Viagra: Withdrawal of the application to change the marketing authorisation

sildenafil

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)
14/09/1998
International non-proprietary name (INN) or common name
  • sildenafil
Active substance
  • sildenafil
Date of withdrawal
19/11/2008
Company making the application
Pfizer Limited
Withdrawal type
Post-authorisation

Related content

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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 90').

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