Register of
Medicinal Products

Product class: Medicinal product with marketing authorization
Medicinal product class: Human medicine
Name of medicinal product: CABAZITAXEL STADA
Active substances:
Cabazitaxel
Estonian, English, Latin
ATC code: L01CD04
Dosage form: concentrate for solution for infusion
Strength: 20mg 1ml
Legal status for supply*: Subject to medicinal prescription
Summary of product characteristics (SPC):  (last updated September 19, 2023)
Package information leaflet (PIL): EST  (last updated September 19, 2023)
Labelling:  (last updated May 22, 2024)
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
Marketing authorization holder: Stada Arzneimittel AG 
Marketing authorization number: 1115623 
Marketing authorization issued on: June 5, 2023 
Marketing authorization expires on: June 5, 2028 
Marketing authorization procedure type: Mutual recognition 
Assessment report:   
Package code Name of medicinal product Dosage form Package Legal status Reimbursements Reference price Last imported PƤritolumaa Additional information
1895429  CABAZITAXEL STADA  concentrate for solution for infusion  20mg 1ml 3ml 1TK  Prescription           
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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