Table of contents
This is a summary of the European Public Assessment Report (EPAR) for BeneFIX. 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 BeneFIX.
BeneFIX : EPAR - Summary for the public (PDF/83.05 KB)
First published: 12/05/2009
Last updated: 30/10/2015
BeneFIX : EPAR - Risk-management-plan summary (PDF/177.73 KB)
First published: 14/05/2020
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
Pfizer Europe MA EEIG
|Date of issue of marketing authorisation valid throughout the European Union||
Boulevard de la Plaine 17
12/10/2022 BeneFIX - EMEA/H/C/000139 - N/0173
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 with haemophilia B (congenital factor-IX deficiency).