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国家药监局关于修订双黄连颗粒等口服制剂处方药和非处方药说明书的公告（2020年 第40号）

2020-03-26 NMPA NMPA

国家药监局双黄连
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　　根据药品不良反应评估结果，为进一步保障公众用药安全，国家药品监督管理局决定对双黄连颗粒等口服制剂（包括颗粒剂、糖浆剂、片剂、泡腾片、分散片、咀嚼片、含片、合剂、滴丸、硬胶囊、软胶囊、滴剂）说明书【

　　根据药品不良反应评估结果，为进一步保障公众用药安全，国家药品监督管理局决定对双黄连颗粒等口服制剂（包括颗粒剂、糖浆剂、片剂、泡腾片、分散片、咀嚼片、含片、合剂、滴丸、硬胶囊、软胶囊、滴剂）说明书【不良反应】、【禁忌】和【注意事项】项进行统一修订。现将有关事项公告如下：
　　一、所有双黄连颗粒等口服制剂处方药和非处方药生产企业均应依据《药品注册管理办法》等有关规定，分别按照相应说明书修订要求（见附件1、2），于2020年6月30日前报省级药品监管部门备案。
　　修订内容涉及药品标签的，应当一并进行修订；说明书及标签其他内容应当与原批准内容一致。在备案之日起生产的药品，不得继续使用原药品说明书。生产企业应当在补充申请备案后6个月内对已出厂的药品说明书及标签予以更换。
　　二、药品生产企业应当对新增不良反应发生机制开展深入研究，采取有效措施做好药品使用和安全性问题的宣传培训，指导医师和患者合理用药。
　　三、临床医师应当仔细阅读上述药品说明书的修订内容，在选择用药时，应当根据新修订说明书进行充分的效益/风险分析。
　　四、患者用药前应当仔细阅读药品说明书，使用处方药的，应严格遵医嘱用药。
　　五、各省级药品监管部门应当督促行政区域内上述药品的生产企业按要求做好相应说明书修订和标签、说明书更换工作，对违法违规行为依法严厉查处。
　　特此公告。
　　
　　附件：1.双黄连颗粒等口服制剂处方药说明书修订要求
　　　　　2.双黄连颗粒等口服制剂非处方药说明书修订要求
　
　　


　　国家药监局
　　2020年3月18日

 

 

 

国家药品监督管理局2020年第40号公告 附件1.doc

国家药品监督管理局2020年第40号公告 附件2.doc

 
 

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    2020-07-13 psybestwish

    #非处方#

    0

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    2020-03-28 xuyu

    #药监局#

    0

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    2020-03-28 pyaili

    #国家药监局#

    0

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    2020-03-28 yangpeizhi

    #说明书#

    0

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    2020-03-28 gracezdd

    #非处方药#

    0

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国家药监局批准我国首台自主知识产权碳离子治疗系统获批上市，应用于实体肿瘤治疗

2019年9月29日，国家药品监督管理局经审查，批准兰州科近泰基新技术有限责任公司的“碳离子治疗系统”医疗器械注册。

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