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.

    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

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