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【第三十九批】仿制药参比制剂目录


【第三十九批】仿制药参比制剂目录


序号药品通用名称英文名称商品名规格持证商备注1备注2
39-1匹维溴铵片Pinaverium Bromide TabletsDicetel50mgAbbott Laboratories Limited国内上市的原研药品原研进口
39-2盐酸阿莫罗芬乳膏Amorolfine Hydrochloride CreamLoceryl(罗每乐)0.25%Galderma Laboratorium GmbH国内上市的原研药品原研进口
39-3硫酸异帕米星注射液Isepamicin Sulfate InjectionExacin(依克沙)2ml:400mg(按异帕米星(C22H43N5O12)计)Asahi Kasei Pharma Corporation国内上市的原研药品原研进口
39-4硫酸异帕米星注射液Isepamicin Sulfate InjectionExacin(依克沙)2ml:200mg(按异帕米星(C22H43N5O12)计)Asahi Kasei Pharma Corporation国内上市的原研药品原研进口
39-5盐酸美金刚多奈哌齐缓释胶囊Memantine Hydrochloride Extended-release and Donepezil Hydrochloride CapsulesNamzaric7mg/10mgAllergan Sales LLC未进口原研药品美国橙皮书
39-6盐酸美金刚多奈哌齐缓释胶囊Memantine Hydrochloride Extended-release and Donepezil Hydrochloride CapsulesNamzaric14mg/10mgAllergan Sales LLC未进口原研药品美国橙皮书
39-7盐酸美金刚多奈哌齐缓释胶囊Memantine Hydrochloride Extended-release and Donepezil Hydrochloride CapsulesNamzaric21mg/10mgAllergan Sales LLC未进口原研药品美国橙皮书
39-8盐酸美金刚多奈哌齐缓释胶囊Memantine Hydrochloride Extended-release and Donepezil Hydrochloride CapsulesNamzaric28mg/10mgAllergan Sales LLC未进口原研药品美国橙皮书
39-9赖氨洛芬注射液Ibuprofen Lysine InjectionNeoProfen20mg/2mlRecordati Rare Diseases Inc.未进口原研药品美国橙皮书
39-10盐酸苯达莫司汀注射液Bendamustine Hydrochloride InjectionBelrapzo100mg/4ml(25mg/ml)Eagle Pharmaceuticals, Inc.未进口原研药品美国橙皮书
39-11米哚妥林胶囊Midostaurin CapsulesRydapt25mgNovartis Pharmaceuticals Corporation未进口原研药品美国橙皮书
39-12盐酸米诺环素缓释片Minocycline Hydrochloride Extended Release TabletsSolodyn55mgMedicis Pharmaceutical Corp未进口原研药品美国橙皮书
39-13盐酸米诺环素缓释片Minocycline Hydrochloride Extended Release TabletsSolodyn65mgMedicis Pharmaceutical Corp未进口原研药品美国橙皮书
39-14盐酸米诺环素缓释片Minocycline Hydrochloride Extended Release TabletsSolodyn80mgMedicis Pharmaceutical Corp未进口原研药品美国橙皮书
39-15盐酸米诺环素缓释片Minocycline Hydrochloride Extended Release TabletsSolodyn105mgMedicis Pharmaceutical Corp未进口原研药品美国橙皮书
39-16盐酸米诺环素缓释片Minocycline Hydrochloride Extended Release TabletsSolodyn115mgMedicis Pharmaceutical Corp未进口原研药品美国橙皮书
39-17盐酸去氧肾上腺素滴眼液Phenylephrine Hydrochloride Ophthalmic Solution-2.50%Akorn Operating Co Llc未进口原研药品美国橙皮书
39-18盐酸去氧肾上腺素滴眼液Phenylephrine Hydrochloride Ophthalmic Solution-10%Akorn Operating Co Llc未进口原研药品美国橙皮书
39-19奥利司他咀嚼片Orlistat Chewable TabletAlli27mgGlaxoSmithKline (Ireland)Limited未进口原研药品欧盟上市
39-20依达拉奉注射液Edaravone Injection-100ml:30mgMitsubishi Tanabe Pharma Corporation国内上市的原研药品原研进口
39-21马来酸阿伐曲泊帕片Avatrombopag Maleate TabletsDoptelet(苏可欣)20mgAkaRx Inc.国内上市的原研药品原研进口
39-22地高辛片Digoxin TabletsLanoxin0.125mgConcordia Pharmaceuticals Inc未进口原研药品美国橙皮书
39-23盐酸奥洛他定滴眼液Olopatadine Hydrochloride ophthalmic solution 0.2%Pataday0.20%Alcon Laboratories Inc未进口原研药品美国橙皮书
39-24富马酸喹硫平片Quetiapine Fumarate TabletsSeroquel25mgAstraZeneca Pharmaceuticals LP未进口原研产品美国橙皮书
39-25富马酸喹硫平片Quetiapine Fumarate TabletsSeroquel300mgAstraZeneca Pharmaceuticals LP未进口原研产品美国橙皮书
39-26沙美特罗替卡松吸入粉雾剂Salmeterol Xinafoate and Fluticasone Propionate Powder for InhalationAdvair Diskus100mcg/50mcgGlaxo Smith Kline未进口原研药品美国橙皮书
39-27沙美特罗替卡松吸入粉雾剂Salmeterol Xinafoate and Fluticasone Propionate Powder for InhalationAdvair Diskus250mcg/50mcgGlaxo Smith Kline未进口原研药品美国橙皮书
39-28沙美特罗替卡松吸入粉雾剂Salmeterol Xinafoate and Fluticasone Propionate Powder for InhalationAdvair Diskus500mcg/50mcgGlaxo Smith Kline未进口原研药品美国橙皮书
39-29沙美特罗替卡松吸入粉雾剂Salmeterol Xinafoate and Fluticasone Propionate Powder for InhalationSeretide Diskus50mcg/100mcgGlaxo Wellcome UK Ltd未进口原研药品欧盟上市
39-30沙美特罗替卡松吸入粉雾剂Salmeterol Xinafoate and Fluticasone Propionate Powder for InhalationSeretide Diskus50mcg/250mcgGlaxo Wellcome UK Ltd未进口原研药品欧盟上市
39-31沙美特罗替卡松吸入粉雾剂Salmeterol Xinafoate and Fluticasone Propionate Powder for InhalationSeretide Diskus50mcg/500mcgGlaxo Wellcome UK Ltd未进口原研药品欧盟上市
39-32雷诺嗪缓释片Ranolazine Prolonged-Release Tablets Ranexa500mgMenarini International Operations Luxembourg S.A未进口原研药品欧盟上市
39-33交联玻璃酸钠注射液Hyaluronic acid, stabilized single injectionDurolane3 ml:玻璃酸钠60mgBioventus LLC未进口原研药品欧盟上市
39-34特立氟胺片Teriflunomide TabletsAubagio14mgSanofi-Aventis Groupe未进口原研药品欧盟上市
39-35盐酸美金刚片Memantine Hydrochloride TabletsEbixa5mgH. Lundbeck A/S未进口原研药品欧盟上市
39-36盐酸美金刚片Memantine Hydrochloride TabletsEbixa15mgH. Lundbeck A/S未进口原研药品欧盟上市
39-37中长链脂肪乳/氨基酸(16)/葡萄糖(30%)注射液Medium and Long Chain Fat Emulsion / Amino Acids (16) / Glucose (30%) InjectionNuTRIflex Lipid plus1875mlB.Braun Melsungen AG未进口原研药品欧盟上市
39-38脂肪乳氨基酸(17)葡萄糖(19%)注射液Fat Emulsion, Amino Acids(17) And Glucose(19%) InjectionKabiven2053mlFresenius Kabi国际公认的同种药品欧盟上市
39-39左甲状腺素钠片Levothyroxine Sodium Tablets-200μgMerck Serono GmbH/Merck Sante/Merck Gesellschaft mbH未进口原研药品欧盟上市
39-40依普利酮片Eplerenone Tablets-25mgファイザー株式会社未进口原研药品日本上市
39-41依普利酮片Eplerenone Tablets-50mgファイザー株式会社未进口原研药品日本上市
39-42依普利酮片Eplerenone Tablets-100mgファイザー株式会社未进口原研药品日本上市
39-43枸橼酸坦度螺酮片Tandospirone Citrate Tablets-5mg大日本住友製薬株式会社未进口原研日本上市
39-44别嘌醇片Allopurinol TabletsZyloric50mgグラクソ・スミスクライン株式会社未进口原研药品日本上市
39-45别嘌醇片Allopurinol TabletsZyloric100mgグラクソ・スミスクライン株式会社未进口原研药品日本上市
39-46吡仑帕奈片Perampanel TabletsFycompa2mgEisai Inc/Eisai Europe Limited未进口原研药品英国上市
39-47吡仑帕奈片Perampanel TabletsFycompa4mgEisai Inc/Eisai Europe Limited未进口原研药品英国上市
39-48吡仑帕奈片Perampanel TabletsFycompa8mgEisai Inc/Eisai Europe Limited未进口原研药品英国上市
39-49吡仑帕奈片Perampanel TabletsFycompa12mgEisai Inc/Eisai Europe Limited未进口原研药品英国上市
39-50硫酸吗啡缓释片Morphine Sulphate Sustained-release Tablets-30mgNapp Pharmaceuticals Limited未进口原研药品英国上市
39-51拉莫三嗪分散片Lamotrigine Dispersible TabletsLamictal2mgThe Wellcome Foundation Ltd.未进口原研药品英国上市
7-25对乙酰氨基酚片Paracetamol TabletsPanadol Advance Tablets0.5gGlaxoSmithKline Consumer Healthcare欧盟上市备注1由“欧盟上市(上市国家:英国;产地:德国)”更正为“欧盟上市”
7-88盐酸溴己新片Bromhexine Hydrochloride TabletsBisolvon8mgBoehringer Ingelheim Pharma GmbH & Co. KG/Sanofi-Aventis Deutschland GmbH未进口原研药品持证商发生变更,增加持证商Sanofi-Aventis Deutschland GmbH
23-219脂肪乳氨基酸(17)葡萄糖(19%)注射液Fat Emulsion,Amino Acids(17) And Glucose(19%) InjectionKabiven1026mlFresenius Kabi AB国内上市的国际公认药品持证商更新为Fresenius Kabi AB
23-220脂肪乳氨基酸(17)葡萄糖(19%)注射液Fat Emulsion,Amino Acids(17) And Glucose(19%) InjectionKabiven2053mlFresenius Kabi AB国内上市的国际公认药品持证商更新为Fresenius Kabi AB
27-104米力农注射液Milrinone Injection /Primacor 1mg/ml Solution for Injection-10mg/10mlAventis Pharma Limited/Sanofi-Aventis/Sanofi未进口原研药品规格更新为10mg/10ml


1、参比制剂选择原则:有原研进口的应选择原研进口药作为参比制剂首选。
2、本网站所有仿制药参比制剂目录数据源自国家药品监督管理局官方网站,如有纰漏请以国家官网为准。


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