Register of
Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 1791468
Name of medicinal product: CABAZITAXEL SANDOZ
Active substances:
Estonian, English, Latin
ATC code: L01CD04
Dosage form: concentrate for solution for infusion
Route of administration: intravenous use
Strengh: 10mg 1ml
Amount in package: 4.5ml 5TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information:  
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
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)
Last imported to Estonia: Never imported to Estonia
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 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Entry/Changing date: April 18, 2024
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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