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    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

    How useful was this page?

    Add your rating
    Average
    16 ratings
    22 ratings
    13 ratings
    21 ratings