Raltegravir Viatris: Withdrawal of the marketing authorisation application

raltegravir potassium


The company Viatris withdrew its application for a marketing authorisation of Raltegravir Viatris for the treatment of human immunodeficiency virus type 1 (HIV-1) infection.

The company withdrew the application on 22 February 2023.

  • List item

    Questions and answers on the withdrawal of application for the marketing authorisation of Raltegravir Viatris (raltegravir) (PDF/121.33 KB)

    First published: 31/03/2023
    Last updated: 21/04/2023

  • Key facts

    Raltegravir Viatris
    Product number
    International non-proprietary name (INN) or common name
    • raltegravir potassium
    Active substance
    • raltegravir potassium
    Date of withdrawal
    Company making the application
    Viatris Limited
    Withdrawal type
    Initial authorisation

    All documents

    Related information on withdrawals

    A question-and-answer (Q&A) document provides a summary of the CHMP's evaluation of the medicine at the time of the withdrawal of the application, 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    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

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