ReFacto AF

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moroctocog 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 ReFacto AF. 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 ReFacto AF.

This EPAR was last updated on 16/08/2018

Authorisation details

Product details
Name
ReFacto AF
Agency product number
EMEA/H/C/000232
Active substance
moroctocog alfa
International non-proprietary name (INN) or common name
moroctocog alfa
Therapeutic area (MeSH)
Hemophilia A
Anatomical therapeutic chemical (ATC) code
B02BD02
Publication details
Marketing-authorisation holder
Pfizer Europe MA EEIG
Revision
35
Date of issue of marketing authorisation valid throughout the European Union
13/04/1999
Contact address

Boulevard de la Plaine 17
1050 Bruxelles
Belgium

Product information

02/08/2018 ReFacto AF - EMEA/H/C/000232 - T/0146

Contents

  • 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

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

Therapeutic indication

Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor-VIII deficiency).

ReFacto AF is appropriate for use in adults and children of all ages, including newborns.

ReFacto AF does not contain von-Willebrand factor, and hence is not indicated in von-Willebrand's disease.

Assessment history

Changes since initial authorisation of medicine

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