Budesonide (Pulmicort Nebulising, Pulmicort Turbuhaler /Dose)
Budesonide
Astrazeneca Pharmaceuticals (Pty) Ltd
Registration
- Applicant
- Astrazeneca Pharmaceuticals (Pty) Ltd
- Registrations
- 6
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Pulmicort nebulising suspension 0,5 mg/ml EACH 1,0 ml SUSPENSION CONTAINS BUDESONIDE 0,5 mg | 0,5 mg/mlSuspension | 30001630/21.5.1/0016 | Registered | Not determined | None |
| Pulmicort nebulising suspension 0,25 mg/ml EACH 1,0 ml SUSPENSION CONTAINS BUDESONIDE 0,25 mg | 0,25 mg/mlSuspension | 30001730/21.5.1/0017 | Registered | Not determined | None |
| Pulmicort nebulising suspension 0,125 mg/ml EACH 1 ml SUSPENSION CONTAINS BUDESONIDE 0,125 mg | 0,125 mg/MLSuspension | 30001830/21.5.1/0018 | Cancelled | Not determined | None |
| Pulmicort turbuhaler 100 ug/dose EACH METERED DOSE CONTAINS BUDESONIDE 100,0 mcg | 100 ug | Y0171Y/21.5.1/171 | Cancelled | Not determined | None |
| Pulmicort turbuhaler 200 ug/dose EACH METERED DOSE CONTAINS BUDESONIDE 200,0 ug | 200 ug | Y0172Y/21.5.1/172 | Registered | Not determined | None |
| Pulmicort turbuhaler 400 ug/dose EACH METERED DOSE CONTAINS BUDESONIDE 400 ug | 400 ug | Z0266Z/21.5.1/266 | Cancelled | 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: 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
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
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
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.
(1S,2S,4R,8S,9S,11S,12S,13R)-11-Hydroxy-8-(2-hydroxyacetyl)-9,13-dimethyl-6-propyl-5,7-dioxapentacyclo[10.8.0.02,9.04,8.013,18]icosa-14,17-dien-16-one
Drag to rotate. Structure from PubChem CID 5281004.
SAHPRA documents
SAHPRA has not published a professional information or patient information leaflet for this product.