EMA 就 Mounjaro（tirzepatide）儿科研究计划修改申请作出决定
Opinion/decision on a Paediatric investigation plan (PIP): Mounjaro, tirzepatide, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Other, PIP number: EMA/PE/0000245851
EMA 对 Mounjaro（tirzepatide）已获批儿科研究计划（PIP）的修改申请作出决定，决定类型为 PM，决定日期 11/07/2025，PIP 编号 EMA/PE/0000245851。该 PIP 对应适应症为肥胖治疗，剂型为注射液，给药途径为皮下注射，合规检查未完成。
Key facts
Invented name
Mounjaro
Active substance
tirzepatide
Therapeutic area
Other
Decision number
EMA/PE/0000245851
PIP number
EMA/PE/0000245851
Pharmaceutical form(s)
Solution for injection
Condition(s) / indication(s)
Treatment of obesity
Route(s) of administration
Subcutaneous use
Contact for public enquiries
Decision type
PM: decision on the application for modification of an agreed PIP
Decision date
11/07/2025
Compliance check done
No
来源：EMA What's New · ema.europa.eu