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添付文書が改訂された場合、改訂された最新の添付文書情報が製薬企業から提供され掲載されます。. お手元の添付文書と内容が異なる場合がありますので、添付文書及び添付文書情報の改訂年月の記載をご確認の上、ご利用ください。. 自らが所属する医療 ...
PMDA shall not be responsible for any consequence resulting from use of the English versions. The review reports were selected for translation among those of drugs with a new active ingredient that recently received marketing approval, in consideration of relevant factors including the novelty and priority. 1.
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医薬品・医療機器・再生医療等製品の承認審査・安全対策・健康被害救済の3つの業務を行う組織。
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Jun 21, 2024 · English Translation of Review Report: Spikevax (bivalent, Original/Omicron BA.4-5) Partial Change Approval. June 26, 2024. Drug.
