Boehringer Ingelheim announced the first approval for Actilyse (alteplase) 2mg within the European Union, which was communicated by the reference member state Germany after successful completion of a mutual recognition procedure.
The new indication is for the thrombolytic treatment of occluded central venous access devices (CVAD), including those used for haemodialysis. This regulatory milestone will result in subsequent approvals of the new indication in the relevant countries of the European Union throughout 2008 onwards.
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