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Alprolix

250 international unit(s) Powder and solvent for solution for injection

Swedish Orphan Biovitrum ABEU/1/16/1098/001

Main Information

Trade NameAlprolix
Active SubstancesEftrenonacog alfa
Strength250 international unit(s)
Dosage FormPowder and solvent for solution for injection
Licence HolderSwedish Orphan Biovitrum AB
Licence NumberEU/1/16/1098/001

Group Information

ATC CodeB02BD Blood coagulation factors
B02BD04 coagulation factor IX

Status

Authorised/WithdrawnAuthorised
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

Documents

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