nonacog beta pegol
Table of contents
This is a summary of the European public assessment report (EPAR) for Refixia. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Refixia.
For practical information about using Refixia, patients should read the package leaflet or contact their doctor or pharmacist.
Refixia : EPAR - Summary for the public (PDF/76.54 KB)
First published: 02/08/2017
Last updated: 02/08/2017
Refixia : EPAR - Risk-management-plan summary (PDF/97.54 KB)
First published: 17/06/2020
|Agency product number||
Nonacog beta pegol
|International non-proprietary name (INN) or common name||
nonacog beta pegol
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.
Novo Nordisk A/S
|Date of issue of marketing authorisation valid throughout the European Union||
12/12/2022 Refixia - EMEA/H/C/004178 - X/0027/G
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.
Treatment and prophylaxis of bleeding in patients 12 years and above with haemophilia B (congenital factor IX deficiency).