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


Prolastin 4000 mg, powder and solvent for solution for infusion



Grifols Deutschland GmbHPA1405/002/002

Main Information

Trade NameProlastin 4000 mg, powder and solvent for solution for infusion
Active SubstancesHuman alpha1-proteinase inhibitor
Dosage FormPowder and solvent for solution for infusion
Licence HolderGrifols Deutschland GmbH
Licence NumberPA1405/002/002

Group Information

ATC CodeB02AB02 alfa1 antitrypsin

Status

License statusAuthorised
Licence Issued13/10/2023
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 StatusNot marketed

Documents

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