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Product class:
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Medicinal product with marketing authorization
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Medicinal product class:
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Human medicine
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Name of medicinal product:
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ICATIBANT FRESENIUS
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Active substances:
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ATC code:
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B06AC02
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Dosage form:
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solution for injection in pre-filled syringe
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Strength:
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30mg 3ml
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Legal status for supply*:
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Subject to medicinal prescription
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Summary of product characteristics (SPC):
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 (last updated February 8, 2022)
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Package information leaflet (PIL):
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EST (last updated February 8, 2022)
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Labelling:
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(last updated February 8, 2022)
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Indication:
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Icatibant Fresenius is indicated for symptomatic treatment of acute attacks of hereditary angioedema (HAE) in adults, adolescents and children aged 2 years and older, with C1-esterase-inhibitor deficiency.
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Safety features:
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Yes
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Marketing authorization holder:
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Fresenius Kabi Polska Sp. z o.o.
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Marketing authorization number:
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1051822
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Marketing authorization issued on:
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February 8, 2022
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Marketing authorization expires on:
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February 8, 2027
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Marketing authorization procedure type:
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Decentralised
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Assessment report:
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Package code
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Name of medicinal product
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Dosage form
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Package
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Legal status
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Reimbursements
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Reference price
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Last imported
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PƤritolumaa
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Additional information
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1822913
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ICATIBANT FRESENIUS
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solution for injection in pre-filled syringe
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30mg 3ml 3ml 1TK
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Prescription
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1822924
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ICATIBANT FRESENIUS
|
solution for injection in pre-filled syringe
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30mg 3ml 3ml 3TK
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Prescription
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Legal status for supply – medicinal product on medical prescription or not subject to medical prescription
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