Taxotere

RSS

docetaxel

Authorised
This medicine is authorised for use in the European Union.

Overview

This is a summary of the European public assessment report (EPAR) for Taxotere. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Taxotere.

This EPAR was last updated on 21/03/2018

Authorisation details

Product details
Name
Taxotere
Agency product number
EMEA/H/C/000073
Active substance
docetaxel
International non-proprietary name (INN) or common name
docetaxel
Therapeutic area (MeSH)
  • Head and Neck Neoplasms
  • Carcinoma, Non-Small-Cell Lung
  • Adenocarcinoma
  • Prostatic Neoplasms
  • Stomach Neoplasms
  • Breast Neoplasms
Anatomical therapeutic chemical (ATC) code
L01CD02
Publication details
Marketing-authorisation holder
Aventis Pharma S.A.
Revision
43
Date of issue of marketing authorisation valid throughout the European Union
27/11/1995
Contact address
20 avenue Raymond Aron
92165 Antony Cedex
France

Product information

01/02/2018 Taxotere - EMEA/H/C/000073 - WS/1267

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

Breast cancer

Taxotere in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with:

  • operable node-positive breast cancer;
  • operable node-negative breast cancer.

For patients with operable node-negative breast cancer, adjuvant treatment should be restricted to patients eligible to receive chemotherapy according to internationally established criteria for primary therapy of early 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 ormetastatic 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 overexpress 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.

Assessment history

Changes since initial authorisation of medicine

How useful was this page?

Add your rating