Docetaxel Teva Pharma

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docetaxel

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for Docetaxel Teva Pharma has lapsed because it ceased to be marketed in the European Union more than three years ago and an exemption granted by the European Commission has expired.

This EPAR was last updated on 21/01/2014

Authorisation details

Product details
Name
Docetaxel Teva Pharma
Agency product number
EMEA/H/C/002032
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
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
Teva Pharma B.V.
Revision
6
Date of issue of marketing authorisation valid throughout the European Union
21/01/2011
Contact address
Computerweg 10
NL-3542 DR Utrecht
The Netherlands

Product information

21/01/2014 Docetaxel Teva Pharma - EMEA/H/C/002032 - IB/7/G

Contents

  • 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

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.

Assessment history

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