EMEA-000428-PIP01-08-M03

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Overview

Product details for NovoEight
Invented nameNovoEight
Active substance

turoctocog alpha

Decision numberP/0207/2016
PIP numberEMEA-000428-PIP01-08-M03
Pharmaceutical form(s)Powder and solvent for solution for injection
Condition(s)/indication(s)

Treatment of hereditary factor-VIII deficiency

Route(s) of administrationIntravenous use
PIP applicant

Novo Nordisk A/S
Denmark
Tel. +45 44448888
E-mail: paediatrics@novonordisk.com

Decision typePM: decision on the application for modification of an agreed PIP

Decision