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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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1618680
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Name of medicinal product:
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AMYVID
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Active substances:
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ATC code:
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V09AX05
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Dosage form:
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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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1900MBq 1ml
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Amount in package:
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15ml 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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This medicinal product is for diagnostic use only.
Amyvid is a radiopharmaceutical indicated for Positron Emission Tomography (PET) imaging of â-amyloid neuritic plaque density in the brains of adult patients with cognitive impairment who are being evaluated for Alzheimer’s disease (AD) and other causes of cognitive impairment. Amyvid should be used in conjunction with a clinical evaluation.
A negative scan indicates sparse or no plaques, which is not consistent with a diagnosis of AD. For the limitations in the interpretation of a positive scan, see sections 4.4 and 5.1.
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Safety features:
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No
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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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Eli Lilly Nederland B.V.
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Marketing authorization number:
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EU/1/12/805
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Marketing authorization issued on:
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January 17, 2013
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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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Ei ole lubatud väljastada korduvretsepti
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Entry/Changing date:
October 2, 2017
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription
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