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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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1764547
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Name of medicinal product:
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ALKINDI
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Active substances:
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ATC code:
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H02AB09
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Dosage form:
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granules in single-dose container
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Route of administration:
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oral use
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Strengh:
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2mg
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Amount in package:
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50TK
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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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Replacement therapy of adrenal insufficiency in infants, children and adolescents (from birth to < 18 years old).
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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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Diurnal Europe B.V.
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Marketing authorization number:
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EU/1/17/1260
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Marketing authorization issued on:
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February 13, 2018
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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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Description
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Additional condition
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Hambaarstil on õigus välja kirjutada
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Entry/Changing date:
December 2, 2022
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription
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