翻译：JULIA 来源：Julia法规翻译
02/08/2018
Update on review of recalled valsartan medicines
被召回缬沙坦药品审核更新
Preliminary assessment of possible risk to patients 对患者潜在风险的初步评估
EMA is conducting a review of the possible health effects inpatients who may have taken valsartan medicines containing N-nitrosodimethylamine (NDMA) – an impurity found in the active substance manufactured by Zhejiang Huahai Pharmaceuticals.
EMA正对可能服用了含有NDMA杂质（浙江华海药业所生产的活性物质中发现的一种杂质）的缬沙坦药品的患者进行潜在健康影响审核。
NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on animal tests. It is present in some foods and water supplies but is not expected to cause harm when ingested in very low levels.
基于动物测试，NDMA被归类为可能的人体致癌物质（可能会引发癌症）。该物质在一些食品和水中会出现，但在摄入极低水平时不会形成伤害。
Following a preliminary evaluation, EMA estimates that there could be one extra case of cancer for every 5,000 patients taking the affected medicines at the highest valsartan dose (320 mg) every day for 7 years. This is based on average levels of this impurity detected in the active substance from Zhejiang Huahai Pharmaceuticals (60 parts per million).
经过初步评估之后，EMA估计以每天最高剂量（320mg）连续7年服用受影响药品的患者中第5000名会有一例确切的癌症案例。这是基于此杂质在浙江华海药业的API中平均检出水平（60ppm—百万分之六十）做出的估计。
The possible cancer risk has been extrapolated from animal studies and should be considered in the context of the lifetime risk of cancer inthe EU (1 in 3) and NDMA exposure from other sources.
可能的致癌风险是从动物研究数据外推而得的，应在EU境内生命周期患癌情境（每3人有1人患癌）以及其它来源NDMA暴露情况下考量。
This preliminary estimate is based on the assumption that the NDMA present in the active substance is carried over in the final productin the same amount.
此初步预测是基于API中NDMA在最终制剂中以相同数据出现的假设。
Companies that had used the active substance from Zhejiang Huahai in their valsartan medicines are required to test samples they hold to determine the actual NDMA levels in the final products. Additional checks are being carried out by EU official control laboratories. Once data from all these tests are available, EMA will be able to provide more information on the risk that the impurity may have posed for patients in the EU.
已在其缬沙坦药品中使用了华海API的公司被要求检测其留样以确定最终制剂中NDMA的实际水平。EU的官方控制实验室正在进行附加检测。一旦得到所有这些检测数据，EMA将可以提供更多关于该杂质对EU内患者可能具有的风险方面的更多信息。
It is important to note that there is no immediate risk topatients. Patients taking the affected medicines who have not yet switched to an alternative should not stop taking their medicines without consulting their doctor or pharmacist.
很重要的一点是要注意患者并没有直接风险。正在服用受影响药品且未换成其它替代药品的患者在咨询其医生或药师之前不应停止服用其药品。
Valsartan medicines are used for patients with serious or potentially serious conditions of the circulatory system (high blood pressure,a recent heart attack and heart failure). It is therefore not advisable to go without treatment if a treatment has been prescribed.
缬沙坦药品被用于循环系统有严重问题或可能有严重问题的患者（高血压，最近有过心脏病发作和心力衰竭）。因此如果指示如此治疗则不建议停止。
All valsartan medicines containing the active substance fromZhejiang Huahai Pharmaceuticals have been recalled from pharmacies in the EU but several other valsartan medicines not affected by the impurity are available. Patients who want more information about their treatments shouldcontact their doctor or pharmacist. Further information is provided by national medicines authorities.
所有含有浙江华海缬沙坦API的药品均已从EU药房召回，但几个未受该杂质影响的其它缬沙坦药品仍在销售。希望获得更多关于其治疗信息的患者应联系其医生或药师。更多信息在国家药监官网有提供。
NDMA was an unexpected impurity believed to have formed as a side product after Zhejiang Huahai introduced changes to its manufacturing process in 2012. No other active substances produced by the company are affected.
NDMA是一种非预期杂质，相信是在浙江华海于2012年对其生产工艺引入变更之后形成的副产物。该公司所生产的其它活性物质不受影响。
EMA is working closely with international partners and will provide further information on its website as the review progresses.
EMA正在与国际伙伴紧密合作，将在其官网提供进一步的审核进展信息。
译者：
另外，EMA于7月30日更新了EU境内已批准上市的缬沙坦药品清单（注意，并非召回清单），官网链接为http://www.ema.europa.eu/docs/en_GB/document_library/Referrals_document/Valsartan_31/WC500252695.pdf
共有341页4634KB，部分国家MAH信息如下，具体参见官方原文。
Amlodipine-Valsartan Mylan EMEA/H/A-31/1471/C/4037/0004
Copalia EMEA/H/A-31/1471/C/774/0099
Copalia HCT EMEA/H/A-31/1471/C/1159/0069
Dafiro EMEA/H/A-31/1471/C/776/0101
Dafiro HCT EMEA/H/A-31/1471/C/1160/0070
Entresto EMEA/H/A-31/1471/C/4062/0021
Exforge EMEA/H/A-31/1471/C/716/0098
Exforge HCT EMEA/H/A-31/1471/C/1068/0068
Neparvis EMEA/H/A-31/1471/C/4343/0020
奥地利：+pharma Arzneimittel Gmbh，阿特维斯，G.L.Pharma，Genericon Pharma Gesellschaft M.B.H.，Teva B.V，Stada Arzneimittel Gmbh，Zentiva, K.S.，诺华，Krka, D.D., Novo Mesto，Stada Arzneimittel Ag，1a Pharma Gmbh，山德士，Laboratorios Liconsa, S.A.，Zaklady Farmaceutyczne -polpharma- Spolka Akcyjna
比利时：阿拉宾度，Apotex Europe B.V.，Eurogenerics N.V.-S.A.，Krka, D.D., Novo Mesto，山德士，Teva Pharma Belgium N.V.-S.A，诺华，迈兰，Eurogenerics N.V.-S.A.
保加利亚：Zentiva, K.S.，Gedeon Richter Plc.，山德士，Laboratorios Liconsa, S.A.，Tchaikapharma High Quality Medicines, Inc.，Pharmacons，Alkaloid-Int D.O.O.，Stada Arzneimittel Ag，Krka, D.D., Novo Mesto，Ecopharm Group，Inbiotech Ltd，阿特维斯，诺华，Gedeon Richter Plc.，Egis Pharmaceuticals Plc，Warszawskie Zaklady Farmaceutyczne Polfa S.A.，Teva Pharmaceuticals Bulgaria Eood
克罗地亚：Genericon Pharma Gesellschaft M.B.H.，山德士，Pliva Hrvatska D.O.O.，诺华，Jadran Galenski Laboratorij D.D.，Belupo lijekovi i kozmetika d.d.，Krka-Farma D.O.O.，Alkaloid D.O.O.
塞浦路斯：诺华，Delorbis Pharmaceuticals Ltd，Codal Synto Ltd，赛诺菲，山德士，Jubilant Pharmaceuticals Nv，Krka, D.D., Novo Mesto，Zentiva Italia Srl，Fairmed Healthcare Gmbh，Elpen Pharmaceutical Co. Inc.，Medochemie Ltd.
捷克：山德士，Zentiva, K.S.，Egis Pharmaceuticals Plc，诺华，Krka, D.D., Novo Mesto，Gedeon Richter Plc.，Aurovitas Pharma Polska Sp. Z O.O，Zaklady Farmaceutyczne “polpharma” Spolka Akcyjna，Medochemie Ltd.
丹麦：Stada Arzneimittel Ag，诺华，迈兰，Teva Denmark A/S，Krka Sverige Ab，Jubilant Pharmaceuticals Nv，Amneal Pharma Europe Limited，Fairmed Healthcare Gmbh，Stada Arzneimittel Ag
爱沙尼亚：山德士，阿特维斯，诺华，Krka, D.D., Novo Mesto，Laboratorios Liconsa, S.A.，Medochemie Ltd.，Zentiva, K.S.，
芬兰：Krka, D.D., Novo Mesto，Ratiopharm Gmbh，Stada Arzneimittel Ag，阿特维斯，诺华，Orion Corporation，山德士，Ratiopharm Gmbh
法国：Arrow Generiques，Biogaran，Cristers，Eg Labo Laboratoires Eurogenerics，Krka, D.D., Novo Mesto，山德士，Teva Santé，赛诺菲，诺华，Ipsen Pharma，迈兰，Laboratoires Alter，Evolupharm，兰伯西，Zydus France，Elpen Pharmaceutical Co. Inc.，Laboratorios Liconsa, S.A.
德国：T&d Pharma Gmbh，Hexal Ag，Betapharm Arzneimittel Gmbh，Farmaprojects, S.A.U.，Zentiva Pharma Gmbh，Denk Pharma Gmbh & Co. Kg，1 A Pharma Gmbh，Abz-Pharma Gmbh，Puren Pharma Gmbh & Co. Kg，Ratiopharm Gmbh，诺华，Holsten Pharma Gmbh，Aaa-Pharma Gmbh，阿特维斯，Aliud Pharma Gmbh，阿拉宾度，Axcount Generika Gmbh，Basics Gmbh，Heumann Pharma Gmbh & Co. Generica Kg，Dexcel Pharma Gmbh，迈兰，Stadapharm Gmbh，Fairmed Healthcare Gmbh，Elpen Pharmaceutical Co. Inc.
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