Budesonide, formoterol, glycopyrronium
Sold as Breztri aerosphere
N-[2-Hydroxy-5-[1-hydroxy-2-[1-(4-methoxyphenyl)propan-2-ylamino]ethyl]phenyl]formamide
Drag to rotate. Structure from PubChem CID 3410.
Background
Registration
- Applicants
- 1
- Registrations
- 1
- Schedule source
- SAHPRA documentation
Applicants and registrations
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Breztri aerosphere EACH DELIVERED DOSE CONTAINS: BUDESONIDE 160,0 μg GLYCOPYRRONIUM BROMIDE EQUIVALENT TO GLYCOPYRRONIUM 7,2 μg FORMOTEROL FUMARATE DIHYDRATE EQUIVALENT TO FORMOTEROL FUMARATE 4,8 μg | 160 microgramsPressurised inhalation, suspension | 59037559/10.3/0375Approved 21 October 2025 | Registered | S4 | PIPIL |
Regulatory status
Where S4 sits on the scale
Prescription-only medicine.
Schedule 4 covers most ordinary prescription medicines. You need a prescription from an authorised prescriber, such as a doctor or dentist, and a pharmacist dispenses it. 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 S4, 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 Budesonide, glycopyrronium bromide equivalent to glycopyrronium, formoterol fumarate dihydrate equivalent to formoterol fumarate
S4: Budesonide
- except when intended for the prophylaxis and treatment of seasonal and perennial allergic rhinitis in adults and children aged 12 years and older; (S2)
- except when intended for inhalation or nasal administration, unless listed in another Schedule. (S3)
Consolidated Schedules 06 July 2026, lines 5577 to 5582
S4: Formoterol
Consolidated Schedules 06 July 2026, line 6443
S3: Budesonide
- when intended inhalation or nasal administration, unless listed in another Schedule. (S4)
- except when intended for the prophylaxis and treatment of seasonal and perennial allergic rhinitis in adults and children aged 12 years and older. (S2)
Consolidated Schedules 06 July 2026, lines 3237 to 3242
S3: Glycopyrronium
Consolidated Schedules 06 July 2026, line 3691
S2: Budesonide
- when intended for the prophylaxis and treatment of seasonal and perennial allergic rhinitis in adults and children aged 12 years and older; (S3)
- except when intended for inhalation and nasal administration, unless listed in another Schedule. (S4)
Consolidated Schedules 06 July 2026, lines 1696 to 1701
Pharmacological class: Others. (class 10.3)
Matched through the components Budesonide, 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.
SAHPRA documents
Schedule Verification
Breztri aerosphere, Astrazeneca Pharmaceuticals (Pty) Ltd is scheduled S4 in its official SAHPRA documents, read with 90% confidence.
These documents are provided by SAHPRA for informational purposes. Always consult with a healthcare professional for medical advice.