{"id":26131,"date":"2018-08-06T01:00:00","date_gmt":"2018-08-09T03:41:08","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/2018\/08\/09\/ema%e8%a2%ab%e5%8f%ac%e5%9b%9e%e7%bc%ac%e6%b2%99%e5%9d%a6%e8%8d%af%e5%93%81%e5%ae%a1%e6%a0%b8%e6%9b%b4%e6%96%b0\/"},"modified":"2018-08-09T11:41:10","modified_gmt":"2018-08-09T03:41:10","slug":"ema%e8%a2%ab%e5%8f%ac%e5%9b%9e%e7%bc%ac%e6%b2%99%e5%9d%a6%e8%8d%af%e5%93%81%e5%ae%a1%e6%a0%b8%e6%9b%b4%e6%96%b0","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/26131\/","title":{"rendered":"EMA\u88ab\u53ec\u56de\u7f2c\u6c99\u5766\u836f\u54c1\u5ba1\u6838\u66f4\u65b0"},"content":{"rendered":"
\n

 \u7ffb\u8bd1\uff1aJULIA \u6765\u6e90\uff1a<\/span>Julia\u6cd5\u89c4\u7ffb\u8bd1<\/span> <\/span><\/p>\n


<\/span><\/p>\n

02\/08\/2018<\/span><\/p>\n

Update on review of recalled valsartan medicines<\/span><\/strong><\/span><\/p>\n

\u88ab\u53ec\u56de\u7f2c\u6c99\u5766\u836f\u54c1\u5ba1\u6838\u66f4\u65b0<\/span><\/strong><\/span><\/p>\n

Preliminary assessment of possible risk to patients<\/span><\/strong> \u5bf9\u60a3\u8005\u6f5c\u5728\u98ce\u9669\u7684\u521d\u6b65\u8bc4\u4f30<\/span><\/strong><\/span><\/p>\n

EMA is conducting a review of the possible health effects inpatients who may have taken valsartan medicines<\/span> containing N-nitrosodimethylamine (NDMA) \u2013 an impurity found in the active substance manufactured by Zhejiang Huahai Pharmaceuticals.<\/span><\/p>\n

EMA<\/span>\u6b63\u5bf9\u53ef\u80fd\u670d\u7528\u4e86\u542b\u6709<\/span>NDMA<\/span>\u6742\u8d28\uff08\u6d59\u6c5f\u534e\u6d77\u836f\u4e1a\u6240\u751f\u4ea7\u7684\u6d3b\u6027\u7269\u8d28\u4e2d\u53d1\u73b0\u7684\u4e00\u79cd\u6742\u8d28\uff09\u7684\u7f2c\u6c99\u5766\u836f\u54c1\u7684\u60a3\u8005\u8fdb\u884c\u6f5c\u5728\u5065\u5eb7\u5f71\u54cd\u5ba1\u6838\u3002<\/span><\/span><\/p>\n

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.<\/span><\/p>\n

\u57fa\u4e8e\u52a8\u7269\u6d4b\u8bd5\uff0c<\/span>NDMA<\/span>\u88ab\u5f52\u7c7b\u4e3a\u53ef\u80fd\u7684\u4eba\u4f53\u81f4\u764c\u7269\u8d28\uff08\u53ef\u80fd\u4f1a\u5f15\u53d1\u764c\u75c7\uff09\u3002\u8be5\u7269\u8d28\u5728\u4e00\u4e9b\u98df\u54c1\u548c\u6c34\u4e2d\u4f1a\u51fa\u73b0\uff0c\u4f46\u5728\u6444\u5165\u6781\u4f4e\u6c34\u5e73\u65f6\u4e0d\u4f1a\u5f62\u6210\u4f24\u5bb3\u3002<\/span><\/span><\/p>\n

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).<\/span><\/p>\n

\u7ecf\u8fc7\u521d\u6b65\u8bc4\u4f30\u4e4b\u540e\uff0c<\/span>EMA<\/span>\u4f30\u8ba1\u4ee5\u6bcf\u5929\u6700\u9ad8\u5242\u91cf\uff08<\/span>320mg<\/span>\uff09\u8fde\u7eed<\/span>7<\/span>\u5e74\u670d\u7528\u53d7\u5f71\u54cd\u836f\u54c1\u7684\u60a3\u8005\u4e2d\u7b2c<\/span>5000<\/span>\u540d\u4f1a\u6709\u4e00\u4f8b\u786e\u5207\u7684\u764c\u75c7\u6848\u4f8b\u3002\u8fd9\u662f\u57fa\u4e8e\u6b64\u6742\u8d28\u5728\u6d59\u6c5f\u534e\u6d77\u836f\u4e1a\u7684<\/span>API<\/span>\u4e2d\u5e73\u5747\u68c0\u51fa\u6c34\u5e73\uff08<\/span>60ppm\u2014<\/span>\u767e\u4e07\u5206\u4e4b\u516d\u5341\uff09\u505a\u51fa\u7684\u4f30\u8ba1\u3002<\/span><\/span><\/p>\n

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.<\/span><\/p>\n

\u53ef\u80fd\u7684\u81f4\u764c\u98ce\u9669\u662f\u4ece\u52a8\u7269\u7814\u7a76\u6570\u636e\u5916\u63a8\u800c\u5f97\u7684\uff0c\u5e94\u5728<\/span>EU<\/span>\u5883\u5185\u751f\u547d\u5468\u671f\u60a3\u764c\u60c5\u5883\uff08\u6bcf<\/span>3<\/span>\u4eba\u6709<\/span>1<\/span>\u4eba\u60a3\u764c\uff09\u4ee5\u53ca\u5176\u5b83\u6765\u6e90<\/span>NDMA<\/span>\u66b4\u9732\u60c5\u51b5\u4e0b\u8003\u91cf\u3002<\/span><\/span><\/p>\n

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.<\/span><\/p>\n

\u6b64\u521d\u6b65\u9884\u6d4b\u662f\u57fa\u4e8e<\/span>API<\/span>\u4e2d<\/span>NDMA<\/span>\u5728\u6700\u7ec8\u5236\u5242\u4e2d\u4ee5\u76f8\u540c\u6570\u636e\u51fa\u73b0\u7684\u5047\u8bbe\u3002<\/span><\/span><\/p>\n

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.<\/span><\/p>\n

\u5df2\u5728\u5176\u7f2c\u6c99\u5766\u836f\u54c1\u4e2d\u4f7f\u7528\u4e86\u534e\u6d77<\/span>API<\/span>\u7684\u516c\u53f8\u88ab\u8981\u6c42\u68c0\u6d4b\u5176\u7559\u6837\u4ee5\u786e\u5b9a\u6700\u7ec8\u5236\u5242\u4e2d<\/span>NDMA<\/span>\u7684\u5b9e\u9645\u6c34\u5e73\u3002<\/span>EU<\/span>\u7684\u5b98\u65b9\u63a7\u5236\u5b9e\u9a8c\u5ba4\u6b63\u5728\u8fdb\u884c\u9644\u52a0\u68c0\u6d4b\u3002\u4e00\u65e6\u5f97\u5230\u6240\u6709\u8fd9\u4e9b\u68c0\u6d4b\u6570\u636e\uff0c<\/span>EMA<\/span>\u5c06\u53ef\u4ee5\u63d0\u4f9b\u66f4\u591a\u5173\u4e8e\u8be5\u6742\u8d28\u5bf9<\/span>EU<\/span>\u5185\u60a3\u8005\u53ef\u80fd\u5177\u6709\u7684\u98ce\u9669\u65b9\u9762\u7684\u66f4\u591a\u4fe1\u606f\u3002<\/span><\/span><\/p>\n

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.<\/span><\/p>\n

\u5f88\u91cd\u8981\u7684\u4e00\u70b9\u662f\u8981\u6ce8\u610f\u60a3\u8005\u5e76\u6ca1\u6709\u76f4\u63a5\u98ce\u9669\u3002\u6b63\u5728\u670d\u7528\u53d7\u5f71\u54cd\u836f\u54c1\u4e14\u672a\u6362\u6210\u5176\u5b83\u66ff\u4ee3\u836f\u54c1\u7684\u60a3\u8005\u5728\u54a8\u8be2\u5176\u533b\u751f\u6216\u836f\u5e08\u4e4b\u524d\u4e0d\u5e94\u505c\u6b62\u670d\u7528\u5176\u836f\u54c1\u3002<\/span><\/p>\n

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.<\/span><\/p>\n

\u7f2c\u6c99\u5766\u836f\u54c1\u88ab\u7528\u4e8e\u5faa\u73af\u7cfb\u7edf\u6709\u4e25\u91cd\u95ee\u9898\u6216\u53ef\u80fd\u6709\u4e25\u91cd\u95ee\u9898\u7684\u60a3\u8005\uff08\u9ad8\u8840\u538b\uff0c\u6700\u8fd1\u6709\u8fc7\u5fc3\u810f\u75c5\u53d1\u4f5c\u548c\u5fc3\u529b\u8870\u7aed\uff09\u3002\u56e0\u6b64\u5982\u679c\u6307\u793a\u5982\u6b64\u6cbb\u7597\u5219\u4e0d\u5efa\u8bae\u505c\u6b62\u3002<\/span><\/p>\n

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<\/span>.<\/span><\/p>\n

\u6240\u6709\u542b\u6709\u6d59\u6c5f\u534e\u6d77\u7f2c\u6c99\u5766<\/span>API<\/span>\u7684\u836f\u54c1\u5747\u5df2\u4ece<\/span>EU<\/span>\u836f\u623f\u53ec\u56de\uff0c\u4f46\u51e0\u4e2a\u672a\u53d7\u8be5\u6742\u8d28\u5f71\u54cd\u7684\u5176\u5b83\u7f2c\u6c99\u5766\u836f\u54c1\u4ecd\u5728\u9500\u552e\u3002\u5e0c\u671b\u83b7\u5f97\u66f4\u591a\u5173\u4e8e\u5176\u6cbb\u7597\u4fe1\u606f\u7684\u60a3\u8005\u5e94\u8054\u7cfb\u5176\u533b\u751f\u6216\u836f\u5e08\u3002\u66f4\u591a\u4fe1\u606f\u5728\u56fd\u5bb6\u836f\u76d1\u5b98\u7f51\u6709\u63d0\u4f9b\u3002<\/span><\/span><\/p>\n

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.<\/span><\/p>\n

NDMA<\/span>\u662f\u4e00\u79cd\u975e\u9884\u671f\u6742\u8d28\uff0c\u76f8\u4fe1\u662f\u5728\u6d59\u6c5f\u534e\u6d77\u4e8e<\/span>2012<\/span>\u5e74\u5bf9\u5176\u751f\u4ea7\u5de5\u827a\u5f15\u5165\u53d8\u66f4\u4e4b\u540e\u5f62\u6210\u7684\u526f\u4ea7\u7269\u3002\u8be5\u516c\u53f8\u6240\u751f\u4ea7\u7684\u5176\u5b83\u6d3b\u6027\u7269\u8d28\u4e0d\u53d7\u5f71\u54cd\u3002<\/span><\/span><\/p>\n

EMA is working closely with international partners and will provide further information on its website as the review progresses.<\/span><\/p>\n

EMA<\/span>\u6b63\u5728\u4e0e\u56fd\u9645\u4f19\u4f34\u7d27\u5bc6\u5408\u4f5c\uff0c\u5c06\u5728\u5176\u5b98\u7f51\u63d0\u4f9b\u8fdb\u4e00\u6b65\u7684\u5ba1\u6838\u8fdb\u5c55\u4fe1\u606f\u3002<\/span><\/span><\/p>\n


<\/span><\/p>\n

\u8bd1\u8005\uff1a<\/span><\/p>\n

\u53e6\u5916\uff0cEMA\u4e8e7\u670830\u65e5\u66f4\u65b0\u4e86EU\u5883\u5185\u5df2\u6279\u51c6\u4e0a\u5e02\u7684\u7f2c\u6c99\u5766\u836f\u54c1\u6e05\u5355\uff08\u6ce8\u610f\uff0c\u5e76\u975e\u53ec\u56de\u6e05\u5355\uff09\uff0c\u5b98\u7f51\u94fe\u63a5\u4e3ahttp:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Referrals_document\/Valsartan_31\/WC500252695.pdf
<\/span><\/p>\n

\u5171\u6709341\u98754634KB\uff0c\u90e8\u5206\u56fd\u5bb6MAH\u4fe1\u606f\u5982\u4e0b\uff0c\u5177\u4f53\u53c2\u89c1\u5b98\u65b9\u539f\u6587\u3002<\/span><\/p>\n


<\/p>\n

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<\/span><\/p>\n

\u5965\u5730\u5229\uff1a+pharma Arzneimittel Gmbh\uff0c\u963f\u7279\u7ef4\u65af\uff0cG.L.Pharma\uff0cGenericon Pharma Gesellschaft M.B.H.\uff0cTeva B.V\uff0cStada Arzneimittel Gmbh\uff0cZentiva, K.S.\uff0c\u8bfa\u534e\uff0cKrka, D.D., Novo Mesto\uff0cStada Arzneimittel Ag\uff0c1a Pharma Gmbh\uff0c\u5c71\u5fb7\u58eb\uff0cLaboratorios Liconsa, S.A.\uff0cZaklady Farmaceutyczne -polpharma- Spolka Akcyjna
<\/span><\/p>\n

\u6bd4\u5229\u65f6\uff1a\u963f\u62c9\u5bbe\u5ea6\uff0cApotex Europe B.V.\uff0cEurogenerics N.V.-S.A.\uff0cKrka, D.D., Novo Mesto\uff0c\u5c71\u5fb7\u58eb\uff0cTeva Pharma Belgium N.V.-S.A\uff0c\u8bfa\u534e\uff0c\u8fc8\u5170\uff0cEurogenerics N.V.-S.A.
<\/span><\/p>\n

\u4fdd\u52a0\u5229\u4e9a\uff1aZentiva, K.S.\uff0cGedeon Richter Plc.\uff0c\u5c71\u5fb7\u58eb\uff0cLaboratorios Liconsa, S.A.\uff0cTchaikapharma High Quality Medicines, Inc.\uff0cPharmacons\uff0cAlkaloid-Int D.O.O.\uff0cStada Arzneimittel Ag\uff0cKrka, D.D., Novo Mesto\uff0cEcopharm Group\uff0cInbiotech Ltd\uff0c\u963f\u7279\u7ef4\u65af\uff0c\u8bfa\u534e\uff0cGedeon Richter Plc.\uff0cEgis Pharmaceuticals Plc\uff0cWarszawskie Zaklady Farmaceutyczne Polfa S.A.\uff0cTeva Pharmaceuticals Bulgaria Eood<\/span><\/p>\n

\u514b\u7f57\u5730\u4e9a\uff1aGenericon Pharma Gesellschaft M.B.H.\uff0c\u5c71\u5fb7\u58eb\uff0cPliva Hrvatska D.O.O.\uff0c\u8bfa\u534e\uff0cJadran Galenski Laboratorij D.D.\uff0cBelupo lijekovi i kozmetika d.d.\uff0cKrka-Farma D.O.O.\uff0cAlkaloid D.O.O.<\/span><\/p>\n

\u585e\u6d66\u8def\u65af\uff1a\u8bfa\u534e\uff0cDelorbis Pharmaceuticals Ltd\uff0cCodal Synto Ltd\uff0c\u8d5b\u8bfa\u83f2\uff0c\u5c71\u5fb7\u58eb\uff0cJubilant Pharmaceuticals Nv\uff0cKrka, D.D., Novo Mesto\uff0cZentiva Italia Srl\uff0cFairmed Healthcare Gmbh\uff0cElpen Pharmaceutical Co. Inc.\uff0cMedochemie Ltd.<\/span><\/p>\n

\u6377\u514b\uff1a\u5c71\u5fb7\u58eb\uff0cZentiva, K.S.\uff0cEgis Pharmaceuticals Plc\uff0c\u8bfa\u534e\uff0cKrka, D.D., Novo Mesto\uff0cGedeon Richter Plc.\uff0cAurovitas Pharma Polska Sp. Z O.O\uff0cZaklady Farmaceutyczne “polpharma” Spolka Akcyjna\uff0cMedochemie Ltd.<\/span><\/p>\n

\u4e39\u9ea6\uff1aStada Arzneimittel Ag\uff0c\u8bfa\u534e\uff0c\u8fc8\u5170\uff0cTeva Denmark A\/S\uff0cKrka Sverige Ab\uff0cJubilant Pharmaceuticals Nv\uff0cAmneal Pharma Europe Limited\uff0cFairmed Healthcare Gmbh\uff0cStada Arzneimittel Ag<\/span><\/p>\n

\u7231\u6c99\u5c3c\u4e9a\uff1a\u5c71\u5fb7\u58eb\uff0c\u963f\u7279\u7ef4\u65af\uff0c\u8bfa\u534e\uff0cKrka, D.D., Novo Mesto\uff0cLaboratorios Liconsa, S.A.\uff0cMedochemie Ltd.\uff0cZentiva, K.S.\uff0c<\/span><\/p>\n

\u82ac\u5170\uff1aKrka, D.D., Novo Mesto\uff0cRatiopharm Gmbh\uff0cStada Arzneimittel Ag\uff0c\u963f\u7279\u7ef4\u65af\uff0c\u8bfa\u534e\uff0cOrion Corporation\uff0c\u5c71\u5fb7\u58eb\uff0cRatiopharm Gmbh
<\/span><\/p>\n

\u6cd5\u56fd\uff1aArrow Generiques\uff0cBiogaran\uff0cCristers\uff0cEg Labo Laboratoires Eurogenerics\uff0cKrka, D.D., Novo Mesto\uff0c\u5c71\u5fb7\u58eb\uff0cTeva Sant\u00e9\uff0c\u8d5b\u8bfa\u83f2\uff0c\u8bfa\u534e\uff0cIpsen Pharma\uff0c\u8fc8\u5170\uff0cLaboratoires Alter\uff0cEvolupharm\uff0c\u5170\u4f2f\u897f\uff0cZydus France\uff0cElpen Pharmaceutical Co. Inc.\uff0cLaboratorios Liconsa, S.A.<\/span><\/p>\n

\u5fb7\u56fd\uff1aT&d Pharma Gmbh\uff0cHexal Ag\uff0cBetapharm Arzneimittel Gmbh\uff0cFarmaprojects, S.A.U.\uff0cZentiva Pharma Gmbh\uff0cDenk Pharma Gmbh & Co. Kg\uff0c1 A Pharma Gmbh\uff0cAbz-Pharma Gmbh\uff0cPuren Pharma Gmbh & Co. Kg\uff0cRatiopharm Gmbh\uff0c\u8bfa\u534e\uff0cHolsten Pharma Gmbh\uff0cAaa-Pharma Gmbh\uff0c\u963f\u7279\u7ef4\u65af\uff0cAliud Pharma Gmbh\uff0c\u963f\u62c9\u5bbe\u5ea6\uff0cAxcount Generika Gmbh\uff0cBasics Gmbh\uff0cHeumann Pharma Gmbh & Co. Generica Kg\uff0cDexcel Pharma Gmbh\uff0c\u8fc8\u5170\uff0cStadapharm Gmbh\uff0cFairmed Healthcare Gmbh\uff0cElpen Pharmaceutical Co. Inc.<\/span><\/p>\n

\"EMA\u88ab\u53ec\u56de\u7f2c\u6c99\u5766\u836f\u54c1\u5ba1\u6838\u66f4\u65b0\"<\/span><\/p>\n

\n

\u59cb\u53d1\u4e8e\u5fae\u4fe1\u516c\u4f17\u53f7\uff1a \u84b2\u516c\u82f1 <\/p>\n<\/blockquote>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

 \u7ffb\u8bd1\uff1aJULIA \u6765\u6e90\uff1aJulia\u6cd5\u89c4\u7ffb\u8bd1  02\/08\/2018 Updat […]<\/p>\n","protected":false},"author":1,"featured_media":26132,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[2],"tags":[],"_links":{"self":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/26131"}],"collection":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/comments?post=26131"}],"version-history":[{"count":1,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/26131\/revisions"}],"predecessor-version":[{"id":26137,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/26131\/revisions\/26137"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media\/26132"}],"wp:attachment":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media?parent=26131"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/categories?post=26131"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/tags?post=26131"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}