Rolufta Ellipta (previously Rolufta)
umeclidinium
Table of contents
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.
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Rolufta Ellipta (previously Rolufta) : EPAR - Medicine overview (PDF/69.76 KB)
First published: 23/03/2017
Last updated: 06/11/2018
EMA/595684/2018 -
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Rolufta Ellipta : EPAR - Risk-management-plan summary (PDF/160.46 KB)
First published: 24/02/2021
Authorisation details
Product details | |
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Name |
Rolufta Ellipta (previously Rolufta)
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Agency product number |
EMEA/H/C/004654
|
Active substance |
umeclidinium bromide
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International non-proprietary name (INN) or common name |
umeclidinium
|
Therapeutic area (MeSH) |
Pulmonary Disease, Chronic Obstructive
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Anatomical therapeutic chemical (ATC) code |
R03BB07
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Additional 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 | |
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Marketing-authorisation holder |
GlaxoSmithKline Trading Services Limited
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Revision |
11
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Date of issue of marketing authorisation valid throughout the European Union |
20/03/2017
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Contact address |
12 Riverwalk |
Product information
09/11/2022 Rolufta Ellipta (previously Rolufta) - EMEA/H/C/004654 - PSUSA/00010263/202112
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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).