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Japan PMDA Drug Precaution Revisions for FY2025
The Japan Pharmaceuticals and Medical Devices Agency (PMDA) has published a list of drug precaution revisions for Fiscal Year 2025, detailing updates for various nonproprietary drug names. These revisions are effective on specific dates in late 2025 and early 2026, with associated investigation summaries available.
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Guidance
Pharmaceuticals
PMDA Japan Drug Precaution Revisions
The PMDA Japan has updated drug precautions for several medications, including Andexanet alfa, Topiramate, and various VEGF/VEGFR inhibitors. These revisions reflect new safety information and investigation results, impacting the labeling and handling of these drugs.
Priority review
Guidance
Pharmaceuticals
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