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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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1829055
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Name of medicinal product:
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ABOXOMA
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Active substances:
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ATC code:
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B01AF02
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Dosage form:
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film-coated tablet
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Route of administration:
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oral use
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Strengh:
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5mg
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Amount in package:
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10TK
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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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Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (NVAF), with one or more risk factors, such as prior stroke or transient ischaemic attack (TIA); age = 75 years; hypertension; diabetes mellitus; symptomatic heart failure (NYHA Class = II).
Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults (see section 4.4 for haemodynamically unstable PE patients).
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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 November 3, 2021)
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Package information leaflet (PIL):
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EST (last updated November 3, 2021)
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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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KRKA d.d. Novo mesto
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Marketing authorization number:
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1045021
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Marketing authorization issued on:
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November 3, 2021
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Marketing authorization expires on:
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November 3, 2026
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Marketing authorization procedure type:
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Decentralised
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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:
November 3, 2021
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription
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