Docetaxel Mylan

Lapsed

This medicine's authorisation has lapsed

docetaxel

Overview

On 31 January 2015, the marketing authorisation of Docetaxel Mylan (docetaxel) ceased to be valid in the European Union (EU). The cessation of validity is due to the fact that the marketing authorisation holder, MYLAN S.A.S., had not marketed Docetaxel Mylan in the EU since its initial marketing authorisation in January 2012. In accordance with provisions of the sunset clause, the marketing authorisation of the medicinal product lapsed as the product had not been marketed in any of the EU Member States within three years of its initial authorisation. MYLAN S.A.S. confirmed that the product had not been marketed due to commercial reasons. 

Docetaxel Mylan was granted marketing authorisation in the EU on 31 January 2012 for treatment of breast cancer, non-small cell lung cancer, prostate cancer, gastric adenocarcinoma and head and neck cancer. 

Docetaxel Mylan 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Report (EPAR) for Docetaxel Mylan is updated accordingly to reflect the fact that the marketing authorisation is no longer valid.

Docetaxel Mylan : EPAR - Summary for the public

Reference Number: EMA/949959/2011

Product information

Docetaxel Mylan : EPAR - Product Information

Docetaxel Mylan : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Docetaxel Mylan
• 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

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

Treatment of breast cancer, special forms of lung cancer (non-small-cell lung cancer), prostate cancer, gastric cancer, or head and neck cancer.

Authorisation details

• EMA product number:
  EMEA/H/C/002317
• 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:
  Mylan S.A.S.

  117 allée des Parcs; F-69 800 Saint Priest; France

• Marketing authorisation issued:
  31/01/2012
• Lapse of marketing authorisation:
  31/01/2015
• Revision:
  6

Assessment history

Changes since initial authorisation of medicine

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

Initial marketing authorisation documents

Docetaxel Mylan : EPAR - Public assessment report

Adopted Reference Number: EMA/40836/2012

CHMP summary of positive opinion for Docetaxel Mylan

Adopted Reference Number: EMA/CHMP/858298/2011