This is a summary of the European public assessment report (EPAR) for DaTSCAN. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for DaTSCAN.
DaTSCAN : EPAR - Summary for the public (PDF/75.82 KB)
First published: 27/07/2007
Last updated: 08/06/2011
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|International non-proprietary name (INN) or common name||
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GE Healthcare B.V.
|Date of issue of marketing authorisation valid throughout the European Union||
GE Healthcare B.V.
10/05/2021 DaTSCAN - EMEA/H/C/000266 - N/0061
- 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.
DaTSCAN 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. DaTSCAN 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. DaTSCAN is unable to discriminate between dementia with Lewy bodies and Parkinson’s disease dementia.