The HPRA advises healthcare professionals not to retain printed versions of Summary of Product Characteristics (SPC) documents. As these documents are subject to frequent content updates, including changes to safety and dose related information, we recommend that you visit our website as necessary to access the most up-to-date versions. If you have any queries about specific SPCs on our website then please e-mail info@hpra.ie


ADYNOVI

2000 IU/5 millilitre(s) Powder and solvent for solution for injection

Baxalta Innovations GmbHEU/1/17/1247/013-014

Main Information

Trade NameADYNOVI
Active SubstancesRurioctocog alfa pegol
Strength2000 IU/5 millilitre(s)
Dosage FormPowder and solvent for solution for injection
Licence HolderBaxalta Innovations GmbH
Licence NumberEU/1/17/1247/013-014

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
« Back