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 info@hpra.ie


Rapilysin



Actavis Group PTC ehfEU/1/96/018/001

Main Information

Trade NameRapilysin
Active SubstancesReteplase
Dosage FormPowder and solvent for solution for injection
Licence HolderActavis Group PTC ehf
Licence NumberEU/1/96/018/001

Group Information

ATC CodeB01AD Enzymes
B01AD07 reteplase

Status

License statusAuthorised
Licence Issued29/08/1996
Legal statusProduct subject to prescription which may not be renewed (A)
Supply StatusSupply through pharmacies only
Advertising StatusAdvertising to healthcare professionals only
Conditions of LicenceMedicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2)
Marketing StatusNot marketed

Documents

Summary of Product CharacteristicsSearch EMA website
Package LeafletSearch EMA website
Public Assessment ReportSearch EMA website
« Back