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NanoFIX 1000 IU, 1000 IU powder and solvent for solution for injection



Octapharma (IP) SPRLPA2219/009/002

Main Information

Trade NameNanoFIX 1000 IU, 1000 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 NumberPA2219/009/002

Group Information

ATC CodeB02BD Blood coagulation factors
B02BD04 coagulation factor IX

Status

License statusWithdrawn
Withdrawn Date11/01/2024
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 1,000 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 1,000 IU must be submitted to the IMB for approval prior to the placing of NanoFIX 1,000 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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