Docefrez (docetaxel)
- Region
- 🇪🇺 EU
- Active substance
- docetaxel
- Company
- Sun Pharmaceutical Industries Europe B.V.
- Status
- Withdrawn
- Therapeutic area
- Stomach Neoplasms; Adenoma; Breast Neoplasms; Carcinoma, Non-Small-Cell Lung; Prostatic Neoplasms
- EU approval
- Mon 10 May 2010
- Designations
- Generic
- Application
- EMEA/H/C/001074
- ATC
- L01CD02
- Official record
- www.ema.europa.eu
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.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Taxotere Authorised · Sanofi Winthrop Industrie
- 🇪🇺 Docetaxel Kabi Authorised · Fresenius Kabi Deutschland GmbH
- 🇪🇺 Docetaxel Accord Authorised · Accord Healthcare S.L.U.
- 🇪🇺 Docetaxel Zentiva (previously Docetaxel Winthrop) Withdrawn · Zentiva k.s.
- 🇪🇺 Docetaxel Teva Withdrawn · Teva B.V.
- 🇪🇺 Taxespira (previously Docetaxel Hospira UK Limited ) Withdrawn · Hospira UK Limited
- 🇪🇺 Docetaxel Mylan Lapsed · Mylan S.A.S.
- 🇪🇺 Docetaxel SUN Application withdrawn · Sun Pharmaceutical Industries Europe B.V.
- 🇪🇺 Docetaxel Teva Pharma Lapsed · Teva Pharma B.V.
- 🇪🇺 Docetaxel Mylan Application withdrawn · Mylan S.A.S.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.