Active substance
Tiotropium
- SFDA 5
- US FDA 4
- Health Canada 4
- US price lines 3
- NHS prices 5
- WHO EML 1
- Safety 9
SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
|---|---|---|---|---|---|---|---|
| SPIRIVA 18MCG HARD CAPSULE | 18 µg | Inhalation powder, hard capsule · Inhalation use | 30 Inhaler | SAR 142.15 | NCE · Prescription | BOEHRINGER INGELHEIM | Valid |
| Tiogiva | 18 µg | Inhalation powder, hard capsule · Inhalation use | 30 Blister | SAR 113.75 | Generic · Prescription | ALPHA PHARMA INDUSTRY | Valid |
| Tiomist | 10 µg | Inhalation powder, hard capsule · Inhalation use | 30 Bottle | SAR 132.70 | NCE · Prescription | Exeltis Healthcare S.L | Valid |
| Tiotropium Eva | 18 µg | Inhalation powder, hard capsule · Inhalation use | 30 Inhaler | SAR 113.75 | Generic · Prescription | Eva pharma for Industry | Valid |
| Triova | 13 µg | Inhalation powder, hard capsule · Inhalation use | 30 Bottle | SAR 123.20 | Generic · Prescription | MS Pharma Saudi (MSPS) | Valid |
Indications — CHI Daman Drug Formulary
ASTHMA; CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD); SICKLE CELL DISEASE - ACS MANAGEMENT
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| SPIRIVA | EQ 0.018MG BASE/INH | powder · inhalation | BOEHRINGER INGELHEIM | Prescription | 30 Jan 2004 |
| SPIRIVA RESPIMAT | EQ 0.0025MG BASE/INH; EQ 0.00125MG BASE/INH | spray, metered · inhalation | BOEHRINGER INGELHEIM | Prescription | 24 Sep 2014 |
| SPIRIVA RESPIMAT | 2.5MCG | spray · inhalation | BOEHRINGER INGELHEIM | Prescription | 15 Sep 2015 |
| TIOTROPIUM BROMIDE | EQ 0.018MG BASE/INH | powder · inhalation | LUPIN | Prescription | 20 Jun 2023 |
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|---|---|---|---|
| APO-TIOTROPIUM | 02550865 | 18 MCG | CAPSULE · INHALATION | APOTEX INC |
| LUPIN-TIOTROPIUM | 02537850 | 18 MCG | CAPSULE · INHALATION | LUPIN PHARMA CANADA LIMITED |
| SPIRIVA | 02246793 | 18 MCG | CAPSULE · INHALATION | BOEHRINGER INGELHEIM (CANADA) LTD LTEE |
| SPIRIVA RESPIMAT | 02435381 | 2.5 MCG / ACT | SOLUTION · INHALATION | BOEHRINGER INGELHEIM (CANADA) LTD LTEE |
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|---|---|---|---|
| US NADAC | SPIRIVA RESPIMAT 1.25 MCG INH | $126.07565 | per GM | 23 Sep 2026 |
| US NADAC | SPIRIVA RESPIMAT 2.5 MCG INH | $126.12032 | per GM | 23 Sep 2026 |
| US NADAC | TIOTROPIUM 18 MCG CAP-INHALER | $11.81093 | per EA | 23 Sep 2026 |
| NHS Drug Tariff | Tiotropium bromide 10microgram inhalation powder capsules with device | £25.80 | 30 capsule | 1 Oct 2026 |
| NHS Drug Tariff | Tiotropium bromide 18microgram inhalation powder capsules | £33.50 | 30 capsule | 1 Oct 2026 |
| NHS Drug Tariff | Tiotropium bromide 18microgram inhalation powder capsules with device | £34.87 | 30 capsule | 1 Oct 2026 |
| NHS Drug Tariff | Tiotropium bromide 2.5micrograms/dose inhalation solution cartridge CFC free | £23.00 | 60 dose | 1 Oct 2026 |
| NHS Drug Tariff | Tiotropium bromide 2.5micrograms/dose solution for inhalation cartridge with device CFC free | £23.00 | 60 dose | 1 Oct 2026 |
NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.
WHO WHO Model List of Essential Medicines (2025)
- 25.1. Antiasthmatic and medicines for chronic obstructive pulmonary disease · core
Chronic obstructive pulmonary disease
Respiratory > Inhalation > powder: 18 µg in capsule | Respiratory > Inhalation > solution: 1.25 µg per actuation in soft mist inhaler; 2.5 µg per actuation in soft mist inhaler
Safety signals and safety-related labeling changes
- US FDA 29 May 2019 STIOLTO RESPIMAT — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 14 Feb 2019 SPIRIVA RESPIMAT — safety-related labeling change
Labeling sections changed: Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 1 Feb 2018 SPIRIVA — safety-related labeling change
Labeling sections changed: Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - EMA PRAC 8 May 2014 PRAC signal: Increased mortality from cardiovascular disease and all-cause mortality - results of TIOSPIR trial
Action for MAH: update of the product information: No - EMA PRAC 5 Dec 2013 PRAC signal: Increased mortality from cardiovascular disease and all-cause mortality - results of TIOSPIR trial
Action for MAH: update of the product information: No - EMA PRAC 13 Jun 2013 PRAC signal: Anaphylactic reaction
Action for MAH: update of the product information: Yes - EMA PRAC 16 May 2013 PRAC signal: Increased mortality from cardiovascular disease and all-cause mortality
Action for MAH: update of the product information: No - EMA PRAC 10 Jan 2013 PRAC signal: Anaphylactic reaction
Action for MAH: update of the product information: No - EMA PRAC 10 Jan 2013 PRAC signal: Increased mortality from cardiovascular disease and all-cause mortality
Action for MAH: update of the product information: No
Combinations containing Tiotropium
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.