Vitekta

Withdrawn

This medicine's authorisation has been withdrawn

elvitegravir

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The European Public Assessment Report (EPAR) for Vitekta is updated to reflect that its marketing authorisation is no longer valid.

Vitekta : EPAR - Summary for the public

Reference Number: EMA/593111/2013

Product information

Vitekta : EPAR - Product Information

Vitekta : EPAR - All Authorised presentations

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

Changes since initial authorisation of medicine

Vitekta : EPAR - Procedural steps taken and scientific information after authorisation

Vitekta-H-C-2577-P46-013 : EPAR - Assessment Report

Adopted Reference Number: EMA/807651/2015

Initial marketing authorisation documents

Vitekta : EPAR - Public assessment report

Adopted Reference Number: EMA/701401/2013

CHMP summary of positive opinion for Vitekta

Adopted Reference Number: EMA/CHMP/5643227/2013