Docetaxel - EPARs for human use [REVISIÓN Y ACTUALIZACIÓN MONOGRÁFICA]

FICHA FARMACOLÓGICA de Docetaxel. 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. MARZO 31, 2010.-

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

Active Substance
Docetaxel
International Nonproprietary Name or Common Name
Docetaxel
Pharmaco-therapeutic Group
Taxanes
ATC Code
L01CD 02

Therapeutic Indications:
Breast cancer

TAXOTERE in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with operable node‑positive breast cancer.

TAXOTERE in combination with doxorubicin is indicated for the treatment of patients with locally advanced or metastatic breast cancer who have not previously received cytotoxic therapy for this condition.

TAXOTERE monotherapy is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic therapy. Previous chemotherapy should have included an anthracycline or an alkylating agent.

TAXOTERE in combination with trastuzumab is indicated for the treatment of patients with metastatic breast cancer whose tumours over express HER2 and who previously have not received chemotherapy for metastatic disease.

TAXOTERE in combination with capecitabine is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. Previous therapy should have included an anthracycline.

Non-small cell lung cancer

TAXOTERE is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of prior chemotherapy.

TAXOTERE in combination with cisplatin is indicated for the treatment of patients with unresectable, locally advanced or metastatic non-small cell lung cancer, in patients who have not previously received chemotherapy for this condition.

Prostate cancer

TAXOTERE in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone refractory metastatic prostate cancer.

Gastric adenocarcinoma

TAXOTERE in combination with cisplatin and 5‑fluorouracil is indicated for the treatment of patients with metastatic gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who have not received prior chemotherapy for metastatic disease.

Head and neck cancer

TAXOTERE in combination with cisplatin and 5‑fluorouracil is indicated for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck.


Date of issue of Marketing Authorisation valid throughout the European Union
27 November 1995

Orphan medicinal product designation date
Not applicable

EPARs for authorised medicinal products for human use