EPARs - Mabthera//Rituximab

FICHA FARMACOLÓGICA de rituximab. Contiene la Monografía en distintos idiomas (de la Comunidad Económica 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. Cerasale. ABRIL 08, 2009.

ABRIR AQUÍ:
EPARs for authorised medicinal products for human use - Mabthera

Active Substance
Rituximab
International Nonproprietary Name or Common Name
Rituximab
Pharmaco-therapeutic Group
Antineoplastic agents Monoclonal antibodies
ATC Code
L01XC02

Therapeutic Indication:
* Non-Hodgkin’s Lymphoma
MabThera is indicated for the treatment of previously untreated patients with stage III-IV follicular lymphoma in combination with chemotherapy.

MabThera maintenance therapy is indicated for patients with relapsed/refractory follicular lymphoma responding to induction therapy with chemotherapy with or without MabThera.

MabThera monotherapy is indicated for treatment of patients with stage III-IV follicular lymphoma who are chemoresistant or are in their second or subsequent relapse after chemotherapy.

MabThera is indicated for the treatment of patients with CD20 positive diffuse large B cell non-Hodgkin’s lymphoma in combination with CHOP (cyclophosphamide, doxorubicin, vincristine, prednisolone) chemotherapy.

* Chronic lymphocytic leukaemia
MabThera is indicated for first-line treatment of patients with chronic lymphocytic leukaemia (CLL) in combination with chemotherapy.

* Rheumatoid arthritis
MabThera in combination with methotrexate is indicated for the treatment of adult patients with severe active rheumatoid arthritis who have had an inadequate response or intolerance to other disease-modifying anti-rheumatic drugs (DMARD) including one or more tumour necrosis factor (TNF) inhibitor therapies.

Date of issue of Marketing Authorisation valid throughout the European Union
2 June 1998