Register of
Medicinal Products

Product class: Medicinal product with marketing authorization
Medicinal product class: Human medicine
Name of medicinal product: CABAZITAXEL ACCORD
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):
Package information leaflet (PIL): EST
Labelling:  
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
Marketing authorization holder: Accord Healthcare S.L.U. 
Marketing authorization number: EU/1/20/1448 
Marketing authorization issued on: August 28, 2020 
Marketing authorization expires on: August 31, 2025 
Marketing authorization procedure type: Centralised 
Assessment report:   
Package code Name of medicinal product Dosage form Package Legal status Reimbursements Reference price Last imported PƤritolumaa Additional information
1826579  CABAZITAXEL ACCORD  concentrate for solution for infusion  20mg 1ml 3ml 1TK  Prescription      25.04.2024     
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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