Rixubis

RSS

nonacog gamma

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

Overview

This is a summary of the European public assessment report (EPAR) for Rixubis. 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 Rixubis.

For practical information about using Rixubis, patients should read the package leaflet or contact their doctor or pharmacist.

This EPAR was last updated on 20/11/2019

Authorisation details

Product details
Name
Rixubis
Agency product number
EMEA/H/C/003771
Active substance
nonacog gamma
International non-proprietary name (INN) or common name
nonacog gamma
Therapeutic area (MeSH)
Hemophilia B
Anatomical therapeutic chemical (ATC) code
B02BD04
Publication details
Marketing-authorisation holder
Baxalta Innovations GmbH
Revision
7
Date of issue of marketing authorisation valid throughout the European Union
19/12/2014
Contact address
Industriestrasse 67
1221 Vienna
Austria

Product information

14/11/2019 Rixubis - EMEA/H/C/003771 - R/0029

Contents

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

  • Antihaemorrhagics
  • blood coagulation factor IX

Therapeutic indication

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

Assessment history

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