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Molecule

Umeclidinium

Also known as umeclidinium bromide
Available on requestRespiratory
Presentations
2
Brands
2
Manufacturers
2
Available from stock
0

Umeclidinium is an anticholinergic indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). It is available as inhalation powder for oral use. MedsAcross supplies Umeclidinium for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.

Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review

Key facts

Pharmacological class
Anticholinergic, Cholinergic Antagonists
ATC classification
R03BB07 Umeclidinium · Anticholinergic
US FDA first approval
30 April 2014
EU status
Authorised
Orphan designation
No
WHO essential medicine
Not recorded
India (CDSCO)
Not yet confirmed against CDSCO approval lists
Routes
Oral
Dosage forms
Inhalation powder
Identifiers
UNII GE2T1418SVRxCUI 1487514CAS 869185-19-3DrugBank DB09076Q21011235

Clinical information

From the regulator-approved product information. Each section names its source.

Uses

Umeclidinium ELLIPTA is indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). Umeclidinium ELLIPTA is an anticholinergic indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD).

Source: US FDA prescribing information

How it works

Umeclidinium is a long-acting muscarinic antagonist, which is often referred to as an anticholinergic. It has similar affinity to the subtypes of muscarinic receptors M1 to M5. In the airways, it exhibits pharmacological effects through inhibition of M3 receptors at the smooth muscle leading to bronchodilation. The competitive and reversible nature of antagonism was shown with human and animal origin receptors and isolated organ preparations. In preclinical in vitro as well as in vivo studies, prevention of methacholine- and acetylcholine-induced bronchoconstrictive effects was dose-dependent and lasted longer than 24 hours. The clinical relevance of these findings is unknown. The bronchodilation following inhalation of umeclidinium is predominantly a site-specific effect.

Source: US FDA prescribing information

Dosing overview

The recommended dosage of Umeclidinium ELLIPTA for maintenance treatment of COPD is 1 actuation (umeclidinium 62.5 mcg) once daily by oral inhalation. • Umeclidinium ELLIPTA should be used at the same time every day. Do not use Umeclidinium ELLIPTA more than 1 time every 24 hours. • No dosage adjustment is required for geriatric patients, patients with renal impairment, or patients with moderate hepatic impairment. • For oral inhalation only. • Maintenance treatment of COPD: 1 actuation of Umeclidinium ELLIPTA once daily administered by oral inhalation.

Source: US FDA prescribing information

Contraindications

Umeclidinium ELLIPTA is contraindicated in the following conditions: • Severe hypersensitivity to milk proteins • Hypersensitivity to umeclidinium or any of the excipients • Severe hypersensitivity to milk proteins. • Hypersensitivity to any ingredient.

Source: US FDA prescribing information

Warnings and precautions

• Do not initiate in acutely deteriorating COPD. Do not use to treat acute symptoms. • If paradoxical bronchospasm occurs, discontinue Umeclidinium ELLIPTA and institute alternative therapy. • Worsening of narrow-angle glaucoma may occur. Use with caution in patients with narrow-angle glaucoma and instruct patients to contact a healthcare provider immediately if symptoms occur. • Worsening of urinary retention may occur. Use with caution in patients with prostatic hyperplasia or bladder-neck obstruction and instruct patients to contact a healthcare provider immediately if symptoms occur.

Source: US FDA prescribing information

Side effects

The following adverse reactions are described in greater detail in other sections: • Paradoxical bronchospasm • Worsening of narrow-angle glaucoma • Worsening of urinary retention Most common adverse reactions (incidence ≥2% and more common than placebo) include nasopharyngitis, upper respiratory tract infection, cough, arthralgia.

Source: US FDA prescribing information

Interactions

Anticholinergics: May interact additively with concomitantly used anticholinergic medications. Avoid administration of Umeclidinium ELLIPTA with other anticholinergic-containing drugs.

Source: US FDA prescribing information

Storage

Store at room temperature between 68°F and 77°F (20°C and 25°C), excursions permitted from 59°F to 86°F (15°C to 30°C). Store in a dry place away from direct heat or sunlight. Umeclidinium ELLIPTA should be stored inside the unopened moisture-protective foil tray and only removed from the tray immediately before initial use.

Source: US FDA prescribing information

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

All presentations

2 presentations of Umeclidinium, sorted by availability.

MedicineManufacturerRegisterAvailability
Incruse Ellipta 62.5 mcg inhalation powderOralGlaxoSmithKlineUS FDAAvailable on request
Umeclidinium Ellipta 62.5 mcg inhalation powderOralPrasco LaboratoriesUS FDAAvailable on request

Brands by market

2 brand names across 1 markets.

Brand names by country

Manufacturers

Regulatory status

Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.

RegisterStatusSource
US FDAFirst approved 30 April 2014Drugs@FDA
EU (EMA)AuthorisedEMA medicines data
India (CDSCO)Not yet confirmed against CDSCO approval lists—
AustriaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BelgiumRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BulgariaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CroatiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CyprusRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CzechiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
DenmarkRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
EstoniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FinlandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FranceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GermanyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GreeceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
HungaryRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IcelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IrelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
ItalyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LatviaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LiechtensteinRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LithuaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LuxembourgRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
MaltaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NetherlandsRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NorwayRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PolandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PortugalRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
RomaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SlovakiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SloveniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SpainRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SwedenRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
United StatesRegisteredUS FDA (NDC directory, openFDA)Checked 12 November 2026

Questions and answers

Is Umeclidinium available for export from India?

Yes, on request. MedsAcross lists 2 presentations of Umeclidinium and sources them for licensed hospitals, importers and physicians against valid import documents.

What brand names does Umeclidinium have?

The catalogue lists 2 brand names for Umeclidinium, including Incruse Ellipta, Umeclidinium Ellipta.

Is Umeclidinium approved by the US FDA?

Yes. The US FDA first approved Umeclidinium on 30 April 2014, according to Drugs@FDA.

Is Umeclidinium authorised in the European Union?

Yes. Umeclidinium has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.

Does Umeclidinium need cold chain shipping?

No listed presentation of Umeclidinium is recorded as needing a cold chain. Storage conditions are shown on each presentation page.

Which ATC class is Umeclidinium in?

Umeclidinium is classified under ATC code R03BB07 (Umeclidinium).

References

  1. Umeclidinium Ellipta prescribing information (Prasco Laboratories). U.S. National Library of Medicine, DailyMed. Retrieved 6 November 2025
  2. Incruse Ellipta (previously Incruse): European public assessment report (EPAR). European Medicines Agency. Retrieved 22 July 2025
  3. Rolufta Ellipta (previously Rolufta): European public assessment report (EPAR). European Medicines Agency. Retrieved 5 August 2026

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