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Tiotropium

Sold as Spiriva, Forvent, Spiriva respimat, Tiores, Tiotor, Tiotropium adco, Fibrotiem, Tiotropium cipla

S3
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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.

Background

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Registration

Applicants
4
Registrations
8
Schedule source
Consolidated Schedules 06 July 2026

Applicants and registrations

ApplicantBrandsDosagesRegistrationsScheduleLeaflets
Ingelheim Pharmaceuticals (Pty) Ltd û Ferndale1 of 3 cancelledSpiriva, Forvent, Spiriva respimatNot stated360044, 360045, 410849S3None
Activo Health (Pty) LtdTioresNot stated500671S3None
Adcock ingram limitedCancelledTiotor, Tiotropium adco10, 16 micrograms511120, 511121.12S3PIPIL
Cipla Medpro (Pty) LtdFibrotiem, Tiotropium cipla18570007, 570008.007S3None

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
Tiores

EACH CAPSULE CONTAINS: TIOTROPIUM BROMIDE EQUIVALENT TO TIOTROPIUM 13,0 μg

Not listed50067150/10.2.1/0671RegisteredS3None
Tiotor 10

EACH HARD CAPSULE FOR INHALATION CONTAINS: TIOTROPIUM BROMIDE EQUIVALENT TO TIOTROPIUM 13,0 μg

1051112051/10.2.1/1120CancelledS3None
Tiotropium adco

EACH HARD CAPSULE FOR INHALATION CONTAINS: TIOTROPIUM BROMIDE EQUIVALENT TO TIOTROPIUM 13,0 μg

16 microgramsHard capsule for inhalation511121.1251/10.2.1/1121.120Approved 5 May 2022CancelledS3PIPIL
Fibrotiem

EACH CAPSULE CONTAINS TIOTROPIUM BROMIDE MONOHYDRATE EQUIVALENT TO TIOTROPIUM 18,0 µg

Not listed57000757/10.2.1/0007RegisteredS3None
Tiotropium 18 cipla

EACH CAPSULE CONTAINS TIOTROPIUM BROMIDE MONOHYDRATE EQUIVALENT TO TIOTROPIUM 18,0 µg

18570008.00757/10.2.1/0008.007RegisteredS3None

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.

SAHPRA documents

Schedule verified from official documents

Schedule Verification

Tiotropium adco, Adcock ingram limited 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.

Research articles

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