Rixubis
nonacog gamma
Table of contents
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.
-
List item
Rixubis : EPAR - Summary for the public (PDF/77.2 KB)
First published: 10/02/2015
Last updated: 10/02/2015
EMA/663763/2014 -
-
List item
Rixubis : EPAR - Risk-management-plan summary (PDF/63.77 KB)
First published: 10/02/2015
Last updated: 10/02/2015
EMA/677082/2014
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 |
11
|
Date of issue of marketing authorisation valid throughout the European Union |
19/12/2014
|
Contact address |
Industriestrasse 67
1221 Vienna Austria |
Product information
22/09/2022 Rixubis - EMEA/H/C/003771 - N/0045
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.
Pharmacotherapeutic group
Antihemorrhagics
Therapeutic indication
Treatment and prophylaxis of bleeding in patients with haemophilia B (congenital factor IX deficiency).