Docetaxel Accord

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docetaxel

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

Overview

Docetaxel Accord is a cancer medicine used to treat the following types of cancer:

  • breast cancer. Docetaxel Accord can be used on its own after other treatments have failed. It can also be used with other cancer medicines (capecitabine, cyclophosphamide, doxorubicin or trastuzumab) in patients who have not yet received treatment for their cancer or after other treatments have failed, depending on the type and stage of the breast cancer being treated;
  • non-small-cell lung cancer. Docetaxel Accord can be used on its own after other treatments have failed. It can also be used with cisplatin (another cancer medicine) in patients who have not yet received any treatment for their cancer;
  • prostate cancer that has spread to other parts of the body (metastatic). Docetaxel Accord is used with androgen-deprivation therapy (therapy greatly reducing the body’s production of testosterone) when such treatment still works. Docetaxel Accord is used with prednisone or prednisolone (anti-inflammatory medicines) when the cancer is castration resistant (androgen- deprivation therapy does not work);
  • metastatic gastric adenocarcinoma (a stomach cancer) in patients who have not yet received any treatment for metastatic cancer. Docetaxel Accord is used with cisplatin and fluorouracil (other cancer medicines);
  • head and neck cancer in patients whose cancer is locally advanced (a cancer that has grown but has not spread). Docetaxel Accord is used with cisplatin and fluorouracil.

Docetaxel Accord is a ‘generic medicine’. This means that Docetaxel Accord contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the EU called Taxotere. For more information on generic medicines, see the question-and-answer document below.

Docetaxel Accord contains the active substance docetaxel.

This EPAR was last updated on 08/04/2020

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
GenericGeneric

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 and hybrid medicines.

Publication details
Marketing-authorisation holder
Accord Healthcare S.L.U.
Revision
13
Date of issue of marketing authorisation valid throughout the European Union
22/05/2012
Contact address

World Trade Center
Moll de Barcelona
s/n, Edifici Est 6ª planta
08039 Barcelona
Spain

Product information

21/02/2020 Docetaxel Accord - EMEA/H/C/002539 - IB/0047

Contents

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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.

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