Docetaxel Teva Pharma (docetaxel)
- Region
- 🇪🇺 EU
- Active substance
- docetaxel
- Company
- Teva Pharma B.V.
- Status
- Lapsed
- Therapeutic area
- Carcinoma, Non-Small-Cell Lung; Breast Neoplasms; Prostatic Neoplasms
- EU approval
- Fri 21 Jan 2011
- Designations
- Generic
- Application
- EMEA/H/C/002032
- ATC
- L01CD02
- Official record
- www.ema.europa.eu
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.
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- 🇪🇺 Docetaxel Zentiva (previously Docetaxel Winthrop) Withdrawn · Zentiva k.s.
- 🇪🇺 Docetaxel Teva Withdrawn · Teva B.V.
- 🇪🇺 Taxespira (previously Docetaxel Hospira UK Limited ) Withdrawn · Hospira UK Limited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- 🇪🇺 Docetaxel SUN Application withdrawn · Sun Pharmaceutical Industries Europe B.V.
- 🇪🇺 Docefrez Withdrawn · Sun Pharmaceutical Industries Europe B.V.
- 🇪🇺 Docetaxel Mylan Application withdrawn · Mylan S.A.S.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.