Docetaxel Teva Pharma

Lapsed

This medicine's authorisation has lapsed

docetaxel

Overview

On 21 January 2014, the marketing authorisation for Docetaxel Teva Pharma (docetaxel) ceased to be valid in the European Union (EU). Docetaxel Teva Pharma is a generic medicinal product of Taxotere. Docetaxel Teva Pharma was never marketed in the EU after its initial marketing authorisation in January 2011. 

In accordance with provisions of the sunset clause, the marketing authorisation of a medicinal product lapses if the product is not marketed in any of the EU Member States within three years of its initial authorisation. There are other generic medicinal products of Taxotere authorised and marketed in the EU. Docetaxel Teva Pharma was granted marketing authorisation in the EU on 21 January 2011 for the treatment of breast cancer, non-small cell lung cancer, and prostate cancer. The marketing authorisation holder was Teva Pharma B.V. 

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Assessment Report (EPAR) for Docetaxel Teva Pharma is updated to reflect the fact that the marketing authorisation is no longer valid.

Docetaxel Teva Pharma : EPAR - Summary for the public

Reference Number: EMA/698861/2010

Product information

Docetaxel Teva Pharma : EPAR - Product Information

Docetaxel Teva Pharma : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Docetaxel Teva Pharma
• Active substance:
  docetaxel
• International non-proprietary name (INN) or common name:
  docetaxel
• Therapeutic area (MeSH):
  • Carcinoma, Non-Small-Cell Lung
  • Breast Neoplasms
  • Prostatic Neoplasms
• Anatomical therapeutic chemical (ATC) code:
  L01CD02

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

Breast cancer

Docetaxel Teva Pharma 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.

Non-small-cell lung cancer

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

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

Authorisation details

• EMA product number:
  EMEA/H/C/002032
• 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 Pharma B.V.

  Computerweg 10; NL-3542 DR Utrecht; The Netherlands

• Marketing authorisation issued:
  21/01/2011
• Lapse of marketing authorisation:
  21/01/2014
• Revision:
  6

Assessment history

Changes since initial authorisation of medicine

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

Initial marketing authorisation documents

Docetaxel Teva Pharma : EPAR - Public assessment report

Adopted Reference Number: EMA/32518/2011

CHMP summary of positive opinion for Docetaxel Teva Pharma

Adopted Reference Number: EMA/CHMP/630633/2010