Aquilda: Withdrawal of the marketing authorisation application


On 23 May 2008, Sanofi-Aventis officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Aquilda, for the treatment of euvolaemic and hypervolaemic dilutional hyponatraemia.

Key facts

Product number
Date of withdrawal
Company making the application
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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

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