Docetaxel Mylan

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docetaxel

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for Docetaxel Mylan has lapsed because 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
Name
Docetaxel Mylan
Agency product number
EMEA/H/C/002317
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
GenericGeneric

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.
Revision
6
Date of issue of marketing authorisation valid throughout the European Union
31/01/2012
Contact address
117 allée des Parcs
F-69 800 Saint Priest
France

Product information

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

Other EU languages available icon This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.

 

Product information documents contain:

  • summary of product characteristics (annex I);
  • manufacturing authorisation holder responsible for batch release (annex IIA);
  • conditions of the marketing authorisation (annex IIB);
  • labelling (annex IIIA);
  • package leaflet (annex IIIB).

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

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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