Blectifor: Withdrawal of the marketing authorisation application

caffeine citrate

Overview

On 9 March 2017, Viridian Pharma Ltd officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Blectifor, for the prevention of bronchopulmonary dysplasia.

  • List item

    Questions and answers on the withdrawal of the marketing authorisation application for Blectifor (caffeine citrate) (PDF/74.71 KB)


    First published: 24/03/2017
    Last updated: 24/03/2017
    EMA/188385/2017

  • Key facts

    Name
    Blectifor
    Product number
    EMEA/H/C/004100
    International non-proprietary name (INN) or common name
    • caffeine citrate
    Active substance
    • Caffeine citrate
    Date of withdrawal
    09/03/2017
    Company making the application
    Viridian Pharma 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    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

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