2、仿制药参比制剂目录(CFDA)

整理文档很辛苦,赏杯茶钱您下走!

免费阅读已结束,点击下载阅读编辑剩下 ...

阅读已结束,您可以下载文档离线阅读编辑

资源描述

-1-仿制药参比制剂目录(第一批)序号药品通用名称英文名称/商品名规格剂型持证商备注1备注21-1盐酸胺碘酮片AmiodaroneHydrochlorideTablets/Cordarone0.2g片剂Sanofi-AventisFrance原研进口1-2阿卡波糖片AcarboseTablets/Glucobay50mg片剂BayerVitalGmbH原研进口1-3尼莫地平片NimodipineTablets/Nimotop30mg片剂BayerVitalGmbH原研进口1-4头孢呋辛酯片CefuroximeAxetilTablets/Ceftin按头孢呋辛(C16H16N4O8S)计0.125g片剂GlaxoSmithKline美国橙皮书1-5头孢呋辛酯片CefuroximeAxetilTablets/Zinacef按头孢呋辛(C16H16N4O8S)计0.25g片剂GlaxoWellcomeUKLimited原研进口1-6辛伐他汀片SimvastatinTablets/Zocor10mg片剂MerckSharp&Dohme(Australia)Pty.Ltd.原研进口1-7辛伐他汀片SimvastatinTablets/Zocor20mg片剂MerckSharp&DohmeB.V.原研进口1-8盐酸氨溴索片AmbroxolHydrochlorideTablets/Mucosolvan30mg片剂BoehringerIngelheimFrance原研进口1-9聚乙二醇4000散Macrogol4000powder/Forlax10g散剂IpsenPharma原研进口-2-1-10醋酸去氨加压素片DesmopressinAcetateTablets/Minirin0.1mg片剂FerringAG原研进口1-11醋酸去氨加压素片DesmopressinAcetateTablets/Minirin0.2mg片剂FerringAG原研进口1-12富马酸比索洛尔片BisoprololFumarateTablets/Concor2.5mg片剂MerckSeronoGmbH原研进口1-13富马酸比索洛尔片BisoprololFumarateTablets/Concor5mg片剂MerckSeronoGmbH原研进口1-14白消安片BusulfanTablets/Myleran2mg片剂AspenPharmacareAustraliaPtyLtd原研进口1-15富马酸喹硫平片QuetiapineFumarateTablets/Seroquel25mg片剂AstraZenecaUKLimited原研进口1-16富马酸喹硫平片QuetiapineFumarateTablets/Seroquel0.1g片剂AstraZenecaUKLimited原研进口1-17醋酸甲羟孕酮片MedroxyprogesteroneAcetateTablets/Provera0.1g片剂PfizerSA/NV原研进口1-18醋酸甲羟孕酮片MedroxyprogesteroneAcetateTablets/Provera0.25g片剂PfizerItalias.r.l欧盟上市(产地:意大利)1-19阿莫西林克拉维酸钾片AmoxicillinandClavulanatePotassiumTablets/Augmentin0.375g(C16H19N3O5S0.25g与C8H9NO50.125g)片剂BeechamGroupPlc欧盟上市(产地:英国;上市国家:英国)-3-1-20阿莫西林克拉维酸钾片AmoxicillinandClavulanatePotassiumTablets/Augmentin0.625g(C16H19N3O5S0.5g与C8H9NO50.125g)片剂BeechamGroupPlc原研进口1-21阿莫西林克拉维酸钾片AmoxicillinandClavulanatePotassiumTablets/Augmentin1g(C16H19N3O5S0.875g与C8H9NO50.125g)片剂BeechamGroupPlc原研进口1-22格列美脲片GlimepirideTablets/Amaryl1mg片剂Sanofi-AventisDeutschlandGmbH原研进口1-23格列美脲片GlimepirideTablets/Amaryl2mg片剂Sanofi-AventisDeutschlandGmbH原研进口1-24环孢素软胶囊CiclosporinSoftCapsules/SandimmunNeoral10mg胶囊剂(软胶囊)NovartisPharmaSchweizAG原研进口1-25环孢素软胶囊CiclosporinSoftCapsules/SandimmunNeoral25mg胶囊剂(软胶囊)NovartisPharmaSchweizAG原研进口1-26环孢素软胶囊CiclosporinSoftCapsules/SandimmunNeoral50mg胶囊剂(软胶囊)NovartisPharmaSchweizAG原研进口1-27甲巯咪唑片ThiamazoleTablets/Thyrozol5mg片剂MerckSeronoGmbH原研进口1-28硫酸氢氯吡格雷片ClopidogrelHydrogenSulphateTablets/Plavix75mg片剂SanofiClirSNC原研进口-4-1-29硝酸甘油舌下片NitroglycerinSublingualTablets/Nitrostat0.6mg片剂(舌下片)PfizerINC原研进口适用于硝酸甘油舌下片和舌下含服的硝酸甘油片1-30克拉霉素片ClarithromycinTablets/Klacid0.25g片剂ABBOTTLABORATORIESLIMITED原研进口1-31阿立哌唑片AripiprazoleTablets/Abilify5mg片剂OtsukaPharmaceuticalCo.Ltd美国橙皮书1-32阿立哌唑片AripiprazoleTablets/Abilify10mg片剂OtsukaPharmaceuticalCo.Ltd美国橙皮书1-33阿立哌唑口崩片AripiprazoleOrallyDisintegratingtablets/Abilify10mg片剂(口崩片)OtsukaPharmaceuticalEuropeLtd.欧盟上市(产地:法国)1-34盐酸环丙沙星片CiprofloxacinHydrochlorideTablets/Ciprobay0.25g(按C17H18FN3O3计)片剂BayerVitalGmbH原研进口进口产品现名为环丙沙星片。1-35盐酸环丙沙星片CiprofloxacinHydrochlorideTablets/Ciprobay0.5g(按C17H18FN3O3计)片剂BayerVitalGmbH原研进口进口产品现名为环丙沙星片。1-36盐酸特拉唑嗪片TerazosinHydrochlorideTablets/Hytrin2mg(按C19H25N5O4计)片剂AbbottLaboratories(Singapore)PrivateLimited原研进口1-37吲达帕胺片IndapamideTablets/Natrilix2.5mg片剂LesLaboratoiresServier原研进口-5-1-38吲达帕胺缓释片IndapamideSustained-releaseTablets/Natrilix1.5mg片剂(缓释片)LesLaboratoiresServier原研进口1-39左甲状腺素钠片LevothyroxineSodiumTablets/Euthyrox50μg片剂MerckSeronoGmbH原研进口1-40佐匹克隆片ZopicloneTablets/Imovane7.5mg片剂Sanofi-AventisFrance原研进口1-41佐匹克隆片ZopicloneTablets/Imovane3.75mg片剂Sanofi-AventisFrance欧盟上市(产地:法国;上市国家:法国)1-42硫唑嘌呤片AzathioprineTablets/Imuran50mg片剂AspenPharmacareAustraliaPtyLtd原研进口1-43奈韦拉平片NevirapineTablets/Viramune0.2g片剂BoehringerIngelheimPharmaceuticalsINC美国橙皮书1-44米索前列醇片MisoprostolTablets/Cytotec0.2mg片剂PharmaciaLimited原研进口1-45马来酸依那普利片EnalaprilMaleateTablets/Renitec5mg片剂MerckSharp&Dohme(Australia)Pty.Ltd.原研进口1-46马来酸依那普利片EnalaprilMaleateTablets/Renitec10mg片剂MerckSharp&Dohme(Australia)Pty.Ltd.原研进口1-47拉米夫定片LamivudineTablets/Epivir(3TC)0.15g片剂ViiVHealthcarePty.Ltd.原研进口1-48拉米夫定片LamivudineTablets/Epivir(3TC)0.3g片剂ViiVHealthcareUKLimited原研进口1-49拉米夫定片LamivudineTablets/Epivir-HBV0.1g片剂GlaxoSmithKline美国橙皮书-6-1-50氯雷他定片LoratadineTablets/Clarityne10mg片剂BayerSA-NV原研进口1-51氯雷他定胶囊LoratadineCapsules/Claritin10mg胶囊剂BayerHealthcareLLC美国橙皮书仿制药参比制剂目录(第二批)序号药品通用名称英文名称/商品名规格剂型持证商备注1备注22-1盐酸胺碘酮片AmiodaroneHydrochlorideTablets/Ancaron0.1g片剂SanofiK.K.日本橙皮书2-2阿卡波糖片AcarboseTablets/Glucobay0.1g片剂BayerVitalGmbH原研进口2-3头孢呋辛酯片CefuroximeAxetilTablets/Ceftin按头孢呋辛(C16H16N4O8S)计0.5g片剂GlaxoSmithKline美国橙皮书2-4头孢呋辛酯干混悬剂CefuroximeAxetilforSuspension/Zinnat按头孢呋辛(C16H16N4O8S)计0.125g口服混悬剂(干混悬剂)GlaxoSmithKline,S.A.欧盟上市(产地:英国;上市国家:西班牙)2-5辛伐他汀片SimvastatinTablets/Zocor5mg片剂MerckSharp&Dohme(Australia)Pty.Ltd.原研进口2-6辛伐他汀片SimvastatinTablets/Zocor40mg片剂MerckSharp&Dohme(Australia)Pty.Ltd.原研进口-7-2-7盐酸氨溴索片AmbroxolHydrochlorideTablets/Mucosolvan60mg片剂BoehringerIngelheimPharmaGmbH&Co.KG欧盟上市(产地:法国;上市国家:德国)2-8盐酸氨溴索缓释胶囊AmbroxolHydrochlorideSustained-releaseCapsules/Mucosolvan75mg胶囊剂(缓释胶囊)BoehringerIngelheimPharmaGmbH&Co.KG原研进口2-9富马酸喹硫平片QuetiapineFumarateTablets/Seroquel0.2g片剂AstraZenecaUKLimited原研进口2-10富马酸喹硫平片QuetiapineFumarateTa

1 / 82
下载文档,编辑使用

©2015-2020 m.777doc.com 三七文档.

备案号:鲁ICP备2024069028号-1 客服联系 QQ:2149211541

×
保存成功