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Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Voncento   
Auth. number : EU/1/13/857
INN : human coagulation factor VIII / human von Willebrand factor
ATC: Anatomical main group: B - Blood and blood forming organs
Therapeutic subgroup: B02 - Antihemorrhagics
Pharmacological subgroup: B02B - Vitamin K and other hemostatics
Chemical subgroup: B02BD - Blood coagulation factors
Chemical substance: B02BD06 - Von Willebrand factor and coagulation factor VIII in combination
(See WHO ATC Index)
Indication: von Willebrand disease (VWD)
Treatment of haemorrhage or prevention and treatment of surgical bleeding in patients with VWD, when desmopressin (DDAVP) treatment alone is ineffective or contraindicated.
Haemophilia A (congenital FVIII deficiency)
Prophylaxis and treatment of bleeding in patients with haemophilia A.
Marketing Authorisation Holder: CSL Behring GmbH
Emil-von-Behring-Straße 76, D-35041 Marburg, Deutschland

  EPAR and active package presentations

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Community Register.

 

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
14/08/2013 Centralised - Authorisation EMEA/H/C/2493 (2013)5450 of 12/08/2013
07/04/2014 Centralised - Variation EMEA/H/C/2493/IB/6