Indacaterol
Sold as Onbrez breezhaler
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.
Background
Registration
- Applicants
- 1
- Registrations
- 1
Applicants and registrations
| Applicant | Brands | Dosages | Registrations | Schedule | Leaflets |
|---|---|---|---|---|---|
| Novartis South Africa (Pty) Ltd | Onbrez breezhaler | 150 ug | 440544 | Not determined | None |
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 |
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
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
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.
SAHPRA documents
SAHPRA has not published a professional information or patient information leaflet for this product.