化学仿制药参比制剂目录(第二十三批)
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
国家药监局关于发布仿制药参比制剂目录（第四十一批）的通告
国家药监局关于发布仿制药参比制剂目录（第四十一
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】2021.04.26
•【文号】国家药品监督管理局通告2021年第29号
•【施行日期】2021.04.26
•【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
2021年第29号
国家药监局关于发布仿制药参比制剂目录（第四十一批）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（第四十一批）。
特此通告。
附件：仿制药参比制剂目录（第四十一批）
国家药监局
2021年4月26日附件
仿制药参比制剂目录（第四十一批）。
化学仿制药参比制剂目录(第三十一批)
Galderma International
国内上市的原研药品
原研进口
31-38
熊去氧胆酸口服混悬液
Ursodeoxycholic acid oral suspension/Ursofalk
250mg:5ml
Dr. Falk Pharma Gmbh
未进口原研药品
欧盟上市
31-39
碘解磷定注射液
Limited
未进口原研药品
欧盟上市
31-30
二甲双胍恩格列净片
Metformin Hydrochloride And Empagliflozin Tablets/Synjardy
每片含盐酸二甲双胍1000mg与恩格列净5mg
Boehringer Ingelheim
未进口原研药品
欧盟上市
31-31
二甲双胍恩格列净片
奥美沙坦酯40mg与氨氯地平5mg与氢氯噻嗪25mg
Daiichi Sankyo Inc
未进口原研药品
美国橙皮书
31-10
奥美沙坦酯氨氯地平氢氯噻嗪片
Olmesartan Medoxomil and Amlodipine and Hydrochlorothiazide Tablets/Tribenzor
31-28
马来酸奈拉替尼片
Neratinib Maleate Tablets/Nerlynx
40mg
Puma Biotechnology Inc.
未进口原研药品
美国橙皮书
31-29
甲磺酸伊马替尼片
Imatinib Mesylate
Tablets/Glivec
400mg
Novartis Europharm
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
化学仿制药参比制剂目录(第三十二批)(征求意见稿)
Melinta Subsidiary Corp
未进口原研药品
美国橙皮书
32-30
盐酸氯米帕明注射液
Clomipramine Hydrochloride Injection / Anafranil
25mg/2ml
Alfasigma France/
Alfasigma S.p.A.
未进口原研药品
国际公认的同种药品
美国橙皮书
32-48
注射用替加环素
Tigecycline for Injection/Tygacil
50mg
PFPrism CV
未进口原研药品
美国橙皮书
32-49
他克莫司胶囊
Tacrolimus Capsules/ Prograf
5mg
Astellas Pharma US Inc
未进口原研药品
32-34
克霉唑乳膏
Clotrimazole Cream/Canesten
1%
Bayer Inc
未进口原研药品
加拿大上市
32-35
曲安奈德乳膏
Triamcinolone Acetonide Cream
0.1%
Fougera Pharmaceuticals Inc
国际公认的同种药品
美国橙皮书
32-36
磺胺甲噁唑800g，甲氧苄啶160mg
Sun Pharmaceutical Industries Inc
未进口原研药品
美国橙皮书
32-23
苯磺顺阿曲库铵注射液
Cisatracurium Besylate Injection/Nimbex
2.5ml:5mg
Aspen Pharma Trading Limited
化学仿制药尚未发布参比制剂目录
Belcher Pharmaceuticals , LLC/BPI Labs, LLC
未进口原研药品
增加持证商BPI Labs, LLC
23-197
依折麦布瑞舒伐他汀钙片
Ezetimibe Rosuvastatin Calcium Film-Coated Tablet
依折麦布10mg/瑞舒伐他汀10mg
氯法齐明软胶囊
Clofazimine Soft Capsules /Lamprene
50mg
Novartቤተ መጻሕፍቲ ባይዱs Pharma AG
未进口原研药品
瑞士上市
69-27
氯法齐明软胶囊
Clofazimine Soft Capsules /Lamprene
100mg
Novartis Pharma AG
未进口原研药品
Oryz-Aspergillus Enzyme And Pancreatin Tablet/慷彼申/Combizym
每片含米曲菌酶提取物24mg，胰酶220mg
Bridging Pharma GmbH
国内上市的原研药品
原研进口
69-3
帕拉米韦氯化钠注射液
Peramivir and Sodium Chloride Injection/力纬
5-11
格列本脲片
Glibenclamide tablets/EUGLUCON
2.5mg
sanofi K.K./太陽ファルマ株式会社
日本上市原研
持证商发生变更，增加变更后的持证商太陽ファルマ株式会社
30-150
盐酸肾上腺素注射液/肾上腺素注射液
Epinephrine Injection/EPINEPHRINE
仿制药参比制剂目录(第二十三批)
4mg
胶囊剂
Eisai Europe Ltd.
国内上市的原研药品
原研进口
23-19
甲磺酸仑伐替尼胶囊
Lenvatinib Mesilate Capsules/Lenvima，Kisplyx
10mg
胶囊剂
Eisai GmbH
未进口原研药品
欧盟集中上市
23-20
阿伐那非片
Avanafil Tablets/Stendra
50mg
片剂
Pfizer Europe Ma Eeig
未进口原研药品
欧盟集中上市
23-11
甲磺酸倍他司汀片
Betahistine Mesilate Tablets /Merislon
12mg
片剂
日本卫材株式会社
未进口原研药品
日本橙皮书
23-12
阿莫西林克拉维酸钾缓释片
Amoxicillin/Clavulanate Potassium
Modified Release Tablets/Augmentin Retard
1000mg/62.5 mg
片剂（缓释片剂）
Glaxosmithkline Pharmaceuticals S.A./N.V.
未进口原研药品
欧盟上市
23-13
甲硝唑注射液
Metronidazole Injection/Flagyl I.V. Rtu In Plastic Container
附件
仿制药参比制剂目录（第二十三批）
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
23-1
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23-5
醋酸戈舍瑞林缓释植入剂
Goserelin Acetate Sustained-Release Depot/ ZOLADEX
10.8mg/支(以戈舍瑞林计)
植入剂
AstraZeneca UK Limited
国内上市的原研药品
原研进口
23-6
醋酸戈舍瑞林缓释植入剂
附件
化学仿制药参比制剂目录（第二十三批）
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
23-1
艾地苯醌片
Idebenone Tablets/ Raxone
150mg
片剂
Santhera Pharmaceuticals（Deutschland）GmbH.
未进口原研药品
欧盟集中上市
23-2
氨酚羟考酮片
500mg
片剂
JANSSEN BIOTECH INC
未进口原研药品
美国橙皮书
23-21
甲硝唑注射液
Metronidazole Injection USP/FLAGYL I.V. RTU IN PLASTIC CONTAINER
500MG/
100ML
注射剂
BAXTER HEALTHCARE CORP
未进口原研药品
原研进口
23-16
枸橼酸西地那非口崩片
Sildenafil Citrate Oral Disintegrating Tablets/VIAGRA
50mg
片剂
Pfizer Europe MA EEIG
未进口原研药品
欧盟集中上市
23-17
甲磺酸倍他司汀片
Betahistine Mesilate Tablets /Merislon
Menarini International Operations Luxembourg S.A.
未进口原研药品
欧盟集中上市
23-30
阿伐那非片
Avanafil Tablets/STENDRA
100mg
片剂
Metuchen Pharmaceuticals, LLC.
未进口原研药品
美国橙皮书
23-31
每片含对乙酰氨基酚300mg，咖啡因15mg，磷酸可待因8mg
片剂
Teva Canada Limited
未进口原研药品
上市国加拿大
23-15
地屈孕酮片
Dydrogesterone Tablets / Duphaston达芙通
10mg
片剂
Abbott Healthcare Products B.V.
进口原研药品
注射剂
塩野義製薬株式会社
未进口原研药品
上市国日本
23-41
甲硫酸新斯的明注射液
Neostigmine Methylsulfate Injection/Vagostigmin
4ml:2mg
注射剂
塩野義製薬株式会社
未进口原研药品
上市国日本
23-42
酒石酸双氢可待因片
Dihydrocodeine Tartrate Tablets/Paracodin
加拿大上市
23-39
加替沙星滴眼液
Gatifloxacin Eye Drops/GATIFLO
0.3%
(5ml:15mg)
滴眼液
千寿製薬株式会社
未进口原研药品
上市国日本
23-40
甲硫酸新斯的明注射液
Neostigmine Methylsulfate Injection/Vagostigmin
1ml:0.5mg
美国橙皮书
23-22
甲硝唑注射液
Metronidazole Injection USP/
METRO I.V. IN PLASTIC CONTAINER
500MG/
100ML
注射液剂
B BRAUN MEDICAL INC
未进口原研药品
美国橙皮书
23-23
甲硝唑注射液
METRONIDAZOLE
Injection, USP/ METRONIDAZOLE IN PLASTIC CONTAINER
10mg
片剂
Teofarma S.r.l.
未进口原研药品
欧盟上市
(上市国德国)
23-43
酒石酸双氢可待因片
Dihydrocodeine Tartrate Tablets/DF 118
30mg
片剂
GLAXOSMITHKLINE LIMITED
未进口原研药品
中国香港上市
23-44
酒石酸双氢可待因片
Dihydrocodeine Tartrate Tablets/DF118
未进口原研药品
美国橙皮书
23-36
恩曲他滨胶囊
Emtricitabine Capsules/EMTRIVA
200mg
胶囊剂
Gilead Sciences, Inc.
未进口原研药品
美国橙皮书
23-37
恩曲他滨口服溶液
Emtricitabine Oral Sulotions/EMTRIVA
10mg/ml
未进口原研药品
上市国日本
23-11
甲磺酸帕珠沙星注射液
Pazufloxacin Mesylate Injection/ PASIL、Pazucross
500mg/100ml
注射剂
富士フイルム富山化学株式会社/田辺三菱製薬株式会社
未进口原研药品
上市国日本
23-12
泛昔洛韦片
Famciclovir Tablets/Famvir
120mg
片剂（缓释片）
Mundipharma GmbH
未进口原研药品
欧盟上市
(上市国德国)
(170ml:1.7g)
口服溶液剂
Gilead Sciences, Inc.
未进口原研药品
美国橙皮书
23-38
布洛芬缓释片
Ibuprofen Extended Release Tablets/ADVIL 12 Hour
600mg
片剂（缓释片）
Pfizer Consumer Healthcare
未进口原研药品
3.6mg/支(以戈舍瑞林计)
植入剂
AstraZeneca UK Limited
国内上市的原研药品
原研进口
23-4
醋酸戈舍瑞林缓释植入剂
Goserelin Acetate Sustained-Release Depot/ Zoladex
3.6mg/支(以戈舍瑞林计)
植入剂
AstraZeneca
未进口原研药品
125mg
片剂
Novartis
未进口原研药品
欧盟上市（产地意大利）
23-13
泛昔洛韦片
Famciclovir Tablets/Famvir
250mg
片剂
Novartis
未进口原研药品
欧盟上市（产地意大利）
23-14
氨咖待因片
Acetaminophen, Caffeine and Codeine Phosphate Tablets /Nratio-LENOLTEC No. 1
EQ 11MG BASE
片剂
PFIZER INC
未进口原研药品
美国橙皮书
23-8
阿替卡因肾上腺素注射液
Articaine Hydrochloride and Epinephrine Injection/ SEPTOCAINE
4%; EQ 0.017MG BASE/1.7ML (4%; EQ 0.01MG BASE/ML)
Goserelin Acetate Sustained-Release Depot/ Zoladex LA
10.8mg/支(以戈舍瑞林计)
植入剂
AstraZeneca
未进口原研药品
欧盟上市（上市国英国、德国等，产地英国）
23-7
枸橼酸托法替布缓释片
Tofacitinib Citrate Extended ReleaseTablets/XELJANZ XR
12mg
片剂
日本卫材株式会社
未进口原研药品
上市国日本
23-18
阿莫西林克拉维酸钾缓释片
amoxicillin/clavulanate potassium
Modified Release Tablets/Augmentin Retard
1000mg/62.5 mg
缓释片剂
GlaxoSmithKline Pharmaceuticals s.a./n.v.
未进口原研药品
欧盟上市
(上市国德国)
23-46
酒石酸双氢可待因缓释片
Dihydrocodeine Tartrate Sustained Realese Tablets/DHC
90mg
片剂（缓释片）
Mundipharma GmbH
未进口ห้องสมุดไป่ตู้研药品
欧盟上市
(上市国德国)
23-47
酒石酸双氢可待因缓释片
Dihydrocodeine Tartrate Sustained Realese Tablets/DHC
40mg
片剂
Martindale Pharmaceuticals Ltd.
未进口原研药品
欧盟上市
(上市国英国)
23-45
酒石酸双氢可待因缓释片
Dihydrocodeine Tartrate Sustained Realese Tablets/DHC