Celsunax is a diagnostic medicine. It is used to detect the loss of nerve cells in an area of the brain called the striatum, specifically the cells that release dopamine, a chemical messenger.
The medicine is used to help in the diagnosis of the following conditions in adults:
- movement disorders such as those in Parkinson’s disease and other related diseases, where a loss of nerve cells leads to tremor (shaking), gait disturbance (problems with the way the patient walks) and stiffness of the muscles. Because tremor can also occur in ‘essential tremor’ (tremor whose cause is unknown), Celsunax can help distinguish between essential tremor and diseases related to Parkinson’s disease;
- dementia (loss of intellectual function). Celsunax is used to help distinguish between a type of dementia known as ‘dementia with Lewy bodies’ and Alzheimer’s disease.
Celsunax contains the active substance ioflupane (123I) and is a ‘generic medicine’. This means that Celsunax contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the EU called DaTSCAN. For more information on generic medicines, see the question-and-answer document
Celsunax : EPAR - Medicine overview (PDF/169.37 KB)
First published: 01/07/2021
Celsunax : EPAR - Risk management plan summary (PDF/101.8 KB)
First published: 02/07/2021
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This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic and hybrid medicines.
Pinax Pharma GmbH
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Lausitz Mühlenweg 5
17/06/2021 Celsunax - EMEA/H/C/005135 -
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
Please note that the size of the above document can exceed 50 pages.
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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.