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Product class:
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Authorized package
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Medicinal product class:
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For human use
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Package code:
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1069433
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Name of medicinal product:
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5-FLUOROURACIL "EBEWE"
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Active substances:
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ATC code:
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L01BC02
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Dosage form:
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solution for injection/infusion
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Route of administration:
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intravenous use; intraarterial use
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Strengh:
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50mg 1ml
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Amount in package:
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20ml 5TK
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Legal status for supply*:
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Subject to medicinal prescription
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Class of active substance:
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Additional information:
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Indication:
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Colorectal, rectal, breast, gastric, pancreatic, hepatic, uterine, ovarian and bladder carcinoma.
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Safety features:
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Yes
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Summary of product characteristics (SPC):
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 (last updated January 31, 2022)
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Package information leaflet (PIL):
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EST (last updated January 31, 2022)
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Labelling:
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(last updated November 12, 2020)
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Last imported to Estonia:
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April 26, 2007
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Marketing authorization holder:
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Sandoz Pharmaceuticals d.d.
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Marketing authorization number:
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245099
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Marketing authorization issued on:
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February 26, 1999
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Marketing authorization expires on:
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Unlimited
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Marketing authorization procedure type:
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National
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Reference price:
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Under reference price:
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Reference price of daily dose:
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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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