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🇪🇺EU · EMAAuthorisedATC: V09AB03

Celsunax(ioflupane (123i))

Radionuclide Imaging;Dementia;Movement Disorders

Marketing Authorisation Holder: Pinax Pharma GmbH

EMA Authorisation: 17/06/2021

INN: ioflupane (123I)

Indication

This medicinal product is for diagnostic use only. Celsunax is indicated for detecting loss of functional dopaminergic neuron terminals in the striatum: In adult patients with clinically uncertain parkinsonian syndromes, for example those with early symptoms, in order to help differentiate essential tremor from parkinsonian syndromes related to idiopathic Parkinson’s disease, multiple system atrophy and progressive supranuclear palsy. Celsunax is unable to discriminate between Parkinson's disease, multiple system atrophy and progressive supranuclear palsy. In adult patients, to help differentiate probable dementia with Lewy bodies from Alzheimer’s disease. Celsunax is unable to discriminate between dementia with Lewy bodies and Parkinson’s disease dementia.

Official EMA Resources

View on EMA (ema.europa.eu)

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Medical disclaimer: This information is intended for qualified healthcare professionals. Always verify with the official EMA Summary of Product Characteristics (SmPC) before clinical use.