Fenoterol, ipratropium
Sold as Adco-nebrafen, Duovent hfa, Atrovent beta U.D.V.
Combination product
This product contains more than one active ingredient, so it has no single molecular structure.
Background
Registration
- Applicants
- 2
- Registrations
- 3
- Schedule source
- SAHPRA documentation
Applicants and registrations
| Applicant | Brands | Dosages | Registrations | Schedule | Leaflets |
|---|---|---|---|---|---|
| Adcock Ingram Critical Care (Pty) LtdCertificate held by Adcock Ingram Critical Care (Pty) Ltd. | Adco-nebrafen | 4 ml | 350004 | S3 | PIPIL |
| Ingelheim Pharmaceuticals (Pty) Ltd û FerndaleCancelled | Duovent hfa, Atrovent beta U.D.V. | Not stated | 350302, Z0078 | Not determined | None |
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Adco-nebrafen EACH 4,0 ml SOLUTION CONTAINS FENOTEROL HYDROBROMIDE 1,25 mg IPRATROPIUM BROMIDE 0,5 mg | 4 mlInhalant solution | 35000435/8.2/0004Approved 1 July 2025 | Registered | S3 | PIPIL |
| Duovent hfa EACH METERED DOSE CONTAINS: FENOTEROL HYDROBROMIDE 50,0 ug, IPRATROPIUM BROMIDE 20,0 ug | Not listed | 35030235/10.2.1/0302 | Cancelled | Not determined | None |
| Atrovent beta U.D.V. EACH VIAL CONTAINS FENOTEROL HYDROBROMIDE 1,25 mg IPRATROPIUM BROMIDE 0,5 mg | Not listed | Z0078Z/10.2.1/78 | Cancelled | Not determined | None |
Regulatory status
Where S3 sits on the scale
Needs a doctor's prescription, dispensed by a pharmacist.
Schedule 3 medicines can only be sold on a prescription from an authorised prescriber, such as a doctor or dentist. A pharmacist dispenses the medicine once they have the written prescription, or a verbal instruction from a prescriber they know. 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 S3, read from the product's PI-PIL leaflet.
The Consolidated Schedules list this ingredient up to S4; the leaflet's S3 applies to this product.
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 Fenoterol hydrobromide, ipratropium bromide
S4: Fenoterol
- when intended for the prevention or delay of labour, and preparations thereof for injection.
Consolidated Schedules 06 July 2026, line 6324
S3: Fenoterol
- when contained in respirator solutions.
Consolidated Schedules 06 July 2026, line 3576
S3: Ipratropium
- when contained in respirator solutions.
Consolidated Schedules 06 July 2026, line 3804
S2: Fenoterol
- when contained in respirator solutions; (S3) and
- when intended for injection or for the prevention or delay of labour. (S4)
Consolidated Schedules 06 July 2026, lines 1984 to 1988
S2: Ipratropium
- except when contained in respirator solutions.
Consolidated Schedules 06 July 2026, line 2177
Pharmacological class: Anticoagulants. (class 8.2)
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
Adco-nebrafen, Adcock Ingram Critical Care (Pty) Ltd is scheduled S3 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.