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ADYNOVI

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

Baxalta Innovations GmbHEU/1/17/1247/001-004

Main Information

Trade NameADYNOVI
Active SubstancesRurioctocog alfa pegol
Strength250 IU/5 millilitre(s)
Dosage FormPowder and solvent for solution for injection
Licence HolderBaxalta Innovations GmbH
Licence NumberEU/1/17/1247/001-004

Group Information

ATC CodeB02BD Blood coagulation factors
B02BD02 coagulation factor VIII

Status

Authorised/WithdrawnAuthorised
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

Documents

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