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500 IU/5 millilitre(s) Powder and solvent for solution for injection

Baxalta Innovations GmbHEU/1/17/1247/005-008

Main Information

Active SubstancesRurioctocog alfa pegol
Strength500 IU/5 millilitre(s)
Dosage FormPowder and solvent for solution for injection
Licence HolderBaxalta Innovations GmbH
Licence NumberEU/1/17/1247/005-008

Group Information

ATC CodeB02BD Blood coagulation factors
B02BD02 coagulation factor VIII


Licence Issued08/01/2018
Legal statusProduct subject to prescription which may not be renewed (A)
Supply StatusSupply through pharmacies only
Advertising StatusAdvertising to healthcare professionals only
Conditions of Licence
Marketing StatusUnknown


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