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European Medicines Agency Recommends Granting a Marketing Authorisation for Docetaxel Hospira UK Limited

It is a generic of Taxotere, which has been authorised in the EU since 1995
07 Jul 2015
Breast cancer;  Genitourinary cancers;  Lung and other thoracic tumours;  Head and neck cancers;  Gastrointestinal cancers;  Anticancer agents & Biologic therapy

On 25 June 2015, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Docetaxel Hospira UK Limited, intended for the treatment of breast cancer, non-small-cell lung cancer, prostate cancer, gastric adenocarcinoma, and head and neck cancer.

The applicant for this medicinal product is Hospira UK Limited. 

Docetaxel Hospira UK Limited will be available as a 20 mg/ml concentrate for solution for infusion. The active substance of Docetaxel Hospira UK Limited is docetaxel, an antineoplastic agent (ATC code:L01CD02) that disrupts intracellular structures necessary for the replication and survival of cells (cytotoxic activity). 

Docetaxel Hospira UK Limited is a generic of Taxotere, which has been authorised in the EU since 27 November 1995. 

Studies have demonstrated the satisfactory quality of Docetaxel Hospira UK Limited. A bioequivalence study versus the reference product Taxotere was not required.

The full indication is: 

Breast cancer 

Docetaxel Hospira UK Limited 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. 

Docetaxel Hospira UK Limited 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 Hospira UK Limited 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 Hospira UK Limited in combination with trastuzumab is indicated for the treatment of patients with metastatic breast cancer whose tumours overexpress HER2 and who previously have not received chemotherapy for metastatic disease.

Docetaxel Hospira UK Limited 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 Hospira UK Limited is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of prior chemotherapy.

Docetaxel Hospira UK Limited 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 Hospira UK Limited in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone refractory metastatic prostate cancer.

Gastric adenocarcinoma

Docetaxel Hospira UK Limited 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 Hospira UK Limited 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. 

It is proposed that Docetaxel Hospira UK Limited should only be administered under the supervision of a physician qualified in the use of anticancer chemotherapy.

Detailed recommendations for the use of this product will be described in the summary of product characteristics, which will be published in the European public assessment report and made available in all official European Union languages after the marketing authorisation has been granted by the European Commission.

Last update: 07 Jul 2015

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