Eviplera: Withdrawal of the application to change the marketing authorisation

emtricitabine / rilpivirine / tenofovir disoproxil

Overview

On 16 July 2013, Gilead Sciences International Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wished to withdraw its application to extend the use of the anti-HIV medicine Eviplera from the treatment of patients with a viral load of 100,000 copies/ml or less to include patients with a viral load of up to 500,000 copies/ml.

Key facts

Name
Eviplera
Product number
EMEA/H/C/002312
Date of issue of market authorisation valid throughout the European Union (if applicable)
27/11/2011
International non-proprietary name (INN) or common name
  • emtricitabine / rilpivirine / tenofovir disoproxil
Active substance
  • emtricitabine
  • rilpivirine hydrochloride / tenofovir disoproxil fumarate
Date of withdrawal
16/07/2013
Company making the application
Gilead Sciences International Ltd 
Withdrawal type
Post-authorisation

Related information on withdrawals

The question-and-answer (Q&A) document provides a summary of the CHMP's evaluation of the application at the time of the withdrawal, and includes a link to the company's formal withdrawal letter.

An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 90').

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