Vitekta

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Withdrawn

This medicine's authorisation has been withdrawn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The European Public Assessment Report (EPAR) for Vitekta is updated to reflect that its marketing authorisation is no longer valid.

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Product information

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Latest procedure affecting product information: WS/0884
03/11/2016
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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).

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dansk (DA) (471.16 KB - PDF)

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slovenščina (SL) (488.63 KB - PDF)

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Suomi (FI) (471.15 KB - PDF)

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svenska (SV) (471.33 KB - PDF)

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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 use

Therapeutic 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.

Authorisation details

EMA product number
EMEA/H/C/002577
Marketing authorisation holder
Gilead Sciences International Ltd

Flowers Building
Granta Park
Abington
Cambridge
CB21 6GT
United Kingdom

Opinion adopted
19/09/2013
Marketing authorisation issued
13/11/2013
Withdrawal of marketing authorisation
03/11/2016
Revision
4

Assessment history

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