Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
Aricept’s Lewy Body Dementia Indication to Be Modified after Post-Launch Trial Miss
For the first time in more than 14 years, the Japanese health ministry is requiring a partial change of approval under its pharmaceutical reexamination system. Eisai’s Aricept (donepezil) now braces for such modification process, which also entails a label revision,…
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