Hyrimoz
adalimumab
Table of contents
Overview
Hyrimoz 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).
Hyrimoz 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 Hyrimoz in all conditions, including when it can be used in children, see the package leaflet or contact your doctor or pharmacist.
Hyrimoz contains the active substance adalimumab and is a ‘biosimilar medicine’. This means that Hyrimoz is highly similar to another biological medicine (the ‘reference medicine’) that is already authorised in the EU. The reference medicine for Hyrimoz is Humira. For more information on biosimilar medicines, see here.
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List item
Hyrimoz : EPAR - Medicine overview (PDF/137.27 KB)
First published: 02/08/2018
Last updated: 07/07/2021
EMA/89930/2020 -
List item
Hyrimoz : EPAR - Risk-management-plan summary (PDF/76.5 KB)
First published: 02/08/2018
Last updated: 19/11/2021
Authorisation details
Product details | |
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Name |
Hyrimoz
|
Agency product number |
EMEA/H/C/004320
|
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 |
10
|
Date of issue of marketing authorisation valid throughout the European Union |
26/07/2018
|
Contact address |
Biochemiestrasse 10 |
Product information
15/02/2023 Hyrimoz - EMEA/H/C/004320 - R/0037
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 Hyrimoz in combination with methotrexate, is indicated for: - Polyarticular juvenile idiopathic arthritis - Ankylosing spondylitis (AS) Hyrimoz is indicated for the treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying anti-rheumatic drug therapy has been inadequate. Hyrimoz is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy. Hyrimoz is indicated for the treatment of severe chronic plaque psoriasis in children and adolescents from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapies. Hyrimoz is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adults and adolescents from 12 years of age with an inadequate response to conventional systemic HS therapy. Hyrimoz is indicated for treatment of moderately to severely active Crohn’s disease in adult patients who have not responded despite a full and adequate course of therapy with a corticosteroid and / or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies. Hyrimoz is indicated for the treatment of moderately to severely active Crohn's disease in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including primary nutrition therapy and a corticosteroid and / or an immunomodulator, or who are intolerant to or have contraindications for such therapies. Paediatric ulcerative colitis Hyrimoz is indicated for the treatment of moderately to severely active ulcerative colitis in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including corticosteroids and/or 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies.
Hyrimoz is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies. Uveitis Hyrimoz is indicated for the treatment of non-infectious intermediate, posterior and panuveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroid-sparing, or in whom corticosteroid treatment is inappropriate. Paediatric uveitis Hyrimoz is indicated for the treatment of paediatric chronic non-infectious anterior uveitis in patients from 2 years of age who have had an inadequate response to or are intolerant to conventional therapy, or in whom conventional therapy is inappropriate. |