Basic Information
Striascan
Regulatory Information
EMEA/H/C/004745
June 25, 2019
June 25, 2019
4
October 3, 2024
Company Information
France
Route Nationale 306, Saclay B.P. 32 F-91192 Gif sur Yvette Cedex
CIS BIO INTERNATIONAL
Drug Classification
Active Ingredients
Active Substances Detail
ioflupane (123l)
EMA Resources
Detailed Information
Therapeutic Indication
### Therapeutic indication This medicinal product is for diagnostic use only. Striascan 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. Striascan 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. Striascan is unable to discriminate between dementia with Lewy bodies and Parkinson’s disease dementia.
Overview Summary
Striascan 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 (aged 18 years or over): - 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), Striascan can help distinguish between essential tremor and diseases related to Parkinson’s disease; - dementia (loss of intellectual function). Striascan is used to help distinguish between a type of dementia known as ‘dementia with Lewy bodies’ and Alzheimer’s disease. Striascan contains the active substance ioflupane (123I) and is a ‘generic medicine’. This means that Striascan contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the EU called DaTSCAN.