Docefrez

Withdrawn

This medicine's authorisation has been withdrawn

docetaxel

Overview

On 10 May 2010 the European Commission issued a marketing authorisation valid throughout the European Union for the medicinal product Docefrez (docetaxel).

The Marketing Authorisation Holder (MAH) responsible for Docefrez was Sun Pharmaceutical Industries Europe B.V. The European Commission was notified by a letter dated 5 December 2011 of the MAH’s decision to voluntarily withdraw the marketing authorisation as of the Commission Decision date for Docefrez for commercial reasons. 

Docefrez was only marketed in Germany. On 25 May 2012 the European Commission issued a decision to withdraw the marketing authorisation for Docefrez. 

Pursuant to this decision the European Public Assessment Report for Docefrez is updated to reflect that the marketing authorisation is no longer valid.

Docefrez : EPAR - Summary for the public

Product information

Docefrez : EPAR - Product Information

Docefrez : EPAR - All Authorised presentations

Product details

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

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

Breast cancer

• Docetaxel in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with operable node-positive breast cancer.
• Docetaxel in combination with doxorubicin is indicated for the treatment of patients with locally advanced or metastatic breast cancer who have not previously received cytotoxic therapy for this condition.
• Docetaxel 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.
• Docetaxel in combination with trastuzumab is indicated for the treatment of patients with metastatic breast cancer whose tumours over express HER2 and who previously have not received chemotherapy for metastatic disease.
• Docetaxel in combination with capecitabine is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. Previous therapy should have included an anthracycline.

Non-small cell lung cancer

• Docetaxel is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of prior chemotherapy.
• Docetaxel 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 in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone refractory metastatic prostate cancer.

Gastric adenocarcinoma

• Docetaxel in combination with cisplatin and 5-fluorouracil is indicated for the treatment of patients with metastatic gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who have not received prior chemotherapy for metastatic disease.

Head and neck cancer

• Docetaxel in combination with cisplatin and 5-fluorouracil is indicated for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck.

Authorisation details

• EMA product number:
  EMEA/H/C/001074
• 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:
  Sun Pharmaceutical Industries Europe B.V.

  SUN Pharmaceutical Industries Europe B.V.; Polaris Avenue 87; 2132 JH Hoofddorp; The Netherlands

• Marketing authorisation issued:
  10/05/2010
• Withdrawal of marketing authorisation:
  25/05/2012
• Revision:
  1

Assessment history

Changes since initial authorisation of medicine

Docefrez : EPAR - Procedural steps taken and scientific information after authorisation

Initial marketing authorisation documents

Docefrez : EPAR - Public assessment report

Committee for Medicinal products for Human use positive summary of opinion for Docefrez

Adopted Reference Number: EMA/CHMP/54045/2010