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NanoFIX 500 IU, 500 IU powder and solvent for solution for injection



Octapharma (IP) SPRLPA2219/009/001

Main Information

Trade NameNanoFIX 500 IU, 500 IU powder and solvent for solution for injection
Active SubstancesFactor ix, human
Dosage FormPowder and solvent for solution for injection
Licence HolderOctapharma (IP) SPRL
Licence NumberPA2219/009/001

Group Information

ATC CodeB02BD Blood coagulation factors
B02BD04 coagulation factor IX

Status

License statusAuthorised
Licence Issued15/10/2010
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 NanoFIX 500 IU marketed in Ireland shall be subject to control authority batch release in accordance with Article 114.2 of directive 2001/83/EC as amended. Final approved mock-ups for NanoFIX 500 IU must be submitted to the IMB for approval prior to the placing of NanoFIX 500 IU on the Irish market.
Marketing StatusNot marketed

Documents

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