Erlotinib (as erlotinib hydrochloride) - EPARs for authorised medicinal products for human use - Tarceva

FICHA FARMACOLÓGICA de Erlotinib (as erlotinib hydrochloride . 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. MAYO 21, 2010.-

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EPARs for authorised medicinal products for human use - Tarceva

Active Substance
Erlotinib (as erlotinib hydrochloride)
International Nonproprietary Name or Common Name
Erlotinib
Pharmaco-therapeutic Group
Antineoplastic agent
ATC Code
L01XE03

Therapeutic Indication
Non-small cell lung cancer (NSCLC):
Tarceva is indicated for the treatment of patients with locally advanced or metastatic non‑small cell lung cancer after failure of at least one prior chemotherapy regimen.

When prescribing Tarceva, factors associated with prolonged survival should be taken into account.

No survival benefit or other clinically relevant effects of the treatment have been demonstrated in patients with EGFR- negative tumours .

Pancreatic cancer:
Tarceva in combination with gemcitabine is indicated for the treatment of patients with metastatic pancreatic cancer.

When prescribing Tarceva, factors associated with prolonged survival should be taken into account .

No survival advantage could be shown for patients with locally advanced disease.


Date of issue of Marketing Authorisation valid throughout the European Union
19 September 2005

Orphan medicinal product designation date
Not applicable


EPARs for authorised medicinal products for human use