NovoSeven: Withdrawal of the application to change the marketing authorisation

eptacog alfa (activated)


On 3 April 2006, Novo Nordisk A/S has officially notified the Committee for Medicinal Products for Human Use (CHMP) that they wish to withdraw their application for a new indication for NovoSeven, in the treatment of acute intracerebral haemorrhage (ICH) in adults for limiting haemorrhage growth and improving clinical outcome.

  • List item

    Questions and answers on the withdrawal of the application for a change to the marketing authorisation for NovoSeven (PDF/35.33 KB)

    First published: 27/04/2006
    Last updated: 27/04/2006

  • Key facts

    Product number
    Date of issue of market authorisation valid throughout the European Union (if applicable)
    International non-proprietary name (INN) or common name
    • eptacog alfa (activated)
    Active substance
    • eptacog alfa (activated)
    Date of withdrawal
    Company making the application
    Novo Nordisk A/S
    Withdrawal type

    All documents

    Related content

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    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 90').

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