Hemlibra

RSS

emicizumab

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

Overview

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).

The medicine 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. It is also used in patients without factor VIII inhibitors if their haemophilia A is severe.

Hemlibra contains the active substance emicizumab.

This EPAR was last updated on 05/06/2019

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
Accelerated assessmentAccelerated assessment

This medicine had an accelerated assessment. This means that it is a medicine of major interest for public health, so its timeframe for review was 150 evaluation days rather than 210. For more information, see Accelerated assessment.

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.

Publication details
Marketing-authorisation holder
Roche Registration Limited
Revision
5
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

11/04/2019 Hemlibra - EMEA/H/C/004406 - IB/0011

Contents

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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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