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https://www.senju.co.jp/system/files/2022-03/20220330_MKLA_IF_0.PDF -

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https://www.senju.co.jp/system/files/2024-01/Mikeluna_IF_20240111.pdf -

視活動 追加の医薬品安全性監視活動 地図状萎縮を伴う萎縮型加齢黄斑変性を有 する日本国内の被験者を対象に ASP3021を 硝子体内投与したときの安全性を評価する 第3/4相、 多施設共同、 単群臨床試験 [3021- CL-3001試験] 特定使用成績調査 3. 有効性に関する調査・試験の計画の概 要 なし ↓上記に基づくリスク最小化のための活動 4. リスク最小化計画の概要 通常のリスク最小化...
https://www.senju.co.jp/system/files/rmp_document/2026-10/IZV_202609_05_RMP.pdf