Register of
Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 1136540
Name of medicinal product: 5-FLUOROURACIL "EBEWE"
Active substances:
Fluorouracil
Estonian, English, Latin
ATC code: L01BC02
Dosage form: solution for injection/infusion
Route of administration: intravenous use; intraarterial use
Strengh: 50mg 1ml
Amount in package: 5ml 5TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information:  
Indication: Colorectal, rectal, breast, gastric, pancreatic, hepatic, uterine, ovarian and bladder carcinoma.
Safety features: Yes
Summary of product characteristics (SPC):  (last updated January 31, 2022)
Package information leaflet (PIL): EST  (last updated January 31, 2022)
Labelling:  (last updated November 12, 2020)
Last imported to Estonia: April 26, 2007
Marketing authorization holder: Sandoz Pharmaceuticals d.d. 
Marketing authorization number: 245099 
Marketing authorization issued on: February 26, 1999 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: National 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Entry/Changing date: January 31, 2022
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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