EFFICACYEFFICACY · 疗效相关变更 · 标准审评 · SUPPL:8
补充批准 · 补充申报 sNDA/sBLA（疗效/人群）
批准信：Prior Approval；批准 Recarbrio (imipenem, cilastatin, and relebactam) 新增儿科患者（出生至 <18 岁，体重 ≥2 kg）适应症，用于复杂尿路感染、复杂腹腔内感染及医院获得性/呼吸机相关细菌性肺炎，并履行 PREA 上市后要求。
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批准信原文要点
This Prior Approval sNDA provides for the addition of pediatric patients (birth to <18 years of age) weighing at least 2 kg to the approved indications for treatment of complicated urinary tract infections (cUTI), including pyelonephritis in patients who have limited or no alternative treatment options; complicated intra-abdominal infections (cIAI) in patients who have limited or no alternative treatment options; and hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP).
Efficacy-New Patient Population（PAT POPUL）
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本节点无额外摘录（产品级靶点/机制见上方产品信息）。
来源：官方文件