Ceprotin: Withdrawal of the application to change the marketing authorisation

human protein C

Overview

On 22 October 2014, Baxter AG officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a new indication for Ceprotin to treat acquired protein C deficiency.

  • List item

    Questions and answers on the withdrawal of the application for a change to the marketing authorisation for Ceprotin (human protein C) (PDF/86.65 KB)


    First published: 21/11/2014
    Last updated: 21/11/2014
    EMA/706787/2014

  • Key facts

    Name
    Ceprotin
    Product number
    EMEA/H/C/000334
    Date of issue of market authorisation valid throughout the European Union (if applicable)
    15/07/2001
    International non-proprietary name (INN) or common name
    • human protein C
    Active substance
    • human protein C
    Date of withdrawal
    22/10/2014
    Company making the application
    Baxter AG
    Withdrawal type
    Post-authorisation

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    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 90').

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