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Salbutamol (Asthavent, Asthavent Dp-caps, Asthavent Ecohaler, Duolin Respules, Duolin Hfa, Asthavent Respules, Cipla-salbutamol Respules)

Salbutamol

Cipla Medpro (Pty) Ltd

S3Read from the PI-PIL document

Registration

Applicant
Cipla Medpro (Pty) Ltd
Registrations
8
Schedule source
SAHPRA documentation

Variants

ProductStrength and formRegistrationStatusScheduleLeaflets
Asthavent

EACH ACTUATION CONTAINS SALBUTAMOL 100 mcg

Not listed30011930/10.2.1/0119CancelledNot determinedNone
Asthavent syrup

EACH 5 ml SYRUP CONTAINS SALBUTAMOL SULPHATE EQUIVALENT TO 2 mg SALBUTAMOL

2,0 mg/5 mLSyrup30020030/10.2.2/0200Approved 8 March 2023RegisteredNot determinedPIPIL
Asthavent dp-caps

EACH ROTACAP CONTAINS SALBUTAMOL SULPHATE EQUIVALENT TO 0,2 mg SALBUTAMOL

Not listed30034530/10.2.1/0345CancelledNot determinedNone
Asthavent ecohaler

EACH ACTUATION CONTAINS SALBUTAMOL SULPHATE EQUIVALENT TO SALBUTAMOL 100,0 ug

100 µgMetered dose inhaler34035434/10.2.1/0354Approved 5 November 2025RegisteredS2PIPIL
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 2026RegisteredS3PIPIL
Duolin hfa inhaler

EACH METERED DOSE CONTAINS IPRATROPIUM BROMIDE EQUIVALENT TO IPRATROPIUM 20,0 ug SALBUTAMOL SULPHATE EQUIVALENT TO SALBUTAMOL 100,0 ug

Inhaler41090841/10.2.1/0908RegisteredNot determinedNone
Asthavent respules

EACH 2,5 ml SOLUTION CONTAINS SALBUTAMOL SULPHATE EQUIVALENT TO SALBUTAMOL 2,5 mg

Not listedA390482A39/10.2.1/0482CancelledNot determinedNone
Cipla-salbutamol respules

EACH 2,5 ml SOLUTION CONTAINS SALBUTAMOL SULPHATE EQUIVALENT TO SALBUTAMOL 2,5 mg

Not listedA390483A39/10.2.1/0483CancelledNot determinedNone

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 equivalent to ipratropium, salbutamol sulphate equivalent to salbutamol

  • 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)

Matched through the component Ipratropium.

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.

C13H21NO3239.31 g/mol

4-[2-(tert-Butylamino)-1-hydroxyethyl]-2-(hydroxymethyl)phenol

Drag to rotate. Structure from PubChem CID 2083.

SAHPRA documents

These documents are provided by SAHPRA for informational purposes. Always consult with a healthcare professional for medical advice.

Background

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Research articles

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