Viagra: Withdrawal of the application to change the marketing authorisation
Table of contents
Overview
On 19 November 2008, Pfizer Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a change to the marketing authorisation for the medicinal product Viagra 50 mg tablets. The change concerned 'switching' the classification of the medicine from 'medicinal product subject to medical prescription' to 'medicinal product not subject to medical prescription'.
Key facts
Name |
Viagra |
Product number |
EMEA/H/C/000202 |
Date of issue of market authorisation valid throughout the European Union (if applicable) |
13/09/1998 |
International non-proprietary name (INN) or common name |
|
Active substance |
|
Date of withdrawal |
19/11/2008 |
Company making the application | |
Withdrawal type |
Post-authorisation |
All documents
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Pfizer withdraws its application to change the marketing authorisation for Viagra 50 mg (sildenafil) from prescription-only to non-prescription (PDF/25.21 KB)
First published: 20/11/2008
Last updated: 20/11/2008
EMEA/619122/2008 -
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Withdrawal letter : Viagra (PDF/36.14 KB)
First published: 19/11/2008
Last updated: 19/11/2008 -
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Withdrawal assessment report for Viagra (PDF/228.26 KB)
Adopted
First published: 26/06/2008
Last updated: 26/06/2008
EMEA/130321/2009 -
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Questions and answers on the withdrawal of the application for a change to the marketing authorisation for Viagra (PDF/36.72 KB)
First published: 18/12/2008
Last updated: 18/12/2008
EMEA/609574/2008
Related information on withdrawals
The question-and-answer (Q&A) document provides a summary of the CHMP's evaluation of the application at the time of the withdrawal, 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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 90').