Temybric Ellipta
fluticasone furoate / umeclidinium / vilanterol
Table of contents
Overview
The marketing authorisation for Temybric Ellipta has lapsed because it has not been marketed in the European Union in the three years following the granting of the authorisation.
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Temybric Ellipta : EPAR - Medicine overview (PDF/224.86 KB)
First published: 23/09/2019
Last updated: 24/11/2022
EMA/247773/2019 -
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Temybric Ellipta : EPAR - Risk-management-plan summary (PDF/561.72 KB)
First published: 23/09/2019
Last updated: 24/11/2022
Authorisation details
| Product details | |
|---|---|
| Name |
Temybric Ellipta
|
| Agency product number |
EMEA/H/C/005254
|
| Active substance |
|
| International non-proprietary name (INN) or common name |
|
| Therapeutic area (MeSH) |
Pulmonary Disease, Chronic Obstructive
|
| Anatomical therapeutic chemical (ATC) code |
R03AL08
|
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 | |
|---|---|
| Marketing-authorisation holder |
GlaxoSmithKline Trading Services Limited
|
| Revision |
4
|
| Date of issue of marketing authorisation valid throughout the European Union |
12/06/2019
|
| Contact address |
12 Riverwalk |
Product information
11/12/2021 Temybric Ellipta - EMEA/H/C/005254 - WS/2130/G
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
Temybric Ellipta is indicated as a maintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (COPD) who are not adequately treated by a combination of an inhaled corticosteroid and a long-acting β2-agonist or a combination of a long-acting β2-agonist and a long-acting muscarinic antagonist (for effects on symptom control and prevention of exacerbations see section 5.1).