Formoterol
Sold as Foradil dry, Foramet dry, Foratec dp-caps, Merck-formoterol clickhaler, Foratec hfa, Cipla-formoterol fumarate hfa
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
- 4
- Registrations
- 6
Applicants and registrations
| Applicant | Brands | Dosages | Registrations | Schedule | Leaflets |
|---|---|---|---|---|---|
| Sandoz South Africa (Pty) LtdCancelled | Foradil dry | powder | 290624 | Not determined | None |
| Adcock ingram limitedCancelled | Foramet dry | powder | 360443 | Not determined | None |
| Cipla Medpro (Pty) Ltd1 of 3 cancelled | Foratec dp-caps, Foratec hfa, Cipla-formoterol fumarate hfa | Not stated | 370084, A400413, A400414 | Not determined | None |
| Merck Generics Rsa (Pty) LtdCancelled | Merck-formoterol clickhaler | Not stated | A380646 | Not determined | None |
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Foradil dry powder EACH CAPSULE CONTAINS FORMOTEROL FUMARATE 0,012 mg | Powder | 29062429/10.2/0624 | Cancelled | Not determined | None |
| Foramet dry powder EACH CAPSULE DELIVERS:FORMOTEROL FUMARATE 12,0 ug | Powder | 36044336/10.2.1/0443 | Cancelled | Not determined | None |
| Foratec dp-caps EACH CAPSULE CONTAINS FORMOTEROL FUMARATE 12,0 ug | Not listed | 37008437/10.2.1/0084 | Registered | Not determined | None |
| Merck-formoterol clickhaler EACH METERED DOSE CONTAINS FORMOTEROL FUMARATE 12,0 ug | Not listed | A380646A38/10.2.1/0646 | Cancelled | Not determined | None |
| Foratec hfa EACH METERED DOSE CONTAINS FORMOTEROL FUMARATE 12,0 ug | Not listed | A400413A40/10.2.1/0413 | Registered | Not determined | None |
| Cipla-formoterol fumarate hfa EACH METERED DOSE CONTAINS FORMOTEROL FUMARATE 12,0 ug | Not listed | A400414A40/10.2.1/0414 | 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
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
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
SAHPRA has not published a professional information or patient information leaflet for this product.