EMA What's New·· 16 小时前AI 评分22
EMA 就 Bylvay（odevixibat sesquihydrate）儿科研究计划修改申请作出决定
Opinion/decision on a Paediatric investigation plan (PIP): Bylvay, odevixibat sesquihydrate, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Hepatobiliary disorders;Gastroentology-Hepatology, PIP number: EMA/PE/0000240317
AI 导读
EMA 对 Bylvay（odevixibat sesquihydrate）已获批儿科研究计划（PIP）的修改申请作出决定，决定编号 EMA/PE/0000240317，决定日期为 10/07/2025。该 PIP 涉及胆道闭锁适应症，拟采用适龄口服液体制剂与硬胶囊两种剂型，经口服给药，未进行合规检查。
来源：EMA What's New · ema.europa.eu