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
Last updated: 21/03/2022
|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
This medicine’s product information is available in all official EU languages.
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Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Long-term prophylactic treatment of bleeding in adult and paediatric patients 6 years and above with congenital factor-XIII-A-subunit deficiency.