Hukyndra
adalimumab
Table of contents
Overview
Hukyndra is a medicine that acts on the immune system (the body’s natural defences) 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);
- polyarticular juvenile idiopathic arthritis and enthesitis-related arthritis (both rare diseases causing inflammation in the joints);
- axial spondyloarthritis (inflammation of the spine causing back pain), including ankylosing spondylitis and when there are clear signs of inflammation, but X-ray does not show disease;
- 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 chronic 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).
Hukyndra 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 Hukyndra in all conditions, including when it can be used in children, see the package leaflet or contact your doctor or pharmacist.
Hukyndra is a ‘biosimilar medicine’. This means that Hukyndra is highly similar to another biological medicine (the ‘reference medicine’) that is already authorised in the EU. The reference medicine for Hukyndra is Humira. For more information on biosimilar medicines, see here.
Hukyndra contains the active substance adalimumab.
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List item
Hukyndra : EPAR - Medicine overview (PDF/137.42 KB)
First published: 18/01/2022
Last updated: 25/01/2022
EMA/544649/2021 -
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List item
Hukyndra : EPAR - Risk management plan summary (PDF/109 KB)
First published: 18/01/2022
Authorisation details
Product details | |
---|---|
Name |
Hukyndra
|
Agency product number |
EMEA/H/C/005548
|
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 |
Stada Arzneimittel AG
|
Revision |
4
|
Date of issue of marketing authorisation valid throughout the European Union |
15/11/2021
|
Contact address |
Stadastrasse 2-18 |
Product information
09/03/2023 Hukyndra - EMEA/H/C/005548 - N/0009
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
Immunosuppressants
Therapeutic indication
Rheumatoid arthritis Ulcerative colitis |