Hemlibra

RSS

emicizumab

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

Overview

An overview of Hemlibra and why it is authorised in the EU

Hemlibra is a medicine used to prevent or reduce bleeding in patients with haemophilia A (an inherited bleeding disorder caused by lack of factor VIII). It is used in patients who have developed factor VIII inhibitors, which are antibodies in the blood that act against factor VIII medicines and prevent them from working properly.

Hemlibra contains the active substance emicizumab.

This EPAR was last updated on 20/09/2018

Authorisation details

Product details
Name
Hemlibra
Agency product number
EMEA/H/C/004406
Active substance
Emicizumab
International non-proprietary name (INN) or common name
emicizumab
Therapeutic area (MeSH)
Hemophilia A
Anatomical therapeutic chemical (ATC) code
B02BX
Additional 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.

Publication details
Marketing-authorisation holder
Roche Registration Limited
Revision
2
Date of issue of marketing authorisation valid throughout the European Union
23/02/2018
Contact address
6 Falcon Way, Shire Park
Welwyn Garden City
AL7 1TW
United Kingdom

Product information

23/08/2018 Hemlibra - EMEA/H/C/004406 - IB/0005

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

ANTIHEMORRHAGICS
 

Therapeutic indication

Hemlibra is indicated for routine prophylaxis of bleeding episodes in patients with haemophilia A with factor VIII inhibitors.

Hemlibra can be used in all age groups.

Assessment history

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