Hemlibra
emicizumab
Table of contents
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.
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List item
Hemlibra : EPAR - Medicine overview (PDF/83.55 KB)
First published: 01/03/2018
Last updated: 12/04/2019
EMA/162298/2019 -
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Hemlibra : EPAR - Risk-management-plan summary (PDF/77.71 KB)
First published: 01/03/2018
Last updated: 12/04/2019
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 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 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 | |
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Marketing-authorisation holder |
Roche Registration Limited
|
Revision |
7
|
Date of issue of marketing authorisation valid throughout the European Union |
23/02/2018
|
Contact address |
Product information
07/12/2020 Hemlibra - EMEA/H/C/004406 - IB/0020
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.