lapatinib - EPARs for authorised medicinal products for human use - Tyverb

FICHA FARMACOLÓGICA de lapatinib . 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. JULIO 09, 2010.-

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EPARs for authorised medicinal products for human use - Tyverb

Active Substance
lapatinib
International Nonproprietary Name or Common Name
lapatinib
Pharmaco-therapeutic Group
Protein kinase inhibitors
ATC Code
L01XE07

Therapeutic Indication:
Tyverb is indicated for the treatment of patients with breast cancer, whose tumours overexpress HER2 (ErbB2);

- in combination with capecitabine for patients with advanced or metastatic disease with progression following prior therapy, which must have included anthracyclines and taxanes and therapy with trastuzumab in the metastatic setting (see section 5.1).

- in combination with an aromatase inhibitor for postmenopausal women with hormone receptor positive metastatic disease, not currently intended for chemotherapy. The patients in the registration study were not previously treated with trastuzumab or an aromatase inhibitor (See section 5.1).

Date of issue of Marketing Authorisation valid throughout the European Union
10 June 2008


Orphan medicinal product designation date
Not applicable


EPARs for authorised medicinal products for human use