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PET用標識化合物合成装置「放射性医薬品合成設備 MPS200Aβ」の使用目的又は効果に関する一部変更承認取得のお知らせ

Announcement of partial changes in the purpose or effects of the use of the PET labeling compound synthesis equipment 'Radiopharmaceutical Synthesis Equipment MPS200Aβ'

Sumitomo Heavy Industries ·  Sep 12 11:00

September 13, 2024

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Sumitomo Heavy Industries, Ltd. (Headquarters: Shinagawa-ku, Tokyo, Representative Director and President: Shinji Shimomura, hereinafter referred to as "the Company") hereby announces that the partial change application to define the efficacy and effect of florbetapir(18F) in the PET (Positron Emission Tomography) imaging system MPS200Aβ, which has been manufactured and sold since 2015, as "visualization of amyloid beta plaques in the brain of patients with mild cognitive impairment or suspected dementia due to Alzheimer's disease" has been approved.
Currently, there are therapeutic drugs for mild cognitive impairment and mild dementia caused by Alzheimer's disease that have been developed and marketed. However, the use of these drugs requires confirmation of findings suggesting amyloid beta pathology based on a diagnosable method approved for use.
With the approval of this partial change application, it will be possible to synthesize florbetapir(18F) injectables for the purpose of visualizing amyloid beta plaques in the brain of patients with mild cognitive impairment or suspected dementia due to Alzheimer's disease.
The Company will continue to focus on the further dissemination of PET imaging techniques and the expansion of their convenience and range of application.
Related Information
About MPS200Aβ (Medical Device Approval Number 22700BZX00277000)

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