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Blue Earth Diagnostics Ireland LtdEU/1/17/1186/002

Main Information

Trade NameAxumin
Active SubstancesFluciclovine (18f)
Dosage FormSolution for injection
Licence HolderBlue Earth Diagnostics Ireland Ltd
Licence NumberEU/1/17/1186/002

Group Information

ATC CodeV09IX Other diagnostic radiopharmaceuticals for tumour detection
V09IX12 Fluciclovine (18F)


License statusAuthorised
Licence Issued22/05/2017
Legal statusProduct subject to prescription which may not be renewed (A)
Supply StatusSupply through pharmacies only
Advertising StatusAdvertising to healthcare professionals only
Conditions of Licence
Marketing StatusUnknown


Summary of Product CharacteristicsSearch EMA website
Package LeafletSearch EMA website
Public Assessment ReportSearch EMA website
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