Register of
Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 1890266
Name of medicinal product: 5-FLUOROURACIL "EBEWE"
Active substances:
Estonian, English, Latin
ATC code: L01BC02
Dosage form: solution for injection/infusion
Route of administration: intraarterial use; intravenous use
Strengh: 50mg 1ml
Amount in package: 10ml 1TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information: Tšehhi pakend
Indication: Colorectal, rectal, breast, gastric, pancreatic, hepatic, uterine, ovarian and bladder carcinoma.
Safety features: Yes
Summary of product characteristics (SPC):  (last updated December 21, 2022)
Package information leaflet (PIL): EST  (last updated December 21, 2022)
Labelling:  (last updated December 21, 2022)
Last imported to Estonia: Never imported to Estonia
Marketing authorization holder: First Pharma OÜ 
Marketing authorization number: 1090222 
Marketing authorization issued on: December 21, 2022 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: National 
Secondary marketing authorization: Yes 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Entry/Changing date: December 21, 2022
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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