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中国:国家药监局关于修订多潘立酮制剂说明书的公告(2022年第93号)(Chinese only)
 
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多潘立酮(英文名称:domperidone)制剂 ( 包括多潘立酮片、多潘立酮分散片、多潘立酮口腔崩解片、多潘立酮胶囊、多潘立酮混悬液、马来酸多潘立酮片)说明书内容进行统一修订。

详情请按以下连结:http://www.nmpa.gov.cn/xxgk/ggtg/../20221027144449188.html

在香港,共有41种注册药剂制品含有多潘立酮,均属医生处方药物。至今,卫生署未接获任何涉及多潘立酮的药物不良反应个案。上述说明书的修订内容,与著名药物文献如《马丁代尔药物大典》所收载的大致相同。多个海外药物监管局早前已公布有关含有多潘立酮的药物安全资讯,而相关资讯已从2012年3月8日起刊登于药物办公室的网页,最新更新于亦已2021年12月31日刊登。卫生署会对其他海外药物监管局就此药物发出的安全更新保持警惕。



2022年10月29日(星期六)
香港时间13时30分
 
Related Information:
Canada: Summary Safety Review: Domperidone: Assessing the potential risks of ser... Posted 2021-12-31
Domperidone for nausea and vomiting: lack of efficacy in children; reminder of c... Posted 2019-12-17
The United Kingdom: Domperidone for nausea and vomiting: lack of efficacy in chi... Posted 2019-12-17
Singapore: New recommendations on the use of domperidone Posted 2017-06-07
Singapore: New recommendations on the use of products containing domperidone Posted 2016-10-20
China: CFDA announcement regarding revision of package insert of domperidone pre... Posted 2016-09-15
Canada: Domperidone Maleate - Association with Serious Abnormal Heart Rhythms an... Posted 2015-01-21
Australia: Monitoring communication: Domperidone (Motilium) and effects on the h... Posted 2014-04-02
Recommendation to restrict the use of domperidone in the European Union (Letter ... Posted 2014-03-10
European Union: PRAC recommends restricting use of domperidone Posted 2014-03-08
Singapore: Domperidone and risk of cardiac arrhythmia and sudden cardiac death Posted 2012-04-21
Canada: Domperidone Maleate - association with serious abnormal heart rhythms an... Posted 2012-03-08
Health Canada: Domperidone Maleate - Association with Serious Abnormal Heart Rhy... Posted 2012-03-08
 
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