Indacaterol (Onbrez Breezhaler, Ultibro Breezhaler)
Indacaterol
Novartis South Africa (Pty) Ltd
Registration
- Applicant
- Novartis South Africa (Pty) Ltd
- Registrations
- 2
- Schedule source
- SAHPRA documentation
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Onbrez breezhaler 150 ug EACH CAPSULE CONTAINS INDACATEROL MALEATE EQUIVALENT TO INDACATEROL 150,0 ug | 150 ug | 44054444/10.2.1/0544 | Registered | Not determined | None |
| Ultibro breezhaler EACH INHALATION CAPSULE CONTAINS GLYCOPYRRONIUM BROMIDE EQUIVALENT TO GLYCOPYRRONIUM 50,0 ug INDACATEROL MALEATE EQUIVALENT TO INDACATEROL 110,0 ug | 110/ 50 μgDry powder inhalation capsules | 47118347/10.2.1/1183Approved 23 August 2020 | Registered | S3 | PIPIL |
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.
The Consolidated Schedules list this ingredient up to S4; the leaflet's S3 applies to this product.
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 Glycopyrronium bromide equivalent to glycopyrronium, indacaterol maleate equivalent to indacaterol
S4: Indacaterol
Consolidated Schedules 06 July 2026, line 6742
S3: Glycopyrronium
Consolidated Schedules 06 July 2026, line 3691
S3: Indacaterol
Consolidated Schedules 06 July 2026, line 3778
Pharmacological class: inhalants. (class 10.2.1)
Matched through the component Glycopyrronium.
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.
5-[(1R)-2-[(5,6-Diethyl-2,3-dihydro-1H-inden-2-yl)amino]-1-hydroxyethyl]-8-hydroxy-1H-quinolin-2-one
Drag to rotate. Structure from PubChem CID 6918554.
SAHPRA documents
Schedule Verification
This medication's schedule (S3) has been verified from official SAHPRA documents with 90% confidence.
These documents are provided by SAHPRA for informational purposes. Always consult with a healthcare professional for medical advice.