Docetaxel Accord

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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 Docetaxel Accord. 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 Docetaxel Accord.

This EPAR was last updated on 06/07/2018

Authorisation details

Product details
Name
Docetaxel Accord
Agency product number
EMEA/H/C/002539
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
  • Breast Neoplasms
Anatomical therapeutic chemical (ATC) code
L01CD02
Generic

This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic medicines.

Publication details
Marketing-authorisation holder
Accord Healthcare Ltd
Revision
10
Date of issue of marketing authorisation valid throughout the European Union
22/05/2012
Contact address
Ground Floor
Sage House
319 Pinner Road
North Harrow
Middlesex
HA1 4HF
United Kingdom

Product information

18/06/2018 Docetaxel Accord - EMEA/H/C/002539 - IB/0036

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

Docetaxel Accord 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.

Docetaxel Accord 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.

Docetaxel Accord 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.

Docetaxel Accord 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.

Docetaxel Accord 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

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

Docetaxel Accord 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

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

Gastric adenocarcinoma

Docetaxel Accord 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

Docetaxel Accord 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

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