Product class: Authorized package
Medicinal product class: For human use
Package code: 1895429
Name of medicinal product: CABAZITAXEL STADA
Active substances:
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 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.
Safety features: Yes
Summary of product characteristics (SPC):  (last updated 19 September 2023)
Package information leaflet (PIL): EST  (last updated 19 September 2023)
Labelling:  (last updated 22 May 2024)
Last imported to Estonia: Never imported to Estonia
Marketing authorization holder: Stada Arzneimittel AG 
Marketing authorization number: 1115623 
Marketing authorization issued on: 05 June 2023 
Marketing authorization expires on: 05 June 2028 
Marketing authorization procedure type: Mutual recognition 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Entry/Changing date: 22 May 2024
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription