Register of
Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 1370438
Name of medicinal product: DOCETAXEL EBEWE 10MG/ML
Active substances:
Docetaxel
Estonian, English, Latin
ATC code: L01CD02
Dosage form: concentrate for solution for infusion
Route of administration: intravenous use
Strengh: 10mg 1ml
Amount in package: 8ml 10TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information:  
Indication: Breast cancer 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 (see section 5.1).. 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. 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. 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. 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 is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of prior chemotherapy. 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 in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone refractory metastatic prostate cancer. Gastric adenocarcinoma 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 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.
Safety features: Yes
Summary of product characteristics (SPC):  (last updated July 1, 2022)
Package information leaflet (PIL): EST  (last updated July 1, 2022)
Labelling:  (last updated October 1, 2018)
Last imported to Estonia: Never imported to Estonia
Marketing authorization holder: Sandoz Pharmaceuticals d.d. 
Marketing authorization number: 668110 
Marketing authorization issued on: February 3, 2010 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: Decentralised 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Entry/Changing date: March 18, 2024
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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