EMA 同意 SAB-142 针对 3 期 1 型糖尿病的儿科研究计划

EMA/PE/0000182592

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EMA 已对 SAB-142（抗胸腺细胞人多克隆免疫球蛋白 G）用于治疗 3 期 1 型糖尿病的儿科研究计划（PIP）作出同意决定，决定编号 EMA/PE/0000182592，决定日期为 2025 年 7 月 2 日。该药为静脉输注用溶液，所属治疗领域为免疫系统疾病，此次决定包含或不包含部分豁免及/或延期，尚未完成合规核查。

正文 · 原文

Key facts

Active substance: human polyclonal immunoglobulin G against thymocyte (SAB-142)
Therapeutic area: Immune system disorders
Decision number: EMA/PE/0000182592
PIP number: EMA/PE/0000182592
Pharmaceutical form(s): Solution for infusion
Condition(s) / indication(s): Treatment of stage 3 type 1 diabetes mellitus
Route(s) of administration: Intravenous use
Contact for public enquiries
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Decision date: 02/07/2025
Compliance check done: No

来源：EMA What's New · ema.europa.eu