Docetaxel Zentiva (previously Docetaxel Winthrop)

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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 Winthrop. 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 Winthrop.

This EPAR was last updated on 19/02/2019

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
28
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

26/11/2018 Docetaxel Zentiva (previously Docetaxel Winthrop) - EMEA/H/C/000808 - T/0056

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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