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定の上、適切に実施すること。 備 考 令和 7 年 9 月 3 日に、添加剤の変更について承認事項一部変更承認を取得。 2 変更の履歴 前回提出日：令和 6 年 6 月 14 日 変更内容の概要： ①備考欄に添加剤変更による承認事項一部変更承認取得を追記した。 変更理由： ①添加剤変更による承認事項一部変更承認を取得したため。 3 1. 医薬品リスク管理計画の概要 1.1 安全性検討事項 重要な特...
https://www.senju.co.jp/system/files/rmp_document/2025-09/ABT_202509_03_RMP.pdf -
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https://www.senju.co.jp/system/files/2021-07/20210705_MK_IF_0.pdf -
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https://www.senju.co.jp/system/files/2021-07/20210705_MK_IF.pdf -
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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/2022-03/20220330_MKLA_IF.PDF