BeneFIX

RSS

nonacog alfa

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

Overview

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.

This EPAR was last updated on 17/10/2022

Authorisation details

Product details
Name
BeneFIX
Agency product number
EMEA/H/C/000139
Active substance
Nonacog alfa
International non-proprietary name (INN) or common name
nonacog alfa
Therapeutic area (MeSH)
Hemophilia B
Anatomical therapeutic chemical (ATC) code
B02BD04
Publication details
Marketing-authorisation holder
Pfizer Europe MA EEIG
Revision
42
Date of issue of marketing authorisation valid throughout the European Union
27/08/1997
Contact address

Boulevard de la Plaine 17
1050 Bruxelles
Belgium

Product information

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:

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).

Assessment history

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