Sildenafil FGK: Withdrawal of the marketing authorisation application
sildenafil
Table of contents
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.
Key facts
Name |
Sildenafil FGK |
Product number |
EMEA/H/C/005439 |
International non-proprietary name (INN) or common name |
|
Active substance |
|
Date of withdrawal |
19/07/2021 |
Company making the application | |
Withdrawal type |
Initial authorisation |
All documents
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Withdrawal assessment report for Sildenafil FGK (sildenafil) (PDF/502.86 KB)
Adopted
First published: 05/10/2021
EMA/409352/2021 -
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Withdrawal letter: Sildenafil FGK (PDF/13.33 KB)
First published: 17/09/2021 -
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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 -
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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').