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罗氏瞒报事件涉及药物6种在华销售 食药监局约谈--亲稳网络舆情监测室
2012-07-21

  

罗氏确认瞒报事件涉及药物6种在华销售 国家食药监局约谈安全官 Roche confirm a botched blood-collection drive drug sales in China involves 6 national food security officer, the administration's interview

  上海罗氏制药有限公司12日回应新华社记者,此次在美涉及“潜在不良事件未及时报告”的共有8种药物,其中6种在中国市场上有销售,分别是安维汀、赫赛汀、美罗华、特罗凯、希罗达、派罗欣,主要为抗癌类药物及肝炎治疗药物。公司传播部称,相关情况已向中国国家食品药品监督管理局报告。

Shanghai roche pharmaceuticals limited company 12 response xinhua,This involves in the United States“Potential adverse events not timely report”The total of eight kinds of drugs,Six of them in the Chinese market has the sale,Statins are was the d、herceptin、mabthera、's tarceva、xeloda、pegasys,Mainly for the anti-cancer drugs and hepatitis treatments。The company said the spread,Related situation has to China's state food and drug administration report。

  罗氏制药当日在声明中还称,基于目前的评估,未发现对罗氏产品的安全性产生影响。

Roche pharmaceuticals that day in the statement says,Based on current evaluation,Did not find the safety of products of roche's impact。

  当日晚间,国家食品药品监督管理局表示,密切关注发生在美国的罗氏公司瞒报事件进展情况,约谈了罗氏(中国)公司安全官,责成罗氏(中国)公司报告该事件的评价结果;并向世界卫生组织和英国、美国药监机构了解有关情况,希望及时通报该事件的调查结果。同时加强对罗氏公司在中国销售的相关品种的不良反应监测。

On that day evening,The state food and drug administration said,Pay close attention to happen in the United States of roche's botched blood-collection drive on progress,Interviewed the roche(China)The company safety officer,Instruct the roche(China)The results of the evaluation of the incident report;And to the world health organization and the UK、The United States about the drug watchdogs,Hope this incident promptly inform the survey results。At the same time, strengthen roche to sell in China related kind of adverse reaction monitoring。

  国家食品药品监管局称,从目前情况看,该事件涉及药品在我国不良反应监测中尚未发现异常报告。 (记者许晓青、胡浩)

The state food and drug supervision bureau says,From what we see,The incident involving drug adverse reaction monitoring in our country has not been found abnormality report。 (Reporter XuXiaoQing、HuHao)


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