EMA What's New·· 15 小时前AI 评分18
EMA 就 Exblifep(Enmetazobactam/cefepime)儿科研究计划修改申请作出决定
Opinion/decision on a Paediatric investigation plan (PIP): Exblifep, Enmetazobactam,cefepime, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Infections and infestations;Infectious diseases, PIP number: EMA/PE/0000247019
AI 导读
EMA 对 Exblifep(Enmetazobactam/cefepime)已获批儿科研究计划的修改申请作出决定,决定编号 EMA/PE/0000247019,决定日期为 10/07/2025。该药为静脉输注用浓缩液粉末,拟用于治疗革兰阴性菌所致感染,此次决定未进行合规性检查。
来源:EMA What's New · ema.europa.eu