EMA 就 Fasenra（Benralizumab）儿科研究计划修改申请作出决定
Opinion/decision on a Paediatric investigation plan (PIP): Fasenra, Benralizumab, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Blood and lymphatic system disorders, PIP number: EMA/PE/0000253868
EMA 对 Fasenra（Benralizumab）用于治疗高嗜酸性粒细胞综合征的儿科研究计划（PIP）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/0000253868。该药拟用剂型为注射液及注射/输注用溶液，给药途径为皮下注射，治疗领域为血液及淋巴系统疾病。
Key facts
Invented name
Fasenra
Active substance
Benralizumab
Therapeutic area
Blood and lymphatic system disorders
Decision number
EMA/PE/0000253868
PIP number
EMA/PE/0000253868
Pharmaceutical form(s)
- Solution for injection
- Solution for injection/infusion
Condition(s) / indication(s)
Treatment of hypereosinophilic syndrome
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