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Beriplex P/N 500 IU, powder and solvent for solution for injection



CSL Behring GmbHPA0800/010/002

Main Information

Trade NameBeriplex P/N 500 IU, powder and solvent for solution for injection
Active SubstancesFactor ii activity
Factor vii activity
Factor x activity
Factor ix activity
Protein c activity
Protein s antigen
Dosage FormPowder and solvent for solution for injection
Licence HolderCSL Behring GmbH
Licence NumberPA0800/010/002

Group Information

ATC CodeB02BD Blood coagulation factors
B02BD01 coagulation factor IX, II, VII and X in combination

Status

License statusAuthorised
Licence Issued06/05/2016
Legal statusProduct subject to prescription which may not be renewed (A)
Supply StatusSupply through pharmacies only
Advertising StatusAdvertising to healthcare professionals only
Conditions of LicenceBatches of blood products marketed in Ireland shall be subject to control authority batch release in accordance with Article 114.2 of Directive 2001/83/EC as amended.
Marketing StatusNot marketed

Documents

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