This is a summary of the European public assessment report (EPAR) for Remsima. It explains how the European Medicines Agency assessed the medicine to recommend its authorisation in the European Union (EU) and its conditions of use. It is not intended to provide practical advice on how to use Remsima.
For practical information about using Remsima, patients should read the package leaflet or contact their doctor or pharmacist.
Remsima : EPAR - Summary for the public (PDF/85.9 KB)
First published: 04/10/2013
Last updated: 04/10/2013
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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.
Celltrion Healthcare Hungary Kft.
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21/06/2018 Remsima - EMEA/H/C/002576 - R/0047
- 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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tumour necrosis factor alpha (TNFα) inhibitors
Remsima, in combination with methotrexate, is indicated for the reduction of signs and symptoms as well as the improvement in physical function in:
- adult patients with active disease when the response to disease‑modifying antirheumatic drugs (DMARDs), including methotrexate, has been inadequate;
- adult patients with severe, active and progressive disease not previously treated with methotrexate or other DMARDs.
In these patient populations, a reduction in the rate of the progression of joint damage, as measured by X‑ray, has been demonstrated.
Adult Crohn’s disease
Remsima 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;
- treatment of fistulising, active Crohn’s disease, in adult patients who have not responded despite a full and adequate course of therapy with conventional treatment (including antibiotics, drainage and immunosuppressive therapy).
Paediatric Crohn’s disease
Remsima is indicated for treatment of severe, active Crohn’s disease in children and adolescents aged six to 17 years, who have not responded to conventional therapy including a corticosteroid, an immunomodulator and primary nutrition therapy; or who are intolerant to or have contraindications for such therapies. Infliximab has been studied only in combination with conventional immunosuppressive therapy.
Remsima 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.
Paediatric ulcerative colitis
Remsima is indicated for treatment of severely active ulcerative colitis in children and adolescents aged six to 17 years, who have had an inadequate response to conventional therapy including corticosteroids and 6‑MP or AZA, or who are intolerant to or have medical contraindications for such therapies.
Remsima is indicated for treatment of severe, active ankylosing spondylitis, in adult patients who have responded inadequately to conventional therapy.
Remsima is indicated for treatment of active and progressive psoriatic arthritis in adult patients when the response to previous DMARD therapy has been inadequate.
Remsima should be administered:
- in combination with methotrexate;
- or alone in patients who show intolerance to methotrexate or for whom methotrexate is contraindicated.
Infliximab has been shown to improve physical function in patients with psoriatic arthritis, and to reduce the rate of progression of peripheral joint damage as measured by X‑ray in patients with polyarticular symmetrical subtypes of the disease.
Remsima is indicated for treatment of moderate to severe plaque psoriasis in adult patients who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapy including cyclosporine, methotrexate or psoralen ultra-violet A (PUVA).