Ingelheim, Germany, 4. November 2011: Boehringer Ingelheim today announced that Actilyse® has been approved through a mutual recognition procedure for15 European countries* for thrombolytic treatment of acute ischaemic stroke up to 4.5 hours of onset of stroke symptoms and after prior exclusion of intracranial haemorrhage. This regulatory milestone was communicated by the reference member state Germany and will result in subsequent national approvals of the extended indication in the respective countries of the EU covered by the procedure. The national product informations will be amended accordingly.
Actilyse® can be used to break up a blood clot which has blocked a blood vessel. This may help blood flow through the blood vessel to return to normal and has the potential to prevent ischaemic damage to brain tissue. Alteplase needs to be given as soon as possible after the occurrence of symptoms to have highest chances of benefit. Until today, the thrombolytic is the only approved treatment option for patients who suffer from an acute ischaemic stroke.