TO MONTELUKAST 10,0 mg | 10 mg | 32032232/10.2.2/0322 | Registered | S3 | None |
| Singulair 4 MG EACH TABLET CONTAINS MONTELUKAST SODIUM EQUIVALENT TO MONTELUKAST 4,0 mg | 4 mg | 35039735/10.2.2/0397 | Registered | S3 | None |
| Monte-air 4 MG EACH TABLET CONTAINS MONTELUKAST SODIUM EQUIVALENT TO MONTELUKAST 4,0 mg | 4 mg | 44005944/10.2.2/0059 | Registered | S3 | None |
| Monte-air 5 MG EACH TABLET CONTAINS MONTELUKAST SODIUM EQUIVALENT TO MONTELUKAST 5,0 mg | 5 mg | 44006044/10.2.2/0060 | Registered | S3 | None |
| Monte-air 10 MG EACH TABLET CONTAINS MONTELUKAST SODIUM EQUIVALENT TO MONTELUKAST 10,0 mg | 10 mg | 44006144/10.2.2/0061 | Registered | S3 | None |
| Monte-air sprinkles EACH SACHET CONTAINS MONTELUKAST SODIUM EQUIVALENT TO MONTELUKAST 4,0 mg | Not listed | 44006244/10.2.2/0062 | Registered | S3 | None |
| Airathon 4 MG EACH TABLET CONTAINS MONTELUKAST SODIUM EQUIVALENT TO MONTELUKAST 4,0 mg | 4 mg | 44066644/10.2.2/0666 | Registered | S3 | None |
| Airathon 5 MG EACH TABLET CONTAINS MONTELUKAST SODIUM EQUIVALENT TO MONTELUKAST 5,0 mg | 5 mg | 44066744/10.2.2/0667 | Registered | S3 | None |
| Airathon 10 MG EACH TABLET CONTAINS MONTELUKAST SODIUM EQUIVALENT TO MONTELUKAST 10,0 mg | 10 mg | 44066844/10.2.2/0668 | Registered | S3 | None |
| Airathon sprinkles EACH PACKET CONTAINS MONTELUKAST SODIUM EQUIVALENT TO MONTELUKAST 4,0 mg | Not listed | 44066944/10.2.2/0669 | Cancelled | S3 | None |
| Singulair sprinkles EACH 500,0 mg PACKET CONTAINS MONTELUKAST SODIUM EQUIVALENT TO MONTELUKAST 4,0 mg | Not listed | A380584A38/10.2.2/0584 | 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 Montelukast sodium equivalent to montelukast
S3: Montelukast
Consolidated Schedules 06 July 2026, line 3967
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.
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.