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Swedish Orphan Biovitrum ABEU/1/16/1098/004

Main Information

Trade NameAlprolix
Active SubstancesEftrenonacog alfa
Dosage FormPowder and solvent for solution for injection
Licence HolderSwedish Orphan Biovitrum AB
Licence NumberEU/1/16/1098/004

Group Information

ATC CodeB02BD Blood coagulation factors
B02BD04 coagulation factor IX


License statusAuthorised
Licence Issued12/05/2016
Legal statusProduct subject to prescription which may not be renewed (A)
Supply StatusSupply through pharmacies only
Advertising StatusAdvertising to healthcare professionals only
Conditions of LicenceMedicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Marketing StatusUnknown


Summary of Product CharacteristicsSearch EMA website
Package LeafletSearch EMA website
Public Assessment ReportSearch EMA website
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