Register of
Medicinal Products

Product class: Medicinal product with marketing authorization
Medicinal product class: Human medicine
Name of medicinal product: CABAZITAXEL SANDOZ
Active substances:
Cabazitaxel
Estonian, English, Latin
ATC code: L01CD04
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 November 3, 2020)
Package information leaflet (PIL): EST  (last updated January 6, 2022)
Labelling:  (last updated October 25, 2023)
Indication: [Nationally completed name] in combination with prednisone or prednisolone is indicated for the treatment of adult patients with metastatic castration resistant prostate cancer previously treated with a docetaxel-containing regimen (see section 5.1).
Safety features: Yes
Marketing authorization holder: Sandoz Pharmaceuticals d.d. 
Marketing authorization number: 1012220 
Marketing authorization issued on: November 3, 2020 
Marketing authorization expires on: November 3, 2025 
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
1791446  CABAZITAXEL SANDOZ  concentrate for solution for infusion  10mg 1ml 4.5ml 1TK  Prescription           
1791457  CABAZITAXEL SANDOZ  concentrate for solution for infusion  10mg 1ml 6ml 1TK  Prescription           
1791468  CABAZITAXEL SANDOZ  concentrate for solution for infusion  10mg 1ml 4.5ml 5TK  Prescription           
1791479  CABAZITAXEL SANDOZ  concentrate for solution for infusion  10mg 1ml 6ml 5TK  Prescription           
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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