Ipratropium, salbutamol
Sold as Combivent U.D.V, Duolin respules, Duolin hfa, Adco-combineb
Combination product
This product contains more than one active ingredient, so it has no single molecular structure.
Background
Registration
- Applicants
- 3
- Registrations
- 4
- Schedule source
- SAHPRA documentation
Applicants and registrations
| Applicant | Brands | Dosages | Registrations | Schedule | Leaflets |
|---|---|---|---|---|---|
| Ingelheim Pharmaceuticals (Pty) Ltd û FerndaleCertificate held by Ingelheim Pharmaceuticals (Pty) Ltd | Combivent U.D.V | 2,5 ml | 300476 | S3 | PIPIL |
| Cipla Medpro (Pty) Ltd | Duolin respules, Duolin hfa | 0,5 mg/2,5 mg in 2,5 mL, inhaler | 370012, 410908 | S3 | PIPIL |
| Adcock ingram limitedCertificate held by Adcock ingram | Adco-combineb | 0.5mg, 2.5mg | A390373 | S3 | PIPIL |
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Combivent U.D.V EACH 2,5 ml SOLUTION CONTAINS IPRATROPIUM BROMIDE MONOHYDRATE 0,522 mg EQUIVALENT TO 0,5 mg IPRATROPIUM BROMIDE SALBUTAMOL SULPHATE 3,013 mg EQUIVALENT TO 2,5 mg SALBUTAMOL | 2,5 mlSolution for inhalation | 30047630/10.2.1/0476Approved 23 July 2010 | Registered | S3 | PIPIL |
| Duolin respules EACH 2,5 ml SOLUTION CONTAINS IPRATROPIUM BROMIDE EQUIVALENT TO IPRATROPIUM 0,5 mg SALBUTAMOL SULPHATE EQUIVALENT TO SALBUTAMOL 2,5 mg | 0,5 mg/2,5 mg in 2,5 mLSolution. | 37001237/10.2.1/0012Approved 6 March 2026 | Registered | S3 | PIPIL |
| Duolin hfa inhaler EACH METERED DOSE CONTAINS IPRATROPIUM BROMIDE EQUIVALENT TO IPRATROPIUM 20,0 ug SALBUTAMOL SULPHATE EQUIVALENT TO SALBUTAMOL 100,0 ug | Inhaler | 41090841/10.2.1/0908 | Registered | Not determined | None |
| Adco-combineb EACH 2,5 ml CONTAINS IPRATROPIUM BROMIDE 0,520 mg, SALBUTAMOL SULPHATE 3,010 mg | 0.5mg. 2.5mgInhalant solution | A390373A39/10.2.1/0373Approved 19 June 2018 | Registered | S3 | PIPIL |
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 Ipratropium bromide monohydrate, salbutamol sulphate
S4: Salbutamol
- when intended for injection.
Consolidated Schedules 06 July 2026, line 7867
S3: Ipratropium
- when contained in respirator solutions.
Consolidated Schedules 06 July 2026, line 3804
S3: Salbutamol
- when contained in respirator solutions.
Consolidated Schedules 06 July 2026, line 4238
S2: Ipratropium
- except when contained in respirator solutions.
Consolidated Schedules 06 July 2026, line 2177
S2: Salbutamol
- when contained in respirator solutions; (S3) and
- when intended for injection. (S4)
Consolidated Schedules 06 July 2026, lines 2654 to 2658
Pharmacological class: inhalants. (class 10.2.1)
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
Combivent U.D.V, Ingelheim Pharmaceuticals (Pty) Ltd û Ferndale 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.