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浙江华海制药缬沙坦原料药发现致癌杂质

发表时间:2018-07-10 14:29:19  来源:  作者:

 因产品检出致癌物,欧盟宣布调查华海,各国纷纷召回

7月5日,欧盟药监局(EMA)发布公告宣布调查浙江华海制药有限公司生产的缬沙坦原料药。起因为在该原料药中发现一种可能致癌的杂质:N-亚硝基二甲胺(NDMA)。EMA表示原料药中存在NDMA是出乎意料的,可能与原料的生产方式的变化有关。目前,欧盟各国政府正在召回含有浙江华海缬沙坦原料的药品。

EMA公告摘译如下:

EMA reviewing medicines containing valsartan from Zhejiang Huahai following detection of an impurity

因检测到一种杂质,EMA审查了以浙江华海供应的缬沙坦为原料的药品。

Some valsartan medicines being recalled across the EU

一些缬沙坦的药品正在欧盟范围内被召回

The European Medicines Agency (EMA) is reviewing medicines containing the active substance valsartan that is supplied by Zhejiang Huahai Pharmaceuticals, a company in Linhai, China.

欧洲药品管理局(EMA)正在审查以中国浙江华海药业供应的缬沙坦为原料的药品。

The review was triggered after the company detected an impurity, N-nitrosodimethylamine (NDMA), in the valsartan active substance which the company supplies to manufacturers producing some of the valsartan medicines available in the EU.

事情的起因是,公司在缬沙坦原料中检测到一种杂质:N-亚硝基二甲胺(NDMA),这些有问题的原料被供应至制剂厂商生产制剂供货至EU。

NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. The presence of NDMA was unexpected and is thought to be related to changes in the way the active substance was manufactured.

据实验室测试的结果,NDMA被归类为可能的人类致癌物(一种可能导致癌症的物质)。NDMA的存在是出乎意料的,可能与原料的生产方式的变化有关。

While the review is underway, national authorities across the EU are recalling medicines containing valsartan supplied by Zhejiang Huahai.

在审查期间,欧盟各国政府正在召回含有浙江华海缬沙坦原料的药品。

Valsartan medicines are used to treat patients with high blood pressure in order to reduce complications such as heart attack and stroke. It is also used in patients who have had heart failure or a recent heart attack.

缬沙坦药物用于治疗高血压患者,以减少心脏病发作和中风等并发症。它也用于心力衰竭或近期心脏病发作的患者。

EMA’s review will investigate the levels of NDMA in these valsartan medicines, its possible impact on patients who have been taking them and what measures can be taken to reduce or eliminate the impurity from future batches produced by the company. As a precaution, the review will also consider whether other valsartan medicines may be affected.

EMA的审查将调查这些缬沙坦药物中NDMA的水平,对服用它们的患者可能产生的影响,以及可以采取哪些措施来减少或消除未来批次原料中的杂质。作为预防措施,该审查还将考虑其他缬沙坦药物是否可能受到影响。

The review will be carried out by EMA’s Committee for Medicinal Products for Human Use (CHMP).

该审查将由EMA的人用药品委员会(CHMP)进行。

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