Product class: Medicinal product with marketing authorization
Medicinal product class: Human medicine
Name of medicinal product: AXITINIB STADA
Active substances:
Axitinib
Estonian, English, Latin
ATC code: L01EK01
Dosage form: film-coated tablet
Strength: 5mg
Legal status for supply*: Subject to medicinal prescription
Summary of product characteristics (SPC):  (last updated 03 April 2023)
Package information leaflet (PIL): EST  (last updated 03 April 2023)
Labelling:  (last updated 03 April 2023)
Indication: [Product name] is indicated for the treatment of adult patients with advanced renal cell carcinoma (RCC) after failure of prior treatment with sunitinib or a cytokine.
Safety features: Yes
Marketing authorization holder: Stada Arzneimittel AG 
Marketing authorization number: 1105123 
Marketing authorization issued on: 03 April 2023 
Marketing authorization expires on: 03 April 2028 
Marketing authorization procedure type: Decentralised 
Assessment report:   
Package code Name of medicinal product Dosage form Package Legal status Reimbursements Reference price Last imported PƤritolumaa Additional information
1857708  AXITINIB STADA  film-coated tablet  5mg 14TK  Prescription           
1857719  AXITINIB STADA  film-coated tablet  5mg 14TK  Prescription          üksikannuseline blister 
1857720  AXITINIB STADA  film-coated tablet  5mg 28TK  Prescription           
1857731  AXITINIB STADA  film-coated tablet  5mg 28TK  Prescription          üksikannuseline blister 
1857742  AXITINIB STADA  film-coated tablet  5mg 56TK  Prescription           
1857753  AXITINIB STADA  film-coated tablet  5mg 56TK  Prescription          üksikannuseline blister 
1857764  AXITINIB STADA  film-coated tablet  5mg 60TK  Prescription           
1857775  AXITINIB STADA  film-coated tablet  5mg 60TK  Prescription          üksikannuseline blister 
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription