Register of
Medicinal Products

Product class: Medicinal product with marketing authorization
Medicinal product class: Human medicine
Name of medicinal product: DOCETAXEL EBEWE 10MG/ML
Active substances:
Docetaxel
Estonian, English, Latin
ATC code: L01CD02
Dosage form: concentrate for solution for infusion
Strength: 10mg 1ml
Legal status for supply*: Subject to medicinal prescription
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)
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
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 
Assessment report:   
Package code Name of medicinal product Dosage form Package Legal status Reimbursements Reference price Last imported PƤritolumaa Additional information
1370359  DOCETAXEL EBEWE 10MG/ML  concentrate for solution for infusion  10mg 1ml 2ml 1TK  Prescription      15.02.2012     
1370371  DOCETAXEL EBEWE 10MG/ML  concentrate for solution for infusion  10mg 1ml 2ml 5TK  Prescription           
1370382  DOCETAXEL EBEWE 10MG/ML  concentrate for solution for infusion  10mg 1ml 2ml 10TK  Prescription           
1370393  DOCETAXEL EBEWE 10MG/ML  concentrate for solution for infusion  10mg 1ml 8ml 1TK  Prescription      20.02.2013     
1370427  DOCETAXEL EBEWE 10MG/ML  concentrate for solution for infusion  10mg 1ml 8ml 5TK  Prescription           
1370438  DOCETAXEL EBEWE 10MG/ML  concentrate for solution for infusion  10mg 1ml 8ml 10TK  Prescription           
1515912  DOCETAXEL EBEWE 10MG/ML  concentrate for solution for infusion  10mg 1ml 16ml 1TK  Prescription      09.02.2016     
1515923  DOCETAXEL EBEWE 10MG/ML  concentrate for solution for infusion  10mg 1ml 16ml 5TK  Prescription           
1515934  DOCETAXEL EBEWE 10MG/ML  concentrate for solution for infusion  10mg 1ml 16ml 10TK  Prescription           
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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