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Community register of medicinal products for human use


Product information

Invented name: Voncento   
Auth. number : EU/1/13/857
Active substance : 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)
Prophylaxis and treatment of haemorrhage or 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, 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
7/04/2014 Centralised - Variation EMEA/H/C/2493/IB/6
Updated with Decision(2015)3151 of 05/05/2015
4/11/2014 Centralised - Variation EMEA/H/C/2493/IA/9
Updated with Decision(2015)3151 of 05/05/2015
8/12/2014 Centralised - Variation EMEA/H/C/2493/IA/11/G
Updated with Decision(2015)3151 of 05/05/2015
7/05/2015 Centralised - Yearly update (2015)3151 of 5/05/2015
4/08/2015 Centralised - 2-Monthly update EMEA/H/C/2493/II/8/G (2015)5579 of 31/07/2015
10/11/2016 Centralised - Variation EMEA/H/C/2493/II/21/G
Updated with Decision(2017)5354 of 25/07/2017
22/07/2017 Centralised - Variation EMEA/H/C/2493/IB/29
Updated with Decision(2017)7736 of 15/11/2017
28/07/2017 Centralised - 2-Monthly update EMEA/H/C/2493/II/17/G (2017)5354 of 25/07/2017
17/11/2017 Referral EMEA/H/C/2493/A31/22 (2017)7736 of 15/11/2017
30/04/2018 Centralised - Renewal EMEA/H/C/2493/R/32 (2018)2697 of 26/04/2018