Infinia: Withdrawal of the marketing authorisation application

alpha-1-antitrypsin

Overview

On 21 June 2017, Kamada BioPharma Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Infinia, for the treatment of adults with lung disease due to congenital deficiency of alpha-1-antitrypsin.

  • List item

    Questions and answers on the withdrawal of the marketing authorisation application for Infinia (alpha-1-antitrypsin) (PDF/75.2 KB)


    First published: 21/07/2017
    Last updated: 16/02/2018
    EMA/440995/2017

  • Key facts

    Name
    Infinia
    Product number
    EMEA/H/C/003934
    International non-proprietary name (INN) or common name
    • alpha-1-antitrypsin
    Active substance
    • alpha-1-antitrypsin
    Date of withdrawal
    21/06/2017
    Company making the application
    Kamada BioPharma Limited at Fieldfisher LLP
    Withdrawal type
    Initial authorisation

    All documents

    Related content

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    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

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