PRECAUTIONS in package inserts include information such as WARNING, CONTRAINDICATIONS, IMPORTANT PRECAUTIONS, and Clinically Significant Adverse Reactions. When a new risk is identified, the PMDA thoroughly investigates the risk and discusses the necessity of revision of PRECAUTIONS with expert advisors so that the PMDA can recommend an additional safety measure to the MHLW. Following the investigation results by the PMDA, the MHLW issues a notice to revise PRECAUTIONS. The marketing authorization holders consequently revise PRECAUTIONS in accordance with the notice.
Therefore, “Detailed information on revisions of PRECAUTIONS” is issued by the MHLW, and “Summary of investigation results” by the PMDA.