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台湾:含ranitidine成分药品得恢复供应、销售品项之最新进度
 
台湾卫生福利部食品药物管理署接获荷商葛兰素史克药厂股份有限公司台湾分公司及鸿汶医药实业有限公司通报,该二公司输入之「"葛兰素"善胃得注射液25毫克/毫升(卫署药输字第017530号)」及「安保胃膜衣锭150公丝(卫署药输字第020323号)」药品,已配合外国原制造厂之通知,自主下架回收。

详情请按以下连结: http://www.fda.gov.tw/../newsContent.aspx?cid=4&id=t549091

在香港,Zantac Inj 25mg/ml (HK-42045)是由葛兰素史克有限公司注册的药剂制品,而Apo-Ranitidine Tab 150mg (HK-42273)和Apo-Ranitidine Tab 300mg (HK-41873)是由显荣行有限公司注册的药剂制品。

现时,有67种在香港注册的药剂制品含有雷尼替丁。这些产品包括口服制剂和注射剂型,分别属于非处方药物和医生处方药物。至今,卫生署未接获任何涉及雷尼替丁的药物不良反应个案。

欧洲药物监管局、美国食物及药物管理局、加拿大卫生局、新加坡卫生科学局、澳洲药物管理局和台湾卫生福利部食品药物管理署早前已公布有关在雷尼替丁产品中检测到N-亚硝基二甲胺(NDMA)的消息,而相关信息已从2019年9月16日起刊登于药物办公室的网页,最新的更新亦已于2019年9月28日刊登。卫生署已在2019年9月18日发信通知本地医护专业人员。卫生署已联络有关海外药物监管局以获取在雷尼替丁产品中检测到NDMA的进一步资料,并继续对有关监管局公布的最新调查结果保持警惕。

有关各海外药物监管局,包括新加坡卫生科学局、加拿大卫生局、台湾卫生福利部食品药物管理署和美国食物及药物管理局,公布暂停销售或回收雷尼替丁产品,部分品牌的产品有在香港注册。当中一些品牌已从香港市场回收,或已暂停销售。其他品牌现时并无在港销售。

于二零一九年九月二十四日,卫生署同意持牌药物批发商葛兰素史克有限公司采取预防措施,从市面回收所有善胃得产品(Zantac; HK-42792, HK-42793, HK-30459, HK-42045),因产品含有杂质NDMA。于二零一九年九月二十五日,卫生署同意持牌药物批发商显荣行有限公司和五丰药业有限公司分别回收爱胃妥药片(Apo-Ranitidine Tablets; HK-42273, HK-41873) 和Zantidon 150毫克药片(HK-64329)。于二零一九年九月二十七日,卫生署同意持牌药物制造商雅柏药业有限公司和持牌药物批发商优俊国际有限公司分别回收胃适好150毫克药片(Amratidine Tablets; HK-53143)和Peptil H 150 150毫克药片(HK-65103)。

卫生署一直联络所有注册雷尼替丁产品的注册证书持有人以跟进这事件的本地影响,并要求所有注册证书持有人提供产品内NDMA的含量低于可接受的水平的证据。卫生署会继续对事件的发展和海外药物监管局就此药物发出的安全更新保持警惕,以考虑任何必要的行动。

正在服用含有雷尼替丁产品的病人不应自行停止服用药物,他们应尽快向其医护人员谘询意见,以作适当安排,例如使用有类似用途的替代药物。


2019年9月30日 (星期一)
香港时间14时正
 
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