Regulatory PathRegulatory requirements compared

Active substances

Olodaterol + Tiotropium

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
SPIOLTO RESPIMAT2.5,2.5 µg,µginhalation solution · Inhalation use1 CartridgeSAR 178.70NCE · PrescriptionBOEHRINGER INGELHEIMValid
SPIOLTO RESPIMATE2.5,2.5 µg,µginhalation solution · Inhalation use1 CartridgeSAR 200.05NCE · PrescriptionBOEHRINGER INGELHEIMValid
Indications — CHI Daman Drug Formulary

CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)

US FDA United States — FDA approvals (Drugs@FDA)

ProductStrengthForm · routeApplicantStatusFirst approved
STIOLTO RESPIMATEQ 0.0025MG BASE/INH;EQ 0.0025MG BASE/INHspray, metered · inhalationBOEHRINGER INGELHEIMPrescription21 May 2015

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
INSPIOLTO RESPIMAT024418882.5 MCG / ACT; 2.5 MCG / ACTSOLUTION · INHALATIONBOEHRINGER INGELHEIM (CANADA) LTD LTEE

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
NHS Drug TariffTiotropium bromide 2.5micrograms/dose / Olodaterol 2.5micrograms/dose inhalation solution cartridge CFC free£32.5060 dose1 Oct 2026
NHS Drug TariffTiotropium bromide 2.5micrograms/dose / Olodaterol 2.5micrograms/dose solution for inhalation cartridge with device CFC free£32.5060 dose1 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.

Components

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.