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
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。
Key facts
Invented name
Bylvay
Active substance
odevixibat sesquihydrate
Therapeutic area
- Hepatobiliary disorders
- Gastroentology-Hepatology
Decision number
EMA/PE/0000240317
PIP number
EMA/PE/0000240317
Pharmaceutical form(s)
- Age appropriate oral liquid dosage formulation
- Capsule, hard
Condition(s) / indication(s)
Treatment of biliary atresia
Route(s) of administration
Oral use
Contact for public enquiries
Decision type
PM: decision on the application for modification of an agreed PIP
Decision date
10/07/2025
Compliance check done
No
来源：EMA What's New · ema.europa.eu