Alprolix

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eftrenonacog 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 Alprolix. 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 Alprolix.

For practical information about using Alprolix, patients should read the package leaflet or contact their doctor or pharmacist.

This EPAR was last updated on 10/04/2019

Authorisation details

Product details
Name
Alprolix
Agency product number
EMEA/H/C/004142
Active substance
eftrenonacog alfa
International non-proprietary name (INN) or common name
eftrenonacog alfa
Therapeutic area (MeSH)
Hemophilia B
Anatomical therapeutic chemical (ATC) code
B02BD04
Additional monitoringAdditional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

OrphanOrphan

This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.

Publication details
Marketing-authorisation holder
Swedish Orphan Biovitrum AB (publ)
Revision
4
Date of issue of marketing authorisation valid throughout the European Union
12/05/2016
Contact address
SE-112 76 Stockholm
Sweden

Product information

21/02/2019 Alprolix - EMEA/H/C/004142 - II/0021

Contents

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

  • VITAMIN K AND OTHER HEMOSTATICS
  • Blood coagulation factors

Therapeutic indication

Treatment and prophylaxis of bleeding in patients with haemophilia B (congenital factor IX deficiency).

Assessment history

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