Hulio
adalimumab
Table of contents
Overview
Hulio 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);
- Crohn’s disease (a disease causing inflammation of the gut);
- ulcerative colitis (a disease causing inflammation and ulcers in the lining of the gut);
- 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).
Hulio is mostly used in adults when their condition is severe, moderately severe or getting worse, or when patients cannot use other treatments. For more information on the use of Hulio in all conditions, including when it can be used in children, see the package leaflet or contact your doctor or pharmacist.
Hulio contains the active substance adalimumab and is a ‘biosimilar medicine’. This means that Hulio is highly similar to another biological medicine (the ‘reference medicine’) that is already authorised in the EU. The reference medicine for Hulio is Humira.
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List item
Hulio : EPAR - Medicine overview (PDF/83.04 KB)
First published: 21/09/2018
Last updated: 21/09/2018
EMA/518630/2018 -
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List item
Hulio : EPAR - Risk-management-plan summary (PDF/191.2 KB)
First published: 21/09/2018
Last updated: 05/08/2022
Authorisation details
Product details | |
---|---|
Name |
Hulio
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Agency product number |
EMEA/H/C/004429
|
Active substance |
adalimumab
|
International non-proprietary name (INN) or common name |
adalimumab
|
Therapeutic area (MeSH) |
|
Anatomical therapeutic chemical (ATC) code |
L04AB04
|
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 |
Biosimilar Collaborations Ireland Limited
|
Revision |
16
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Date of issue of marketing authorisation valid throughout the European Union |
17/09/2018
|
Contact address |
Unit 35/36 |
Product information
30/11/2023 Hulio - EMEA/H/C/004429 - IAIN/0045
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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
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Immunosuppressants
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Tumor necrosis factor alpha (TNF-α) inhibitors