abatacept - EPARs for human use - orencia

FICHA FARMACOLÓGICA de abatacept. 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. FEBRERO 25, 2010.-

abrir aquí para acceder al documento EMEA completo:
http://www.ema.europa.eu/humandocs/Humans/EPAR/orencia/orencia.htm

Active Substance
abatacept
International Nonproprietary Name or Common Name
abatacept
Pharmaco-therapeutic Group
Selective immunosuppressive agents
ATC Code
L04AA24

Therapeutic Indication:
Rheumathoid arthritis:

ORENCIA in combination with methotrexate is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have had an insufficient response or intolerance to other disease modifying anti- rheumatic drugs (DMARDs) including at least one tumour necrosis factor (TNF) inhibitor. A reduction in the progression of joint damage and improvement of physical function have been demonstrated during combination treatment with abatacept and methotrexate.



Polyarticular juvenile idiopathic arthritis:

ORENCIA in combination with methotrexate is indicated for the treatment of moderate to severe active polyarticular juvenile idiopathic arthritis (JIA) in paediatric patients 6 years of age and older who have had an insufficient response to other DMARDs including at least one TNF inhibitor. ORENCIA has not been studied in children under 6 years old

Date of issue of Marketing Authorisation valid throughout the European Union
21 May 2007


Orphan medicinal product designation date
Not applicable


EPARs for authorised medicinal products for human use