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

Ximelagatran 36 mg film coated tablets are reddish yellow tablets containing 36 mg of the active substance ximelagatran.

Ximelagatran 36 mg film coated tablets were to be used to prevent strokes and other complications due to excessive clotting in patients who suffer from atrial fibrillation (irregular contractions of the upper chambers of the heart).

Ximelagatran, the active substance in the medicine, is transformed in the body into the active form melagatran. Melagatran is an anti-coagulant medicine. It is an inhibitor of the formation of one of the enzymes in the blood, alpha-thrombin, that is involved in the coagulation (clotting) process, thus helping to prevent the complications due to excessive clotting (such as strokes) that can occur in patients with atrial fibrillation.

The effects of the medicine were first tested in experimental models before being studied in humans. The Company has submitted the results of studies where Ximelagatran 36 mg film coated tablets used twice daily for an average of 17 or 20 months, were compared to warfarin (another anti-coagulant medicine). The studies measured the number of complications due to excessive clotting that happened during the studies.

The CHMP takes up to 210 days to evaluate a new application. Based on the review of the initial documentation, the CHMP prepares a list of questions (at day 120), which is sent to the company. Once the company has supplied responses to the questions, the CHMP reviews them and may, before give an opinion, ask any remaining questions (at day 180) to be answered by the company in writing or during a hearing. Following CHMP opinion, it usually takes around 2 months to the European Commission to give a licence.

The application was at day 48 when the company withdrew.

The CHMP was evaluating the initial documentation provided by the company.

The CHMP was evaluating the initial documentation provided by the company and had not made any recommendation yet.

Withdrawal letter is available under the tab 'All documents'.

At the time of the withdrawal all ongoing clinical trials with ximelagatran were being stopped. Doctors involved in these trials have received information from AstraZeneca on what to do to close the trials, including how to change patients to alternative treatment. If you are in a clinical trial and need more information about your treatment, contact the doctor who is giving it to you. Patients must not stop treatment without consulting their doctor.