EMEA-000312-PIP01-08-M07

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Overview

Product details for Voncento
Invented nameVoncento
Active substance

Human coagulation factor VIII / von Willebrand factor

Decision numberP/0274/2014
PIP numberEMEA-000312-PIP01-08-M07
Pharmaceutical form(s)Powder and solvent for solution for injection, powder and solvent for solution for infusion
Condition(s)/indication(s)

Treatment of von Willebrand disease

Treatment of hereditary factor-VIII deficiency (Haemophilia A)

Route(s) of administrationIntravenous use
PIP applicant

CSL Behring
Germany
E-mail: biostate@cslbehring.com
Tel. +49 642 1395212
Fax +49 642 1394196

Decision typePM: decision on the application for modification of an agreed PIP
Compliance check procedure numberEMEA-C-000312-PIP01-08-M07
Compliance check opinion date22/05/2015
Compliance check outcomePositive

Decision