Is Aclidinium + Formoterol registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 0 valid registrations of Aclidinium + Formoterol.

Is Aclidinium + Formoterol approved by the US FDA?

Drugs@FDA lists 1 application product line for Aclidinium + Formoterol, including DUAKLIR PRESSAIR (Prescription).

Is Aclidinium + Formoterol authorised in the European Union?

EMA lists 2 centrally authorised medicines containing Aclidinium + Formoterol: Duaklir Genuair, Brimica Genuair.

Active substances

Aclidinium + Formoterol

SFDA 1
US FDA 1
EMA 2
Health Canada 1
NHS prices 1

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
DUAKLIR GENUAIR 340mcg/12mcg Inhalation	340,12 µg,µg	Inhalation powder · Inhalation use	1 Inhaler	SAR 150.85	NCE · Prescription	AstraZeneca AB	Withdrawn by MAH · Not Marketed

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

Product	Strength	Form · route	Applicant	Status	First approved
DUAKLIR PRESSAIR	0.4MG/INH;0.012MG/INH	powder, metered · inhalation	AZURITY	Prescription	29 Mar 2019

EMA European Union — centrally authorised medicines

Duaklir Genuair Covis Pharma Europe B.V. · Authorised · authorised 19 Nov 2014 · ATC R03AL

Therapeutic indication (EMA)

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

Brimica Genuair Covis Pharma Europe B.V. · Authorised · authorised 19 Nov 2014 · ATC R03AL05

Therapeutic indication (EMA)

Brimica Genuair is indicated as a maintenance bronchodilator treatment for airflow obstruction and relief of symptoms in adult patients with chronic obstructive pulmonary disease (COPD).

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
DUAKLIR GENUAIR	02439530	12 MCG / ACT; 400 MCG / ACT	POWDER (METERED-DOSE) · INHALATION	COVIS PHARMA GMBH

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
NHS Drug Tariff	Aclidinium bromide 396micrograms/dose / Formoterol 11.8micrograms/dose dry powder inhaler	£32.50	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.

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.