经国家药品监督管理局仿制药质量和疗效一致性评价专家委员会审核确定，现发布仿制药参比制剂目录（第六十批）。特此通告。附件：仿制药参比制剂目录（第六十批）国家药监局****年*月**日序号药品通用名称英文名称/商品名规格持证商备注*备注*拉米夫定多替拉韦片Lamivudine and Dolutegravir Sodium Tablets/多伟托每片含拉米夫定***mg和多替拉韦钠（以多替拉韦计）**mgViiV Healthcare B.V.国内上市的原研药品原研进口磷/碳酸氢钠血滤置换液Hemofiltration Replacement Fluid of Sodium Bicarbonate and Phosphate****ml（***ml/****ml）Gambro Lundia AB国内上市的原研药品原研进口咪康唑口腔贴片Miconazole Buccal Tablet/ 诺弥可** mgVECTANS PHARMA国内上市的原研药品原研进口甲苯磺酸卢美哌隆胶囊Lumateperone tosylate capsule/Caplyta** mg（以卢美哌隆计）Intra-Cellular Therapies Inc未进口原研药品美国橙皮书复方电解质注射液Multiple Electrolytes Injection/Plasma-Lyte A***mlBaxter Healthcare Corp未进口原研药品美国橙皮书碳酸氢钠注射液Sodium Bicarbonate Injection*.*MEQ/ML（*.*%）Exela Pharma Sciences LLC国际公认的同种药品美国橙皮书碳酸氢钠注射液Sodium Bicarbonate Injection*MEQ/ML（*.*%）Exela Pharma Sciences LLC国际公认的同种药品美国橙皮书非奈利酮片Finerenone Tablets/Kerendia**mgBayer Healthcare Pharmaceuticals INC未进口原研药品美国橙皮书非奈利酮片Finerenone Tablets/Kerendia**mgBayer Healthcare Pharmaceuticals INC未进口原研药品美国橙皮书氯苯唑酸软胶囊Tafamidis soft Capsules /Vyndamax**mgFoldrx Pharmaceuticals LLC A Wholly Owned Sub Of Pfizer INC未进口原研药品美国橙皮书氨基己酸口服溶液Aminocaproic Acid Oral Solution /Amicar*.** g/mlAkorn Operating CO LLC未进口原研药品美国橙皮书维利西呱片Vericiguat Tablets/Verquvo*.*mgMerck Sharp And Dohme Corp未进口原研药品美国橙皮书维利西呱片Vericiguat Tablets/Verquvo*mgMerck Sharp And Dohme Corp未进口原研药品美国橙皮书维利西呱片Vericiguat Tablets/Verquvo**mgMerck Sharp And Dohme Corp未进口原研药品美国橙皮书度骨化醇软胶囊Doxercalciferol Capsules /Hectorol*.*μgSanofi Genzyme未进口原研药品美国橙皮书度骨化醇软胶囊Doxercalciferol Capsules /Hectorol*μgSanofi Genzyme未进口原研药品美国橙皮书度骨化醇软胶囊Doxercalciferol Capsules /Hectorol*.*μgSanofi Genzyme未进口原研药品美国橙皮书泼尼松龙磷酸钠口服溶液Prednisolone Sodium phosphate Oral solution/ Pediapred*mg/*mlSeton Pharmaceutical LLC未进口原研药品美国橙皮书环磷酰胺注射液Cyclophosphamide Injection***mg/*.*ml（***mg/ml）Ingenus Pharmaceuticals,LLC未进口原研药品美国橙皮书环磷酰胺注射液Cyclophosphamide Injection*g/*ml（***mg/ml）Ingenus Pharmaceuticals,LLC未进口原研药品美国橙皮书环磷酰胺注射液Cyclophosphamide Injection*g/**ml（***mg/ml）Ingenus Pharmaceuticals,LLC未进口原研药品美国橙皮书枸橼酸托法替布口服溶液Tofacitinib Citrate Oral Solution*mg/ml，***mlPfizer Inc.未进口原研药品美国橙皮书非那雄胺他达拉非胶囊Finasteride and Tadalafil Capsules / Entadfi*mg/*mgVeru Inc未进口原研药品美国橙皮书依托咪酯注射液Etomidate Injection/Amidate**ml∶**mgHospira INC未进口原研药品美国橙皮书玛巴洛沙韦干混悬剂Baloxavir Marboxil for Suspension/Xofluza*mg/mlGenentech Inc.未进口原研药品美国橙皮书盐酸沙瑞环素片Sarecycline Hydrochloride Tablet/Seysara**mgAlmirall LLC未进口原研药品美国橙皮书盐酸沙瑞环素片Sarecycline Hydrochloride Tablet/Seysara***mgAlmirall LLC未进口原研药品美国橙皮书盐酸沙瑞环素片Sarecycline Hydrochloride Tablet/Seysara***mgAlmirall LLC未进口原研药品美国橙皮书注射用盐酸替拉凡星Telavancin Hydrochloride for Injection/Vibativ*** mgCumberland Pharmaceuticals Inc.未进口原研药品美国橙皮书托吡卡胺滴眼液Tropicamide Ophthalmic Solution/ Mydriacyl*.**%Sandoz INC未进口原研药品美国橙皮书磷酸二氨基吡啶片Amifampridine phosphate tablets/Firdapse**mgSERB S.A.未进口原研药品欧盟上市比拉斯汀口服溶液Bilastine Oral Solution*.*mg/mlMenarini International Operations Luxembourg S.A./FAES Farma, S.A.未进口原研药品欧盟上市盐酸巴尼地平缓释胶囊Barnidipine Hydrochloride Sustained-Release Capsules / Libradin**mgAlfasigma ***.******.***.未进口原研药品欧盟上市盐酸喹高利特片Quinagolide Hydrochloride Tablets/Norprolac**μg（按C**H**N*O*S计）Ferring Arzneimittel GmbH未进口原研药品欧盟上市盐酸喹高利特片Quinagolide Hydrochloride Tablets/Norprolac**μg（按C**H**N*O*S计）Ferring Arzneimittel GmbH未进口原研药品欧盟上市盐酸喹高利特片Quinagolide Hydrochloride Tablets/Norprolac**μg（按C**H**N*O*S计）Ferring Arzneimittel GmbH未进口原研药品欧盟上市盐酸喹高利特片Quinagolide Hydrochloride Tablets/Norprolac***μg（按C**H**N*O*S计）Ferring Arzneimittel GmbH未进口原研药品欧盟上市枸橼酸托法替布口服溶液Tofacitinib Citrate Oral Solution*mg/ml，***mlPfizer Europe MA EEIG未进口原研药品欧盟上市亚甲蓝肠溶缓释片Methylthioninium Chloride Enteric-coated Sustained-Release Tablets / Lumeblue**mgAlfasigma ***.******.***.欧盟上市异康唑二氟可龙乳膏Isoconazole Nitrate and Diflucortolone Valerate Cream /Travocort®Cream*%,*.*%LEO Pharma A/S欧盟上市盐酸美贝维林片Mebeverine Hydrochloride Tablets / Colofac***mgMylan Products Ltd.未进口原研药品欧盟上市水合氯醛灌肠剂Chloral Hydrate Enemas/ Escre*.**g：*.*g久光製薬株式会社未进口原研药品日本上市复方聚乙二醇电解质散（Ⅱ）Polyethylene Glycol Electrolytes Powder (II)/Niflec***.***g/袋EAファーマ株式会社未进口原研药品日本上市硝酸异康唑乳膏Isoconazole Nitrate Cream/Adestan Cream*%バイエル薬品株式会社未进口原研药品日本上市醋酸兰瑞肽缓释注射液（预充式）Lanreotide Acetate Sustained-release Injection (a pre-filled syringe)**mgIpsen Pharma国内上市的原研药品原研进口醋酸兰瑞肽缓释注射液（预充式）Lanreotide Acetate Sustained-release Injection (a pre-filled syringe)**mgIpsen Pharma国内上市的原研药品原研进口醋酸兰瑞肽缓释注射液（预充式）Lanreotide Acetate Sustained-release Injection (a pre-filled syringe)***mgIpsen Pharma国内上市的原研药品原研进口阿法骨化醇软胶囊Alfacalcidol Soft Capsules / Etalpha*μgCHEPLAPHARM Arzneimittel GmbH国内上市的原研药品原研进口玛巴洛沙韦片Baloxavir Marboxil Tablets/Xofluza(速福达)**mgRoche Pharma (Schweiz) AG国内上市的原研药品原研进口硫酸氢氯吡格雷片Clopidogrel Hydrogen Sulphate Tablets/Plavix**mg赛诺菲（杭州）******经审核确定的国外原研企业在中国境内生产的药品原研地产化注射用头孢哌酮钠舒巴坦钠Cefoperazone Sodium and Sulbactam Sodium for Injection/舒普深*.*g（C**H**N*O*S**.*g与C*H**NO*S *.*g）******经审核确定的国外原研企业在中国境内生产的药品原研地产化注射用头孢哌酮钠舒巴坦钠Cefoperazone Sodium and Sulbactam Sodium for Injection/舒普深*.*g（C**H**N*O*S**.*g与C*H**NO*S *.*g）******经审核确定的国外原研企业在中国境内生产的药品原研地产化尼洛替尼胶囊Nilotinib Capsules/Tasigna**mgNovartis Pharmaceuticals Corp未进口原研药品美国橙皮书尼洛替尼胶囊Nilotinib Capsules/Tasigna***mgNovartis Pharmaceuticals Corp未进口原研药品美国橙皮书尼洛替尼胶囊Nilotinib Capsules/Tasigna***mgNovartis Pharmaceuticals Corp未进口原研药品美国橙皮书酮咯酸氨丁三醇注射液Ketorolac Tromethamine Injection**mg/ml（*ml:**mg）Hospira INC.国际公认的同种药品美国橙皮书环孢素软胶囊Ciclosporin Soft Capsules/Neoral***mgNovartis Pharmaceuticals Corporation未进口原研药品美国橙皮书吸入用布地奈德混悬液Budesonide Suspension For Inhalation/ Pulmicort Respules*ml：*.*mgAstrazeneca Pharmaceuticals LP未进口原研药品美国橙皮书吸入用布地奈德混悬液Budesonide Suspension For Inhalation/ Pulmicort Respules*ml：*mgAstrazeneca Pharmaceuticals LP未进口原研药品美国橙皮书奥美沙坦酯氢氯噻嗪片Hydrochlorothiazide;Olmesartan Medoxomil /Benicar Hct**mg/**.*mgDaiichi Sankyo Inc未进口原研药品美国橙皮书布洛芬注射液※Ibuprofen Injection/Caldolor***MG/*ML (***MG/ML)Cumberland Pharmaceuticals Inc未进口原研药品美国橙皮书氟维司群注射液Faslodex *** mg solution for injection/Faslodex*ml:*.**gAstraZeneca AB/AstraZeneca UK Limited未进口原研药品欧盟上市氯苯唑酸葡胺软胶囊Tafamidis Meglumine Soft Capsules/Vyndaqel**mgPfizer Europe MA EEIG未进口原研药品欧盟上市恩他卡朋片Entacapone Tablets /Comtess***mgOrion Pharma GmbH未进口原研药品欧盟上市卡格列净片Canagliflozin Tablets/Invokana***mgJanssen-Cilag International NV,未进口原研药品欧盟上市硫酸羟氯喹片Hydroxychloroquine Sulfate Tablets/Plaquenil*.*gSanofi-Aventis未进口原研药品欧盟上市二硫化硒洗剂Selenium Sulfide Lotion/Selsun*.*%Sanofi-Aventis Netherlands B.V./ Opella Healthcare France SAS未进口原研药品欧盟上市碳酸司维拉姆干混悬剂Sevelamer Carbonate Powder for oral suspension/Renvela*.*gGenzyme Europe B.V.未进口原研药品欧盟上市碳酸司维拉姆干混悬剂Sevelamer Carbonate Powder for oral suspension/Renvela*.*gGenzyme Europe B.V.未进口原研药品欧盟上市达肝素钠注射液Dalteparin Sodium Injection/Fragmin*.*ml:****IUPfizer Pharma Pfe GmbH未进口原研药品欧盟上市比沙可啶肠溶片Bisacodyl Enteric-coated Tablets/Dulcolax*mgOpella Healthcare France SAS未进口原研药品欧盟上市盐酸文拉法辛缓释胶囊Venlafaxine Hydrochloride Sustained-Release Capsules/Efexor XL**mg（以文拉法辛计）Upjohn UK Limited未进口原研药品欧盟上市盐酸文拉法辛缓释胶囊Venlafaxine Hydrochloride Sustained-Release Capsules/Efexor XL***mg（以文拉法辛计）Upjohn UK Limited未进口原研药品欧盟上市骨化三醇注射液Calcitriol Injection/Rocaltrol*ml:*.*μg協和キリン株式会社未进口原研药品日本上市骨化三醇注射液Calcitriol Injection/Rocaltrol*ml:*μg協和キリン株式会社未进口原研药品日本上市*-**盐酸帕罗西汀片Paroxetine Hydrochloride Tablets/Paxil**mgApotex Technologies Inc/Apotex Inc未进口原研药品增加持证商Apotex Inc**-***普伐他汀钠片Pravastatin Sodium Tablet/Sanaprav**mgDAIICHI SANKYO ITALIA ***.******.***./Daiichi Sankyo Belgium S.A/Daiichi Sankyo Europe Gmbh欧盟上市增加持证商Daiichi Sankyo Belgium S.A/Daiichi Sankyo Europe Gmbh，不限定上市国和产地**-***盐酸曲唑酮片Trazodone Hydrochloride Tablets/RESLIN**mgMSD K.K./オルガノン株式会社日本橙皮书增加持证商オルガノン株式会社**-***盐酸曲唑酮片Trazodone Hydrochloride Tablets/RESLIN**mgMSD K.K./オルガノン株式会社日本橙皮书增加持证商オルガノン株式会社**-***盐酸利多卡因注射液Lidocaine Hydrochloride Injection*%（以C**H**N*O• HCL计）（*ml、**ml、**ml）Aspen/Aspen Pharma Trading Limited未进口原研药品增加持商：Aspen Pharma Trading Limited，不限定商品名**-***盐酸多巴胺注射液Dopamine Hydrochloride Injection/Inovan*.*ml:**mg協和発酵キリン株式会社/協和キリン株式会社未进口原研药品增加持证商協和キリン株式会社**-***盐酸多巴胺注射液Dopamine Hydrochloride Injection/Inovan*ml:***mg協和発酵キリン株式会社/協和キリン株式会社未进口原研药品增加持证商協和キリン株式会社**-*丙酸氟替卡松乳膏Fluticasone Propionate Cream/Cutivate*.**% （包装规格**、**、**、***g）Glaxo Wellcome/GlaxoSmithKline/GlaxoSmithKline（Ireland）Limited未进口原研药品增加持商：GlaxoSmithKline（Ireland）Limited**-***依折麦布阿托伐他汀钙片Ezetimibe and Atorvastatin Calcium Trihydrate Tablets**mg/**mgMerck Sharp & Dohme/Organon Healthcare GmbH /Organon France未进口原研药品增加持证商Organon France**-***依折麦布阿托伐他汀钙片Ezetimibe and Atorvastatin Calcium Trihydrate Tablets**mg/**mgMerck Sharp & Dohme/Organon Healthcare GmbH /Organon France未进口原研药品增加持证商Organon France**-***羟乙基淀粉***/*.*氯化钠注射液Hydroxyethyl Starch ***/*.* and Sodium Chloride Injection/Voluven Fresenius羟乙基淀粉***/*.*:**g/L，氯化钠:*.*g/L（***ml，***ml）Fresenius Kabi Deutschland GmbH/Fresenius Kabi Italia ***.******.***./Fresenius Kabi Pharma Portugal, Lda未进口原研药品增加持证商Fresenius Kabi Pharma Portugal, Lda，**-***氯/硝/西/泮注射液Clonazepam Injection*ml:*mgRoche Pharma（Schweiz）AG/CPS Cito Pharma Services GmbH未进口原研药品增加持证商CPS Cito Pharma Services GmbH**-***盐酸帕罗西汀片Paroxetine Hydrochloride Tablets/Paxil**mgApotex Technologies Inc/Apotex Inc未进口原研药品增加持证商Apotex Inc**-***盐酸肾上腺素注射液/肾上腺素注射液Epinephrine Injection/ADRENALIN*ml:*mgPar Pharmaceutical, Inc/Par Sterile Products Llc未进口原研药品增加持证商Par Sterile Products Llc**-**乙酰半胱氨酸口服溶液Acetylcysteine Oral Solution*%（**ml、***ml、***ml）Zambon GmbH未进口原研药品不限定商品名**-**盐酸帕罗西汀片Paroxetine Hydrochloride Tablets/Paxil**mgApotex Technologies Inc/Apotex Inc未进口原研药品增加持证商Apotex Inc**-**盐酸帕罗西汀片Paroxetine Hydrochloride Tablets/Paxil**mgApotex Technologies Inc/Apotex Inc未进口原研药品增加持证商Apotex Inc**-**丙酸氟替卡松乳膏Fluticasone Propionate Cream*.**%Perrigo Israel Pharmaceuticals Ltd / Padagis Israel Pharmaceuticals Ltd国际公认的同种药品增加持证商Padagis Israel Pharmaceuticals Ltd备注*.目录中所列尚未在国内上市品种的通用名、剂型等，以药典委核准的为准。*.参比制剂目录公示后，未正式发布的品种将进行专题研究，根据研究结果另行发布。*.欧盟上市的参比制剂包括其在英国上市的同一药品。*.选择未进口参比制剂开展仿制药研究除满足其质量要求外，还需满足现行版《中国药典》和相关指导原则要求。*.放射性药物不同于普通化学药物，具有一定的特殊性如放射性、时效性、按放射性活度给药等特点，参比制剂主要用于明确其研发目标和基本要求，可根据其药物特性同时结合参比制剂的可获得性进行研究。*.布洛芬注射液※：仿制本品时应特别关注基础输液配伍稳定性研究，满足临床需要。