Register of
Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 1857708
Name of medicinal product: AXITINIB STADA
Active substances:
Estonian, English, Latin
ATC code: L01EK01
Dosage form: film-coated tablet
Route of administration: oral use
Strengh: 5mg
Amount in package: 14TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information:  
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
Summary of product characteristics (SPC):  (last updated April 3, 2023)
Package information leaflet (PIL): EST  (last updated April 3, 2023)
Labelling:  (last updated April 3, 2023)
Last imported to Estonia: Never imported to Estonia
Marketing authorization holder: Stada Arzneimittel AG 
Marketing authorization number: 1105123 
Marketing authorization issued on: April 3, 2023 
Marketing authorization expires on: April 3, 2028 
Marketing authorization procedure type: Decentralised 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Entry/Changing date: November 13, 2023
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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