Bayer Schering Pharma has notified the EMEA of its decision to withdraw its application for a centralised marketing authorisation for the medicine Recothrom (thrombin alfa) 1,000 IU/ml. Recothrom was still under the review process by the CHMP at the time of withdrawl. In its official letter, the company stated that the withdrawal of the application was based on the concerns raised by the Committee regarding the choice of study population for the label in general surgery as well as the choice of comparator relative to the CHMP fibrin sealant guideline.
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