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Octaplex 500 IU coagulation factor IX per vial, powder and solvent for solution for infusionHuman Prothrombin Complex



Octapharma (IP) SPRLPA2219/005/001

Main Information

Trade NameOctaplex 500 IU coagulation factor IX per vial, powder and solvent for solution for infusionHuman Prothrombin Complex
Active SubstancesHuman plasma coagulation factor ii
Human plasma coagulation factor vii
Human plasma coagulation factor ix
Human plasma coagulation factor x
Protein c
Protein s
Dosage FormPowder and solvent for solution for infusion
Licence HolderOctapharma (IP) SPRL
Licence NumberPA2219/005/001

Group Information

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

Status

Authorised/WithdrawnAuthorised
Licence Issued02/07/2004
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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