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: Immune system disorders;Pneumology-allergology, PIP number: EMA/PE/0000241178
EMA 对 Fasenra（Benralizumab）用于嗜酸性肉芽肿性多血管炎的儿科研究计划（PIP）修改申请作出决定，决定类型为 PM，决定编号 EMA/PE/0000241178，决定日期 2025 年 7 月 10 日。该药为皮下注射用溶液，治疗领域为免疫系统疾病及呼吸-变态反应学，合规检查未完成。
Key facts
Invented name
Fasenra
Active substance
Benralizumab
Therapeutic area
- Immune system disorders
- Pneumology-allergology
Decision number
EMA/PE/0000241178
PIP number
EMA/PE/0000241178
Pharmaceutical form(s)
Solution for injection
Condition(s) / indication(s)
Treatment of eosinophilic granulomatosis with polyangiitis
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
10/07/2025
Compliance check done
No
来源：EMA What's New · ema.europa.eu