翻译： JULIA 来源：Julia法规翻译
21/09/2018
Valsartan: review of impurities extended to other sartan medicines
A batch of losartan found to contain low levels of NDEA
缬沙坦：杂质审核延伸至其它沙坦类药品
一批氯沙坦检出含有低水平NDEA
The European Medicines Agency (EMA) is expanding its review of impurities in valsartan following the detection of very low levels of N-nitrosodiethylamine (NDEA) in another active substance, losartan, made by Hetero Labs in India.
在印度HETERO生产的另一原料药氯沙坦中检出非常低水平NDEA之后，EMA正在延伸其缬沙坦中杂质审核。
As a result of the detection of this impurity by German authorities, the review will now include medicines containing four other ‘sartans’, namely candesartan, irbesartan, losartan and olmesartan.
由于此杂质是德国药监检出的，因此该审核目前包括了含有4种其它沙坦类的药品，即坎地沙坦、厄贝沙坦、氯沙坦和奥美沙坦。
Like valsartan, these active substances have aspecific ring structure (tetrazole) whose synthesis could potentially lead to the formation of impurities such as NDEA. Other medicines of the class which do not have this ring are not included in the review.
与缬沙坦类似，这些原料药具有特定的环状结构（四唑环），其合成可能会导致形成如NDEA这样的杂质。其它不含该环的类别药品不在审核之列。
Both NDEA and a related compound N-nitrosodimethylamine (NDMA) are classified as probable human carcinogens (substances that could cause cancer). How these impurities came to be present during the manufacture of sartans is yet to be fully established and is being evaluated in the ongoing review.
NDEA和有关物质NDMA均被列为人体可能致癌物。但这些杂质在沙坦类生产过程中是如何出现的尚不完全清楚，仍在持续审核中。
Based on the trace amounts of NDEA seen so far in one batch of losartan from Hetero Labs, there is no immediate risk to patients.Patients are therefore advised not to stop taking losartan or other sartan medicines without speaking to their doctor.
基于目前仅在HETERO所生产的一批氯沙坦中所看到痕量的NDEA，患者并无直接风险。因此建议患者在未与其医生沟通之前不要停用氯沙坦或其它沙坦类药品。
Further tests are required to determine the extentof the contamination and whether impurities are present in sartan medicines above levels that can be considered acceptable.
目前需要进一步检查以确定污染程度以及在沙坦类药品中出现的杂质是否高于可接受水平。
This review was started when unacceptable levels of NDMA were found in some valsartan medicines, which have now been recalled inthe EU. Subsequently, NDEA was detected in some of the recalled valsartan products.
该审核始于在有些缬沙坦药品中发现不可接受水平的NDMA，目前这些药品在EU已经召回。随后，在被召回的缬沙坦药品中检出了NDEA。
The extension of the review to other sartans is precautionary. EMA is working closely with national authorities, international partners and EDQM to gather data on these medicines as quickly as possible.
将审核延伸至其它沙坦类是预防措施。EMA正与各国家药监局、国际伙伴和EDQM紧密合作以尽快收集这些药品的数据。
EMA will continue providing updates as more information becomes available and will take any necessary actions to protect patients’ health.
如获得更多信息，EMA将持续更新并采取必要措施保护患者健康。