Kalbitor:

Withdrawal of the marketing authorisation application

ecallantide

Overview

On 11 November 2011, Dyax s.a. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Kalbitor, intended for the treatment of symptoms of acute attacks of hereditary angioedema.

  • List item

    Questions and answers on the withdrawal of the marketing authorisation application for Kalbitor (PDF/57.51 KB)


    First published: 23/11/2011
    Last updated: 09/02/2012
    EMA/888548/2011

  • Key facts

    Name
    Kalbitor
    Product number
    EMEA/H/C/002200
    International non-proprietary name (INN) or common name
    • ecallantide
    Active substance
    • ecallantide
    Date of withdrawal
    11/11/2011
    Company making the application
    Dyax s.a.
    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    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

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