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 04/11/2021

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
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
8
Date of issue of marketing authorisation valid throughout the European Union
12/05/2016
Contact address

SE-112 76 Stockholm
Sweden

Product information

09/09/2021 Alprolix - EMEA/H/C/004142 - II/0036/G

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

  • 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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