Halimatoz
adalimumab
Table of contents
Overview
An overview of Halimatoz and why it is authorised in the EU
Halimatoz is a medicine that acts on the immune system and is used to treat the following conditions:
- plaque psoriasis (a disease causing red, scaly patches on the skin);
- psoriatic arthritis (a disease causing red, scaly patches on the skin with inflammation of the joints);
- rheumatoid arthritis (a disease causing inflammation of the joints);
- axial spondyloarthritis (inflammation of the spine causing back pain), including ankylosing spondylitis and when X-ray does not show disease but there are clear signs of inflammation;
- polyarticular juvenile idiopathic arthritis and active enthesitis-related arthritis (both rare diseases causing inflammation in the joints);
- hidradenitis suppurativa (acne inversa), a long-term skin disease that causes lumps, abscesses (collections of pus) and scarring on the skin;
- non-infectious uveitis (inflammation of the layer beneath the white of the eyeball).
Halimatoz is mostly used in adults when their conditions are severe, moderately severe or getting worse, or when patients cannot use other treatments. For more information on the use of Halimatoz in all conditions, including when it can be used in children, see the package leaflet or contact your doctor or pharmacist.
Halimatoz contains the active substance adalimumab and is a ‘biosimilar medicine’. This means that Halimatoz is highly similar to another biological medicine (the ‘reference medicine’) that is already authorised in the EU. The reference medicine for Halimatoz is Humira.
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List item
Halimatoz : EPAR - Medicine overview (PDF/83.75 KB)
First published: 03/08/2018
Last updated: 03/08/2018
EMA/509804/2018 -
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Halimatoz : EPAR - Risk-management-plan summary (PDF/527.26 KB)
First published: 03/08/2018
Last updated: 03/08/2018
Authorisation details
Product details | |
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Name |
Halimatoz
|
Agency product number |
EMEA/H/C/004866
|
Active substance |
adalimumab
|
International non-proprietary name (INN) or common name |
adalimumab
|
Therapeutic area (MeSH) |
|
Anatomical therapeutic chemical (ATC) code |
L04AB04
|
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. |
Biosimilar |
This is a biosimilar medicine, which is a biological medicine highly similar to another already approved biological medicine called the ‘reference medicine’. For more information, see Biosimilar medicines. |
Publication details | |
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Marketing-authorisation holder |
Sandoz GmbH
|
Revision |
1
|
Date of issue of marketing authorisation valid throughout the European Union |
26/07/2018
|
Contact address |
Product information
15/10/2018 Halimatoz - EMEA/H/C/004866 - IB/0002/G
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
Immunosuppressants
Therapeutic indication
Please refer to the product information document.