infliximab - EPARs for authorised medicinal products for human use - Remicade

FICHA FARMACOLÓGICA de infliximab . Contiene la Monografía en distintos idiomas (de la Unión Europea), así como la discusión científica que sustenta su aprobación terapéutica. Para acceder a la monografía en idioma español, hacer doble clik en la sigla (es) en la fila que se sitúa más abajo del centro de la página oficial. Se recuerda que todas las informaciones científico-clínicas, así como técnicas propias de la producción, sólo se publican en idioma inglés. Cerasale. MAYO 28, 2010.-

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EPARs for authorised medicinal products for human use - Remicade

Active Substance
infliximab
International Nonproprietary Name or Common Name
infliximab
Pharmaco-therapeutic Group
Selective immunosuppressive agents
ATC Code
L04AB02

Therapeutic Indication
Rheumatoid arthritis:
Remicade, in combination with methotrexate, is indicated for:
the reduction of signs and symptoms as well as the improvement in physical function in:
- patients with active disease when the response to disease-modifying anti-rheumatic drugs (DMARDs), including methotrexate, has been inadequate.
- 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 (see section 5.1).


Adult Crohn’s disease:
Remicade is indicated for:
- treatment of severe, active Crohn’s disease, in 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 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:
Remicade is indicated for:
Treatment of severe, active Crohn’s disease, in paediatric patients aged 6 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. Remicade has been studied only in combination with conventional immunosuppressive therapy.

Ulcerative colitis:
Remicade is indicated for:
Treatment of moderately to severely active ulcerative colitis in patients 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.

Ankylosing spondylitis:
Remicade is indicated for:
Treatment of severe, active ankylosing spondylitis, in adult patients who have responded inadequately to conventional therapy.

Psoriatic arthritis:
Remicade is indicated for:
Treatment of active and progressive psoriatic arthritis in adults when the response to previous DMARD therapy has been inadequate
Remicade should be administered
- in combination with methotrexate
- or alone in patients who show intolerance to methotrexate or for whom methotrexate is contraindicated.
Remicade 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 (see Section 5.1).

Psoriasis:
Remicade is indicated for:
Treatment of moderate to severe plaque psoriasis in adults who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapy including cyclosporine, methotrexate or PUVA (see section 5.1).


Date of issue of Marketing Authorisation valid throughout the European Union
13 August 1999

Orphan medicinal product designation date
Not applicable


EPARs for authorised medicinal products for human use