Ximelagatran 36 mg film coated tablets: Withdrawal of the marketing authorisation application


On 14 February 2006, AstraZeneca officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Ximelagatran 36 mg film coated tablets, for the prevention of stroke and other thromboembolic complications associated with atrial fibrillation.The withdrawal is part of a global withdrawal of all medicines containing ximelagatran or melegatran, and the impact of the withdrawal of medicines already on the market is being taken care of by the authorities in the countries where the medicines were marketed.

Key facts

Ximelagatran 36 mg film coated tablets
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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

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