Register of
Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 1733330
Name of medicinal product: ANIDULAFUNGIN SANDOZ
Active substances:
Estonian, English, Latin
ATC code: J02AX06
Dosage form: powder for concentrate for solution for infusion
Route of administration: intravenous use
Strengh: 100mg
Amount in package: 1TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information:  
Indication: Treatment of invasive candidiasis in adults and paediatric patients aged 1 month to <18 years.
Safety features: Yes
Summary of product characteristics (SPC):  (last updated November 7, 2023)
Package information leaflet (PIL): EST  (last updated December 30, 2021)
Labelling:  (last updated September 4, 2020)
Last imported to Estonia: July 20, 2023
Marketing authorization holder: Sandoz Pharmaceuticals d.d. 
Marketing authorization number: 977518 
Marketing authorization issued on: December 31, 2018 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: Decentralised 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Description Additional condition
Hambaarstil on õigus välja kirjutada
Entry/Changing date: November 7, 2023
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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