lunes, 19 de abril de 2010

golimumab - EPARs for authorised medicinal products for human use - Simponi



FICHA FARMACOLÓGICA de golimumab. 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. ABRIL 19, 2010.-

abrir aquí para acceder al documento EMA completo:
EPARs for authorised medicinal products for human use - Simponi

Active Substance
golimumab
International Nonproprietary Name or Common Name
golimumab
Pharmaco-therapeutic Group
Tumor necrosis factor alpha (TNF-α) inhibitors
ATC Code
L04AB06

Therapeutic Indication
Rheumatoid arthritis (RA)

Simponi, in combination with methotrexate (MTX), is indicated for the treatment of moderate to severe, active rheumatoid arthritis in adult patients when the response to disease‑modifying anti‑rheumatic drug (DMARD) therapy including MTX has been inadequate.

Simponi has also been shown to improve physical function in this patient population.

Psoriatic arthritis (PsA)
Simponi, alone or in combination with MTX, is indicated for the treatment of active and progressive psoriatic arthritis in adult patients when the response to previous disease‑modifying anti‑rheumatic drug (DMARD) therapy has been inadequate.

Simponi has also been shown to improve physical function in this patient population.

Ankylosing spondylitis (AS)

Simponi is indicated for the treatment of severe, active ankylosing spondylitis in adult patients who have responded inadequately to conventional therapy.

Date of issue of Marketing Authorisation valid throughout the European Union
1 October 2009

Orphan medicinal product designation date
Not applicable


EPARs for authorised medicinal products for human use

No hay comentarios:

Publicar un comentario