翻译：JULIA 来源： Julia法规翻译
EMA官网原文链接 http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2018/07/news_detail_002984.jsp&mid=WC0b01ac058004d5c1
5 July 2018
EMA/459276/2018
EMA reviewing medicines containing valsartan from Zhejiang Huahai following detection of an impurity
发现杂质—EMA正在审核浙江华海含有缬沙坦的药品
Some valsartan medicines being recalled across the EU
一些缬沙坦药品正在全欧盟召回
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.
EMA正在审核含有浙江华海制药（中国临海的一家公司）供应的活性成分缬沙坦的药品。
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.
审核是在公司在缬沙坦活性成分中检出一种杂质N-二甲基亚硝胺（N-Nitrosodimethylamine，NDMA）后而启动的。华海为一些欧盟内缬沙坦药品生产商供应此活性物质。
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.
基于实验室测试结果，NDMA被归类为可能的人体致癌物（可能会导致癌症的物质）。NDMA是不应该被检出的，其出现可能与活性物质生产方法变更有关。
While the review is underway, national authorities across the EU are recalling medicines containing valsartan supplied by Zhejiang Huahai.
由于审核仍在进行中，EU的国家药监局正在召回含有浙江华海的缬沙坦的药品。
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 inpatients who have had heart failure or a recent heart attack.
缬沙坦药品被用于治疗有高血压的患者，以减少并发症如心脏病发作。它还被用于曾有过心力衰竭或最近有心脏病发作的患者。
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的审核将调查这些缬沙坦药品中NDMA的水平，其对已服用患者可能产生的影响，以及可采取的降低或清除该公司未来所生产批次产品中杂质的措施。作为预防措施，审核亦会考虑是否有其它缬沙坦药品受到影响。
The review will be carried out by EMA’s Committee for Medicinal Products for Human Use (CHMP).
审核将由EMA的CHMP执行。
Information for patients 给患者的信息
o An unexpected impurity has been found in the active ingredient used to make some valsartan medicines.
o 在用于生产一些缬沙坦药品的活性成分中发现了一种非预期杂质
o Only some valsartan medicines in the EU are affected and these are being recalled.
o 在欧盟只有某些缬沙坦药品受到影响并将被召回
o You should not stop taking your valsartan medicine unless you have been told to do so by your doctor or pharmacist.
o 除非你的医生或药师告诉你停止服用缬沙坦药品，否则不应停用
o You may be given a different valsartan medicine (or an alternative treatment) when you go for your next prescription.
o 如果你下次去开处方，可能会配用不同的缬沙坦药品（或替代性治疗）
o If you have anyquestions about your treatment, speak to your pharmacist who can tell you if your medicine is being recalled.
o 如果你在治疗方面还有任何问题，请找你的药师，他会告诉你你的药品是否被召回
o If you are in a clinical trial withvalsartan and have any questions, speak to the doctor treating you in thetrial.
o 如果你正在参加缬沙坦的一个临床试验，如果你有任何问题，请找临床试验项目中你的主治医生
o EMA will assess whether the impuritymay pose any risk for patients. Further information will be provided onceavailable.
o EMA将评估是否该杂质对患者具有任何风险。如有更多信息将立即提供
Information for healthcareprofessionals 给医疗专业人员的信息
o N-nitrosodimethylamine (NDMA) has been detected in the valsartan active substance manufactured by Zhejiang Huahai Pharmaceuticals.
o 在浙江华海制药生产的缬沙坦活性成分中已检出N-二甲基亚硝胺（N-Nitrosodimethylamine，NDMA）
o As a result, valsartan medicines containing the active substance from Zhejiang Huahai are being recalled in the EU.
o 作为应对，含有浙江华海所生产活性成分的缬沙坦药品在EU范围内全面召回
o National authorities are contacting pharmacists with information on the medicines to be recalled.
o 国家药监局正在联络药剂师，通知其关于要被召回的药品信息
o EMA is now evaluating potential impact on patients of the exposure to NDMA in valsartan medicines. Further information will be provided once available.
o EMA正在评估患者暴露于缬沙坦药品中NDMA的潜在影响。如有更多信息将立即提供
More about the medicine 关于药品的更多信息
Valsartan is anangiotensin-II-receptor antagonist used to treat hypertension (high blood pressure), recent heart attack and heart failure. It is available on its own orin combination with other active substances.
缬沙坦是一种血管紧张素II受体拮抗剂，用于治疗高血压、近期心脏病发作和心力衰竭。可单独成药亦可与其它活性成份一起成药。
The review covers all medicines that contain valsartan supplied by Zhejiang Huahai Pharmaceuticals. As a precaution,the review will also consider whether other valsartan medicines may be affected.
审核覆盖了浙江华海制药供应的所有含有缬沙坦的药品。作为预防措施，审核亦会考虑是否有其它缬沙坦药品受到影响。
More about the procedure 更多程序相关信息
The review of medicines containing valsartan supplied by Zhejiang Huahai Pharmaceuticals was triggered on 5 July 2018 by the request of the European Commission, under Article 31 of Directive 2001/83/EC.
对华海制药供应的含有缬沙坦的药品的审核是由2018年7月5日欧盟委员会依据指令2001/83/EC第31条要求而启动的。
The review will be carried out by the Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use, which will adopt the Agency’s opinion. The CHMP opinion will then be forwarded to the European Commission, which will issue afinal legally binding decision applicable in all EU Member States.
该审核将由负责人药相关问题的人药委员会（CHMP）执行，审核将采纳EMA的意见。CHMP的意见将被提交给欧盟委员会，欧委会将签发一份最终最有法律约束力的决定，并适用于所有欧盟成员国。
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