Sildenafil FGK: Withdrawal of the marketing authorisation application

sildenafil

Overview

FGK Representative Service GmbH withdrew its application for a marketing authorisation of Sildenafil FGK for the treatment of adult men with erectile dysfunction.

The company withdrew the application on 19 July 2021.

  • List item

    Questions and answers on the withdrawal of application for the marketing authorisation of Sildenafil FGK (sildenafil) (PDF/115.35 KB)


    First published: 17/09/2021

  • Key facts

    Name
    Sildenafil FGK
    Product number
    EMEA/H/C/005439
    International non-proprietary name (INN) or common name
    • sildenafil
    Active substance
    • sildenafil citrate
    Date of withdrawal
    19/07/2021
    Company making the application
    FGK Representative Service GmbH
    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    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

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