2019年10月14-17日,欧洲人用药物委员会(CHMP)建议批准七种新药上市

2019-10-20 不详 MedSci原创

EMA的人用药物委员会(CHMP)在其2019年10月的会议上推荐了七种药物以供批准上市。

EMA的人用药物委员会(CHMP)在其2019年10月的会议上推荐了七种药物以供批准上市。

1. Ervebo(Ebola的埃博拉疫苗)喜获委员会建议授予有条件的上市许可,用于18岁及以上埃博拉病毒感染的高危人群预防疫苗。

2. Baqsimi(胰高血糖素),用于严重低血糖(血糖过低)、且有糖尿病病史4年以上的非注射治疗。

3. 当认为不宜使用其他抗菌剂时,Quofenix(地拉氟沙星)获得了CHMP的积极评价,用于治疗成人急性细菌性皮肤和皮肤结构感染

4. 委员会建议授予营销授权Rinvoq (upadacitinib)用于治疗类风湿关节炎。

5. Spravato(esketamine)在具有治疗抵抗力的重度抑郁症成人中接受联合治疗授予积极评价。

6.生物仿制药Mundipharma(培非司亭),用于治疗由于化疗引起的中性粒细胞减少的持续时间和中性粒细胞减少发热发病率,收到委员会的肯定意见。

7.  CHMP建议授予Evenity(romosozumab)上市授权,用于治疗绝经后妇女骨质疏松症的严重骨折的高风险。

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