NovoThirteen

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catridecacog

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

Overview

This is a summary of the European public assessment report (EPAR) for NovoThirteen. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for NovoThirteen.

This EPAR was last updated on 28/07/2017

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
5
Date of issue of marketing authorisation valid throughout the European Union
02/09/2012
Contact address
Novo Allé
DK-2880 Bagsvaerd
Denmark

Product information

24/05/2017 NovoThirteen - EMEA/H/C/002284 - R/0020

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

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