仿制药参比制剂目录(第二十四批)
国家药监局关于发布仿制药参比制剂目录（第七十四批）的通告
国家药监局关于发布仿制药参比制剂目录（第七十四
批）的通告
文章属性
•【制定机关】国家药品监督管理局
•【公布日期】2023.12.19
•【文号】国家药监局通告2023年第67号
•【施行日期】2023.12.19
•【效力等级】部门规范性文件
•【时效性】现行有效
•【主题分类】药政管理
正文
国家药监局通告
2023年第67号
关于发布仿制药参比制剂目录（第七十四批）的通告
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（第七十四批）。
特此通告。
附件：化学仿制药参比制剂目录（第七十四批）
国家药监局
2023年12月19日。
国家药监局关于发布仿制药参比制剂目录（第七十九批）的通告
国家药监局关于发布仿制药参比制剂目录（第七十九
批）的通告
文章属性
•【制定机关】国家药品监督管理局
•【公布日期】2024.04.12
•【文号】国家药监局通告2024年第14号
•【施行日期】2024.04.12
•【效力等级】部门规范性文件
•【时效性】现行有效
•【主题分类】药政管理
正文
国家药监局通告
2024年第14号
关于发布仿制药参比制剂目录（第七十九批）的通告
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（第七十九批）。
特此通告。
附件：化学仿制药参比制剂目录（第七十九批）
国家药监局
2024年4月12日。
汇总24批参比制剂
汇总24批参比制剂序号药品通用名称英文名称/商品名1月22日2月22日3月22日4月22日5月22日6月22日盐酸阿芬太尼注射液8月22日Azilsartan Tablets9月22日阿齐沙坦片/AZILVA Azilsartan Tablets10月22日阿齐沙坦片/AZILVA11月22日12月22日22-1322-1422-15丙氨酰谷氨酰胺注射液Alanyl Glutamine Injection/Dipeptiven （力太）丙氨酰谷氨酰胺注射液Alanyl Glutamine Injection/Dipeptiven （力太）盐酸阿芬太尼注射液Alfentanil Hydrochloride Injection/Rapifen Intensive Care盐酸阿芬太尼注射液Alfentanil Hydrochloride Injection/ALFENTA 7月22日Alfentanil Hydrochloride Injection/RAPIFEN 盐酸阿芬太尼注射液Alfentanil Hydrochloride Injection/ALFENTA 盐酸阿芬太尼注射液Alfentanil Hydrochloride Injection/RAPIFEN 盐酸阿芬太尼注射液Alfentanil Hydrochloride Injection/ALFENTA 奥氮平盐酸氟西汀胶囊Olanzapine and Fluoxetine HydrochlorideCapsules/SYMBYAX 奥氮平盐酸氟西汀胶囊Olanzapine and Fluoxetine HydrochlorideCapsules/SYMBYAX 奥氮平盐酸氟西汀胶囊Olanzapine and Fluoxetine HydrochlorideCapsules/SYMBYAX氨氯地平阿托伐他汀钙片Amlodipine Besylate and AtorvastatinCalcium Tablets /CADUET 奥氮平盐酸氟西汀胶囊Olanzapine and Fluoxetine HydrochlorideCapsules/SYMBYAX 奥氮平盐酸氟西汀胶囊Olanzapine and Fluoxetine HydrochlorideCapsules/SYMBYAX22-1622-17白消安注射液Compound Amino Acids22-18(15) and Dipeptides (2) Injection/GlaminCompound Amino Acids 22-19(15) and Dipeptides (2)Injection/Glamin(谷安光)Compound Amino Acids 22-20(15) and Dipeptides (2)Injection/Glamin(谷安光)Fat Emulsion,Amino Acids(17) andGlucose(11%)脂肪乳氨基酸 (17)葡萄糖 (11%)注射液Injection/Kabiven PI(卡22-21文)Fat Emulsion,Amino Acids(17) and 脂肪乳氨基酸(17)葡萄糖(11%)注射液Glucose(11%) Injection/Kabiven PI(卡文)22-22Fat Emulsion,Amino Acids(17) andGlucose(11%)脂肪乳氨基酸 (17)葡萄糖 (11%)注射液Injection/Kabiven PI(卡22-23文)Compound Amino Acid Injection/Aminoplasmal 22-24Hepa-10%(安平)22-2522-26酮咯酸氨丁三醇注射液酮咯酸氨丁三醇注射液酮咯酸氨丁三醇注射液22-3022-31苯丁酸钠片Sodium Phenylbutyrate Tablets/BUPHENYL 22-32Busulfan Injection/BUSULFEX(白舒非)复方氨基酸(15) 双肽(2)注射液奥氮平盐酸氟西汀胶囊Olanzapine and Fluoxetine HydrochlorideCapsules/SYMBYAX 醋酸艾替班特注射液Icatibant Acetate Solution for Injection inPre-filled Syringe/Firazyr 复方氨基酸注射液(20AA)复方氨基酸注射液(20AA)Compound Amino AcidInjection/Aminoplasmal Hepa-10%复方氨基酸(15) 双肽(2)注射液复方氨基酸(15) 双肽(2)注射液22-29Ketorolac Tromethamine Injection苯丁酸钠散/颗粒Sodium Phenylbutyrate Powder/BUPHENYL 22-27Ketorolac Tromethamine Injection 22-28Ketorolac Tromethamine Injection 阿立哌唑口崩片Aripiprazole OrodispersibleTablets/ABILIFY 阿立哌唑口崩片Aripiprazole Orodispersible Tablets/ABILIFY22-3322-3422-3522-3622-37阿立哌唑长效肌肉注射剂22-38阿立哌唑长效肌肉注射剂盐酸阿那格雷胶囊22-40盐酸阿那格雷胶囊Anagrelide Hydrochloride Capsules 22-41奥美沙坦酯氢氯噻嗪片22-42奥美沙坦酯氢氯噻嗪片22-43丙戊酸钠口服溶液22-4522-46丙戊酸钠注射液丙戊酸钠注射液22-48盐酸氨溴索口腔喷雾溶液Ambroxol Hydrochloride Oral Spray 阿立哌唑口服溶液Aripiprazole Oral Solution/ABILIFY 阿立哌唑口服溶液Aripiprazole Oral Solution/ABILIFY 阿立哌唑口崩片Aripiprazole OrodispersibleTablets/ABILIFY HYDROCHLOROTHIAZ IDE;OLMESARTANMEDOXOMIL/BENICAR HCT HYDROCHLOROTHIAZ IDE;OLMESARTANMEDOXOMIL/BENICAR HCT 丙戊酸钠口服溶液Sodium Valproate Liquid/Epilim （德巴金）Aripiprazole Powder and Solvent for Prolonged- release Suspension for Injection/Abilify Maintena 22-39Anagrelide Hydrochloride Capsules/AGRYLIN阿立哌唑口服溶液Aripiprazole Oral Solution/ABILIFY Aripiprazole Powder and Solvent for Prolonged- release Suspension for Injection/Abilify Maintenainjection/Orfiril丙戊酸钠注射液Sodium Valproate for intravenousinjection/Depacon Sodium Valproate for intravenousinjection/Orfiril 22-47Sodium Valproate for intravenous22-44Sodium Valproate Liquid/DEPAKINE 硫酸阿托品滴眼液Atropine Sulfate Ophthalmic Solution,USP 1%22-49/AMBROSPRAY 5%22-5022-51ALOGLIPTIN BENZOATE 22-52苯甲酸阿格列汀片TABLETs/NESINA （尼欣那）22-53ALOGLIPTIN BENZOATE TABLETs/NESINA （尼22-54苯甲酸阿格列汀片欣那）22-5522-5622-5722-5822-5922-60盐酸表柔比星注射液Epirubicin hydrochloride injection/ELLENCEDabigatran etexilate mesylate capsules22-61/PRADAXA 达比加群酯胶囊22-6322-6422-6522-66盐酸表柔比星注射液Epirubicin Hydrochloride Injection/FARMORUBICI NE 苯甲酸阿格列汀片ALOGLIPTIN BENZOATETABLET/NESINA 苯甲酸阿格列汀片ALOGLIPTIN BENZOATETABLET/NESINA 苯甲酸阿格列汀片ALOGLIPTIN BENZOATE ORALTABLET/NESINA 盐酸表柔比星注射液Epirubicin hydrochloride injection/ELLENCE 盐酸表柔比星注射液Epirubicin Hydrochloride Injection/FARMORUBICI NE盐酸表柔比星注射液Epirubicin Hydrochloride Injection/FARMORUBICI NE 盐酸表柔比星注射液Epirubicin Hydrochloride Injection/FARMORUBICI NE 阿普唑仑缓释片Alprazolam extended- release tablets/XANAX XR?阿普唑仑缓释片Alprazolam extended- release tablets/XANAX XR?22-62 Dabigatran Etexilate Capsules /Pradaxa达比加群酯胶囊阿普唑仑缓释片Alprazolam extended- release tablets/XANAX XR?阿普唑仑缓释片Alprazolam extended- release tablets/XANAX XR?醋酸艾司利卡西平片醋酸艾司利卡西平片醋酸艾司利卡西平片醋酸艾司利卡西平片22-71泊马度胺胶囊Pomalidomide capsules/Pomalyst?22-73泊马度胺胶囊Pomalidomide capsules/Pomalyst?22-75泊马度胺胶囊Pomalidomide capsules/Pomalyst?22-77泊马度胺胶囊Pomalidomide capsules/Pomalyst?22-79泊沙康唑肠溶片泊沙康唑肠溶片22-82苯甲酸利扎曲普坦片Rizatriptan Monobenzoate Tablets/Maxalt 22-83苯甲酸利扎曲普坦口腔崩解片Disintegrating Tablets/Maxalt-MLT22-85阿哌沙班片Apixaban Tablets/Eliquis Diclofenac Sodium Dual 22-86Release Enteric-coated Capsules/Difene(戴芬)22-87利格列汀二甲双胍片22-68Eslicarbazepine acetate tablets/APTIOM 22-67Eslicarbazepine acetate tablets/APTIOM 22-74泊马度胺胶囊Pomalidomide capsules/Pomalyst?22-72泊马度胺胶囊Pomalidomide capsules/Pomalyst?22-70Eslicarbazepine acetate tablets/APTIOM 22-69Eslicarbazepine acetate tablets/APTIOM 泊沙康唑注射液Posaconazole Injection/NOXAFIL 22-80Posaconazole Enteric- coated TabletsNOXAFIL22-78泊马度胺胶囊Pomalidomide capsules/Pomalyst?22-76泊马度胺胶囊Pomalidomide capsules/Pomalyst?双氯芬酸钠双释放肠溶胶囊苯甲酸利扎曲普坦片Rizatriptan Monobenzoate Tablets/Maxalt22-84Rizatriptan Monobenzoate Oral 22-81Posaconazole Enteric- coatedTablets/NOXAFIL Linagliptin and Metformin Hydrochloride Tablets/ Trajenta Duo(欧双宁)Linagliptin and Metformin HydrochlorideTablets/ Trajenta Duo(欧双宁)22-88利格列汀二甲双胍片利格列汀二甲双胍片Linagliptin and Metformin hydrochloridetablets/Jentadueto22-89Mepivacaine Hydrochloride Injection22-91/CarbocainMepivacaine Hydrochloride Injection22-92/CarbocainMepivacaine Hydrochloride Injection22-93/CarbocainMepivacaine Hydrochloride Injection22-94/CarbocainMepivacaine Hydrochloride Injection22-95/Carbocain 22-9622-97卡谷氨酸片22-98卡谷氨酸片唑来膦酸注射液唑来膦酸注射液Zoledronic Acid Injection/22-101ゾメタ(ZOMETA)Empagliflozin Tablets 22-102恩格列净片/Jardiance （欧唐静）Empagliflozin Tablets 22-103恩格列净片/Jardiance （欧唐静）Metformin Hydrochloride andVildagliptin 22-104二甲双胍维格列汀片（II ）Tablets (II)/Eucreas （宜合地塞米松棕榈酸酯注射液Dexamethasone Palmitate Injection/多力生Carglumic Acid DispersibleTablets/Carbaglu 盐酸甲哌卡因注射液盐酸甲哌卡因注射液盐酸甲哌卡因注射液盐酸甲哌卡因注射液盐酸甲哌卡因注射液Linagliptin and Metformin HydrochlorideTablets/ Trajenta Duo(欧双宁)22-90苯丁酸氮芥片Chlorambucil Tablets/Leukeran(留可然)唑来膦酸注射液22-100Zoledronic Acid Injection/ZometaCarglumic Acid Tablet For Oral Suspension/CARBAGLU 22-99 Zoledronic Acid Injection/ZOMETA瑞）Metformin Hydrochloride andVildagliptin22-105二甲双胍维格列汀片（III ）Tablets (III)/Eucreas （宜合瑞）22-106二甲双胍维格列汀片（I ）22-10722-10822-10922-110Ioversol Injection/Optiray（安射力）Ioversol Injection/Optiray（安射力）Ioversol Injection/Optiray（安射力）Ioversol Injection/Optiray（安射力）Ioversol Injection/Optiray（安射力）Ioversol Injection/Optiray（安射力）Ioversol Injection/Optiray（安射力）Ioversol Injection/Optiray（安射力）Ioversol Injection/Optiray（安射力）Emtricitabine and tenofovir disoproxilfumarate恩曲他滨替诺福韦片tablets/Truvada(舒发泰)Metformin Hydrochloride and Vildagliptin Tablets/Galvumet 22-112碘佛醇注射液注射用多种维生素(12)Multivitamin for Injection (12)/Cernevit（施尼维他）22-111碘佛醇注射液羟乙基淀粉130/0.4 电解质注射液Hydroxyethyl Starch 130/0.4 and Electrolyte Injection/Volulyte 6 %Infusionsl?sung羟乙基淀粉 130/0.4 电解质注射液Hydroxyethyl Starch 130/0.4 and Electrolyte Injection/Volulyte 6 %Infusionsl?sung 度他雄胺软胶囊Dutasteride Soft Capsules/Avodart （安福达）22-115碘佛醇注射液22-116碘佛醇注射液22-113碘佛醇注射液22-114碘佛醇注射液22-119碘佛醇注射液22-117碘佛醇注射液22-118碘佛醇注射液22-12022-121福多司坦口服溶液22-123注射用福沙匹坦双葡甲胺富马酸丙酚替诺福韦片Polaprezinc Granules 22-125聚普瑞锌颗粒/Promac22-126钆塞酸二钠注射液Gadoxetic Acid Disodium Injection/Primovist（普美显）22-127注射用更昔洛韦Ganciclovir for Injection/Cymevene（赛美维）22-128Vortioxetine22-129氢溴酸伏硫西汀片Hydrobromide Tablets/Brintellix （心达悦）Vortioxetine22-130氢溴酸伏硫西汀片Hydrobromide Tablets/Brintellix （心达悦）22-131Gadoteric Acid Meglumine SaltInjection/DOTAREM22-132钆特酸葡胺注射液（多它灵）22-133钆特酸葡胺注射液Gadoteric Acid Meglumine Salt Injection/DOTAREM22-134恩替卡韦口服溶液Entecavir oral solution/BARACLUDE 氟维司群注射液Fulvestrant Injection/Faslodex（芙仕得）氢溴酸伏硫西汀片Vortioxetine HydrobromideTablets/TRINTELLIXFosaprepitant Dimeglumine forInjection/EMEND22-124Tenofovir alafenamide Fumarate Tablets/--22-122Fudosteine oral solution/Cleanal左乙拉西坦注射用浓溶液Levetiracetam Concentrated Solution forInjection/KEPPRA左乙拉西坦氯化钠注射液Levetiracetam in Sodium Chloride Injection22-135左乙拉西坦氯化钠注射液Levetiracetam in Sodium Chloride Injection22-136左乙拉西坦氯化钠注射液Levetiracetam in Sodium Chloride Injection22-137硫酸阿米卡星注射液硫酸阿米卡星注射液磺达肝癸钠注射液Sorafenib T osylate tablet/NEXAVAR 22-141多吉美Carbetocin injection/Duratocin 22-142（巧特欣）22-14322-14422-14522-146伏林司他胶囊Vorinostat capsule/ZOLINZA枸橼酸芬太尼Fentanyl buccal tablets口腔黏膜贴片//FENTORA枸橼酸芬太尼口腔贴片枸橼酸芬太尼22-148口腔黏膜贴片/ 枸橼酸芬太尼口腔贴片Fentanyl buccal tablets/FENTORA 枸橼酸芬太尼22-149口腔黏膜贴片/ 枸橼酸芬太尼口腔贴片Fentanyl buccal tablets/FENTORA22-139Amikacin Sulfate injection/Nichiiko 22-138Amikacin Sulfate injection/Nichiiko注射用甲泼尼龙琥珀酸钠Methylprednisolone Sodium Succinate for injection/Solu-Medrol注射用甲泼尼龙琥珀酸钠Methylprednisolone Sodium Succinate for injection/Solu-Medrol甲苯磺酸索拉非尼片卡贝缩宫素注射液注射用甲泼尼龙琥珀酸钠Methylprednisolone Sodium Succinate for injection/Solu-Medrol22-140Fondaparinux sodium injection/ARIXTRA22-147枸橼酸芬太尼22-150口腔黏膜贴片/ 枸橼酸芬太尼口腔贴片Fentanyl buccal tablets/FENTORA枸橼酸芬太尼22-151口腔黏膜贴片/ 枸橼酸芬太尼口腔贴片Fentanyl buccal tablets/FENTORA枸橼酸芬太尼22-152口腔黏膜贴片/ 枸橼酸芬太尼口腔贴Fentanyl buccal tablets/EFFENTORA 枸橼酸芬太尼22-153口腔黏膜贴片/ 枸橼酸芬太尼口腔贴Fentanyl buccal tablets/EFFENTORA 枸橼酸芬太尼22-154口腔黏膜贴片/ 枸橼酸芬太尼口腔贴Fentanyl buccal tablets/EFFENTORA 枸橼酸芬太尼22-155口腔黏膜贴片/ 枸橼酸芬太尼口腔贴Fentanyl buccal tablets/EFFENTORA 枸橼酸芬太尼22-156口腔黏膜贴片/ 枸橼酸芬太尼口腔贴Fentanyl buccal tablets/EFFENTORA 22-157米力农注射液Milrinone Injection/Corotrope22-158米力农葡萄糖注射液Milrinone and Glucose Injection 22-15922-16022-16122-16222-163注射用达托霉素Fluconazole and Sodium Chloride盐酸美金刚缓释胶囊Memantine Hydrochloride Sustained-release Capsules/Namenda XR 盐酸美金刚缓释胶囊Memantine Hydrochloride Sustained-release Capsules/Namenda XR 注射用达托霉素Daptomycin for Injection/CUBICIN （克必信）22-164Daptomycin for Injection/CUBICIN 盐酸美金刚缓释胶囊Memantine Hydrochloride Sustained-release Capsules/Namenda XR 盐酸美金刚缓释胶囊Memantine Hydrochloride Sustained-release Capsules/Namenda XR22-165氟康唑氯化钠注射液Injection/Diflucan （大扶康）Fluconazole and Sodium Chloride22-166氟康唑氯化钠注射液Injection/Diflucan （大扶康）Moxifloxacin Hydrochloride Eye盐酸莫西沙星滴眼液Drops/Vigamox （维莫22-167思）盐酸莫西沙星滴眼液22-169那屈肝素钙注射液22-170那屈肝素钙注射液22-171那屈肝素钙注射液22-172那屈肝素钙注射液22-173那屈肝素钙注射液22-174利奈唑胺葡萄糖注射液22-176利奈唑胺葡萄糖注射液Linezolid and Glucose Injection /Zyvox（斯沃）22-177哌柏西利胶囊22-178哌柏西利胶囊Palbociclib Capsules/IBRANCE 22-168Moxifloxacin Hydrochloride Eye DropsNadroparin Calcium Injection/Fraxiparine（速碧林）Nadroparin Calcium Injection/Fraxiparine（速碧林）注射用替考拉宁Teicoplanin for Injection/Targocid （他格适）Nadroparin Calcium Injection/Fraxiparine（速碧林）Nadroparin Calcium Injection/Fraxiparine（速碧林）Nadroparin Calcium Injection/Fraxiparine（速碧林）Palbociclib Capsules/IBRANCE （爱博新）Palbociclib Capsules/IBRANCE （爱博新）22-175Linezolid and Glucose Injection /Zyvox22-179哌柏西利胶囊22-180哌柏西利胶囊Palbociclib Capsules/IBRANCE 22-181哌柏西利胶囊22-182哌柏西利胶囊Palbociclib Capsules/IBRANCE22-183注射用米卡芬净钠Fluticasone Propionate InhaledAerosol/Flixotide 22-185（辅舒酮）Fluticasone Propionate Inhaled Aerosol/Flixotide 22-186（辅舒酮）22-187丙酸氟替卡松吸入气雾剂Flixotide 250 micrograms Evohaler Fluticasone Propionate Nasal Spray/Flixonase 22-188（辅舒良）22-189Indacaterol Maleate Powder for22-190马来酸茚达特罗吸入粉雾剂Inhalation/Onbrez （昂润）22-191拉考沙胺片22-192拉考沙胺片22-193拉考沙胺片22-194拉考沙胺片22-19522-19622-19722-19822-184Micafungin Sodium for Injection/MycaminePalbociclib Capsules/IBRANCE （爱博新）Palbociclib Capsules/IBRANCE （爱博新）丙酸氟替卡松鼻喷雾剂糠酸氟替卡松鼻用喷雾剂Fluticasone Furoate Nasal Spray/Avamys （文适）丙酸氟替卡松吸入气雾剂丙酸氟替卡松吸入气雾剂注射用米卡芬净钠Micafungin Sodium forInjection/Mycamine （米开民）盐酸可乐定缓释片Clonidine hydrochloride extended-release tablets/KAPVAY 艾塞那肽注射液Exenatide Injection/BYETTA （百泌达）Lacosamide Tablets/VIMPAT （维派特）地氯雷他定口服溶液Desloratadine oral solution/Aerius/Azomyr Neoclarityn Lacosamide Tablets/VIMPAT （维派特）Lacosamide Tablets/VIMPAT （维派特）Lacosamide Tablets/VIMPAT （维派特）艾塞那肽注射液Exenatide Injection/BYETTA （百泌达）22-19922-200醋酸奥曲肽注射液22-20222-20322-20422-20522-20622-20722-20822-20922-21022-21122-212Degarelix Acetate for Injection /FIRMAGON 22-213注射用醋酸地加瑞克（费蒙格）Degarelix Acetate for Injection /FIRMAGON 22-214注射用醋酸地加瑞克（费蒙格）肠内营养乳剂Enteral Nutritional22-215（TPF-D ）Emulsion(TPF-D)/ Fresubin Diabetes(瑞代)醋酸奥曲肽注射液Octreotide Acetate Injection/ Sandostatin （善宁）22-201Octreotide Acetate Injection/SANDOSTATIN利拉鲁肽注射液Liraglutide Injection/Victoza （诺和力）盐酸羟吗啡酮片oxymorphone hydrochloridetablets/OPANA 盐酸羟吗啡酮缓释片oxymorphone hydrochloride extended-release tablets 醋酸奥曲肽注射液Octreotide Acetate Injection/SANDOSTATIN 盐酸羟吗啡酮片Oxymorphone hydrochloridetablets/OPANA 醋酸奥曲肽注射液Octreotide Acetate Injection/SANDOSTATIN 醋酸奥曲肽注射液Octreotide Acetate Injection/SANDOSTATIN 盐酸氢吗啡酮缓释片Hydromorphone hydrochloride Prolonged-release tablets /JURNISTA盐酸氢吗啡酮缓释片Hydromorphone hydrochloride extended-release tablets /JURNISTA 盐酸氢吗啡酮缓释片Hydromorphone hydrochloride Prolonged-release tablets /JURNISTA 盐酸氢吗啡酮缓释片Hydromorphone hydrochloride Prolonged-release tablets /JURNISTA 盐酸氢吗啡酮缓释片Hydromorphone hydrochloride Prolonged-release tablets /JURNISTA肠内营养乳剂Enteral Nutritional22-216（TPF-D ）Emulsion(TPF-D)/ Fresubin Diabetes(瑞代)肠内营养乳剂Enteral Nutritional Emulsion(TPF-D)/22-217（TPF-D ）Fresubin Diabetes(瑞代)22-218Melphalan Hydrochloride forInjection/EVOMELA22-219（迈维宁）注射用左亚叶酸钙注射用左亚叶酸钙注射用左亚叶酸钙注射用左亚叶酸钙左亚叶酸钙注射液左亚叶酸钙注射液左亚叶酸钙注射液注射用左亚叶酸注射用左亚叶酸左亚叶酸注射Levofolinic acid Injection液/Levofolic 左亚叶酸注射液左亚叶酸注射液22-233米诺膦酸片22-235米诺膦酸片Mirabegron Sustained- releaseTablets/BETMIGA 22-236（贝坦利）Mirabegron Sustained- releaseTablets/BETMIGA22-221Levoleucovorin Calcium forInjection/Fusilev 注射用盐酸美法仑22-220Levofolinate Calcium for Injection/ISOVORIN 门冬氨酸鸟氨酸注射液Ornithine Aspartate Injection/Hepa-Merz（雅博司）22-225Calcium Levofolinate Injection/ISOVORIN 22-224Calcium Levofolinate Injection/ISOVORIN 22-223Levoleucovorin Calcium forInjection/Fusilev 22-222Levofolinate Calcium for Injection/ISOVORIN 22-228Levoleucovorin for Injection/Khapzory22-226Calcium Levofolinate Injection/ISOVORIN 22-227Levoleucovorin for Injection/Khapzory 22-231Levofolinic acid Injection/Levofolic 22-22922-230Levofolinic acid Injection/Levofolic Minodronic acid Tablets/Bonoteo 米拉贝隆缓释片米拉贝隆缓释片Minodronic acid Tablets/Bonoteo 22-234米诺膦酸片Minodronic acid Tablets/Recalbon 22-232米诺膦酸片Minodronic acid Tablets/Recalbon22-237（贝坦利）Paliperidone Extended- ReleaseTablets/INVEGA22-238（芮达）Paliperidone Extended- ReleaseTablets/INVEGA22-239（芮达）Paliperidone Extended- ReleaseTablets/INVEGA22-240（芮达）22-241卡泊三醇软膏22-242卡泊三醇软膏MycophenolateSodium22-243Enteric-coated tablets/Myfortic （米芙）22-244Leuprorelin Acetate Microspheres forInjection/22-245Enantone （抑那通）Leuprorelin Acetate Microspheres for Injection 22-246/ Enantone （抑那通）22-247注射用醋酸亮丙瑞林微球Injection/LUPRON DEPOT/LUPRONDEPOT-PED22-249注射用醋酸亮丙瑞林微球22-250注射用醋酸亮丙瑞林微球注射用醋酸亮丙瑞林微球22-25122-252注射用醋酸亮丙瑞林微球注射用吗替麦考酚酯22-254注射用吗替麦考酚酯Mycophenolate Mofetil for Injection/CELLCEPT米拉贝隆缓释片麦考酚钠肠溶片麦考酚钠肠溶片Mycophenolate Sodium Enteric-coatedtablets/Myfortic 帕利哌酮缓释片Calcipotriol Ointment/Daivonex （达力士）Calcipotriol Ointment/Daivonex （达力士）帕利哌酮缓释片帕利哌酮缓释片22-253Mycophenolate Mofetil for Injection/CELLCEPT 注射用醋酸亮丙瑞林微球Leuprorelin Acetate Microspheres for Injection 22-248Leuprorelin Acetate Microspheres for 注射用醋酸亮丙瑞林微球注射用醋酸亮丙瑞林微球Leuprorelin Acetate Microspheres for Injection/LUPRON DEPOT-PED Leuprorelin Acetate Microspheres forInjection/LUPRON DEPOT Leuprorelin Acetate Microspheres for Injection/LUPRON DEPOT/LUPRONDEPOT-PED Leuprorelin Acetate Microspheres forInjection/LUPRON DEPOT舒更葡糖钠注射液Sugammadex Sodium Injection/BRIDION（布瑞亭）22-255舒更葡糖钠注射液Sugammadex Sodium Injection/BRIDION（布瑞亭）22-256Lanthanum Carbonate ChewableTablets/Fosrenol 22-257碳酸镧咀嚼片（福斯利诺）22-258碳酸镧咀嚼片Lanthanum Carbonate ChewableTablets/Fosrenol 22-259碳酸镧咀嚼片（福斯利诺）Lanthanum Carbonate ChewableTablets/Fosrenol 22-260碳酸镧咀嚼片（福斯利诺）Telmisartan and Amlodipine Tablets/Twynsta （双加）替米沙坦氨氯地平片22-26122-26222-263替米沙坦氨氯地平片22-26422-265替米沙坦氨氯地平片替米沙坦氨氯地平片Telmisartan and AmlodipineTablets/Twynsta Lanthanum Carbonate ChewableTablets/Fosrenol/Foznol Telmisartan and AmlodipineTablets/TWYNSTATelmisartan and AmlodipineTablets/TWYNSTA 替米沙坦氨氯地平片Telmisartan and AmlodipineTablets/Twynsta22-26622-26722-268他卡西醇软膏22-269他卡西醇软膏氯化锶[89Sr]注射液22-271吸入用色甘酸钠溶液22-273Bupropion hydrochloride sustained-release tablets22-274盐酸安非他酮缓释片/WELLBUTRIN SR/ZYBAN 22-275盐酸安非他酮缓释片22-27622-277盐酸安非他酮缓释片22-278曲前列尼尔注射液22-280曲前列尼尔注射液Treprostinil Injection/REMODULIN 曲前列尼尔注射液22-282替米沙坦氨氯地平片Telmisartan and AmlodipineTablets/TWYNSTATacalcitol Ointment/Bonalfa （萌尔夫）替米沙坦氨氯地平片Telmisartan and AmlodipineTablets/Twynsta 吸入用色甘酸钠溶液Sodium Cromoglicate Inhalation Solution/LOMUDAL 22-272Sodium Cromoglicate InhalationSolution/IntalTacalcitol Ointment/Bonalfa 22-270Strontium [89Sr] Chloride Injection/Metastron22-279Treprostinil Injection/REMODULIN盐酸安非他酮缓释片Bupropion hydrochloride sustained-release tablets/WELLBUTRIN SR Bupropion hydrochloride extended-releasetablets/WELLBUTRIN XL 盐酸安非他酮缓释片Bupropion hydrochloride extended-releasetablets/FORFIVO XL 盐酸安非他酮缓释片Bupropion hydrochloride sustained-release tablets/WELLBUTRIN SR Bupropion hydrochloride extended-releasetablets/WELLBUTRIN XL 曲前列尼尔注射液Treprostinil Injection/REMODULIN22-281Treprostinil Injection/TREPROST22-283曲前列尼尔注射液Treprostinil Injection/REMODULIN 曲前列尼尔注射液曲前列尼尔注射液22-286曲前列尼尔注射液Treprostinil Injection/REMODULIN 曲前列尼尔注射液曲前列尼尔注射液22-289曲前列尼尔注射液Treprostinil Injection/REMODULIN 曲前列尼尔注射液22-29122-292注射用盐酸瑞芬太尼22-294注射用盐酸瑞芬太尼Remifentanil Hydrochloride forInjection/Ultiva22-29522-29622-29722-285Treprostinil Injection/REMODULIN22-284Treprostinil Injection/TREPROST 22-290 Treprostinil Injection/TREPROST 22-288 Treprostinil Injection/REMODULIN22-287Treprostinil Injection/TREPROST 22-293 Remifentanil Hydrochloride forInjection/Ultiva乳果糖口服溶液Lactulose Oral Solution/Duphalac （杜密克）注射用盐酸瑞芬太尼Remifentanil Hydrochloride forInjection/Ultiva 注射用盐酸瑞芬太尼Remifentanil Hydrochloride forInjection/Ultiva注射用盐酸瑞芬太尼Remifentanil Hydrochloride forInjection/Ultiva注射用盐酸瑞芬太尼Remifentanil Hydrochloride forInjection/Ultiva注射用盐酸瑞芬太尼Remifentanil Hydrochloride forInjection/Ultiva22-29822-299Sacubitril Valsartan SodiumTablets/Entresto沙库巴曲缬沙坦钠片（诺欣妥）22-300Sacubitril Valsartan SodiumTablets/Entresto沙库巴曲缬沙坦钠片（诺欣妥）22-301Sacubitril Valsartan SodiumTablets/Entresto沙库巴曲缬沙坦钠片（诺欣妥）22-30222-303沙利度胺胶囊Thalidomide Capsules/ THALED 22-304沙利度胺胶囊Thalidomide Capsules/ THALED 22-305沙利度胺胶囊22-306沙利度胺胶囊Thalidomide Capsules/THALOMID 22-307沙利度胺胶囊Thalidomide Capsules/ THALED 22-308沙利度胺胶囊Thalidomide Capsules/THALOMID 22-309沙利度胺胶囊Thalidomide Capsules/THALOMID 22-310沙利度胺胶囊Thalidomide Capsules/THALOMID22-311吡非尼酮片22-312Thalidomide Capsules/ThalidomideCelgene Pirfenidone Tablets/Pirespa 注射用甲磺酸萘莫司他Nafamostat Mesilate For Injection/FUTHAN 注射用盐酸瑞芬太尼Remifentanil Hydrochloride forInjection/Ultiva注射用甲磺酸萘莫司他Nafamostat Mesilate For Injection/ FUTHAN。
仿制药参比制剂目录(CFDA)
1-44
米索前列醇片
Misoprostol Tablets/Cytotec
0.2mg
片剂
Pharmacia Limited
原研进口
1-45
马来酸依那普利片
Enalapril Maleate Tablets/Renitec
5mg
片剂
Merck Sharp & Dohme（Australia）Pty. Ltd.
10mg
片剂
Merck Sharp & Dohme (Australia) Pty. Ltd.
原研进口
1-7
辛伐他汀片
Simvastatin Tablets/Zocor
20mg
片剂
Merck Sharp & Dohme B.V.
原研进口
1-8
盐酸氨溴索片
Ambroxol Hydrochloride Tablets/Mucosolvan
50mg
片剂
Bayer Vital GmbH
原研进口
1-3
尼莫地平片
Nimodipine Tablets/Nimotop
30mg
片剂
Bayer Vital GmbH
原研进口
1-4
头孢呋辛酯片
Cefuroxime Axetil Tablets/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
Cefuroxime Axetil Tablets/Zinacef
按头孢呋辛(C16H16N4O8S)计0.25g
片剂
CFDA发布的仿制药参比制剂目录汇总
Amoxicillin for Suspension/Clamoxyl Amoxicillin Capsules/Amoxil Amoxicillin Capsules/Amoxil Amoxicillin Chewable Tablets/Amoxicillin Amoxicillin Chewable Tablets/Amoxicillin Amoxicillin Chewable Tablets/Amoxicillin Amoxicillin Chewable Tablets/Amoxicillin Amoxicillin and Clavulanate Potassium for Suspension/Augmentin Amoxicillin and Clavulanate Potassium for Suspension/Augmentin
1-19 1-20 1-21 3-16
8-8 8-219 8-9 7-1 4-33 3-27 3-26 4-31 4-32 7-97 6-35 3-13 3-13 4-20 4-20 4-19 4-19 3-14 3-15 10-1 10-271 3-18 3-19 4-26
8-10 8-11 8-12 8-13 8-14
8-17
Aminobutyric Acid Tablets/GAMMALON Amlodipine Besylate and Atorvastatin Calcium Tablets/-Amlodipine Besylate and Atorvastatin Calcium Tablets/-Amlodipine Besylate and Atorvastatin Calcium Tablets/-Olanzapine Orally Disintegrating Tablets/ Zyprexa Olanzapine Orally Disintegrating Tablets/ Zyprexa Olanzapine Orally Disintegrating Tablets/ Zyprexa Olanzapine Orally Disintegrating Tablets/ Zyprexa Olanzapine Tablets/ Zyprexa Olanzapine Tablets/ Zyprexa Olanzapine Tablets/ Zyprexa Oxcarbazepine Tablets/Trileptal Oxcarbazepine Tablets/Trileptal Oxcarbazepine Tablets/Trileptal Orlistat Capsules/Alli Orlistat Capsules/Xenical
国家药监局关于发布仿制药参比制剂目录（第三十九批）的通告-国家药品监督管理局通告2021年第20号
国家药监局关于发布仿制药参比制剂目录（第三十九批）的通告正文：----------------------------------------------------------------------------------------------------------------------------------------------------国家药品监督管理局通告2021年第20号国家药监局关于发布仿制药参比制剂目录（第三十九批）的通告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（第三十九批）。
特此通告。
附件：仿制药参比制剂目录（第三十九批）国家药监局2021年3月1日附件仿制药参比制剂目录（第三十九批）序号药品通用名称英文名称/商品名规格备注1备注239-1匹维溴铵片Pinaverium Bromide Tablets/ Dicetel50mgAbbott 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 Cream/Loceryl（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 Injection/Exacin（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 Injection/Exacin（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39-5盐酸美金刚多奈哌齐缓释胶囊Memantine Hydrochloride Extended-release and Donepezil Hydrochloride Capsules/Namzaric 7mg/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 Capsules/Namzaric 14mg/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 Capsules/Namzaric 21mg/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 Capsules/Namzaric 28mg/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 Injection/NeoProfen20mg/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 Injection/Belrapzo100mg/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 Capsules/Rydapt25mgNovartis 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 Tablets/Solodyn 55mgMedicis 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 Tablets/Solodyn65mgMedicis 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 Tablets/Solodyn 80mgMedicis 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 Tablets/Solodyn 105mgMedicis 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 Tablets/Solodyn 115mgMedicis 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 Solution2.5%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 Tablet/Alli27mgGlaxoSmithKline （Ireland）Limited未进口原研药品欧盟上市39-20依达拉奉注射液Edaravone Injection100ml: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 Tablets/Doptelet（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 Tablets/Lanoxin0.125mgConcordia 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%/ Pataday 0.2%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 Tablets/ Seroquel25mgAstraZeneca 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 Tablets/ Seroquel300mgAstraZeneca 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 Inhalation/Advair Diskus 100mcg/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 Inhalation/Advair Diskus 250mcg/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 Inhalation/Advair Diskus 500mcg/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 Inhalation/Seretide Diskus 50mcg/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 Inhalation/Seretide Diskus 50mcg/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 Inhalation/Seretide Diskus 50mcg/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 injection/ Durolane3 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 Tablets/Aubagio14mgSanofi-Aventis Groupe未进口原研药品欧盟上市39-35盐酸美金刚片Memantine Hydrochloride Tablets/Ebixa5mgH. Lundbeck A/S未进口原研药品欧盟上市39-36盐酸美金刚片Memantine Hydrochloride Tablets/Ebixa15mgH. 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%) Injection/NuTRIflex 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%） Injection/Kabiven2053mlFresenius 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 Tablets200μgMerck 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 Tablets25mg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 Tablets50mg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 Tablets100mg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 Tablets / Zyloric 50mg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 Tablets / Zyloric 100mg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 Tablets/Fycompa2mgEisai Inc/Eisai Europe Limited未进口原研药品英国上市39-47吡仑帕奈片Perampanel Tablets/Fycompa4mgEisai Inc/Eisai Europe Limited未进口原研药品英国上市39-48吡仑帕奈片Perampanel Tablets/Fycompa8mgEisai Inc/Eisai Europe Limited未进口原研药品英国上市39-49吡仑帕奈片Perampanel Tablets/Fycompa12mgEisai 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 Tablets/Lamictal2mgThe Wellcome Foundation Ltd.未进口原研药品英国上市7-25对乙酰氨基酚片Paracetamol Tablets/Panadol 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 Tablets/Bisolvon8mgBoehringer 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 GmbH23-219脂肪乳氨基酸（17）葡萄糖（19％）注射液Fat Emulsion,Amino Acids（17） And Glucose（19%） Injection/Kabiven1026mlFresenius Kabi AB国内上市的国际公认药品持证商更新为Fresenius Kabi AB23-220脂肪乳氨基酸（17）葡萄糖（19％）注射液Fat Emulsion,Amino Acids（17） And Glucose（19%） Injection/Kabiven2053mlFresenius Kabi AB国内上市的国际公认药品持证商更新为Fresenius Kabi AB27-104米力农注射液Milrinone Injection /Primacor 1mg/ml Solution for Injection10mg/10mlAventis Pharma Limited/Sanofi-Aventis/Sanofi未进口原研药品规格更新为10mg/10ml备注1.未在国内上市品种，需参照原食品药品监管总局2015年第230号公告等的相关要求开展研究，通用名、剂型等经药典委核准后为准。
汇总24批参比制剂
序号药品通用名称英文名称/商品名1月22日2月22日3月22日4月22日5月22日6月22日盐酸阿芬太尼注射液8月22日Azilsartan Tablets9月22日阿齐沙坦片/AZILVA Azilsartan Tablets10月22日阿齐沙坦片/AZILVA11月22日12月22日22-1322-1422-15丙氨酰谷氨酰 胺注射液Alanyl Glutamine Injection/Dipeptiven（力 太）丙氨酰谷氨酰 胺注射液Alanyl Glutamine Injection/Dipeptiven（力 太）盐酸阿芬太尼 注射液Alfentanil Hydrochloride Injection/Rapifen Intensive Care盐酸阿芬太尼 注射液Alfentanil Hydrochloride Injection/ALFENTA 7月22日Alfentanil Hydrochloride Injection/RAPIFEN 盐酸阿芬太尼 注射液Alfentanil Hydrochloride Injection/ALFENTA 盐酸阿芬太尼 注射液Alfentanil Hydrochloride Injection/RAPIFEN 盐酸阿芬太尼 注射液Alfentanil Hydrochloride Injection/ALFENTA 奥氮平盐酸氟 西汀胶囊Olanzapine and Fluoxetine HydrochlorideCapsules/SYMBYAX 奥氮平盐酸氟 西汀胶囊Olanzapine and Fluoxetine HydrochlorideCapsules/SYMBYAX 奥氮平盐酸氟 西汀胶囊Olanzapine and Fluoxetine HydrochlorideCapsules/SYMBYAX氨氯地平阿托 伐他汀钙片Amlodipine Besylate and AtorvastatinCalcium Tablets /CADUET 奥氮平盐酸氟 西汀胶囊Olanzapine and Fluoxetine HydrochlorideCapsules/SYMBYAX 奥氮平盐酸氟 西汀胶囊Olanzapine and Fluoxetine HydrochlorideCapsules/SYMBYAX22-1622-17白消安注射液Compound Amino Acids22-18(15) and Dipeptides (2) Injection/GlaminCompound Amino Acids 22-19(15) and Dipeptides (2)Injection/Glamin(谷安光)Compound Amino Acids 22-20(15) and Dipeptides (2)Injection/Glamin(谷安光)Fat Emulsion,Amino Acids(17) andGlucose(11%)脂肪乳氨基酸 (17)葡萄糖 (11%)注射液Injection/Kabiven PI(卡22-21文)Fat Emulsion,Amino Acids(17) and 脂肪乳氨基酸 (17)葡萄糖 (11%)注射液Glucose(11%) Injection/Kabiven PI(卡文)22-22Fat Emulsion,Amino Acids(17) andGlucose(11%)脂肪乳氨基酸 (17)葡萄糖 (11%)注射液Injection/Kabiven PI(卡22-23文)Compound Amino Acid Injection/Aminoplasmal 22-24Hepa-10%(安平)22-2522-26酮咯酸氨丁三醇注射液酮咯酸氨丁三醇注射液酮咯酸氨丁三醇注射液22-3022-31苯丁酸钠片Sodium Phenylbutyrate Tablets/BUPHENYL 22-32Busulfan Injection/BUSULFEX(白 舒非)复方氨基酸(15) 双肽(2)注射液奥氮平盐酸氟 西汀胶囊Olanzapine and Fluoxetine HydrochlorideCapsules/SYMBYAX 醋酸艾替班特 注射液Icatibant Acetate Solution for Injection inPre-filled Syringe/Firazyr 复方氨基酸注 射液(20AA)复方氨基酸注 射液(20AA)Compound Amino AcidInjection/Aminoplasmal Hepa-10%复方氨基酸(15) 双肽(2)注射液复方氨基酸(15) 双肽(2)注射液22-29Ketorolac Tromethamine Injection苯丁酸钠散/颗 粒Sodium Phenylbutyrate Powder/BUPHENYL 22-27Ketorolac Tromethamine Injection 22-28Ketorolac Tromethamine Injection 阿立哌唑口崩 片Aripiprazole OrodispersibleTablets/ABILIFY 阿立哌唑口崩 片Aripiprazole Orodispersible Tablets/ABILIFY22-3322-3422-3522-3622-37阿立哌唑长效 肌肉注射剂22-38阿立哌唑长效 肌肉注射剂盐酸阿那格雷胶囊22-40盐酸阿那格雷 胶囊Anagrelide Hydrochloride Capsules 22-41奥美沙坦酯氢 氯噻嗪片22-42奥美沙坦酯氢 氯噻嗪片22-43丙戊酸钠口服溶液22-4522-46丙戊酸钠注射 液丙戊酸钠注射液22-48盐酸氨溴索口 腔喷雾溶液Ambroxol Hydrochloride Oral Spray阿立哌唑口服 溶液Aripiprazole Oral Solution/ABILIFY 阿立哌唑口服 溶液Aripiprazole Oral Solution/ABILIFY 阿立哌唑口崩 片Aripiprazole OrodispersibleTablets/ABILIFY HYDROCHLOROTHIAZ IDE;OLMESARTANMEDOXOMIL/BENICAR HCT HYDROCHLOROTHIAZ IDE;OLMESARTANMEDOXOMIL/BENICAR HCT 丙戊酸钠口服 溶液Sodium Valproate Liquid/Epilim （德巴金）Aripiprazole Powder and Solvent for Prolonged- release Suspension for Injection/Abilify Maintena 22-39Anagrelide Hydrochloride Capsules/AGRYLIN阿立哌唑口服 溶液Aripiprazole Oral Solution/ABILIFY Aripiprazole Powder and Solvent for Prolonged- release Suspension for Injection/Abilify Maintenainjection/Orfiril丙戊酸钠注射 液Sodium Valproate for intravenousinjection/Depacon Sodium Valproate for intravenousinjection/Orfiril 22-47Sodium Valproate for intravenous22-44Sodium Valproate Liquid/DEPAKINE 硫酸阿托品滴 眼液Atropine Sulfate Ophthalmic Solution,USP 1%22-49/AMBROSPRAY 5%22-5022-51ALOGLIPTIN BENZOATE 22-52苯甲酸阿格列 汀片TABLETs/NESINA （尼欣那）22-53ALOGLIPTIN BENZOATE TABLETs/NESINA （尼22-54苯甲酸阿格列 汀片欣那）22-5522-5622-5722-5822-5922-60盐酸表柔比星 注射液Epirubicin hydrochloride injection/ELLENCEDabigatran etexilate mesylate capsules22-61/PRADAXA 达比加群酯胶囊22-6322-6422-6522-66盐酸表柔比星 注射液Epirubicin Hydrochloride Injection/FARMORUBICI NE 苯甲酸阿格列 汀片ALOGLIPTIN BENZOATETABLET/NESINA 苯甲酸阿格列 汀片ALOGLIPTIN BENZOATETABLET/NESINA 苯甲酸阿格列 汀片ALOGLIPTIN BENZOATE ORALTABLET/NESINA 盐酸表柔比星 注射液Epirubicin hydrochloride injection/ELLENCE 盐酸表柔比星 注射液Epirubicin Hydrochloride Injection/FARMORUBICI NE盐酸表柔比星 注射液Epirubicin Hydrochloride Injection/FARMORUBICI NE 盐酸表柔比星 注射液Epirubicin Hydrochloride Injection/FARMORUBICI NE 阿普唑仑缓释 片Alprazolam extended- release tablets/XANAX XR™阿普唑仑缓释 片Alprazolam extended- release tablets/XANAX XR™22-62Dabigatran Etexilate Capsules /Pradaxa达比加群酯胶 囊阿普唑仑缓释 片Alprazolam extended- release tablets/XANAX XR™阿普唑仑缓释 片Alprazolam extended- release tablets/XANAX XR™醋酸艾司利卡西平片醋酸艾司利卡西平片醋酸艾司利卡西平片醋酸艾司利卡西平片22-71泊马度胺胶囊Pomalidomide capsules/Pomalyst®22-73泊马度胺胶囊Pomalidomide capsules/Pomalyst®22-75泊马度胺胶囊Pomalidomide capsules/Pomalyst®22-77泊马度胺胶囊Pomalidomide capsules/Pomalyst®22-79泊沙康唑肠溶片泊沙康唑肠溶片22-82苯甲酸利扎曲 普坦片Rizatriptan Monobenzoate Tablets/Maxalt 22-83苯甲酸利扎曲普坦口腔崩解片Disintegrating Tablets/Maxalt-MLT22-85阿哌沙班片Apixaban Tablets/Eliquis Diclofenac Sodium Dual 22-86Release Enteric-coated Capsules/Difene(戴芬)22-87利格列汀二甲 双胍片22-68Eslicarbazepine acetate tablets/APTIOM 22-67Eslicarbazepine acetate tablets/APTIOM 22-74泊马度胺胶囊Pomalidomide capsules/Pomalyst®22-72泊马度胺胶囊Pomalidomide capsules/Pomalyst®22-70Eslicarbazepine acetate tablets/APTIOM 22-69Eslicarbazepine acetate tablets/APTIOM 泊沙康唑注射 液Posaconazole Injection/NOXAFIL 22-80Posaconazole Enteric- coated TabletsNOXAFIL22-78泊马度胺胶囊Pomalidomide capsules/Pomalyst®22-76泊马度胺胶囊Pomalidomide capsules/Pomalyst®双氯芬酸钠双 释放肠溶胶囊苯甲酸利扎曲 普坦片Rizatriptan Monobenzoate Tablets/Maxalt22-84Rizatriptan Monobenzoate Oral 22-81Posaconazole Enteric- coatedTablets/NOXAFIL Linagliptin and Metformin HydrochlorideTablets/ Trajenta Duo(欧双宁)Linagliptin and Metformin HydrochlorideTablets/ Trajenta Duo(欧双宁)22-88利格列汀二甲 双胍片利格列汀二甲 双胍片Linagliptin and Metformin hydrochloridetablets/Jentadueto22-89Mepivacaine Hydrochloride Injection22-91/CarbocainMepivacaine Hydrochloride Injection22-92/CarbocainMepivacaine Hydrochloride Injection22-93/CarbocainMepivacaine Hydrochloride Injection22-94/CarbocainMepivacaine Hydrochloride Injection22-95/Carbocain 22-9622-97卡谷氨酸片22-98卡谷氨酸片唑来膦酸注射液唑来膦酸注射液Zoledronic Acid Injection/22-101ゾメタ(ZOMETA)Empagliflozin Tablets 22-102恩格列净片/Jardiance （欧唐静）Empagliflozin Tablets 22-103恩格列净片/Jardiance （欧唐静）Metformin Hydrochloride andVildagliptin 22-104二甲双胍维格 列汀片（II ）Tablets (II)/Eucreas （宜合地塞米松棕榈 酸酯注射液Dexamethasone Palmitate Injection/多力生Carglumic Acid DispersibleTablets/Carbaglu 盐酸甲哌卡因 注射液盐酸甲哌卡因 注射液盐酸甲哌卡因 注射液盐酸甲哌卡因 注射液盐酸甲哌卡因 注射液Linagliptin and Metformin HydrochlorideTablets/ Trajenta Duo(欧双宁)22-90苯丁酸氮芥片Chlorambucil Tablets/Leukeran(留可然)唑来膦酸注射 液22-100Zoledronic Acid Injection/ZometaCarglumic Acid Tablet For Oral Suspension/CARBAGLU 22-99Zoledronic Acid Injection/ZOMETA瑞）Metformin Hydrochloride andVildagliptin22-105二甲双胍维格 列汀片（III ）Tablets (III)/Eucreas （宜合瑞）22-106二甲双胍维格 列汀片（I ）22-10722-10822-10922-110Ioversol Injection/Optiray（安射力）Ioversol Injection/Optiray（安射力）Ioversol Injection/Optiray（安射力）Ioversol Injection/Optiray（安射力）Ioversol Injection/Optiray（安射力）Ioversol Injection/Optiray（安射力）Ioversol Injection/Optiray（安射力）Ioversol Injection/Optiray（安射力）Ioversol Injection/Optiray（安射力）Emtricitabine and tenofovir disoproxilfumarate恩曲他滨替诺 福韦片tablets/Truvada(舒发泰)Metformin Hydrochloride and Vildagliptin Tablets/Galvumet 22-112碘佛醇注射液注射用多种维 生素(12)Multivitamin for Injection (12)/Cernevit（施尼维 他）22-111碘佛醇注射液羟乙基淀粉 130/0.4 电解质 注射液Hydroxyethyl Starch 130/0.4 and Electrolyte Injection/Volulyte 6 %Infusionslösung羟乙基淀粉 130/0.4 电解质 注射液Hydroxyethyl Starch 130/0.4 and Electrolyte Injection/Volulyte 6 %Infusionslösung 度他雄胺软胶 囊Dutasteride Soft Capsules/Avodart （安福达）22-115碘佛醇注射液22-116碘佛醇注射液22-113碘佛醇注射液22-114碘佛醇注射液22-119碘佛醇注射液22-117碘佛醇注射液22-118碘佛醇注射液22-12022-121福多司坦口服溶液22-123注射用福沙匹 坦双葡甲胺富马酸丙酚替诺福韦片Polaprezinc Granules 22-125聚普瑞锌颗粒/Promac22-126钆塞酸二钠注 射液Gadoxetic Acid Disodium Injection/Primovist（普美 显）22-127注射用更昔洛 韦Ganciclovir for Injection/Cymevene（赛美维）22-128Vortioxetine22-129氢溴酸伏硫西 汀片Hydrobromide Tablets/Brintellix（心达悦）Vortioxetine22-130氢溴酸伏硫西 汀片Hydrobromide Tablets/Brintellix（心达悦）22-131Gadoteric Acid Meglumine SaltInjection/DOTAREM22-132钆特酸葡胺注 射液（多它灵）22-133钆特酸葡胺注 射液Gadoteric Acid Meglumine Salt Injection/DOTAREM22-134恩替卡韦口服 溶液Entecavir oral solution/BARACLUDE 氟维司群注射 液Fulvestrant Injection/Faslodex（芙仕得）氢溴酸伏硫西 汀片Vortioxetine HydrobromideTablets/TRINTELLIXFosaprepitant Dimeglumine forInjection/EMEND22-124Tenofovir alafenamide Fumarate Tablets/--22-122Fudosteine oral solution/Cleanal左乙拉西坦注 射用浓溶液Levetiracetam Concentrated Solution forInjection/KEPPRA左乙拉西坦氯 化钠注射液Levetiracetam in Sodium ChlorideInjection22-135左乙拉西坦氯 化钠注射液Levetiracetam in Sodium ChlorideInjection22-136左乙拉西坦氯 化钠注射液Levetiracetam in Sodium ChlorideInjection22-137硫酸阿米卡星注射液硫酸阿米卡星注射液磺达肝癸钠注射液Sorafenib Tosylate tablet/NEXAVAR 22-141多吉美Carbetocin injection/Duratocin 22-142（巧特欣）22-14322-14422-14522-146伏林司他胶囊Vorinostat capsule/ZOLINZA枸橼酸芬太尼Fentanyl buccal tablets口腔黏膜贴片//FENTORA枸橼酸芬太尼口腔贴片枸橼酸芬太尼22-148口腔黏膜贴片/ 枸橼酸芬太尼 口腔贴片Fentanyl buccal tablets/FENTORA 枸橼酸芬太尼22-149口腔黏膜贴片/ 枸橼酸芬太尼 口腔贴片Fentanyl buccal tablets/FENTORA22-139Amikacin Sulfate injection/Nichiiko 22-138Amikacin Sulfate injection/Nichiiko注射用甲泼尼 龙琥珀酸钠Methylprednisolone Sodium Succinate for injection/Solu-Medrol注射用甲泼尼 龙琥珀酸钠Methylprednisolone Sodium Succinate for injection/Solu-Medrol甲苯磺酸索拉 非尼片卡贝缩宫素注 射液注射用甲泼尼 龙琥珀酸钠Methylprednisolone Sodium Succinate for injection/Solu-Medrol22-140Fondaparinux sodium injection/ARIXTRA22-147枸橼酸芬太尼22-150口腔黏膜贴片/ 枸橼酸芬太尼 口腔贴片Fentanyl buccal tablets/FENTORA枸橼酸芬太尼22-151口腔黏膜贴片/ 枸橼酸芬太尼 口腔贴片Fentanyl buccal tablets/FENTORA枸橼酸芬太尼22-152口腔黏膜贴片/ 枸橼酸芬太尼 口腔贴Fentanyl buccal tablets/EFFENTORA 枸橼酸芬太尼22-153口腔黏膜贴片/ 枸橼酸芬太尼 口腔贴Fentanyl buccal tablets/EFFENTORA 枸橼酸芬太尼22-154口腔黏膜贴片/ 枸橼酸芬太尼 口腔贴Fentanyl buccal tablets/EFFENTORA 枸橼酸芬太尼22-155口腔黏膜贴片/ 枸橼酸芬太尼 口腔贴Fentanyl buccal tablets/EFFENTORA 枸橼酸芬太尼22-156口腔黏膜贴片/ 枸橼酸芬太尼 口腔贴Fentanyl buccal tablets/EFFENTORA 22-157米力农注射液Milrinone Injection/Corotrope22-158米力农葡萄糖 注射液Milrinone and Glucose Injection 22-15922-16022-16122-16222-163注射用达托霉素Fluconazole and Sodium Chloride盐酸美金刚缓 释胶囊Memantine Hydrochloride Sustained-release Capsules/Namenda XR 盐酸美金刚缓 释胶囊Memantine Hydrochloride Sustained-release Capsules/Namenda XR 注射用达托霉 素Daptomycin for Injection/CUBICIN （克必信）22-164Daptomycin for Injection/CUBICIN 盐酸美金刚缓 释胶囊Memantine Hydrochloride Sustained-release Capsules/Namenda XR 盐酸美金刚缓 释胶囊Memantine Hydrochloride Sustained-release Capsules/Namenda XR22-165氟康唑氯化钠 注射液Injection/Diflucan （大扶康）Fluconazole and Sodium Chloride22-166氟康唑氯化钠 注射液Injection/Diflucan （大扶康）Moxifloxacin Hydrochloride Eye盐酸莫西沙星 滴眼液Drops/Vigamox （维莫22-167思）盐酸莫西沙星滴眼液22-169那屈肝素钙注 射液22-170那屈肝素钙注 射液22-171那屈肝素钙注 射液22-172那屈肝素钙注 射液22-173那屈肝素钙注 射液22-174利奈唑胺葡萄糖注射液22-176利奈唑胺葡萄 糖注射液Linezolid and Glucose Injection /Zyvox（斯沃）22-177哌柏西利胶囊22-178哌柏西利胶囊Palbociclib Capsules/IBRANCE 22-168Moxifloxacin Hydrochloride Eye DropsNadroparin Calcium Injection/Fraxiparine（速 碧林）Nadroparin Calcium Injection/Fraxiparine（速 碧林）注射用替考拉 宁Teicoplanin for Injection/Targocid （他格适）Nadroparin Calcium Injection/Fraxiparine（速 碧林）Nadroparin Calcium Injection/Fraxiparine（速 碧林）Nadroparin Calcium Injection/Fraxiparine（速 碧林）Palbociclib Capsules/IBRANCE （爱 博新）Palbociclib Capsules/IBRANCE （爱 博新）22-175Linezolid and Glucose Injection /Zyvox22-179哌柏西利胶囊22-180哌柏西利胶囊Palbociclib Capsules/IBRANCE 22-181哌柏西利胶囊22-182哌柏西利胶囊Palbociclib Capsules/IBRANCE22-183注射用米卡芬净钠Fluticasone Propionate InhaledAerosol/Flixotide 22-185（辅舒酮）Fluticasone Propionate Inhaled Aerosol/Flixotide 22-186（辅舒酮）22-187丙酸氟替卡松 吸入气雾剂Flixotide 250 micrograms Evohaler Fluticasone Propionate Nasal Spray/Flixonase 22-188（辅舒良）22-189Indacaterol Maleate Powder for22-190马来酸茚达特 罗吸入粉雾剂Inhalation/Onbrez （昂润）22-191拉考沙胺片22-192拉考沙胺片22-193拉考沙胺片22-194拉考沙胺片22-19522-19622-19722-19822-184Micafungin Sodium for Injection/MycaminePalbociclib Capsules/IBRANCE （爱 博新）Palbociclib Capsules/IBRANCE （爱 博新）丙酸氟替卡松 鼻喷雾剂糠酸氟替卡松 鼻用喷雾剂Fluticasone Furoate Nasal Spray/Avamys （文适）丙酸氟替卡松 吸入气雾剂丙酸氟替卡松 吸入气雾剂注射用米卡芬 净钠Micafungin Sodium forInjection/Mycamine （米 开民）盐酸可乐定缓 释片Clonidine hydrochloride extended-releasetablets/KAPVAY 艾塞那肽注射 液Exenatide Injection/BYETTA （百泌达）Lacosamide Tablets/VIMPAT （维派特）地氯雷他定口 服溶液Desloratadine oral solution/Aerius/Azomyr Neoclarityn Lacosamide Tablets/VIMPAT （维派特）Lacosamide Tablets/VIMPAT （维派特）Lacosamide Tablets/VIMPAT （维派特）艾塞那肽注射 液Exenatide Injection/BYETTA （百泌达）22-19922-200醋酸奥曲肽注射液22-20222-20322-20422-20522-20622-20722-20822-20922-21022-21122-212Degarelix Acetate for Injection/FIRMAGON 22-213注射用醋酸地 加瑞克（费蒙格）Degarelix Acetate for Injection /FIRMAGON 22-214注射用醋酸地 加瑞克（费蒙格）肠内营养乳剂Enteral Nutritional22-215（TPF-D ）Emulsion(TPF-D)/ Fresubin Diabetes(瑞代)醋酸奥曲肽注 射液Octreotide Acetate Injection/ Sandostatin（善 宁）22-201Octreotide Acetate Injection/SANDOSTATIN利拉鲁肽注射 液Liraglutide Injection/Victoza （诺和 力）盐酸羟吗啡酮 片oxymorphone hydrochloridetablets/OPANA 盐酸羟吗啡酮 缓释片oxymorphone hydrochloride extended-release tablets 醋酸奥曲肽注 射液Octreotide Acetate Injection/SANDOSTATIN 盐酸羟吗啡酮 片Oxymorphone hydrochloridetablets/OPANA 醋酸奥曲肽注 射液Octreotide Acetate Injection/SANDOSTATIN 醋酸奥曲肽注 射液Octreotide Acetate Injection/SANDOSTATIN 盐酸氢吗啡酮 缓释片Hydromorphone hydrochloride Prolonged-release tablets /JURNISTA盐酸氢吗啡酮 缓释片Hydromorphone hydrochloride extended-release tablets /JURNISTA 盐酸氢吗啡酮 缓释片Hydromorphone hydrochloride Prolonged-release tablets /JURNISTA 盐酸氢吗啡酮 缓释片Hydromorphone hydrochloride Prolonged-release tablets /JURNISTA 盐酸氢吗啡酮 缓释片Hydromorphone hydrochloride Prolonged-release tablets /JURNISTA肠内营养乳剂Enteral Nutritional22-216（TPF-D ）Emulsion(TPF-D)/ Fresubin Diabetes(瑞代)肠内营养乳剂Enteral Nutritional Emulsion(TPF-D)/22-217（TPF-D ）Fresubin Diabetes(瑞代)22-218Melphalan Hydrochloride forInjection/EVOMELA22-219（迈维宁）注射用左亚叶酸钙注射用左亚叶酸钙注射用左亚叶酸钙注射用左亚叶酸钙左亚叶酸钙注射液左亚叶酸钙注射液左亚叶酸钙注射液注射用左亚叶酸注射用左亚叶酸左亚叶酸注射Levofolinic acid Injection液/Levofolic 左亚叶酸注射液左亚叶酸注射液22-233米诺膦酸片22-235米诺膦酸片Mirabegron Sustained- releaseTablets/BETMIGA 22-236（贝坦利）Mirabegron Sustained- releaseTablets/BETMIGA22-221Levoleucovorin Calcium forInjection/Fusilev 注射用盐酸美 法仑22-220Levofolinate Calcium for Injection/ISOVORIN 门冬氨酸鸟氨 酸注射液Ornithine Aspartate Injection/Hepa-Merz（雅 博司）22-225Calcium Levofolinate Injection/ISOVORIN 22-224Calcium Levofolinate Injection/ISOVORIN 22-223Levoleucovorin Calcium forInjection/Fusilev 22-222Levofolinate Calcium for Injection/ISOVORIN 22-228Levoleucovorin for Injection/Khapzory22-226Calcium Levofolinate Injection/ISOVORIN 22-227Levoleucovorin for Injection/Khapzory 22-231Levofolinic acid Injection/Levofolic 22-22922-230Levofolinic acid Injection/Levofolic Minodronic acid Tablets/Bonoteo 米拉贝隆缓释 片米拉贝隆缓释 片Minodronic acid Tablets/Bonoteo 22-234米诺膦酸片Minodronic acid Tablets/Recalbon 22-232米诺膦酸片Minodronic acid Tablets/Recalbon22-237（贝坦利）Paliperidone Extended- ReleaseTablets/INVEGA22-238（芮达）Paliperidone Extended- ReleaseTablets/INVEGA22-239（芮达）Paliperidone Extended- ReleaseTablets/INVEGA22-240（芮达）22-241卡泊三醇软膏22-242卡泊三醇软膏Mycophenolate Sodium22-243Enteric-coated tablets/Myfortic （米芙）22-244Leuprorelin Acetate Microspheres forInjection/22-245Enantone （抑那通）Leuprorelin Acetate Microspheres for Injection 22-246/ Enantone （抑那通）22-247注射用醋酸亮丙瑞林微球Injection/LUPRON DEPOT/LUPRONDEPOT-PED22-249注射用醋酸亮 丙瑞林微球22-250注射用醋酸亮 丙瑞林微球注射用醋酸亮 丙瑞林微球22-25122-252注射用醋酸亮 丙瑞林微球注射用吗替麦考酚酯22-254注射用吗替麦 考酚酯Mycophenolate Mofetil for Injection/CELLCEPT米拉贝隆缓释 片麦考酚钠肠溶 片麦考酚钠肠溶 片Mycophenolate Sodium Enteric-coatedtablets/Myfortic 帕利哌酮缓释 片Calcipotriol Ointment/Daivonex （达 力士）Calcipotriol Ointment/Daivonex （达 力士）帕利哌酮缓释 片帕利哌酮缓释 片22-253Mycophenolate Mofetil for Injection/CELLCEPT 注射用醋酸亮 丙瑞林微球Leuprorelin Acetate Microspheres for Injection 22-248Leuprorelin Acetate Microspheres for 注射用醋酸亮 丙瑞林微球注射用醋酸亮 丙瑞林微球Leuprorelin Acetate Microspheres for Injection/LUPRON DEPOT-PED Leuprorelin Acetate Microspheres forInjection/LUPRON DEPOT Leuprorelin Acetate Microspheres for Injection/LUPRON DEPOT/LUPRONDEPOT-PED Leuprorelin Acetate Microspheres forInjection/LUPRON DEPOT舒更葡糖钠注 射液Sugammadex Sodium Injection/BRIDION（布 瑞亭）22-255舒更葡糖钠注 射液Sugammadex Sodium Injection/BRIDION（布 瑞亭）22-256Lanthanum Carbonate ChewableTablets/Fosrenol 22-257碳酸镧咀嚼片（福斯利诺）22-258碳酸镧咀嚼片Lanthanum Carbonate ChewableTablets/Fosrenol 22-259碳酸镧咀嚼片（福斯利诺）Lanthanum Carbonate ChewableTablets/Fosrenol 22-260碳酸镧咀嚼片（福斯利诺）Telmisartan and Amlodipine Tablets/Twynsta （双加）替米沙坦氨氯 地平片22-26122-26222-263替米沙坦氨氯 地平片22-26422-265替米沙坦氨氯 地平片替米沙坦氨氯 地平片Telmisartan and AmlodipineTablets/Twynsta Lanthanum Carbonate ChewableTablets/Fosrenol/Foznol Telmisartan and AmlodipineTablets/TWYNSTATelmisartan and AmlodipineTablets/TWYNSTA 替米沙坦氨氯 地平片Telmisartan and AmlodipineTablets/Twynsta22-26622-26722-268他卡西醇软膏22-269他卡西醇软膏氯化锶[89Sr]注射液22-271吸入用色甘酸钠溶液22-273Bupropion hydrochloride sustained-release tablets22-274盐酸安非他酮 缓释片/WELLBUTRIN SR/ZYBAN 22-275盐酸安非他酮 缓释片22-27622-277盐酸安非他酮 缓释片22-278曲前列尼尔注射液22-280曲前列尼尔注 射液Treprostinil Injection/REMODULIN 曲前列尼尔注射液22-282替米沙坦氨氯 地平片Telmisartan and AmlodipineTablets/TWYNSTATacalcitol Ointment/Bonalfa （萌尔 夫）替米沙坦氨氯 地平片Telmisartan and AmlodipineTablets/Twynsta 吸入用色甘酸 钠溶液Sodium Cromoglicate Inhalation Solution/LOMUDAL 22-272Sodium Cromoglicate InhalationSolution/IntalTacalcitol Ointment/Bonalfa 22-270Strontium [89Sr] Chloride Injection/Metastron22-279Treprostinil Injection/REMODULIN盐酸安非他酮 缓释片Bupropion hydrochloride sustained-release tablets/WELLBUTRIN SR Bupropion hydrochloride extended-releasetablets/WELLBUTRIN XL 盐酸安非他酮 缓释片Bupropion hydrochloride extended-releasetablets/FORFIVO XL 盐酸安非他酮 缓释片Bupropion hydrochloride sustained-release tablets/WELLBUTRIN SR Bupropion hydrochloride extended-releasetablets/WELLBUTRIN XL 曲前列尼尔注 射液Treprostinil Injection/REMODULIN22-281Treprostinil Injection/TREPROST22-283曲前列尼尔注 射液Treprostinil Injection/REMODULIN 曲前列尼尔注射液曲前列尼尔注射液22-286曲前列尼尔注 射液Treprostinil Injection/REMODULIN 曲前列尼尔注射液曲前列尼尔注射液22-289曲前列尼尔注 射液Treprostinil Injection/REMODULIN 曲前列尼尔注射液22-29122-292注射用盐酸瑞芬太尼22-294注射用盐酸瑞 芬太尼Remifentanil Hydrochloride forInjection/Ultiva22-29522-29622-29722-285Treprostinil Injection/REMODULIN22-284Treprostinil Injection/TREPROST 22-290Treprostinil Injection/TREPROST 22-288Treprostinil Injection/REMODULIN22-287Treprostinil Injection/TREPROST 22-293Remifentanil Hydrochloride forInjection/Ultiva乳果糖口服溶 液Lactulose Oral Solution/Duphalac （杜密克）注射用盐酸瑞 芬太尼Remifentanil Hydrochloride forInjection/Ultiva 注射用盐酸瑞 芬太尼Remifentanil Hydrochloride forInjection/Ultiva注射用盐酸瑞 芬太尼Remifentanil Hydrochloride forInjection/Ultiva注射用盐酸瑞 芬太尼Remifentanil Hydrochloride forInjection/Ultiva注射用盐酸瑞 芬太尼Remifentanil Hydrochloride forInjection/Ultiva22-29822-299Sacubitril Valsartan SodiumTablets/Entresto沙库巴曲缬沙 坦钠片（诺欣妥）22-300Sacubitril Valsartan SodiumTablets/Entresto沙库巴曲缬沙 坦钠片（诺欣妥）22-301Sacubitril Valsartan SodiumTablets/Entresto沙库巴曲缬沙 坦钠片（诺欣妥）22-30222-303沙利度胺胶囊Thalidomide Capsules/ THALED 22-304沙利度胺胶囊Thalidomide Capsules/ THALED 22-305沙利度胺胶囊22-306沙利度胺胶囊Thalidomide Capsules/THALOMID 22-307沙利度胺胶囊Thalidomide Capsules/ THALED 22-308沙利度胺胶囊Thalidomide Capsules/THALOMID 22-309沙利度胺胶囊Thalidomide Capsules/THALOMID 22-310沙利度胺胶囊Thalidomide Capsules/THALOMID22-311吡非尼酮片22-312Thalidomide Capsules/ThalidomideCelgene Pirfenidone Tablets/Pirespa 注射用甲磺酸 萘莫司他Nafamostat Mesilate For Injection/FUTHAN 注射用盐酸瑞 芬太尼Remifentanil Hydrochloride forInjection/Ultiva注射用甲磺酸 萘莫司他Nafamostat Mesilate For Injection/FUTHAN22-313帕立骨化醇注射液帕立骨化醇注射液22-316Paroxetine Hydrochloride Enteric-Coated22-317盐酸帕罗西汀 肠溶缓释片Sustained-Release Tablets/--Paroxetine Hydrochloride Enteric-Coated22-318盐酸帕罗西汀 肠溶缓释片Sustained-Release Tablets/--Zidovudine and Lamivudine22-319齐多拉米双夫 定片Tablets/Combivir （双汰芝）曲氟尿苷盐酸 替匹嘧啶片Trifluridine and Tipiracil HydrochlorideTablets/Lonsurf22-32022-321曲氟尿苷盐酸 替匹嘧啶片22-322甲磺酸沙非胺片Tablets/XadagoSevoflurane for Inhalation/Sevofrane22-324吸入用七氟烷（喜保福宁）22-325吸入用七氟烷Isoflurane/Aerrane （艾思美）Isoflurane/Aerrane （艾思美）前列地尔注射液前列地尔注射液帕立骨化醇注 射液Paricalcitol Injection/ZEMPLAR （胜 普乐）Trifluridine and Tipiracil HydrochlorideTablets/Lonsurf甲磺酸沙非胺 片Safinamide MethansulfonateTablets/Xadago 22-315Paricalcitol Injection/ZEMPLAR 注射用甲磺酸 萘莫司他Nafamostat Mesilate For Injection/FUTHAN 22-314Paricalcitol Injection/ZEMPLAR 22-327异氟烷Sevoflurane for Inhalation/Ultane （悦坦）22-326异氟烷22-323Safinamide Methansulfonate 盐酸氢吗啡酮 注射液Hydromorphone HydrochlorideInjection/DILAUDID22-329Alprostadil Injection/Palux 22-328Alprostadil Injection/Palux22-33022-33122-332Tapentadol Tablets/NUCYNTA22-333他喷他多片Tapentadol Tablets/NUCYNTA22-334他喷他多片Tapentadol Tablets/NUCYNTA22-335他喷他多片Doxorubicin Hydrochloride LiposomeInjection/DOXIL22-336盐酸多柔比星 脂质体注射液（LIPOSOMAL ）Doxorubicin Hydrochloride LiposomeInjection/DOXIL22-337盐酸多柔比星 脂质体注射液（LIPOSOMAL ）22-33822-339Desogestrel and EthinylestradiolTablets/Marvelon22-340去氧孕烯炔雌 醇片（妈富隆）Sevelamer Carbonate Tablets/Renvela 22-341（诺维乐）Ezetimibe Tablets/Ezetrol（益适纯）22-343索磷布韦片头孢地尼细粒盐酸氢吗啡酮 注射液Hydromorphone HydrochlorideInjection/DILAUDID 盐酸氢吗啡酮 注射液Hydromorphone HydrochlorideInjection/DILAUDID 碳酸司维拉姆 片22-342依折麦布片盐酸多柔比星 脂质体注射液Doxorubicin Hydrochloride LiposomeInjection/Caelyx 盐酸多柔比星 脂质体注射液Doxorubicin Hydrochloride LiposomeInjection/Caelyx 盐酸氢吗啡酮 注射液Hydromorphone HydrochlorideInjection/DILAUDID 22-345Cefdinir Fine Granules/CefzonSofosbuvir Tablets/SOVALDI （索华迪）22-344西他沙星片Sitafloxacin Tablets /-剂22-346注射用头孢地 嗪钠Cefodizime Sodium for Injection/MODIVID 22-347NIFURATEL VAGINAL TABLETS/MACMIROR(22-348麦咪诺)22-34922-35022-35122-352曲伏前列素滴眼液曲伏前列素滴眼液22-355蔗糖铁注射液异丙托溴铵吸入气雾剂Ipratropium Bromide22-357吸入用异丙托 溴铵溶液Solution for Inhalation/Atrovent(爱全 乐)Ipratropium Bromide22-358吸入用异丙托 溴铵溶液Solution for Inhalation/Atrovent(爱全 乐)注射用头孢地 嗪钠Cefodizime Sodium for Injection/MODIVID 硝呋太尔阴道 片伊曲康唑口服 溶液Itraconazole Oral Solution/SporanoxOS(斯 皮仁诺)22-345Cefdinir Fine Granules/Cefzon 22-354Travoprost Eye Drops/Travatan(苏为坦)盐酸伊伐布雷 定片Ivabradine Hydrochloride Tablets/CORLENTOR(可 兰特)22-353Travoprost Eye Drops/Travatan(苏为坦)伊曲康唑注射 液Itraconazole Injection/Sporanox(斯皮 仁诺)盐酸伊伐布雷 定片Ivabradine Hydrochloride Tablets/CORLENTOR(可 兰特)注射用磷酸特 地唑胺Tedizolid Phosphate For Injection/Sivextro(赛威乐)Aerosol/Atrovent(爱全乐)Iron Sucrose Injection/Venofer(维乐福)22-356Ipratropium Bromide Inhalation22-35922-360注射用盐酸头孢吡肟/MAXIPIME®Cefepime Dihydrochloride for Injectionn22-362/MAXIPIME®Cefepime Dihydrochloride for Injectionn22-363/MAXIPIME®Cefepime Dihydrochloride for Injectionn22-364/MAXIPIME®Cefepime Dihydrochloride for Injectionn22-365/MAXIPIME®Cefepime Dihydrochloride for Injectionn22-366/MAXIPIME®Cefepime Dihydrochloride for Injectionn22-367/MAXIPIME®Cefepime Dihydrochloride for Injectionn22-368/MAXIPIME®注射用头孢曲松钠注射用头孢曲松钠注射用头孢曲松钠22-372伊曲茶碱片22-37322-37422-375伊立替康脂质 体注射液Irinotecan liposome injection/ONIVYDE™22-378依维莫司片注射用磷酸特 地唑胺Tedizolid Phosphate For Injection/Sivextro(赛威乐)注射用盐酸头 孢吡肟注射用盐酸头 孢吡肟注射用盐酸头 孢吡肟注射用盐酸头 孢吡肟磷酸特地唑胺 片Tedizolid Phosphate Tablets/Sivextro(赛威乐)22-361Cefepime Dihydrochloride for Injectionn 22-371Ceftriaxone Sodium for Injection/ROCEPHIN®22-370Ceftriaxone Sodium for Injection/ROCEPHIN®注射用盐酸头 孢吡肟注射用盐酸头 孢吡肟注射用盐酸头 孢吡肟22-369Ceftriaxone Sodium for Injection/ROCEPHIN®22-377依维莫司片Everolimus Tablets/Afinitor(飞尼妥)22-376依维莫司片Everolimus Tablets/Afinitor(飞尼妥)Istradefylline Tablets/NOURIAST右兰索拉唑肠 溶胶囊Dexlansoprazole Enteric Capsules/DEXILANT 右兰索拉唑肠 溶胶囊Dexlansoprazole Enteric Capsules/DEXILANTEverolimus Tablets/AFINITOR 22-379依维莫司片Everolimus Tablets/Afinitor(飞尼妥)22-380依维莫司片22-381依托考昔片22-382依托考昔片Etoricoxib Tablets/Arcoxia 22-383依托考昔片22-384依托考昔片22-385依托考昔片Etoricoxib Tablets/Arcoxia 22-386依托考昔片盐酸格拉司琼注射液22-38822-38922-39022-39122-39222-39322-39422-395Etoricoxib Tablets/ARCOXIA(安康 信)Etoricoxib Tablets/ARCOXIA(安康 信)Everolimus Tablets/AFINITOR Etoricoxib Tablets/ARCOXIA(安康 信)注射用头孢唑 林钠Cefazolin Sodium forInjection/CEFAZOLIN SODIUM 注射用头孢唑 林钠Cefazolin Sodium forInjection/CEFAZOLIN SODIUM 注射用头孢西 丁钠Cefoxitin Sodium for Injection /-注射用头孢西 丁钠Cefoxitin Sodium for Injection/-Etoricoxib Tablets/ARCOXIA(安康 信)22-387Granisetron Hydrochloride injection 注射用头孢唑 林钠Cefazolin Sodium Pentahydrate forInjection/Cefamezin α注射用头孢唑 林钠Cefazolin Sodium Pentahydrate forInjection/Cefamezin α注射用头孢唑 林钠Cefazolin Sodium Pentahydrate forInjection/Cefamezin α注射用头孢唑 林钠Cefazolin Sodium Pentahydrate forInjection/Cefamezin α脂肪乳注射液Fat Emulsion Injection（C14~24）（C14~24）/A 10%Intravenous Fat Emulsion/INTRALIPID10%Fat Emulsion Injection22-397脂肪乳注射液（C14~24）/A 10% Intravenous Fat（C14~24）/INTRALIPID10%Fat Emulsion Injection22-398脂肪乳注射液（C14~24）/A 10% Intravenous Fat（C14~24）/INTRALIPID10%Fat Emulsion Injection22-399脂肪乳注射液（C14~24）/A 20% Intravenous Fat（C14~24）/INTRALIPID20%Fat Emulsion Injection22-400脂肪乳注射液（C14~24）/A 20% Intravenous Fat（C14~24）/INTRALIPID20%Fat Emulsion Injection22-401脂肪乳注射液（C14~24）/A 20% Intravenous Fat（C14~24）/INTRALIPID20%Fat Emulsion Injection22-402脂肪乳注射液（C14~24）/A 20% Intravenous Fat（C14~24）/INTRALIPID20%Fat Emulsion Injection22-403脂肪乳注射液（C14~24）/A 30% Intravenous Fat（C14~24）/INTRALIPID30%中/长链脂肪乳 注射液（C6-22-40424）中/长链脂肪乳 注射液（C6-22-40524）中/长链脂肪乳 注射液（C6-22-40624）中/长链脂肪乳 注射液（C6-22-40724）中/长链脂肪乳注射液（C6-24）Injection/Emulsion zur Infusion/LipovenösMCT2 0%22-396Medium and Long Chain Fat EmulsionInjection/Emulsion zur Infusion/LipovenösMCT1 0%Medium and Long Chain Fat EmulsionInjection/Emulsion zur Infusion/LipovenösMCT1 0%Medium and Long Chain Fat EmulsionInjection/Emulsion zur Infusion/LipovenösMCT1 0%Medium and Long Chain Fat EmulsionInjection/Emulsion zur Infusion/LipovenösMCT2 0%Medium and Long Chain Fat EmulsionInjection/Emulsion zur Infusion/LipovenösMCT2 0%22-408Medium and Long Chain Fat Emulsion。
仿制药参比制剂目录1-27批
Tablets/Zyprexa
5mg
26-53 26-54 26-55 26-56 26-57 26-58 26-59 26-60 26-61 26-62 26-63 26-64 26-65 26-66 26-67 26-68
奥氮平片 奥氮平片 奥氮平片 奥氮平片 奥氮平口崩片 奥氮平口崩片 奥氮平口崩片 奥氮平口崩片 奥氮平口崩片 奥氮平口崩片 奥氮平口崩片 奥氮平口崩片 奥氮平口崩片 奥氮平口崩片 奥氮平口崩片 阿哌沙班片
美奇）
75IU FSH+75IU LH
Indocyaninegreen for Injection/
OnIcd-aGnrseeetrnon Hydrochloride Injection/Zophren; OnZdaonfrsaentron Hydrochloride Injection/Zophren;
μg。（10ml）
Fat-Soluble Vitamin Injection（Ⅱ） /Vitalipid Adult; Vitalipide Adultes
1ml:维生素A 99μg、维 生素D2 0.5μg、维生素 E 910μg、维生素K1 15
μg。（10ml）
Highly Purified
Menotrophin for Injection/Menopur（贺
Arginine and Ibuprofen
精氨酸布洛芬颗粒
Granules/Spedifen;
Spididol
200mg（以布洛芬计）
地平10mg 阿齐沙坦20mg/氨氯地
TAazbilseatsrt/aZnacarnads Amlodipine
平2.5mg 阿齐沙坦20mg/氨氯地
国家食品药品监管总局关于发布仿制药参比制剂目录(第二批)的通告
国家食品药品监管总局关于发布仿制药参比制剂目录(第二批)
的通告
【法规类别】药品管理
【发文字号】国家食品药品监管总局通告2017年第46号
【发布部门】国家食品药品监督管理总局
【发布日期】2017.03.20
【实施日期】2017.03.20
【时效性】现行有效
【效力级别】XE0303
国家食品药品监管总局关于发布仿制药参比制剂目录（第二批）的通告
（国家食品药品监管总局通告2017年第46号）
经国家食品药品监督管理总局仿制药质量与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（第二批）。
特此通告。
附件：仿制药参比制剂目录（第二批）
国家食品药品监管总局
2017年3月20日附件
仿制药参比制剂目录（第二批）。
化学仿制药参比制剂目录（第二十四批）
国内上市原 研药品
片剂
BOEHRINGER INGELHEIM PHARMAC EUTICAL
S INC
未进口原研 药品
备注 2 欧盟互认
上市 原研进口
原研进口
原研进口
原研进口
美国橙皮 书
5
序号 药品通用名称
二甲双胍恩格列
24-39
净片(Ⅲ)
二甲双胍恩格列
24-40
净片(Ⅳ)
二甲双胍恩格列
24-41
Amoxicillin Capsules/PASETOCIN
250mg 250mg
胶囊剂 胶囊剂
Amoxicillin Capsules/C LAMO XYL
500mg
胶囊剂
Bimatoprost and Timolol Maleate Eye Drops/克法特
(GANFORT)
Prednisolone Acetate Ophthalmic Suspension/ 百力特(PRED FORTE)
24-25 尼替西农胶囊
尼替西农口服混
24-26
悬液
24-27
尼替西农片
24-28
尼替西农片
24-29
尼替西农片
酮咯酸氨丁三醇
24-30
注射液
24-31 24-32
酮咯酸氨丁三醇 注射液
酮咯酸氨丁三醇 注射液
英文名称/商品名
Nitisinone Capsules/ORFADIN
Nitisinone Capsules/ORFADIN
Prednisolone Acetate Ophthalmic Suspension/ 百力特(PRED FORTE)
3ml：贝美前列 素 0.9mg 与噻吗 洛尔 15mg（相 当于 20.4mg 马 来酸噻吗洛尔）
仿制药参比制剂目录(第二十四批)
Diltiazem Hydrochloride Exte nded-Release Capsules/CardizemCd
180mg
控释
胶囊
剂
Bausch Health
US LLC
国际公认的
同种药品
美国橙皮书
24-6
盐酸地尔硫卓控
释胶囊
Diltiazem Hydrochloride Exte nded-Release Capsules/CardizemCd
0.05%（60g）
凝胶
剂
Leo Pharma As
未进口原研
药品
美国橙皮书
24-40
丁丙诺啡透皮贴
剂
Bupre norphine Tran sdermal Patches/-
5mg/贴
贴剂
Mun dipharma GmbH
国内上市的
原研药品
原研进口
24-41
丁丙诺啡透皮贴
剂
Bupre norphine Tran sdermal Patches/-
片剂
Boehri nger In gel Heim Pty Ltd
国内上市原
研药品
原研进口
24-33
二甲双胍恩格列
净片（W）
Metformin Hydrochloride And Empaglifloz in
Tablets( W )/-
每片含盐酸二甲双胍
850mg与恩格列净12.5mg
片剂
Boehri nger In gel Heim Pty Ltd
附件
仿制药参比制剂目录（第二十四批）
序号
药品通用名称
英文名称/商品名
仿制药参比制剂目录(第二十四批)
美国橙皮书
24-23
尼替西农片
Nitisinone Tablets/Nityr
10mg
片剂
Cycle Pharmaceuticals Ltd.
未进口原研药品
美国橙皮书
24-24
酮咯酸氨丁三醇注射液
Ketorolac Trometamol Injection/Toradol
10mg/ml（1ml:10mg）
国内上市的原研药品
原研进口
24-3
醋酸泼尼松龙滴眼液
Prednisolone Acetate Ophthalmic Suspension/Pred Forte（百力特）
10ml:100mg
眼用制剂
Allergan Pharmaceuticals Ireland
国内上市的原研药品
原研进口
24-4
盐酸地尔硫卓控释胶囊
Tablets/Synjardy
5mg;500mg
片剂
Boehringer Ingelheim Pharmaceuticals Inc
未进口原研药品
美国橙皮书
24-32
二甲双胍恩格列净片（Ⅲ）
Metformin Hydrochloride And Empagliflozin
Tablets（Ⅲ）/-
每片含盐酸二甲双胍850mg与恩格列净5mg
Heim Pty Ltd
国内上市原研药品
原研进口
24-34
二甲双胍恩格列净片（Ⅴ）
Metformin Hydrochloride And Empagliflozin
Tablets（Ⅴ）/-
每片含盐酸二甲双胍1000mg与恩格列净5mg
仿制药参比制剂十八批-汇总至20181230
10--142替吉奥胶囊Tegafur，Gimeracil and Oteracil PotassiumCapsules/--10--143替米沙坦氢氯噻嗪片Telmisartan and HydrochlorothiazideTablets/Micardis HCT10--144头孢丙烯干混悬剂Cefprozil for Suspension/--10--145头孢丙烯干混悬剂Cefprozil for Suspension/--10--146头孢丙烯片Cefprozil Tablets/--10--147头孢丙烯片Cefprozil Tablets/--10--148头孢泊肟酯颗粒Cefpodoxime Proxetil Granules/ORELOX ENFANTS ETNOURRISSONS10--149头孢泊肟酯片Cefpodoxime Proxetil Tablets/BANAN10--150头孢泊肟酯片Cefpodoxime Proxetil Tablets/Orelox10--151头孢克洛胶囊Cefaclor Capsules/CEFACLOR10--152托吡酯片Topiramate Tablets/TOPAMAX10--153托吡酯片Topiramate Tablets/TOPAMAX10--154托伐普坦片Tolvaptan Tablets/SAMSCA10--155托伐普坦片Tolvaptan Tablets/SAMSCA10--156托拉塞米片Torasemide Tablets/DEMADEX10--157托拉塞米片Torasemide Tablets/DEMADEX10--158托拉塞米片Torasemide Tablets/DEMADEX10--159西吡氯铵含片Cetylpyridinium Chloride Buccal Tablets/--10--160西洛他唑片Cilostazol Tablets/PLETAL10--161西洛他唑片Cilostazol Tablets/PLETAL10--162西尼地平片Cilnidipine Tablets/Atelec10--163西尼地平片Cilnidipine Tablets/Atelec10--164消旋卡多曲胶囊Racecadotril Capsules/--10--165缬沙坦氢氯噻嗪片Valsartan and Hydrochlorothiazide Tablets/Co-Diovan10--166烟酸片Nicotinic Acid Tablets/Nyclin10--167盐酸贝那普利片Benazepril Hydrochloride Tablets/Cibacen10--168盐酸贝那普利片Benazepril Hydrochloride Tablets/Cibacen10--169盐酸贝那普利片Benazepril Hydrochloride Tablets/Cibacen10--170盐酸丁螺环酮片Buspirone Hydrochloride Tablets/--10--171盐酸度洛西汀肠溶胶囊Duloxetine Hydrochloride EntericCapsules/Cymbalta10--172盐酸多奈哌齐片Donepezil Hydrochloride Tablets/ARICEPT10--173盐酸多奈哌齐片Donepezil Hydrochloride Tablets/ARICEPT10--174盐酸多奈哌齐片口崩片Donepezil Hydrochloride Orally DisintegratingTablets/Aricept D替加氟25mg，吉美嘧啶7.25mg，胶囊Taiho Pharmaceutical Co.,Ltd.奥替拉西钾24.5mg替米沙坦40mg，氢氯噻嗪12.5mg片剂Boehringer Ingelheim0.25g/5ml（按C18H19N305S计）口服混悬剂Lupin LTD（干混悬剂）0.125g/5ml（按C18H19N305S计）口服混悬剂Lupin LTD（干混悬剂）0.5g（按C18H19N305S计）片剂Lupin LTD0.25g（按C18H19N305S计）片剂Lupin LTD40mg/5ml颗粒剂SANOFI-AVENTIS FRANCE 100mg（按C15H17N5O6S2计）片剂Daiichi Sankyo Co., Ltd.200mg（按C15H17N5O6S2计）片剂Daiichi Sankyo Europe GmbH0.5g（按C15H14ClN3O4S计）胶囊剂HIKMA PHARMACEUTICALS100mg片剂JANSSEN PHARMACEUTICALS INC25mg片剂JANSSEN PHARMACEUTICALS INC15mg片剂OTSUKA AMERICA PHARMACEUTICALINC30mg片剂OTSUKA AMERICA PHARMACEUTICALINC20mg片剂MYLAN SPECIALTY LP10mg片剂MYLAN SPECIALTY LP5mg片剂MYLAN SPECIALTY LP2mg片剂（含片）岩城製薬株式会社50mg片剂Otsuka Pharmaceutical EuropeLtd0.1g片剂Otsuka Pharmaceutical EuropeLtd5mg片剂EA Pharma Co., Ltd.10mg片剂EA Pharma Co., Ltd.100mg胶囊剂Laboratoire bioprojet Pharma每片含缬沙坦80mg，氢氯噻嗪片剂Novartis Pharma Schweiz AG12.5mg50mg片剂TOA EIYO LTD.5mg片剂MEDA Pharma GmbH & Co. KG10mg片剂MEDA Pharma GmbH & Co. KG20mg片剂MEDA Pharma GmbH & Co. KG5mg片剂TEVA PHARMACEUTICALS USA INCELI LILLY AND CO 20mg(以度洛西汀计)胶囊剂（肠溶胶囊）5mg片剂EISAI INC10mg片剂EISAI INCEisai Co., Ltd.5mg片剂 （口崩片）。
仿制药参比制剂目录(第三十一至四十批)
Guanfacine Hydrochloride Extended Release Tablets/
Intuniv Guanfacine Hydrochloride Extended Release Tablets/
Intuniv Guanfacine Hydrochloride Extended Release Tablets/
片
Tablets/Odefsey
Bimatoprost ophthalmic 31-24 贝美前列素涂剂
solution/Latisse
3ml:0.9mg
Allergan INC
31-25 奥泽沙星乳膏 Ozenoxacin Cream/Xepi 1%（10g、30g、45g）Ferrer Internacional SA
Intuniv
Lidocaine and Tetracaine Cream/Pliaglis
规格 15mg 30mg
1mg
持证商 Specgx LLC Specgx LLC
Shire Development Inc
2mg
Shire Development Inc
3mg
Shire Development Inc
Infants' Motrin
40mg:ml（15ml、 30ml）
Johnson And Johnson Consumer Inc Mcneil Consumer Healthcare
Divisioon
利巴韦林冻干粉 Ribavirin For Inhalation
31-17
6g
吸入剂
Solution/Virazole
CFDA化学仿制药参比制目录总(精编)1-22
0.25g(按 C17H18FN3O3
计)
片剂
Bayer Vital GmbH
原研进口
进口产品现名为 环丙沙星片。
— 4 ——
1-35
盐酸环丙沙星 片
Ciprofloxacin Hydrochloride Tablets/Ciprobay
0.5g(按 C17H18FN3O3
计)
片剂
Bayer Vital GmbH
Tablets/Augmentin
Amoxicillin and Clavulanate Potassium
Tablets/Augmentin
Amoxicillin and Clavulanate Potassium
Tablets/Augmentin
Glimepiride Tablets/Amaryl
片剂
Bayer SA-NV
原研进口
胶囊剂
Bayer Healthcare LLC
美国橙皮书
附件
序号 2-1
药品通 用名称
盐酸胺 碘酮片
仿制药参比制剂目录（第二批）
英文名称/商品名
Amiodarone Hydrochloride Tablets/Ancaron
规格 0.1g
剂型 片剂
持证商 Sanofi K.K.
Nimodipine Tablets/Nimotop
Cefuroxime Axetil Tablets/Ceftin
Cefuroxime Axetil Tablets/Zinacef
Simvastatin Tablets/Zocor Simvastatin Tablets/Zocor
规格
0.2g
第1至第24批仿制药参比制剂目录(截止2019年9月)
Limited Les Laboratoires Servier
原研进口 原研进口 原研进口
进口产品现名为 环丙沙星片。
片剂（缓 释片）
Les Laboratoires Servier
原研进口
-4-
1-39
左甲状腺素钠 片
1g （C16H19N3O5 S 0.875g 与
C8H9NO5 0.125g）
1mg
2mg
10mg
25mg
50mg
5mg
75mg
片剂
片剂
片剂
片剂 胶囊剂 （软胶 囊） 胶囊剂 （软胶 囊） 胶囊剂 （软胶 囊） 片剂
片剂
Beecham Group Plc
Beecham Group Plc
Sanofi-Aventis Deutschland GmbH Sanofi-Aventis Deutschland GmbH Novartis Pharma Schweiz
10g
剂型 片剂 片剂 片剂 片剂
片剂 片剂 片剂 片剂 散剂
持证商 Sanofi-Aventis France
备注 1 原研进口
Bayer Vital GmbH Bayer Vital GmbH
原研进口 原研进口
GlaxoSmithKline
美国橙皮书
Glaxo Wellcome UK Limited 原研进口
Amoxicillin and Clavulanate Potassium
Tablets/Augmentin
Glimepiride Tablets/Amaryl
Glimepiride Tablets/Amaryl Ciclosporin Soft Capsules/Sandimmun
国家药品监督管理局通告2020年第5号——国家药监局关于发布仿制药参比制剂目录（第二十四批）的通告
国家药品监督管理局通告2020年第5号——国家药监局关于发布仿制药参比制剂目录（第二十四批）的通
告
文章属性
•【制定机关】国家药品监督管理局
•【公布日期】2020.01.03
•【文号】国家药品监督管理局通告2020年第5号
•【施行日期】2020.01.03
•【效力等级】部门规范性文件
•【时效性】现行有效
•【主题分类】药政管理
正文
国家药品监督管理局通告
2020年第5号
国家药监局关于发布仿制药参比制剂目录（第二十四批）的
通告
经国家药品监督管理局仿制药质量与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（第二十四批）。
特此通告。
附件：仿制药参比制剂目录（第二十四批）
国家药监局
2020年1月3日。
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胶囊剂
Swedish Orphan Biovitrum AB Publ
未进口原研药品
美国橙皮书
24-18
尼替西农胶囊
Nitisinone Capsules/Orfadin
10mg
胶囊剂
Swedish Orphan Biovitrum AB Publ
未进口原研药品
美国橙皮书
24-19
尼替西农胶囊
Pemirolast Potassium Eye Drops/Alegysal（研立双）
5ml:5mg
滴眼剂
Santen Pharmaceutical Co.,Ltd.
国内上市的原研药品
原研进口
24-13
艾地骨化醇胶囊
Eldecalcitol Capsule/Edirol
0.5μg
胶囊剂
中外製薬株式会社
未进口原研药品
日本橙皮书
24-14
艾地骨化醇胶囊
Eldecalcitol Capsule/Edirol
0.75μg
胶囊剂
中外製薬株式会社
未进口原研药品
日本橙皮书
24-15
硫酸阿巴卡韦口服溶液
Abacavir Sulfate Oral Solution/Ziagen（赛进）
240ml:4.8g
（20mg/ml）
Nitisinone Capsules/Orfadin
20mg
胶囊剂
Swedish Orphan Biovitrum AB Publ
未进口原研药品
美国橙皮书
24-20
尼替西农口服混悬液
Nitisinone Oral Suspension/Orfadin
4mg/ml（90ml:360mg）
口服混悬液
Swedish Orphan Biovitrum International AB
未进口原研药品
美国橙皮书
24-23
尼替西农片
Nitisinone Tablets/Nityr
10mg
片剂
Cycle Pharmaceuticals Ltd.
未进口原研药品
美国橙皮书
24-24
酮咯酸氨丁三醇注射液
Ketorolac Trometamol Injection/Toradol
10mg/ml（1ml:10mg）
Diltiazem Hydrochloride Extended-Release Capsules/
CardizemCd
120mg
控释胶囊剂
Bausch Health US LLC
国际公认的同种药品
美国橙皮书
24-5
盐酸地尔硫卓控释胶囊
Diltiazem Hydrochloride Extended-Release Capsules/CardizemCd
眼用制剂
Allergan Pharmaceuticals Ireland
国内上市的原研药品
原研进口
24-2
醋酸泼尼松龙滴眼液
Prednisolone Acetate Ophthalmic Suspension/Pred Forte（百力特）
5ml:50mg
眼用制剂
Allergan Pharmaceuticals Ireland
附件
仿制药参比制剂目录（第二十四批）
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2
24-1
贝美素噻吗洛尔滴眼液
Bimatoprost And Timolol Maleate Eye Drops/Ganfort（克法特）
3ml：贝美前列素0.9mg与噻吗洛尔15mg（相当于20.4mg马来酸噻吗洛尔）
360mg
控释胶囊剂
Bausch Health US LLC
国际公认的同种药品
美国橙皮书
24-9
间苯三酚注射液
Phloroglucinol Injection/Spasfon
4ml:40mg
注射剂
Teva Sante
未进口原研药品
欧盟上市
24-10
阿伐斯汀胶囊
Acrivastine Capsules/Benadryl Allergy Relief
180mg
控释胶囊剂
Bausch Health US LLC
国际公认的同种药品
美国橙皮书
24-6
盐酸地尔硫卓控释胶囊
Diltiazem Hydrochloride Extended-Release Capsules/CardizemCd
240mg
控释胶囊剂
Bausch Health US LLC
国际公认的同种药品
美国橙皮书
24-7
盐酸地尔硫卓控释胶囊
Diltiazem Hydrochloride Extended-Release Capsules/CardizemCd
300mg
控释胶囊剂
Bausch Health US LLC
国际公认的同种药品
美国橙皮书
24-8
盐酸地尔硫卓控释胶囊
Diltiazem Hydrochloride Extended-Release Capsules/CardizemCd
口服溶液
Viiv Healthcare UK Limited
国内上市的原研药品
原研进口
24-16
尼替西农胶囊
Nitisinone Capsules/Orfadin
2mg
胶囊剂
Swedish Orphan Biovitrum AB Publ
未进口原研药品
美国橙皮书
24-17
尼替西农胶囊
Nitisinone Capsules/Orfadin
8mg
胶囊剂
Mcneil Products Limited
国际公认的同种药品
欧盟上市
24-11
雌三醇乳膏
Estriol Cream/Ovestin（欧维婷）
15mg/15g/支
乳膏剂
Aspen Pharmacare Australia Pty Ltd
国内上市的原研药品
原研进口
24-12
吡嘧司特钾滴眼液
未进口原研药品
欧盟上市
24-21
尼替西农片
Nitisinone Tablets/Nityr
2mg
片剂
Cycle Pharmaceuticals Ltd.
未进口原研药品
美国橙皮书
24-22
尼替西农片
Nitisinone Tablets/Nitቤተ መጻሕፍቲ ባይዱr
5mg
片剂
Cycle Pharmaceuticals Ltd.
注射剂
Atnahs Pharma UK Limited
未进口原研药品
欧盟上市
国内上市的原研药品
原研进口
24-3
醋酸泼尼松龙滴眼液
Prednisolone Acetate Ophthalmic Suspension/Pred Forte（百力特）
10ml:100mg
眼用制剂
Allergan Pharmaceuticals Ireland
国内上市的原研药品
原研进口
24-4
盐酸地尔硫卓控释胶囊