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Baxalta Innovations GmbHEU/1/17/1247/015-016

Main Information

Trade NameAdynovi
Active SubstancesRurioctocog alfa pegol
Dosage FormPowder for solution for injection
Licence HolderBaxalta Innovations GmbH
Licence NumberEU/1/17/1247/015-016

Group Information

ATC CodeB02BD02 coagulation factor VIII


License statusAuthorised
Licence Issued06/01/2022
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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