Is Aclidinium 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.

Is Aclidinium approved by the US FDA?

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

Is Aclidinium authorised in the European Union?

EMA lists 2 centrally authorised medicines containing Aclidinium: Eklira Genuair, Bretaris Genuair.

Is Aclidinium on the WHO Model List of Essential Medicines?

Yes — 25.1. Antiasthmatic and medicines for chronic obstructive pulmonary disease (core list): Therapeutic equivalent to tiotropium bromide for Chronic obstructive pulmonary disease.

Are there safety signals or safety updates for Aclidinium?

US FDA: 1 entry (latest 2019-03-29).

Active substance

Aclidinium

SFDA 1
US FDA 1
EMA 2
Health Canada 1
US price lines 2
NHS prices 1
WHO EML 1
Safety 1

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
EKLIRA GENUAIR 322 mcg INHALATION POWDER	322 µg	Inhalation powder · Inhalation use	1 Inhaler	SAR 125.70	NCE · Prescription	AstraZeneca	Withdrawn by MAH · Not Marketed

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

Product	Strength	Form · route	Applicant	Status	First approved
TUDORZA PRESSAIR	0.4MG/INH	powder, metered · inhalation	AZURITY	Prescription	23 Jul 2012

EMA European Union — centrally authorised medicines

Eklira Genuair Covis Pharma Europe B.V. · Authorised · authorised 20 Jul 2012 · ATC R03BB

Therapeutic indication (EMA)

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

Bretaris Genuair Covis Pharma Europe B.V. · Authorised · authorised 20 Jul 2012 · ATC R03BB

Therapeutic indication (EMA)

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

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
TUDORZA GENUAIR	02409720	400 MCG / ACT	POWDER (METERED-DOSE) · INHALATION	COVIS PHARMA GMBH

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	TUDORZA PRESSAIR 400 MCG INHAL	$431.5	per EA	23 Sep 2026
US NADAC	TUDORZA PRESSAIR 400 MCG INHAL	$257.59286	per EA	23 Sep 2026
NHS Drug Tariff	Aclidinium bromide 375micrograms/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.

WHO WHO Model List of Essential Medicines (2025)

25.1. Antiasthmatic and medicines for chronic obstructive pulmonary disease · core
Therapeutic equivalent to tiotropium bromide for Chronic obstructive pulmonary disease

Safety signals and safety-related labeling changes

US FDA 29 Mar 2019 TUDORZA PRESSAIR — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Use in Specific Populations

All safety entries for aclidinium →

Combinations containing Aclidinium

Aclidinium + formoterol

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.