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
24/06/2021 BeneFIX - EMEA/H/C/000139 - P46/147
- 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
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Treatment and prophylaxis of bleeding in patients with haemophilia B (congenital factor-IX deficiency).