Taxespira (previously Docetaxel Hospira UK Limited )

Withdrawn

This medicine's authorisation has been withdrawn

docetaxel

Overview

On 30 October 2018, the European Commission withdrew the marketing authorisation for Taxespira (docetaxel) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Hospira UK Limited, which notified the European Commission of its decision not to market the product in the EU for commercial reasons. 

Taxespira was granted marketing authorisation in the EU on 28 August 2015 for treatment of breast cancer, non small cell lung cancer, prostate cancer, gastric adenocarcinoma and head and neck cancer. The marketing authorisation was initially valid for a 5-year period. 

Taxespira 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Public Assessment Report (EPAR) for Taxespira is updated to reflect the fact that the marketing authorisation is no longer valid.

Taxespira (previously Docetaxel Hospira UK Limited) : EPAR - Summary for the public

Reference Number: EMA/471475/2015

Taxespira (previously Docetaxel Hospira UK Limited) : EPAR - Risk-management-plan summary

Product information

Taxespira : EPAR - Product Information

Taxespira (previously Docetaxel Hospira UK Limited) : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Taxespira (previously Docetaxel Hospira UK Limited )
• Active substance:
  docetaxel trihydrate
• International non-proprietary name (INN) or common name:
  docetaxel
• Therapeutic area (MeSH):
  • Stomach Neoplasms
  • Prostatic Neoplasms
  • Breast Neoplasms
  • Head and Neck Neoplasms
  • Carcinoma, Non-Small-Cell Lung
• Anatomical therapeutic chemical (ATC) code:
  L01CD02

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

Breast cancer

Taxespira in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with:

• operable node-positive breast cancer;
• operable node-negative breast cancer.

For patients with operable node-negative breast cancer, adjuvant treatment should be restricted to patients eligible to receive chemotherapy according to internationally established criteria for primary therapy of early breast cancer.

Taxespira 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.

Taxespira 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.

Taxespira 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.

Taxespira 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

Taxespira indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of prior chemotherapy.

Taxespira 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

Taxespira in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone refractory metastatic prostate cancer.

Gastric adenocarcinoma

Taxespira 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

Taxespira 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/003925
• 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:
  Hospira UK Limited

  Horizon, Honey Lane; Hurley, Maidenhead, SL6 6RJ; United Kingdom

• Opinion adopted:
  20/05/2015
• Marketing authorisation issued:
  28/08/2015
• Withdrawal of marketing authorisation:
  30/10/2018
• Revision:
  8

Assessment history

Changes since initial authorisation of medicine

Taxespira (previously Docetaxel Hospira UK Limited) : EPAR - Procedural steps taken and scientific information after authorisation

Initial marketing authorisation documents

Docetaxel Hospira UK Limited : EPAR - Public assessment report

AdoptedReference Number: EMA/CHMP/289489/2015

CHMP summary of opinion for Docetaxel Hospira UK Limited

AdoptedReference Number: EMA/CHMP/289487/2015