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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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1736782
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Name of medicinal product:
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RUCONEST
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Active substances:
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ATC code:
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B06AC04
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Dosage form:
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powder and solvent for solution for injection
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Route of administration:
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intravenous use
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Strengh:
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2100ühik
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Amount in package:
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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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lahusti 20 ml
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Indication:
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Ruconest is indicated for treatment of acute angioedema attacks in adults, adolescents, and children (aged
2 years and above) with hereditary angioedema (HAE) due to 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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Never imported to Estonia
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Marketing authorization holder:
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Pharming Group N.V.
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Marketing authorization number:
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EU/1/10/641
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Marketing authorization issued on:
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January 11, 2017
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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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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 19, 2023
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription
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