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
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。
Key facts
Invented name
Exblifep
Active substance
- Enmetazobactam
- cefepime
Therapeutic area
- Infections and infestations
- Infectious diseases
Decision number
EMA/PE/0000247019
PIP number
EMA/PE/0000247019
Pharmaceutical form(s)
Powder for concentrate for solution for infusion
Condition(s) / indication(s)
Treatment of infections caused by gram-negative organisms
Route(s) of administration
Intravenous 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