EMEA-000312-PIP01-08-M07

Key facts

Invented name
Voncento
Active substance
  • Human coagulation factor VIII
  • von Willebrand factor
Therapeutic area
Haematology-Hemostaseology
Decision number
P/0274/2014
PIP number
EMEA-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 administration
Intravenous use
Contact for public enquiries
CSL Behring
Germany
E-mail: eu-cslbehring@cslbehring.com
Tel. +49 642 1395212
Fax +49 642 1394196
Decision type
PM: decision on the application for modification of an agreed PIP
Compliance procedure number
EMEA-C-000312-PIP01-08-M07
Compliance opinion date
22/05/2015
Compliance outcome
positive

Decision

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