Ruvise:

Withdrawal of the marketing authorisation application

imatinib

Overview

On 17 January 2013, Novartis Europharm Ltd officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Ruvise, for the treatment of pulmonary arterial hypertension.

  • List item

    Questions and answers on the withdrawal of the marketing-authorisation application for Ruvise (PDF/68 KB)


    First published: 22/02/2013
    Last updated: 22/02/2013
    EMA/38204/2013

  • Key facts

    Name
    Ruvise
    Product number
    EMEA/H/C/002551
    International non-proprietary name (INN) or common name
    • imatinib
    Active substance
    • imatinib
    Date of withdrawal
    21/02/2013
    Company making the application
    Novartis Europharm Ltd
    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 (withdrawal letter Doc. type, leave the 'Author' in properties blank).

    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

    How useful was this page?

    Add your rating
    Average
    1 rating