Regulatory PathRegulatory requirements compared

Active substances

Formoterol + Glycopyrronium

Open in the medicines table

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

ProductStrengthForm · routeApplicantStatusFirst approved
BEVESPI AEROSPHERE0.0048MG/INH;0.0090MG/INHaerosol, metered · inhalationASTRAZENECAPrescription25 Apr 2016

EMA European Union — centrally authorised medicines

Bevespi Aerosphere AstraZeneca AB · Authorised · authorised 18 Dec 2018 · ATC R03AL07

Therapeutic indication (EMA)

Bevespi Aerosphere is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
NHS Drug TariffGlycopyrronium 7.2micrograms/dose / Formoterol 5micrograms/dose inhaler CFC free£32.50120 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.