P/0381/2017

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Overview

Product details for Obizur
Invented nameObizur
Active substance

Susoctocog alfa

Decision numberEMEA-000753-PIP02-16
PIP numberP/0381/2017
Pharmaceutical form(s)Powder and solvent for solution for injection
Condition(s)/indication(s)

Treatment of congenital haemophilia A with antibodies (inhibitors) to human factor VIII

Route(s) of administrationIntravenous use
PIP applicant

Baxalta Innovations GmbH
Tel. +43 1201000
E-mail: eu.ra.Info@baxalta.com

Decision typeP: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)

Decision

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