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【第三十五批】仿制药参比制剂目录


【第三十五批】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
35-1注射用六氟化硫微泡Sulfur Hexafluoride Microbubbles for InjectionSonoVue(声诺维)59 mgBracco International B.V.国内上市的原研药品原研进口
35-2注射用利培酮微球Risperidone for Depot SuspensionRisperdal Consta25 mgJanssen-Cilag AG/Janssen Pharmaceutica N.V.国内上市的原研药品原研进口
35-3注射用利培酮微球Risperidone for Depot SuspensionRisperdal Consta37.5 mgJanssen-Cilag AG/Janssen Pharmaceutica N.V.国内上市的原研药品原研进口
35-4注射用利培酮微球Risperidone for Depot SuspensionRisperdal Consta50 mgJanssen-Cilag AG/Janssen Pharmaceutica N.V.国内上市的原研药品原研进口
35-5注射用利培酮微球Risperidone Long-acting InjectionRisperdal Consta12.5mgJanssen Pharmaceuticals, Inc.未进口原研药品美国橙皮书
35-6注射用利培酮微球Risperidone Long-acting InjectionRisperdal Consta25 mgJanssen Pharmaceuticals, Inc.未进口原研药品美国橙皮书
35-7注射用利培酮微球Risperidone Long-acting InjectionRisperdal Consta37.5 mgJanssen Pharmaceuticals, Inc.未进口原研药品美国橙皮书
35-8注射用利培酮微球Risperidone Long-acting InjectionRisperdal Consta50 mgJanssen Pharmaceuticals, Inc.未进口原研药品美国橙皮书
35-9注射用利培酮微球Risperidone powder and solvent for depot suspension for InjectionRisperdal Consta25 mgJanssen-Cilag GmbH未进口原研药品欧盟上市
35-10注射用利培酮微球Risperidone powder and solvent for depot suspension for InjectionRisperdal Consta37.5 mgJanssen-Cilag GmbH未进口原研药品欧盟上市
35-11注射用利培酮微球Risperidone powder and solvent for depot suspension for InjectionRisperdal Consta50 mgJanssen-Cilag GmbH未进口原研药品欧盟上市
35-12普拉曲沙注射液Pralatrexate InjectionFolotyn20mg/mlAcrotechBiopharma LLC未进口原研药品美国橙皮书
35-13酒石酸匹莫范色林片Pimavanserin Tartrate TabletsNuplazid10mg(以匹莫范色林计)AcadiaPharmaceuticals Inc未进口原研药品美国橙皮书
35-14注射用苯唑西林钠Oxacillin Sodium for Injection-以C19H19N3O5S计1.0gSagent Pharmaceuticals Inc国际公认的同种药品美国橙皮书
35-15注射用苯唑西林钠Oxacillin Sodium for Injection-以C19H19N3O5S计2.0gSagent Pharmaceuticals Inc国际公认的同种药品美国橙皮书
35-16盐酸去氧肾上腺素注射液Phenylephrine Hydrochloride InjectionVazculep10mg/mlAvaedl Legacy未进口原研药品美国橙皮书
35-17小儿复方氨基酸注射液(20AA)Amino Acid Solution for InfusionPrimene10%(100ml/250ml)Baxter未进口原研药品欧盟上市
35-18小儿复方氨基酸注射液(20AA)Amino Acid Intravenous InfusionPrimene10%(100ml/250ml)Baxter Healthcare Pty Ltd未进口原研药品澳大利亚上市
35-19琥珀酸呋罗曲坦片Frovatriptan TabletIsimig2.5mgMenarini International Operations Luxembourg SA未进口原研药品欧盟上市
35-20间苯三酚口服冻干片Phloroglucinol Oral LyophilisatesSpasfon Lyoc160mgTeva Sante未进口原研药品欧盟上市
35-21复方磺胺甲噁唑注射液Sulfamethoxazole and Trimethoprim InjectionBactrim5ml,磺胺甲噁唑80mg/ml,甲氧苄啶16mg/mlRoche S.p.A未进口原研药品欧盟上市
35-22依托芬那酯凝胶Etofenamate GelTraumon5%(50g,100g)MEDA Manufacturing GmbH未进口原研药品欧盟上市
35-23依托芬那酯凝胶Etofenamate GelTraumon10%(50g,100g)MEDA Manufacturing GmbH未进口原研药品欧盟上市
35-24盐酸非索非那定干糖浆Fexofenadine Hydrochloride Dry SyrupAllegra1g中含盐酸非索非那定50mgサノフィ株式会社(赛诺菲株式会社)未进口原研药品日本上市
35-25甲基多巴片Methyldopa TabletsAldomet250mg株式会社ミノファーゲン製薬未进口原研药品日本上市
35-26注射用盐酸罗沙替丁醋酸酯Roxatidine Acetate Hydrochloride For InjectionAltat75mgあすか製薬株式会社未进口原研药品日本上市
35-27瑞卢戈利片Relugolix TabletsRelumina40mg武田药品工业株式会社/あすか制药株式会社未进口原研药品日本上市
35-28拉考沙胺注射液Lacosamide InjectionVimpat10mg/mlUCB Pharma S.A.国内上市的原研药品原研进口
35-29注射用醋酸卡泊芬净Caspofungin Acetate for InjectionCancidas50mgMerck and Co INC未进口原研药品美国橙皮书
35-30注射用醋酸卡泊芬净Caspofungin Acetate for InjectionCancidas70mgMerck and Co INC未进口原研药品美国橙皮书
35-31注射用唑来膦酸浓溶液Zoledronic Acid Concentrated Solution for InjectionZometa5ml:4mgNovartis Pharmaceuticals Corp未进口原研药品美国橙皮书
35-32盐酸多塞平片Doxepin Hydrochloride Tablets Silenor6mgCurrax Pharmaceuticals LLC未进口原研药品美国橙皮书
35-33氯氮平片Clozapine TabletsClozaril0.1gHeritage Life Sciences Barbados INC未进口原研药品美国橙皮书
35-34麦考酚钠肠溶片Mycophenolate Sodium Enteric-coated tabletsMyfortic180mgNovartis Pharmaceuticals Corporation未进口原研药品美国橙皮书
35-35盐酸二甲双胍缓释片Metformin Hydrochloride Extended-release TabletsFortamet1gAndrx Labs LLC未进口原研药品美国橙皮书
35-36司来帕格片Selexipag Tablets Uptravi0.4mgJanssen-Cilag International NV未进口原研药品欧盟上市
35-37左氧氟沙星氯化钠注射液Levofloxacin and Sodium Chloride Injection Tavanic50ml:250mgSanofi-Aventis Deutschland GmbH未进口原研药品德国上市
35-38托拉塞米片Torasemide Tablets Unat5mgMEDA Pharma GmbH & Co. KG未进口原研药品德国上市
35-39紫杉醇注射液Paclitaxel InjectionTaxol16.7ml:100mgBristol-Myers Squibb S.R.L.未进口原研药品瑞士上市
35-40氨甲环酸注射液Tranexamic Acid InjectionTransamin5%(5ml:0.25g)第一三共株式会社未进口原研药品日本上市
35-41氨甲环酸注射液Tranexamic Acid InjectionTransamin10%(2.5ml:0.25g、10ml:1g)第一三共株式会社未进口原研药品日本上市
35-42氨甲环酸注射液Tranexamic Acid InjectionCyklokapron5ml:0.5g、10ml:1gPfizer未进口原研药品欧盟上市
35-43氨甲环酸注射液Tranexamic Acid InjectionCyklokapron10ml:1gPharmacia and Upjohn Co未进口原研药品美国橙皮书
8-88利巴韦林片Ribavirin TabletsCopegus0.2gRoche Products Limited/Roche S.p.A/Roche Pharma AG欧盟上市增加持证商Roche S.p.A/Roche Pharma AG;不限定产地
8-179盐酸替扎尼定片Tizanidine Hydrochloride Tablets Sirdalud2mgNovartis Pharma GmbH欧盟上市修订,不限定产地
8-147硝苯地平控释片Nifedipine Controlled-release TabletsAdalat30mgBayer Pharma AG /Bayer AG原研进口持证商变更,增加变更后持证商Bayer AG
8-236硝苯地平控释片Nifedipine Controlled-release TabletsAdalat60mgBayer Pharma AG /Bayer AG原研进口持证商变更,增加变更后持证商Bayer AG
22-40丙戊酸钠注射用浓溶液Sodium Valproate Concentrated Solution for Injection Depacon5ml:500mgABBVIE INC未进口原研药品修订药品通用名称及英文名称为丙戊酸钠注射用浓溶液及Sodium Valproate Concentrated Solution for Injection
23-334丙戊酸钠注射用浓溶液Sodium Valproate Concentrated Solution for Injection Orfiril3ml:300mgDesitin Arzneimittel GmbH
修订药品通用名称及英文名称为丙戊酸钠注射用浓溶液及Sodium Valproate Concentrated Solution for Injection
23-335丙戊酸钠注射用浓溶液Sodium Valproate Concentrated Solution for Injection Orfiril10ml:1gDesitin Arzneimittel GmbH
修订药品通用名称及英文名称为丙戊酸钠注射用浓溶液及Sodium Valproate Concentrated Solution for Injection
26-15丙戊酸钠注射用浓溶液Sodium Valproate Concentrated Solution for Injection Ergenyl100mg/ml(以丙戊酸钠计)(4ml)Sanofi-Aventis Deutschland GmbH
修订药品通用名称及英文名称为丙戊酸钠注射用浓溶液及Sodium Valproate Concentrated Solution for Injection
29-85丙戊酸钠注射用浓溶液Sodium Valproate Concentrated Solution for Injection
100mg/ml(以丙戊酸计)(5ml)Hikma Farmaceutica (Portugal)SA国际公认的同种药品修订药品通用名称及英文名称为丙戊酸钠注射用浓溶液及Sodium Valproate Concentrated Solution for Injection
30-147ω-3鱼油中长链脂肪乳/氨基酸(16)/葡萄糖(36%)注射液ω-3 Fish Oil Medium and Long Chain Fat Emulsion/Amino Acids(16)/Glucose(36%)Injection-1250ml、1875ml、2500mlB. Braun Melsungen AG未进口原研药品修订,不限定商品名
31-96ω-3鱼油中长链脂肪乳/氨基酸(16)/葡萄糖(36%)注射液ω-3 Fish Oil Medium and Long Chain Fat Emulsion/Amino Acids(16)/Glucose(36%)Injection-625mlB. Braun Melsungen AG未进口原研药品修订,不限定商品名
32-65盐酸法舒地尔注射液Fasudil Hydrochloride InjectionEril2ml:30mgAsahi Kasei Pharma Corporation未进口原研药品修订持证商为Asahi Kasei Pharma Corporation


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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