Budesonide, formoterol
Sold as Symbicord turbuhaler 80: /dose, Symbicord turbuhaler 160: /dose, Symbicord turbuhaler 320: /dose, Facet turbuhaler 80: dose, Facet turbuhaler 160: dose, Fcet turbuhaler 320:, Halecord, Budofor 80:4,5, Budofor 160:4,5, Budetram 80:4,5, Budetram 160:4,5, Vannair 80:4,5, Vannair 160:4,5
Combination product
This product contains more than one active ingredient, so it has no single molecular structure.
Background
Registration
- Applicants
- 3
- Registrations
- 15
- Schedule source
- SAHPRA documentation
Applicants and registrations
| Applicant | Brands | Dosages | Registrations | Schedule | Leaflets |
|---|---|---|---|---|---|
| Astrazeneca Pharmaceuticals (Pty) Ltd | Symbicord turbuhaler 80: /dose, Symbicord turbuhaler 160: /dose, Symbicord turbuhaler 320: /dose, Facet turbuhaler 80: dose, Facet turbuhaler 160: dose, Fcet turbuhaler 320:, Vannair 80:4,5, Vannair 160:4,5 | 4,5 ug, 9 ug, 80 μg, 160 μg | 350404, 350405, 380187, 450257, 450258, 450259, A390506, A390507 | S4 | PI |
| Innovata pharmaceuticals | Halecord | 100/6, 200/6, 400/12 | 550322, 550323, 550324 | Not determined | None |
| Cipla Medpro (Pty) Ltd | Budofor 80:4,5, Budofor 160:4,5, Budetram 80:4,5, Budetram 160:4,5 | inhaler | 580162, 580163, 580164.162, 580165.163 | Not determined | None |
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Symbicord turbuhaler 80:4,5 ug/dose EACH DELIVERED DOSE CONTAINS BUDESONIDE 80,0 µg FORMOTEROL FUMARATE DIHYDRATE 4,5 µg | 4,5 ug | 35040435/21.5.1/0404 | Registered | Not determined | None |
| Symbicord turbuhaler 160:4,5 ug/dose EACH DELIVERED DOSE CONTAINS BUDESONIDE 160,0 ug FORMOTEROL FUMARATE DIHYDRATE 4,5 ug | 4,5 ug | 35040535/21.5.1/405 | Registered | Not determined | None |
| Symbicord turbuhaler 320:9 ug/dose EACH DELIVERED DOSE CONTAINS BUDESONIDE 320,0 ug FORMOTEROL FUMARATE 9,0 ug | 9 ug | 38018738/21.5.1/0187 | Registered | Not determined | None |
| Facet turbuhaler 80:4,5 ug dose EACH DELIVERED DOSE CONTAINS: BUDESONIDE 80,0 μg FORMOTEROL FUMARATE DIHYDRATE 4,5 μgNone | 4,5 ug | 45025745/2.1/0257 | Registered | Not determined | None |
| Facet turbuhaler 160:4,5 ug dose EACH DELIVERED DOSE CONTAINS: BUDESONIDE 160,0 μg FORMOTEROL FUMARATE DIHYDRATE 4,5 μg | 4,5 ug | 45025845/21.5.1/0258 | Registered | Not determined | None |
| Fcet turbuhaler 320:9 ug EACH DELIVERED DOSE CONTAINS: BUDESONIDE 320,0 μg FORMOTEROL FUMARATE DIHYDRATE 9,0 μg | 9 ug | 45025945/21.5.1/0259 | Registered | Not determined | None |
| Halecord 100/6 EACH DOSE CONTAINS BUDESONIDE 100,0 ug FORMOTEROL FUMARATE DIHYDRATE 6,0 ug | 100/6 | 55032255/21.5.1/0322 | Registrered | Not determined | None |
| Halecord 200/6 EACH DOSE CONTAINS BUDESONIDE 200,0 ug FORMOTEROL FUMARATE DIHYDRATE 6,0 ug | 200/6 | 55032355/25.5.1/0323 | Registrered | Not determined | None |
| Halecord 400/12 EACH DOSE CONTAINS BUDESONIDE 400,0 ug FORMOTEROL FUMARATE DIHYDRATE 12,0 ug | 400/12 | 55032455/21.5.1/0324 | Registrered | Not determined | None |
| 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 |
| Vannair 80:4,5 EACH ACTUATION CONTAINS BUDESONIDE 80,0 ug FORMOTEROL FUMARATE 4,5 ug | 80 μg, 160 μgInhaler | A390506A39/21.5.1/0506Approved 16 October 2020 | Registered | S4 | PI |
| Vannair 160:4,5 EACH ACTUATION CONTAINS BUDESONIDE 160,0 ug FORMOTEROL FUMARATE 4,5 ug | Not listed | A390507A39/21.5.1/0507 | Registered | Not determined | None |
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, 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
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: Corticosteroids and analogues. (class 21.5.1)
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
Vannair 80:4,5, 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.