ioflupane (123I)

This medicine is authorised for use in the European Union.


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

This EPAR was last updated on 02/07/2021

Authorisation details

Product details
Agency product number
Active substance
ioflupane (123i)
International non-proprietary name (INN) or common name
ioflupane (123I)
Therapeutic area (MeSH)
  • Radionuclide Imaging
  • Dementia
  • Movement Disorders
Anatomical therapeutic chemical (ATC) code

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.

Publication details
Marketing-authorisation holder
Pinax Pharma GmbH
Date of issue of marketing authorisation valid throughout the European Union
Contact address

Lausitz Mühlenweg 5
04924 Bad Liebenwerda

Product information

17/06/2021 Celsunax - EMEA/H/C/005135 -

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Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

Diagnostic radiopharmaceuticals

Therapeutic 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.

Assessment history

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