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中生制药(01177.HK):阿法骨化醇软胶囊国内首家通过一致性评价
格隆汇 02-10 12:05

格隆汇2月10日丨中生制药(01177.HK)宣布,集团的抗骨质疏松药物“阿法骨化醇软胶囊”(商品名:盖诺真)已获中华人民共和国国家药品监督管理局颁发药品补充申请批准通知书,获通过仿制药质量和疗效一致性评价,为国内同品种首家通过一致性评价。

阿法骨化醇是一种活性维生素D3类药物,适用于治疗肾性骨营养不良、术后性或特发性甲状旁腺功能低下症、假性甲状旁腺功能低下症、作为第三性甲状旁腺功能亢进的辅助治疗、抗维生素D性佝偻病或骨软化症、维生素D依赖型佝偻病、新生儿低钙血症或佝偻病、钙吸收不良症、骨质疏松症、吸收不良性及营养性佝偻病及骨软化症。阿法骨化醇软胶囊具有口服生物利用度高、起效快、安全性高、不良反应发生率极低、药效持久等优势,是治疗和预防骨质疏松的基础用药。

阿法骨化醇软胶囊已入选国家基本药物目录,入编《骨质疏松骨折诊疗指南》、《糖皮质激素诱导的骨质疏松诊治的专家共识》等多项权威指南。通过了一致性评价,盖诺真被正式认可可作为原研药的替代,为患者提供更多优质低价的用药选择。

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