Product class:
|
Medicinal product with marketing authorization
|
Medicinal product class:
|
Human medicine
|
Name of medicinal product:
|
5-FLUOROURACIL "EBEWE"
|
Active substances:
|
|
ATC code:
|
L01BC02
|
Dosage form:
|
solution for injection/infusion
|
Strength:
|
50mg 1ml
|
Legal status for supply*:
|
Subject to medicinal prescription
|
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)
|
Indication:
|
Colorectal, rectal, breast, gastric, pancreatic, hepatic, uterine, ovarian and bladder carcinoma.
|
Safety features:
|
Yes
|
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
|
Assessment report:
|
|
Package code
|
Name of medicinal product
|
Dosage form
|
Package
|
Legal status
|
Reimbursements
|
Reference price
|
Last imported
|
PƤritolumaa
|
Additional information
|
1021778
|
5-FLUOROURACIL "EBEWE"
|
solution for injection/infusion
|
50mg 1ml 5ml 1TK
|
Prescription
|
|
|
21.01.2011
|
|
|
1069400
|
5-FLUOROURACIL "EBEWE"
|
solution for injection/infusion
|
50mg 1ml 10ml 1TK
|
Prescription
|
|
|
30.12.2011
|
|
|
1069411
|
5-FLUOROURACIL "EBEWE"
|
solution for injection/infusion
|
50mg 1ml 20ml 1TK
|
Prescription
|
|
|
15.02.2012
|
|
|
1069422
|
5-FLUOROURACIL "EBEWE"
|
solution for injection/infusion
|
50mg 1ml 100ml 1TK
|
Prescription
|
|
|
08.09.2022
|
|
|
1069433
|
5-FLUOROURACIL "EBEWE"
|
solution for injection/infusion
|
50mg 1ml 20ml 5TK
|
Prescription
|
|
|
26.04.2007
|
|
|
1136540
|
5-FLUOROURACIL "EBEWE"
|
solution for injection/infusion
|
50mg 1ml 5ml 5TK
|
Prescription
|
|
|
26.04.2007
|
|
|
1150018
|
5-FLUOROURACIL "EBEWE"
|
solution for injection/infusion
|
50mg 1ml 10ml 5TK
|
Prescription
|
|
|
09.07.2010
|
|
|
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription
You can download Acrobat Reader fromhere