Docetaxel Zentiva (previously Docetaxel Winthrop)

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docetaxel

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

Overview

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

  • breast cancer. Docetaxel Zentiva can be used on its own after other treatments have failed. It can also be used with other cancer medicines (doxorubicin, cyclophosphamide, trastuzumab or capecitabine) in patients who have not yet received any 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 Zentiva 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, when the cancer does not respond to hormonal treatment. Docetaxel Zentiva is used with prednisone or prednisolone (anti‑inflammatory medicines);
  • gastric adenocarcinoma (a type of stomach cancer) in patients who have not yet received any treatment for their cancer. Docetaxel Zentiva is used with cisplatin and 5‑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 Zentiva is used with cisplatin and 5‑fluorouracil.

Docetaxel Zentiva contains the active substance docetaxel.

This EPAR was last updated on 23/05/2019

Authorisation details

Product details
Name
Docetaxel Zentiva (previously Docetaxel Winthrop)
Agency product number
EMEA/H/C/000808
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
Zentiva k.s.
Revision
30
Date of issue of marketing authorisation valid throughout the European Union
20/04/2007
Contact address

U kabelovny 130
Dolni Mecholupy
102 37 Prague 10
Czech Republic

Product information

14/02/2019 Docetaxel Zentiva (previously Docetaxel Winthrop) - EMEA/H/C/000808 - WS/1540

Contents

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Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

Breast cancer

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

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

Gastric adenocarcinoma

Docetaxel Winthrop 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 Winthrop 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

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