Rolufta Ellipta (previously Rolufta)

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umeclidinium

Authorised
This medicine is authorised for use in the European Union.

Overview

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 22/10/2019

Authorisation details

Product details
Name
Rolufta Ellipta (previously Rolufta)
Agency product number
EMEA/H/C/004654
Active substance
umeclidinium bromide
International non-proprietary name (INN) or common name
umeclidinium
Therapeutic area (MeSH)
Pulmonary Disease, Chronic Obstructive
Anatomical therapeutic chemical (ATC) code
R03BB07
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
Revision
7
Date of issue of marketing authorisation valid throughout the European Union
20/03/2017
Contact address

12 Riverwalk
Citywest Business Campus
Dublin 24
Ireland

Product information

19/09/2019 Rolufta Ellipta (previously Rolufta) - EMEA/H/C/004654 - WS/1505

Contents

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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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