Temybric Ellipta
Lapsed
This medicine's authorisation has lapsed
fluticasone furoate / umeclidinium / vilanterol
MedicineHumanLapsed
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
On 14 June 2022, the marketing authorisation of Temybric Ellipta (fluticasone furoate / umeclidinium / vilanterol) ceased to be valid in the European Union (EU). The cessation of validity is due to the fact that the marketing authorisation holder, GlaxoSmithKline Trading Services Limited, had not marketed Temybric Ellipta in the EU since its initial marketing authorisation.
In accordance with provisions of the sunset clause, the marketing authorisation of the medicinal product lapsed as the product had not been marketed in any of the EU Member States within three years of its initial authorisation. GlaxoSmithKline Trading Services Limited confirmed that the product had not been marketed due to commercial reasons.
Temybric Ellipta was granted marketing authorisation in the EU on 12 June 2019 for treatment of adult patients with chronic obstructive pulmonary disease (COPD). The marketing authorisation was initially valid for a 5-year period. Temybric Ellipta was a duplicate application to Trelegy Ellipta, which is marketed in several EU countries. The marketing authorisation holder will maintain the marketing authorisation for Trelegy Ellipta and its other duplicate Elebrato Ellipta.
The European Public Assessment Report (EPAR) for Temybric Ellipta is updated to indicate that the marketing authorisation is no longer valid.
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).
News on Temybric Ellipta
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