MedPath
HSA Product

DATSCAN SOLUTION FOR INJECTION 74 MBQ/ML

Product approved by Health Sciences Authority (SG)

Basic Information

DATSCAN SOLUTION FOR INJECTION 74 MBQ/ML

INJECTION, SOLUTION

Regulatory Information

SIN15325P

September 4, 2017

Prescription Only

Therapeutic

INTRAVENOUS

August 10, 2023

May 30, 2025

XV09AB03

Company Information

GE Healthcare B.V.

GE HEALTHCARE PTE. LTD.

GE HEALTHCARE PTE. LTD.

Active Ingredients

Ioflupane (123I)

Strength: 74 MBq/mL at reference time

Detailed Information

Contraindications

**4.3 Contraindications** - Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_. - Pregnancy (see section 4.6 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).

Indication Information

**4.1 Therapeutic indications** DaTSCAN is a radiopharmaceutical indicated for striatal dopamine transporter visualisation using single photon emission computed tomography (SPECT) brain imaging to assist evaluation: - In adult patients with clinically uncertain Parkinsonian Syndromes, for example those with early symptoms, in order to help differentiate Essential Tremor from tremor due to 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. DaTSCAN is an adjunct to other diagnostic evaluations.

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