Docetaxel Teva

Withdrawn

This medicine's authorisation has been withdrawn

docetaxel

Overview

On 11 October 2021, the European Commission withdrew the marketing authorisation for Docetaxel Teva (docetaxel) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Teva B.V., which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons. 

Docetaxel Teva was granted marketing authorisation in the EU on 26 January 2010 for the treatment of breast cancer, non-small cell lung cancer, prostate cancer, gastric adenocarcinoma and head and neck cancer. 

The marketing authorisation was initially valid for a 5-year period. It was then granted unlimited validity in 2014. Docetaxel Teva is a generic medicine of Taxotere. There are other generic medicinal products of Taxotere authorised and marketed in the EU. 

The European Public Assessment Report (EPAR) for Docetaxel Teva is updated to indicate that the marketing authorisation is no longer valid.

Docetaxel Teva : EPAR - Medicine overview

Reference Number: EMA/112747/2011

Product information

Docetaxel Teva : EPAR - Product Information

Docetaxel Teva : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Docetaxel Teva
• 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

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

Breast cancer

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

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

Gastric adenocarcinoma

Docetaxel Teva 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 Teva 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.

Authorisation details

• EMA product number:
  EMEA/H/C/001107
• 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 and hybrid medicines.

• Marketing authorisation holder:
  Teva B.V.

  Teva B.V.; Swensweg 5; 2031 GA Haarlem; The Netherlands

• Opinion adopted:
  19/11/2009
• Marketing authorisation issued:
  26/01/2010
• Revision:
  18

Assessment history

Changes since initial authorisation of medicine

Docetaxel Teva : EPAR - Procedural steps taken and scientific information after authorisation

Initial marketing authorisation documents

Docetaxel Teva : EPAR - Public assessment report

CHMP summary of positive opinion for Docetaxel Teva

AdoptedReference Number: EMEA/CHMP/726960/2009