Docetaxel Mylan



This medicine is now withdrawn from use in the European Union.


The marketing authorisation for Docetaxel Mylan has lapsed becasue it has not been marketed in the European Union in the three years following the granting of the authorisation.

This EPAR was last updated on 12/03/2015

Authorisation details

Product details
Docetaxel Mylan
Agency product number
Active substance
docetaxel, anhydrous
International non-proprietary name (INN) or common name
Therapeutic area (MeSH)
  • Head and Neck Neoplasms
  • Carcinoma, Non-Small-Cell Lung
  • Adenocarcinoma
  • Prostatic Neoplasms
  • Breast Neoplasms
Anatomical therapeutic chemical (ATC) code

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.

Publication details
Marketing-authorisation holder
Mylan S.A.S.
Date of issue of marketing authorisation valid throughout the European Union
Contact address
117 allée des Parcs
F-69 800 Saint Priest

Product information

01/02/2015 Docetaxel Mylan - EMEA/H/C/002317 - IB/0006


  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

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.

Assessment history

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