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Pharmaceuticals - Community Register


Community register of medicinal products for human use


Product information

Invented name: NovoThirteen   
Auth. number : EU/1/12/775
Active substance : catridecacog
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: B02BD11 - catridecacog
(See WHO ATC Index)
Indication: Long term prophylactic treatment of bleeding in adult and paediatric patients with congenital factor XIII A-subunit deficiency.
Marketing Authorisation Holder: Novo Nordisk A/S
Novo Allé, 2880 Bagsvaerd, Danmark
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
05/09/2012 Centralised - Authorisation EMEA/H/C/2284 (2012)6198 of 03/09/2012
05/09/2012 Centralised - Authorisation - Decision addressed to Member States EMEA/H/C/2284 (2012)6197 of 03/09/2012
25/02/2014 Centralised - 2-Monthly update EMEA/H/C/2284/II/2 (2014)1302 of 21/02/2014
26/05/2016 Centralised - Variation EMEA/H/C/2284/II/13
Updated with Decision(2017)3749 of 24/05/2017
23/03/2017 Centralised - Variation EMEA/H/C/2284/II/18
Updated with Decision(2017)3749 of 24/05/2017
30/06/2017 Centralised - Renewal EMEA/H/C/2284/R/20 (2017)3749 of 24/05/2017