Rolufta Ellipta (previously Rolufta)



This medicine is authorised for use in the European Union.


Rolufta Ellipta is a medicine used to relieve the symptoms of chronic obstructive pulmonary disease (COPD) in adults. COPD is a long-term disease in which the airways and air sacs inside the lungs become damaged or blocked, leading to difficulty breathing. Rolufta Ellipta is used for maintenance (regular) treatment.

Rolufta Ellipta contains the active substance umeclidinium bromide.

This EPAR was last updated on 21/11/2022

Authorisation details

Product details
Rolufta Ellipta (previously Rolufta)
Agency product number
Active substance
umeclidinium bromide
International non-proprietary name (INN) or common name
Therapeutic area (MeSH)
Pulmonary Disease, Chronic Obstructive
Anatomical therapeutic chemical (ATC) code
Additional monitoringAdditional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Publication details
Marketing-authorisation holder
GlaxoSmithKline Trading Services Limited
Date of issue of marketing authorisation valid throughout the European Union
Contact address

12 Riverwalk
Citywest Business Campus
Dublin 24
D24 YK11

Product information

09/11/2022 Rolufta Ellipta (previously Rolufta) - EMEA/H/C/004654 - PSUSA/00010263/202112

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Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

Drugs for obstructive airway diseases

Therapeutic indication

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

Assessment history

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