Pristiqs: Withdrawal of the marketing authorisation application

Overview

On 10 March 2008, Wyeth Europe Ltd officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Pristiqs, for the treatment of vasomotor symptoms (hot flushes) associated with the menopause.

Key facts

Name
Pristiqs
Product number
EMEA/H/C/000794
Date of withdrawal
10/03/2008
Company making the application
Wyeth Europe Ltd.
Withdrawal type
Initial authorisation

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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

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