The HPRA advises healthcare professionals not to retain printed versions of Summary of Product Characteristics (SPC) documents. As these documents are subject to frequent content updates, including changes to safety and dose related information, we recommend that you visit our website as necessary to access the most up-to-date versions. If you have any queries about specific SPCs on our website then please e-mail

Actilyse 50 mg powder and solvent for solution for injection and infusion

Boehringer Ingelheim International GmbHPA0775/011/003

Main Information

Trade NameActilyse 50 mg powder and solvent for solution for injection and infusion
Active SubstancesAlteplase
Dosage FormPowder and solvent for solution for injection/infusion
Licence HolderBoehringer Ingelheim International GmbH
Licence NumberPA0775/011/003

Group Information

ATC CodeB01AD Enzymes
B01AD02 alteplase


License statusAuthorised
Licence Issued19/06/1989
Legal statusProduct subject to prescription which may not be renewed (A)
Supply StatusSupply through pharmacies only
Advertising StatusAdvertising to healthcare professionals only
Conditions of Licence
Marketing StatusMarketed


Summary of Product CharacteristicsPDF Version
Package LeafletPDF Version
Public Assessment ReportNo document available
« Back