Product class: Authorized package
Medicinal product class: For human use
Package code: 1826579
Name of medicinal product: CABAZITAXEL ACCORD
Active substances:
Cabazitaxel
Estonian, English, Latin
ATC code: L01CD04
Dosage form: concentrate for solution for infusion
Route of administration: intravenous use
Strengh: 20mg 1ml
Amount in package: 3ml 1TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information:  
Indication: Cabazitaxel Accord 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):
Package information leaflet (PIL): EST
Labelling:  
Last imported to Estonia: 25 April 2024
Marketing authorization holder: Accord Healthcare S.L.U. 
Marketing authorization number: EU/1/20/1448 
Marketing authorization issued on: 28 August 2020 
Marketing authorization expires on: 31 August 2025 
Marketing authorization procedure type: Centralised 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Entry/Changing date: 21 December 2023
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription