Temybric Ellipta
Lapsed
This medicine's authorisation has lapsed
fluticasone furoate / umeclidinium / vilanterol
MedicineHumanLapsed
- Application under evaluation
- CHMP opinion
- European Commission decision
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.
Product information
Latest procedure affecting product information:
WS/2130/G
11/12/2021
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).
Product details
- Name of medicine
- Temybric Ellipta
- Active substance
- fluticasone furoate
- umeclidinium bromide
- vilanterol trifenatate
- International non-proprietary name (INN) or common name
- fluticasone furoate
- umeclidinium
- vilanterol
- Therapeutic area (MeSH)
- Pulmonary Disease, Chronic Obstructive
- Anatomical therapeutic chemical (ATC) code
- R03AL08
Pharmacotherapeutic group
Drugs for obstructive airway diseasesTherapeutic 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 ?2-agonist or a combination of a long-acting ?2-agonist and a long-acting muscarinic antagonist (for effects on symptom control and prevention of exacerbations see section 5.1).
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