Budesonide (Budeflam, Budeflam Aquanase, Cipla Budesonide Dp-caps, Budeflam Dp-caps, Budeflam Respules, Budesonide Respules Cipla)
Budesonide
Cipla Medpro (Pty) Ltd
Registration
- Applicant
- Cipla Medpro (Pty) Ltd
- Registrations
- 12
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Budeflam EACH ACTUATION DELIVERS BUDESONIDE 100 mcg | Not listed | 30025530/21.5.1/0255 | Registered | Not determined | None |
| Budeflam 200 EACH METERED DOSE CONTAINS BUDESONIDE 200,0 ug | 200 | 32011532/21.5.1/0115 | Registered | Not determined | None |
| Budeflam aquanase EACH METERED DOSE CONTAINS BUDESONIDE 100,0 ug | Not listed | 33004533/21.5.1/0045 | Cancelled | Not determined | None |
| Cipla budesonide 100 dp-caps EACH CAPSULE CONTAINS BUDESONIDE 100,0 ug | 100 | 36024936/21.5.1/0249 | Cancelled | Not determined | None |
| Budeflam 100 dp-caps EACH CAPSULE CONTAINS BUDESONIDE 100,0 ug | 100 | 36025736/21.5.1/0257 | Cancelled | Not determined | None |
| Budeflam 200 dp-caps EACH CAPSULE CONTAINS BUDESONIDE 200,0 ug | 200 | 36025836/21.5.1/0258 | Cancelled | Not determined | None |
| Budeflam 0,123 mg/ml respules EACH 1,0 ml SUSPENSION CONTAINS BUDESONIDE 0,125 mg | 0,123 mg/ml | 57000157/21.5.1/0001 | Registered | Not determined | None |
| Budeflam 0,25 mg/ml respules EACH 1,0 ml SUSPENSION CONTAINS BUDESONIDE 0,25 mg | 0,25 mg/ml | 57000257/21.5.1/0002 | Registered | Not determined | None |
| Budeflam 0,5 mg/ml respules EACH 1,0 ml SUSPENSION CONTAINS BUDESONIDE 0,5 mg | 0,5 mg/ml | 57000357/21.5.1/0003 | Registered | Not determined | None |
| Budesonide 0,125 mg/ml respules cipla EACH 1,0 ml SUSPENSION CONTAINS BUDESONIDE 0,125 mg | 0,125 mg/ml | 570004.00157/21.5.1/0004.001 | Registered | Not determined | None |
| Budesonide 0,25 mg/ml respules cipla EACH 1,0 ml SUSPENSION CONTAINS BUDESONIDE 0,25 mg | 0,25 mg/ml | 570005.00257/21.5.1/0005.002 | Registered | Not determined | None |
| Budesonide 0,5 mg/ml respules cipla EACH 1,0 ml SUSPENSION CONTAINS BUDESONIDE 0,5 mg | 0,5 mg/ml | 570006.00357/21.5.1/0006.003 | 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: 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.