Halimatoz
adalimumab
Table of contents
Overview
The marketing authorisation for Halimatoz has been withdrawn at the request of the marketing-authorisation holder.
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List item
Halimatoz : EPAR - Medicine overview (PDF/671.76 KB)
First published: 03/08/2018
Last updated: 29/01/2021
EMA/509804/2018 -
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Halimatoz : EPAR - Risk-management-plan summary (PDF/695.34 KB)
First published: 03/08/2018
Last updated: 29/01/2021
Authorisation details
| Product details | |
|---|---|
| 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 | |
|---|---|
| Marketing-authorisation holder |
Sandoz GmbH
|
| Revision |
8
|
| Date of issue of marketing authorisation valid throughout the European Union |
26/07/2018
|
| Contact address |
Biochemiestrasse 10
6250 Kundl Austria |
Product information
18/12/2020 Halimatoz - EMEA/H/C/004866 - IG/1290
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.
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Pharmacotherapeutic group
Immunosuppressants
Therapeutic indication
Rheumatoid arthritis
Halimatoz in combination with methotrexate, is indicated for:
- the treatment of moderate to severe, active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drugs including methotrexate has been inadequate.
- the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate.
Halimatoz can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.
Adalimumab has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function, when given in combination with methotrexate.
Juvenile idiopathic arthritis
- Polyarticular juvenile idiopathic arthritis
Halimatoz in combination with methotrexate is indicated for the treatment of active polyarticular juvenile idiopathic arthritis, in patients from the age of 2 years who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDs). Halimatoz can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate (for the efficacy in monotherapy see section 5.1). Adalimumab has not been studied in patients aged less than 2 years.
- Enthesitis-related arthritis
Halimatoz is indicated for the treatment of active enthesitis-related arthritis in patients, 6 years of age and older, who have had an inadequate response to, or who are intolerant of, conventional therapy.
Axial spondyloarthritis
- Ankylosing spondylitis (AS)
Halimatoz is indicated for the treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy.
- Axial spondyloarthritis without radiographic evidence of AS
Halimatoz is indicated for the treatment of adults with severe axial spondyloarthritis without radiographic evidence of AS but with objective signs of inflammation by elevated CRP and / or MRI, who have had an inadequate response to, or are intolerant to nonsteroidal anti-inflammatory drugs.
Psoriatic arthritis
Halimatoz 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.
Adalimumab has been shown to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease and to improve physical function.
Psoriasis
Halimatoz is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy.
- Paediatric plaque psoriasis
Halimatoz 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.
Hidradenitis suppurativa (HS)
Halimatoz 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.
Crohn’s disease
Halimatoz 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.
- Paediatric Crohn's disease
Halimatoz 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.
- Ulcerative colitis/ Uveitis/ Paediatric uveitis
For full indication see 4.1.