EMA What's New·· 2 小时前AI 评分22
EMA 就 emapalumab 治疗噬血细胞性淋巴组织细胞增生症的 PIP 修改申请作出决定
EMA/PE/0000225490
AI 导读
EMA 对 emapalumab 治疗噬血细胞性淋巴组织细胞增生症的已同意 PIP 修改申请作出决定，决定编号 EMA/PE/0000225490，决定日期 11/07/2025。该药为静脉输注用浓缩液，未进行合规检查。
正文 · 原文
Key facts
Active substance
emapalumab
Therapeutic area
Immune system disorders
Decision number
EMA/PE/0000225490
PIP number
EMA/PE/0000225490
Pharmaceutical form(s)
Concentrate for solution for infusion
Condition(s) / indication(s)
Treatment of haemophagocytic lymphohistiocytosis
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
11/07/2025
Compliance check done
No
来源：EMA What's New · ema.europa.eu