Celsunax (ioflupane (123I))
- Region
- 🇪🇺 EU
- Active substance
- ioflupane (123I)
- Company
- Pinax Pharma GmbH
- Status
- Authorised
- Therapeutic area
- Radionuclide Imaging; Dementia; Movement Disorders
- CHMP opinion
- Thu 22 Apr 2021
- EU approval
- Thu 17 Jun 2021
- Designations
- Generic
- Application
- EMEA/H/C/005135
- ATC
- V09AB03
- Official record
- www.ema.europa.eu
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.
Regulatory milestones
No milestones recorded in the last year.
Follow Celsunax
Get VigiEye Daily: approvals, opinions, safety actions and PDUFA dates every morning.
Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.