Striascan

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ioflupane (123i)

Overview

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.

This EPAR was last updated on 02/08/2019

Authorisation details

Product details
Name
Striascan
Agency product number
EMEA/H/C/004745
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
V09AB03
GenericGeneric

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
CIS bio international
Date of opinion
25/06/2019
Date of issue of marketing authorisation valid throughout the European Union
25/06/2019
Contact address

Route Nationale 306, Saclay
B.P. 32
F-91192 Gif sur Yvette Cedex
France

Product information

Striascan - EMEA/H/C/004745 -

Contents

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Pharmacotherapeutic group

DIAGNOSTIC RADIOPHARMACEUTICALS

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.

Assessment history

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