Rasival: Withdrawal of the marketing authorisation application

aliskiren/valsartan

Overview

On 15 September 2010, Novartis Europharm Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Rasival, for the treatment of essential hypertension in adults whose blood pressure is already adequately controlled with a combination of aliskiren and valsartan taken separately.

  • List item

    Questions and answers on withdrawal of the marketing authorisation application for Rasival (aliskiren / valsartan) (PDF/50.42 KB)


    First published: 28/09/2010
    Last updated: 28/09/2010
    EMA/584655/2010

  • Key facts

    Name
    Rasival
    Product number
    EMEA/H/C/001191
    International non-proprietary name (INN) or common name
    • aliskiren/valsartan
    Active substance
    • aliskiren/valsartan
    Date of withdrawal
    15/09/2010
    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    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

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