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Montelukast Unicorn

Montelukast

S3Read from the PI-PIL document and verified
Loading the molecular structure
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; arrow keys step through the atoms. Structure from PubChem CID 5281040.

Registration

Applicants
1
Registrations
4
Schedule source
SAHPRA documentation

Applicants and registrations

ApplicantBrandsDosagesRegistrationsScheduleLeaflets
Sandoz South Africa (Pty) LtdCertificate held by Sandoz SA (Pty) Ltd, Sandoz SA (Pty) Ltd1Montelukast unicorn4, 4.15 mg, 5, 10 mg440204, 440487, 440488, 470742S3PIPIL

Variants

ProductStrength and formRegistrationStatusScheduleLeaflets
Montelukast unicorn 10

EACH TABLET CONTAINS MONTELUKAST SODIUM EQUIVALENT TO MONTELUKAST 10,0 mg

10 mgFilm-coated tablet44020444/10.2.2/0204Approved 25 February 2025RegisteredS3PIPIL
Montelukast unicorn 4

EACH TABLET CONTAINS MONTELUKAST SODIUM EQUIVALENT TO MONTELUKAST 4,0 mg

444048744/10.2.2/0487RegisteredS3None
Montelukast unicorn 5

EACH TABLET CONTAINS MONTELUKAST SODIUM EQUIVALENT TO MONTELUKAST 5,0 mg

544048844/10.2.2/0488RegisteredS3None
Montelukast oral granules unicorn4.15 mgOral granules.47074247/10.3/0742Approved 20 February 2025RegisteredS3PIPIL

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.

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.

Background

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SAHPRA documents

Schedule verified from official documents

Schedule Verification

Montelukast unicorn 10, Sandoz South Africa (Pty) Ltd is scheduled S3 in its official SAHPRA documents, read with 90% confidence.

These documents come from SAHPRA's PI-PIL repository unless the line under a document says otherwise. Always consult with a healthcare professional for medical advice.

Research articles

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