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【第三十九批】仿制藥參比制劑目錄


【第三十九批】仿制藥參比制劑目錄


序號藥品通用名稱英文名稱商品名規(guī)格持證商備注1備注2
39-1匹維溴銨片Pinaverium Bromide TabletsDicetel50mgAbbott Laboratories Limited國內(nèi)上市的原研藥品原研進(jìn)口
39-2鹽酸阿莫羅芬乳膏Amorolfine?Hydrochloride CreamLoceryl(羅每樂)0.25%Galderma Laboratorium GmbH國內(nèi)上市的原研藥品原研進(jìn)口
39-3硫酸異帕米星注射液Isepamicin Sulfate InjectionExacin(依克沙)2ml:400mg(按異帕米星(C22H43N5O12)計(jì))Asahi Kasei Pharma Corporation國內(nèi)上市的原研藥品原研進(jìn)口
39-4硫酸異帕米星注射液Isepamicin Sulfate InjectionExacin(依克沙)2ml:200mg(按異帕米星(C22H43N5O12)計(jì))Asahi Kasei Pharma Corporation國內(nèi)上市的原研藥品原研進(jìn)口
39-5鹽酸美金剛多奈哌齊緩釋膠囊Memantine Hydrochloride Extended-release and Donepezil Hydrochloride CapsulesNamzaric7mg/10mgAllergan Sales LLC未進(jìn)口原研藥品美國橙皮書
39-6鹽酸美金剛多奈哌齊緩釋膠囊Memantine Hydrochloride Extended-release and Donepezil Hydrochloride CapsulesNamzaric14mg/10mgAllergan Sales LLC未進(jìn)口原研藥品美國橙皮書
39-7鹽酸美金剛多奈哌齊緩釋膠囊Memantine Hydrochloride Extended-release and Donepezil Hydrochloride CapsulesNamzaric21mg/10mgAllergan Sales LLC未進(jìn)口原研藥品美國橙皮書
39-8鹽酸美金剛多奈哌齊緩釋膠囊Memantine Hydrochloride Extended-release and Donepezil Hydrochloride CapsulesNamzaric28mg/10mgAllergan Sales LLC未進(jìn)口原研藥品美國橙皮書
39-9賴氨洛芬注射液Ibuprofen Lysine InjectionNeoProfen20mg/2mlRecordati Rare Diseases Inc.未進(jìn)口原研藥品美國橙皮書
39-10鹽酸苯達(dá)莫司汀注射液Bendamustine Hydrochloride InjectionBelrapzo100mg/4ml(25mg/ml)Eagle Pharmaceuticals, Inc.未進(jìn)口原研藥品美國橙皮書
39-11米哚妥林膠囊Midostaurin CapsulesRydapt25mgNovartis Pharmaceuticals Corporation未進(jìn)口原研藥品美國橙皮書
39-12鹽酸米諾環(huán)素緩釋片Minocycline Hydrochloride Extended Release TabletsSolodyn55mgMedicis Pharmaceutical Corp未進(jìn)口原研藥品美國橙皮書
39-13鹽酸米諾環(huán)素緩釋片Minocycline Hydrochloride Extended Release TabletsSolodyn65mgMedicis Pharmaceutical Corp未進(jìn)口原研藥品美國橙皮書
39-14鹽酸米諾環(huán)素緩釋片Minocycline Hydrochloride Extended Release TabletsSolodyn80mgMedicis Pharmaceutical Corp未進(jìn)口原研藥品美國橙皮書
39-15鹽酸米諾環(huán)素緩釋片Minocycline Hydrochloride Extended Release TabletsSolodyn105mgMedicis Pharmaceutical Corp未進(jìn)口原研藥品美國橙皮書
39-16鹽酸米諾環(huán)素緩釋片Minocycline Hydrochloride Extended Release TabletsSolodyn115mgMedicis Pharmaceutical Corp未進(jìn)口原研藥品美國橙皮書
39-17鹽酸去氧腎上腺素滴眼液Phenylephrine Hydrochloride Ophthalmic Solution-2.50%Akorn Operating Co Llc未進(jìn)口原研藥品美國橙皮書
39-18鹽酸去氧腎上腺素滴眼液Phenylephrine Hydrochloride Ophthalmic Solution-10%Akorn Operating Co Llc未進(jìn)口原研藥品美國橙皮書
39-19奧利司他咀嚼片Orlistat Chewable TabletAlli27mgGlaxoSmithKline (Ireland)Limited未進(jìn)口原研藥品歐盟上市
39-20依達(dá)拉奉注射液Edaravone Injection-100ml:30mgMitsubishi Tanabe Pharma Corporation國內(nèi)上市的原研藥品原研進(jìn)口
39-21馬來酸阿伐曲泊帕片Avatrombopag Maleate TabletsDoptelet(蘇可欣)20mgAkaRx Inc.國內(nèi)上市的原研藥品原研進(jìn)口
39-22地高辛片Digoxin TabletsLanoxin0.125mgConcordia Pharmaceuticals Inc未進(jìn)口原研藥品美國橙皮書
39-23鹽酸奧洛他定滴眼液Olopatadine Hydrochloride ophthalmic solution 0.2%Pataday0.20%Alcon Laboratories Inc未進(jìn)口原研藥品美國橙皮書
39-24富馬酸喹硫平片Quetiapine Fumarate TabletsSeroquel25mgAstraZeneca Pharmaceuticals LP未進(jìn)口原研產(chǎn)品美國橙皮書
39-25富馬酸喹硫平片Quetiapine Fumarate TabletsSeroquel300mgAstraZeneca Pharmaceuticals LP未進(jìn)口原研產(chǎn)品美國橙皮書
39-26沙美特羅替卡松吸入粉霧劑Salmeterol Xinafoate and Fluticasone Propionate Powder for InhalationAdvair Diskus100mcg/50mcgGlaxo Smith Kline未進(jìn)口原研藥品美國橙皮書
39-27沙美特羅替卡松吸入粉霧劑Salmeterol Xinafoate and Fluticasone Propionate Powder for InhalationAdvair Diskus250mcg/50mcgGlaxo Smith Kline未進(jìn)口原研藥品美國橙皮書
39-28沙美特羅替卡松吸入粉霧劑Salmeterol Xinafoate and Fluticasone Propionate Powder for InhalationAdvair Diskus500mcg/50mcgGlaxo Smith Kline未進(jìn)口原研藥品美國橙皮書
39-29沙美特羅替卡松吸入粉霧劑Salmeterol Xinafoate and Fluticasone Propionate Powder for InhalationSeretide Diskus50mcg/100mcgGlaxo Wellcome UK Ltd未進(jìn)口原研藥品歐盟上市
39-30沙美特羅替卡松吸入粉霧劑Salmeterol Xinafoate and Fluticasone Propionate Powder for InhalationSeretide Diskus50mcg/250mcgGlaxo Wellcome UK Ltd未進(jìn)口原研藥品歐盟上市
39-31沙美特羅替卡松吸入粉霧劑Salmeterol Xinafoate and Fluticasone Propionate Powder for InhalationSeretide Diskus50mcg/500mcgGlaxo Wellcome UK Ltd未進(jìn)口原研藥品歐盟上市
39-32雷諾嗪緩釋片Ranolazine Prolonged-Release Tablets?Ranexa500mgMenarini International Operations Luxembourg S.A未進(jìn)口原研藥品歐盟上市
39-33交聯(lián)玻璃酸鈉注射液Hyaluronic acid, stabilized single injectionDurolane3 ml:玻璃酸鈉60mgBioventus LLC未進(jìn)口原研藥品歐盟上市
39-34特立氟胺片Teriflunomide TabletsAubagio14mgSanofi-Aventis Groupe未進(jìn)口原研藥品歐盟上市
39-35鹽酸美金剛片Memantine Hydrochloride TabletsEbixa5mgH. Lundbeck A/S未進(jìn)口原研藥品歐盟上市
39-36鹽酸美金剛片Memantine Hydrochloride TabletsEbixa15mgH. Lundbeck A/S未進(jìn)口原研藥品歐盟上市
39-37中長鏈脂肪乳/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未進(jìn)口原研藥品歐盟上市
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國際公認(rèn)的同種藥品歐盟上市
39-39左甲狀腺素鈉片Levothyroxine Sodium Tablets-200μgMerck Serono GmbH/Merck Sante/Merck Gesellschaft mbH未進(jìn)口原研藥品歐盟上市
39-40依普利酮片Eplerenone Tablets-25mgファイザー株式會社未進(jìn)口原研藥品日本上市
39-41依普利酮片Eplerenone Tablets-50mgファイザー株式會社未進(jìn)口原研藥品日本上市
39-42依普利酮片Eplerenone Tablets-100mgファイザー株式會社未進(jìn)口原研藥品日本上市
39-43枸櫞酸坦度螺酮片Tandospirone Citrate Tablets-5mg大日本住友製薬株式會社未進(jìn)口原研日本上市
39-44別嘌醇片Allopurinol TabletsZyloric50mgグラクソ?スミスクライン株式會社未進(jìn)口原研藥品日本上市
39-45別嘌醇片Allopurinol TabletsZyloric100mgグラクソ?スミスクライン株式會社未進(jìn)口原研藥品日本上市
39-46吡侖帕奈片Perampanel TabletsFycompa2mgEisai Inc/Eisai Europe Limited未進(jìn)口原研藥品英國上市
39-47吡侖帕奈片Perampanel TabletsFycompa4mgEisai Inc/Eisai Europe Limited未進(jìn)口原研藥品英國上市
39-48吡侖帕奈片Perampanel TabletsFycompa8mgEisai Inc/Eisai Europe Limited未進(jìn)口原研藥品英國上市
39-49吡侖帕奈片Perampanel TabletsFycompa12mgEisai Inc/Eisai Europe Limited未進(jìn)口原研藥品英國上市
39-50硫酸嗎啡緩釋片Morphine Sulphate Sustained-release Tablets-30mgNapp Pharmaceuticals Limited未進(jìn)口原研藥品英國上市
39-51拉莫三嗪分散片Lamotrigine Dispersible TabletsLamictal2mgThe Wellcome Foundation Ltd.未進(jìn)口原研藥品英國上市
7-25對乙酰氨基酚片Paracetamol TabletsPanadol Advance Tablets0.5gGlaxoSmithKline Consumer Healthcare歐盟上市備注1由“歐盟上市(上市國家:英國;產(chǎn)地:德國)”更正為“歐盟上市”
7-88鹽酸溴己新片Bromhexine Hydrochloride TabletsBisolvon8mgBoehringer Ingelheim Pharma GmbH & Co. KG/Sanofi-Aventis Deutschland GmbH未進(jìn)口原研藥品持證商發(fā)生變更,增加持證商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國內(nèi)上市的國際公認(rèn)藥品持證商更新為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國內(nèi)上市的國際公認(rèn)藥品持證商更新為Fresenius Kabi AB
27-104米力農(nóng)注射液Milrinone Injection /Primacor 1mg/ml Solution for Injection-10mg/10mlAventis Pharma Limited/Sanofi-Aventis/Sanofi未進(jìn)口原研藥品規(guī)格更新為10mg/10ml


1、參比制劑選擇原則:有原研進(jìn)口的應(yīng)選擇原研進(jìn)口藥作為參比制劑首選。
2、本網(wǎng)站所有仿制藥參比制劑目錄數(shù)據(jù)源自國家藥品監(jiān)督管理局官方網(wǎng)站,如有紕漏請以國家官網(wǎng)為準(zhǔn)。


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