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Tiotropium (Spiriva, Forvent, Spiriva Respimat)

Tiotropium

Ingelheim Pharmaceuticals (Pty) Ltd û Ferndale

S3

Registration

Applicant
Ingelheim Pharmaceuticals (Pty) Ltd û Ferndale
Registrations
3
Schedule source
Consolidated Schedules 06 July 2026

Variants

ProductStrength and formRegistrationStatusScheduleLeaflets
Spiriva

EACH CAPSULE FOR INHALATION CONTAINS TIOTROPIUM BROMIDE EQUIVALENT TO TIOTROPIUM 18,0 ug

Not listed36004436/10.2.1/0044RegisteredS3None
Forvent

EACH CAPSULE FOR INHALATION CONTAINS TIOTROPIUM BROMIDE EQUIVALENT TO TIOTROPIUM 18,0 ug

Not listed36004536/10.2.1/0045RegisteredS3None
Spiriva respimat

EACH DELIVERED DOSE CONTAINS TIOTROPIUM BROMIDE EQUIVALENT TO TIOTROPIUM 2,5 ug

Not listed41084941/10.2.1/0849CancelledS3None

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, matched to the Consolidated Schedules by ingredient, confidence high.

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 Tiotropium bromide equivalent to tiotropium

  • S3: Tiotropium

    Consolidated Schedules 06 July 2026, line 4327

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.

C19H22NO4S2+392.50 g/mol

[(1S,2S,4R,5R)-9,9-Dimethyl-3-oxa-9-azoniatricyclo[3.3.1.02,4]nonan-7-yl] 2-hydroxy-2,2-dithiophen-2-ylacetate

Drag to rotate. Structure from PubChem CID 5487427.

SAHPRA documents

SAHPRA has not published a professional information or patient information leaflet for this product.

Background

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Research articles

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