DaTSCAN

RSS

ioflupane (123l)

Authorised
This medicine is authorised for use in the European Union.

Overview

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.

This EPAR was last updated on 10/06/2021

Authorisation details

Product details
Name
DaTSCAN
Agency product number
EMEA/H/C/000266
Active substance
ioflupane (123l)
International non-proprietary name (INN) or common name
ioflupane (123l)
Therapeutic area (MeSH)
  • Tomography, Emission-Computed, Single-Photon
  • Lewy Body Disease
  • Parkinson Disease
  • Alzheimer Disease
Anatomical therapeutic chemical (ATC) code
V09AB03
Publication details
Marketing-authorisation holder
GE Healthcare B.V.
Revision
23
Date of issue of marketing authorisation valid throughout the European Union
27/07/2000
Contact address

GE Healthcare B.V.
De Rondom 8
5612 AP, Eindhoven 
The Netherlands

Product information

10/05/2021 DaTSCAN - EMEA/H/C/000266 - N/0061

Contents

  • 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.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

Diagnostic radiopharmaceuticals

Therapeutic indication

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.

Assessment history

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