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Axumin

1600 MBq/ml Solution for injection

Blue Earth Diagnostics Ireland LtdEU/1/17/1186/001

Main Information

Trade NameAxumin
Active SubstancesFluciclovine (18f)
Strength1600 MBq/ml
Dosage FormSolution for injection
Licence HolderBlue Earth Diagnostics Ireland Ltd
Licence NumberEU/1/17/1186/001

Group Information

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

Status

Authorised/WithdrawnAuthorised
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

Documents

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