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.
Therapeutic Indication
### 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.
Therapeutic Area (MeSH)
ATC Code
V09AB03
ATC Item
iodine ioflupane (123I)
Pharmacotherapeutic Group
Diagnostic radiopharmaceuticals
Active Substance (Summary)
INN / Common Names
| Substance | CAS | Monograph |
|---|---|---|
| ioflupane (123l) | N/A | ioflupane (123 l) |
EMA Name
DaTSCAN
Medicine Name
DaTSCAN
Aliases
N/ANo risk management plan link.
