Etanercept - EPARs for authorised medicinal products for human use - Enbrel

FICHA FARMACOLÓGICA de Etanercept . 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. JUNIO 02, 2010.-

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EPARs for authorised medicinal products for human use - Enbrel

Active Substance
Etanercept
Internationa Nonproprietary Name or Common Name
Etanercept
Pharmaco-therapeutic Group
Immunosuppressants, Tumour necrosis factor alpha (TNF-α) inhibitors
ATC Code
L04 AB01

Therapeutic Indication
Rheumatoid arthritisEnbrel in combination with methotrexate is indicated for the treatment of moderate to severe active rheumatoid arthritis in adults when the response to disease-modifying antirheumatic drugs, including methotrexate (unless contraindicated), has been inadequate. (Enbrel 25mg - Enbrel 50mg)

Enbrel can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. (Enbrel 25mg - Enbrel 50mg)

Enbrel is also indicated in the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate. (Enbrel 25mg - Enbrel 50mg)

Enbrel, alone or in combination with methotrexate, has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function. (Enbrel 25mg - Enbrel 50mg)



Polyarticular juvenile idiopathic arthritis
Treatment of active polyarticular juvenile idiopathic arthritis in children and adolescents from the age of 4 years who have had an inadequate response to, or who have proved intolerant of, methotrexate. Enbrel has not been studied in children aged less than 4 years. (Enbrel 25mg - Enbrel 25 mg/ml)



Psoriatic arthritis
Treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying antirheumatic drug therapy has been inadequate. Enbrel 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. (Enbrel 25mg - Enbrel 50mg)



Ankylosing spondylitis
Treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy. (Enbrel 25mg - Enbrel 50mg)



Plaque psoriasis
Treatment of adults with moderate to severe plaque psoriasis who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapy including ciclosporin, methotrexate or psoralen and ultraviolet-A light (PUVA)


Paediatric plaque psoriasis
Treatment of chronic severe plaque psoriasis in children and adolescents from the age of 8 years who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies. (Enbrel 25mg – Enbrel 25mg/ml - Enbrel 50mg)



Date of issue of Marketing Authorisation valid throughout the European Union
3 February 2000

Orphan medicinal product designation date
Not applicable


EPARs for authorised medicinal products for human use