Vitekta
Withdrawn
This medicine's authorisation has been withdrawn
elvitegravir
MedicineHumanWithdrawn
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
On 3 November 2016, the European Commission withdrew the marketing authorisation for Vitekta (elvitegravir) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Gilead Sciences International Ltd, which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons.
Vitekta was granted marketing authorisation in the EU on 13 November 2013 for treatment of human immunodeficiency virus-1 (HIV-1) infection in adults. The marketing authorisation was initially valid for a 5-year period.
The European Public Assessment Report (EPAR) for Vitekta is updated to reflect that its marketing authorisation is no longer valid.
Product information
Latest procedure affecting product information:
WS/0884
03/11/2016
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
- Vitekta
- Active substance
- elvitegravir
- International non-proprietary name (INN) or common name
- elvitegravir
- Therapeutic area (MeSH)
- HIV Infections
- Anatomical therapeutic chemical (ATC) code
- J05AX11
Pharmacotherapeutic group
Antivirals for systemic useTherapeutic indication
Vitekta co-administered with a ritonavir-boosted protease inhibitor and with other antiretroviral agents, is indicated for the treatment of human-immunodeficiency-virus-1 (HIV-1) infection in adults who are infected with HIV-1 without known mutations associated with resistance to elvitegravir.
News on Vitekta
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