翻译:JULIA 来源: Julia法规翻译 10/08/2018Update on review of valsartan medicines due to detectionof NDMA因检出NDMA缬沙坦药品审核更新EMA reviewing valsartan produced by another company Zhejiang TianyuEMA正在审核另一公司浙江天宇生产的缬沙坦As part of the ongoing review of valsartan medicines, EMA has learnt that low levels of N-nitrosodimethylamine (NDMA) have been detected in the valsartan active substance manufactured by a second company, Zhejiang Tianyu.作为缬沙坦药品持续审核的一部分,EMA已经知晓在另一公司,浙江天宇所生产的缬沙坦API中检出低水平NDMA。NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests.基于实验室测试结果,NDMA被归类为可能的人体致癌物。The NDMA levels detected in batches of valsa
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