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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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1691737
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Name of medicinal product:
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LUMARK
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Active substances:
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ATC code:
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V10XX84
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Dosage form:
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radiopharmaceutical precursor, solution
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Route of administration:
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route of administration not applicable
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Strengh:
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80GBq 1ml
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Amount in package:
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5ml 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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Lumark is a radiopharmaceutical precursor. It is not intended for direct use in patients. It must be used only
for the radiolabelling of carrier molecules, which have been specifically developed and authorised for
radiolabelling with this radionuclide.
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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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Idb Holland B.V.
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Marketing authorization number:
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EU/1/15/1013
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Marketing authorization issued on:
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June 19, 2015
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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 3, 2023
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription
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