Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
MHLW Orders Label Revisions for Samsca Acute Liver Failure Added to Significant ADR List
The Ministry of Health, Labor and Welfare (MHLW) ordered on March 20 revisions to package inserts for Otsuka Pharmaceutical’s selective vasopressin V2 receptor antagonist Samsca (tolvaptan). Acute hepatic failure will be added to the list of clinically significant adverse drug…
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REGULATORY
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