NovoThirteen is a medicine that prevents excessive bleeding in patients with an inherited blood clotting disorder called ‘congenital factor XIII A-subunit deficiency’. It is used to prevent bleeding and to treat any episodes of bleeding that occur during preventative treatment.
NovoThirteen contains the active substance catridecacog.
NovoThirteen : EPAR - Medicine overview (PDF/140.73 KB)
First published: 25/09/2012
Last updated: 26/11/2020
NovoThirteen : EPAR - Risk-management-plan summary (PDF/90.45 KB)
First published: 26/11/2020
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
Blood Coagulation Disorders, Inherited
|Anatomical therapeutic chemical (ATC) code||
Novo Nordisk A/S
|Date of issue of marketing authorisation valid throughout the European Union||
27/08/2020 NovoThirteen - EMEA/H/C/002284 - II/0026/G
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
Please note that the size of the above document can exceed 50 pages.
You are therefore advised to be selective about which sections or pages you wish to print.
Long-term prophylactic treatment of bleeding in adult and paediatric patients 6 years and above with congenital factor-XIII-A-subunit deficiency.