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Medicinal Products

Product class: Medicinal product with marketing authorization
Medicinal product class: Human medicine
Name of medicinal product: DOCETAXEL KABI
Active substances:
Docetaxel
Estonian, English, Latin
ATC code: L01CD02
Dosage form: concentrate for solution for infusion
Strength: 20mg 1ml
Legal status for supply*: Subject to medicinal prescription
Summary of product characteristics (SPC):
Package information leaflet (PIL): EST
Labelling:  
Indication: Breast cancer DOCETAXEL KABI 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). DOCETAXEL KABI 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 KABI 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 KABI 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 KABI 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 KABI is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of prior chemotherapy. DOCETAXEL KABI 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 KABI in combination with prednisone or prednisolone is indicated for the treatment of patients with castration-resistant metastatic prostate cancer. DOCETAXEL KABI in combination with androgen-deprivation therapy (ADT), with or without prednisone or prednisolone, is indicated for the treatment of patients with metastatic hormonesensitive prostate cancer. Gastric adenocarcinoma DOCETAXEL KABI 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 KABI 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: Fresenius Kabi Deutschland GmbH 
Marketing authorization number: EU/1/12/770 
Marketing authorization issued on: June 11, 2012 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: Centralised 
Assessment report:   
Package code Name of medicinal product Dosage form Package Legal status Reimbursements Reference price Last imported PƤritolumaa Additional information
1584200  DOCETAXEL KABI  concentrate for solution for infusion  20mg 1ml 4ml 1TK  Prescription      30.10.2015     
1584211  DOCETAXEL KABI  concentrate for solution for infusion  20mg 1ml 6ml 1TK  Prescription           
1584222  DOCETAXEL KABI  concentrate for solution for infusion  20mg 1ml 8ml 1TK  Prescription      05.06.2024     
1584233  DOCETAXEL KABI  concentrate for solution for infusion  20mg 1ml 9ml 1TK  Prescription           
1611504  DOCETAXEL KABI  concentrate for solution for infusion  20mg 1ml 1ml 1TK  Prescription      24.09.2014     
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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