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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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1725780
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Name of medicinal product:
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ENDOLUCINBETA
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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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40GBq 1ml
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Amount in package:
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2ml 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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EndolucinBeta is a radiopharmaceutical precursor, and it is not intended for direct use in patients. It is to be used only for the radiolabelling of carrier molecules that have been specifically developed and authorised for radiolabelling with Lutetium (177Lu) chloride.
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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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ITM Medical Isotopes GmbH
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Marketing authorization number:
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EU/1/16/1105
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Marketing authorization issued on:
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July 6, 2016
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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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