NovoThirteen

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catridecacog

Authorised
This medicine is authorised for use in the European Union.

Overview

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.

This EPAR was last updated on 21/03/2022

Authorisation details

Product details
Name
NovoThirteen
Agency product number
EMEA/H/C/002284
Active substance
catridecacog
International non-proprietary name (INN) or common name
catridecacog
Therapeutic area (MeSH)
Blood Coagulation Disorders, Inherited
Anatomical therapeutic chemical (ATC) code
B02BD11
Publication details
Marketing-authorisation holder
Novo Nordisk A/S
Revision
7
Date of issue of marketing authorisation valid throughout the European Union
03/09/2012
Contact address

Novo Allé
DK-2880 Bagsvaerd
Denmark

Product information

27/08/2020 NovoThirteen - EMEA/H/C/002284 - II/0026

Other EU languages available icon This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.

 

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.

Pharmacotherapeutic group

Antihemorrhagics

Therapeutic indication

Long-term prophylactic treatment of bleeding in adult and paediatric patients 6 years and above with congenital factor-XIII-A-subunit deficiency.

Assessment history

Changes since initial authorisation of medicine

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