国家药剂监管局(NPRA)已批准Solution Biologics私人有限公司更新克威莎(Convidecia)新冠疫苗保质期限的申请。
卫生部药剂服务组高级主任诺哈丽扎说,所批准的新保质期为15至18个月,储存温度介于2至8摄氏度。
她今日(21日)发文告说,延长保质期限的疫苗涉及在中国康希诺生物(Cansino Biologics Inc)生产的MAL21066050AZ批疫苗,以及在大马Solution Biologics私人有限公司生产的MAL22126013ASZ批疫苗。
她提到,当局根据制造商提呈的最新稳定性数据,批准延长产品保质期。
“获批的延长保质期具有可追溯性,这意味着它也适用于所有库存,包括在此保质期延长获批之前收到的库存。”
诺哈丽扎说,卫生部向来致力确保在国内供应的所有医药产品包括新冠疫苗,已通过国家药剂监管局对质量、安全及有效性展开的评估。
来源:马新社
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