Anoro Ellipta (previously Anoro)
umeclidinium bromide / vilanterol
Table of contents
Overview
Anoro 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. Anoro Ellipta is used for maintenance (regular) treatment.
Anoro Ellipta contains the active substances umeclidinium bromide and vilanterol.
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Anoro Ellipta : EPAR - Medicine overview (PDF/79.59 KB)
First published: 16/06/2014
Last updated: 16/10/2018 -
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Anoro : EPAR - Risk-management-plan summary (PDF/232.46 KB)
First published: 16/06/2014
Last updated: 12/11/2020
Authorisation details
Product details | |
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Name |
Anoro Ellipta (previously Anoro)
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Agency product number |
EMEA/H/C/002751
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Active substance |
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International non-proprietary name (INN) or common name |
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Therapeutic area (MeSH) |
Pulmonary Disease, Chronic Obstructive
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Anatomical therapeutic chemical (ATC) code |
R03AL03
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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 (Ireland) Limited
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Revision |
15
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Date of issue of marketing authorisation valid throughout the European Union |
08/05/2014
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Contact address |
Product information
09/12/2020 Anoro Ellipta (previously Anoro) - EMEA/H/C/002751 - N/0032
Contents
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
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Pharmacotherapeutic group
Drugs for obstructive airway diseases
Therapeutic indication
Anoro Ellipta is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).