(New drug application (NDA)) Review report

審査報告書

Report on the deliberation results

審議結果報告書

Clinical trial (study) report

治験総括報告書

Summary technical documentation (STED)

申請資料概要

Application for marketing approval; new drug application (NDA)

製造販売承認申請書

Application dossier

申請資料

Summary basis of approval (SBA)

新医薬品承認審査概要

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