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Octaplex 1000 IU coagulation factor IX per vial, powder and solvent for solution for infusionHuman Prothrombin Complex



Octapharma (IP) SPRLPA2219/005/002

Main Information

Trade NameOctaplex 1000 IU coagulation factor IX per vial, powder and solvent for solution for infusionHuman Prothrombin Complex
Active SubstancesHuman coagulation factor ii
Human coagulation factor vii
Human coagulation factor ix
Human coagulation factor x
Protein c
Protein s
Dosage FormPowder and solvent for solution for infusion
Licence HolderOctapharma (IP) SPRL
Licence NumberPA2219/005/002

Group Information

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

Status

License statusAuthorised
Licence Issued13/11/2015
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 marketed in Ireland shall be subject to control authority batch release in accordance with Article 114.2 of Directive 2001/83/EC.
Marketing StatusMarketed

Documents

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