← Drug database

DaTSCAN (ioflupane (123l))

Region

🇪🇺 EU

Active substance

ioflupane (123l)

Company

GE Healthcare B.V.

Status

Authorised

Therapeutic area

Tomography, Emission-Computed, Single-Photon; Lewy Body Disease; Parkinson Disease; Alzheimer Disease

EU approval

Thu 27 Jul 2000

Application

EMEA/H/C/000266

ATC

V09AB03

Official record

www.ema.europa.eu

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.

Regulatory milestones

No milestones recorded in the last year.

Same substance in other markets

• 🇪🇺 Striascan Authorised · CIS bio international

Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.