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 26/11/2020

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
6
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/G

Contents

  • 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.

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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