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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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1857012
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Name of medicinal product:
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ICATIBANT ACCORD
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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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Route of administration:
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subcutaneous use
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Strengh:
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30mg 3ml
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Amount in package:
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3ml 1TK
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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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Icatibant Accord 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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Summary of product characteristics (SPC):
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Package information leaflet (PIL):
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EST
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Labelling:
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Last imported to Estonia:
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May 25, 2022
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Marketing authorization holder:
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Accord Healthcare S.L.U.
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Marketing authorization number:
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EU/1/21/1567
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Marketing authorization issued on:
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July 16, 2021
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Marketing authorization expires on:
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July 20, 2026
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Marketing authorization procedure type:
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Centralised
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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:
September 6, 2021
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription
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