Refixia

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nonacog beta pegol

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

Overview

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.

This EPAR was last updated on 02/08/2017

Authorisation details

Product details
Name
Refixia
Agency product number
EMEA/H/C/004178
Active substance
Nonacog beta pegol
International non-proprietary name (INN) or common name
nonacog beta pegol
Therapeutic area (MeSH)
Hemophilia B
Anatomical therapeutic chemical (ATC) code
B02BD04
Additional monitoring

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.

Publication details
Marketing-authorisation holder
Novo Nordisk A/S
Revision
0
Date of issue of marketing authorisation valid throughout the European Union
01/06/2017
Contact address
Novo Alle
2880 Bagsvaerd
Denmark

Product information

02/06/2017 Refixia - EMEA/H/C/004178 - -

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

Treatment and prophylaxis of bleeding in patients 12 years and above with haemophilia B (congenital factor IX deficiency).

Assessment history

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