Budesonide, formoterol (Budofor 80:4,5, Budofor 160:4,5, Budetram 80:4,5, Budetram 160:4,5)
Budesonide, formoterol
Cipla Medpro (Pty) Ltd
Registration
- Applicant
- Cipla Medpro (Pty) Ltd
- Registrations
- 4
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Budofor 80:4,5 inhaler EACH SINGLE ACTUATION CONTAINS: BUDESONIDE 80,0 μg FORMOTEROL FUMARATE DIHYDRATE 4,5 μg | Inhaler | 58016258/10.2.1/0162 | Registered | Not determined | None |
| Budofor 160:4,5 inhaler EACH SINGLE ACTUATION CONTAINS: BUDESONIDE 160,0 μg FORMOTEROL FUMARATE DIHYDRATE 4,5 μg | Inhaler | 58016358/10.2.1/0163 | Registered | Not determined | None |
| Budetram 80:4,5 inhaler EACH SINGLE ACTUATION CONTAINS: BUDESONIDE 80,0 μg FORMOTEROL FUMARATE DIHYDRATE 4,5 μg | Inhaler | 580164.16258/10.2.1/0164.162 | Registered | Not determined | None |
| Budetram 160:4,5 inhaler EACH SINGLE ACTUATION CONTAINS: BUDESONIDE 160,0 μg FORMOTEROL FUMARATE DIHYDRATE 4,5 μg | Inhaler | 580165.16358/10.2.1/0165.163 | 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
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
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.
Combination product
This product contains more than one active ingredient, so it has no single molecular structure.
SAHPRA documents
SAHPRA has not published a professional information or patient information leaflet for this product.