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【第六十批】仿制药参比制剂目录


【第六十批】仿制药参比制剂目录


序号药品通用名称英文名称/商品名规格持证商备注1备注2
60-1拉米夫定多替拉韦片Lamivudine and Dolutegravir Sodium Tablets/多伟托每片含拉米夫定300mg和多替拉韦钠(以多替拉韦计)50mgViiV Healthcare B.V.国内上市的原研药品原研进口
60-2磷/碳酸氢钠血滤置换液Hemofiltration Replacement Fluid of Sodium Bicarbonate and Phosphate5000ml(250ml/4750ml)Gambro Lundia AB国内上市的原研药品原研进口
60-3咪康唑口腔贴片Miconazole Buccal Tablet/ 诺弥可50 mgVECTANS PHARMA国内上市的原研药品原研进口
60-4甲苯磺酸卢美哌隆胶囊Lumateperone tosylate capsule/Caplyta42 mg(以卢美哌隆计)Intra-Cellular Therapies Inc未进口原研药品美国橙皮书
60-5复方电解质注射液Multiple Electrolytes Injection/Plasma-Lyte A500mlBaxter Healthcare Corp未进口原研药品美国橙皮书
60-6碳酸氢钠注射液Sodium Bicarbonate Injection0.9MEQ/ML(7.5%)Exela Pharma Sciences LLC国际公认的同种药品美国橙皮书
60-7碳酸氢钠注射液Sodium Bicarbonate Injection1MEQ/ML(8.4%)Exela Pharma Sciences LLC国际公认的同种药品美国橙皮书
60-8非奈利酮片Finerenone Tablets/Kerendia10mgBayer Healthcare Pharmaceuticals INC未进口原研药品美国橙皮书
60-9非奈利酮片Finerenone Tablets/Kerendia20mgBayer Healthcare Pharmaceuticals INC未进口原研药品美国橙皮书
60-10氯苯唑酸软胶囊Tafamidis soft Capsules /Vyndamax61mgFoldrx Pharmaceuticals LLC A Wholly Owned Sub Of Pfizer INC未进口原研药品美国橙皮书
60-11氨基己酸口服溶液Aminocaproic Acid Oral Solution /Amicar0.25 g/mlAkorn Operating CO LLC未进口原研药品美国橙皮书
60-12维利西呱片Vericiguat Tablets/Verquvo2.5mgMerck Sharp And Dohme Corp未进口原研药品美国橙皮书
60-13维利西呱片Vericiguat Tablets/Verquvo5mgMerck Sharp And Dohme Corp未进口原研药品美国橙皮书
60-14维利西呱片Vericiguat Tablets/Verquvo10mgMerck Sharp And Dohme Corp未进口原研药品美国橙皮书
60-15度骨化醇软胶囊Doxercalciferol Capsules /Hectorol2.5μgSanofi Genzyme未进口原研药品美国橙皮书
60-16度骨化醇软胶囊Doxercalciferol Capsules /Hectorol1μgSanofi Genzyme未进口原研药品美国橙皮书
60-17度骨化醇软胶囊Doxercalciferol Capsules /Hectorol0.5μgSanofi Genzyme未进口原研药品美国橙皮书
60-18泼尼松龙磷酸钠口服溶液Prednisolone Sodium phosphate Oral solution/ Pediapred5mg/5mlSeton Pharmaceutical LLC未进口原研药品美国橙皮书
60-19环磷酰胺注射液Cyclophosphamide Injection500mg/2.5ml(200mg/ml)Ingenus Pharmaceuticals,LLC未进口原研药品美国橙皮书
60-20环磷酰胺注射液Cyclophosphamide Injection1g/5ml(200mg/ml)Ingenus Pharmaceuticals,LLC未进口原研药品美国橙皮书
60-21环磷酰胺注射液Cyclophosphamide Injection2g/10ml(200mg/ml)Ingenus Pharmaceuticals,LLC未进口原研药品美国橙皮书
60-22枸橼酸托法替布口服溶液Tofacitinib Citrate Oral Solution1mg/ml,240mlPfizer Inc.未进口原研药品美国橙皮书
60-23非那雄胺他达拉非胶囊Finasteride and Tadalafil Capsules / Entadfi5mg/5mgVeru Inc未进口原研药品美国橙皮书
60-24依托咪酯注射液Etomidate Injection/Amidate10ml∶20mgHospira INC未进口原研药品美国橙皮书
60-25玛巴洛沙韦干混悬剂Baloxavir Marboxil for Suspension/Xofluza2mg/mlGenentech Inc.未进口原研药品美国橙皮书
60-26盐酸沙瑞环素片 Sarecycline Hydrochloride Tablet/Seysara60mgAlmirall LLC未进口原研药品美国橙皮书
60-27盐酸沙瑞环素片 Sarecycline Hydrochloride Tablet/Seysara100mgAlmirall LLC未进口原研药品美国橙皮书
60-28盐酸沙瑞环素片 Sarecycline Hydrochloride Tablet/Seysara150mgAlmirall LLC未进口原研药品美国橙皮书
60-29注射用盐酸替拉凡星Telavancin Hydrochloride for Injection/Vibativ750 mgCumberland Pharmaceuticals Inc.未进口原研药品美国橙皮书
60-30托吡卡胺滴眼液Tropicamide Ophthalmic Solution/ Mydriacyl0.50%Sandoz INC未进口原研药品美国橙皮书
60-31磷酸二氨基吡啶片Amifampridine phosphate tablets/Firdapse10mgSERB S.A.未进口原研药品欧盟上市
60-32比拉斯汀口服溶液Bilastine Oral Solution2.5mg/mlMenarini International Operations Luxembourg S.A./FAES Farma, S.A.未进口原研药品欧盟上市
60-33盐酸巴尼地平缓释胶囊Barnidipine Hydrochloride  Sustained-Release Capsules / Libradin10mgAlfasigma S.p.A.未进口原研药品欧盟上市
60-34盐酸喹高利特片Quinagolide Hydrochloride Tablets/Norprolac25μg(按C20H33N3O3S计)Ferring Arzneimittel GmbH未进口原研药品欧盟上市
60-35盐酸喹高利特片Quinagolide Hydrochloride Tablets/Norprolac50μg(按C20H33N3O3S计)Ferring Arzneimittel GmbH未进口原研药品欧盟上市
60-36盐酸喹高利特片Quinagolide Hydrochloride Tablets/Norprolac75μg(按C20H33N3O3S计)Ferring Arzneimittel GmbH未进口原研药品欧盟上市
60-37盐酸喹高利特片Quinagolide Hydrochloride Tablets/Norprolac150μg(按C20H33N3O3S计)Ferring Arzneimittel GmbH未进口原研药品欧盟上市
60-38枸橼酸托法替布口服溶液Tofacitinib Citrate Oral Solution1mg/ml,240mlPfizer Europe MA EEIG未进口原研药品欧盟上市
60-39亚甲蓝肠溶缓释片Methylthioninium Chloride Enteric-coated Sustained-Release Tablets / Lumeblue25mgAlfasigma S.p.A.
欧盟上市
60-40异康唑二氟可龙乳膏Isoconazole Nitrate and Diflucortolone Valerate Cream /Travocort®Cream1%,0.1%LEO Pharma A/S
欧盟上市
60-41盐酸美贝维林片 Mebeverine Hydrochloride Tablets / Colofac135mgMylan Products Ltd.未进口原研药品欧盟上市
60-42水合氯醛灌肠剂Chloral Hydrate Enemas/ Escre1.34g:0.5g久光製薬株式会社未进口原研药品日本上市
60-43复方聚乙二醇电解质散(Ⅱ)Polyethylene Glycol Electrolytes Powder (II)/Niflec137.155g/袋EAファーマ株式会社未进口原研药品日本上市
60-44硝酸异康唑乳膏Isoconazole Nitrate Cream/Adestan Cream1%バイエル薬品株式会社未进口原研药品日本上市
60-45醋酸兰瑞肽缓释注射液(预充式)Lanreotide Acetate Sustained-release Injection (a pre-filled syringe)60mgIpsen Pharma国内上市的原研药品原研进口
60-46醋酸兰瑞肽缓释注射液(预充式)Lanreotide Acetate Sustained-release Injection (a pre-filled syringe)90mgIpsen Pharma国内上市的原研药品原研进口
60-47醋酸兰瑞肽缓释注射液(预充式)Lanreotide Acetate Sustained-release Injection (a pre-filled syringe)120mgIpsen Pharma国内上市的原研药品原研进口
60-48阿法骨化醇软胶囊Alfacalcidol Soft Capsules / Etalpha1μgCHEPLAPHARM Arzneimittel GmbH国内上市的原研药品原研进口
60-49玛巴洛沙韦片 Baloxavir Marboxil Tablets/Xofluza(速福达)40mgRoche Pharma (Schweiz) AG国内上市的原研药品原研进口
60-50硫酸氢氯吡格雷片Clopidogrel Hydrogen Sulphate Tablets/Plavix75mg赛诺菲(杭州)制药有限公司 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
60-51注射用头孢哌酮钠舒巴坦钠Cefoperazone Sodium and Sulbactam Sodium for Injection/舒普深1.5g(C25H27N9O8S2 1.0g与C8H11NO5S 0.5g)辉瑞制药有限公司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
60-52注射用头孢哌酮钠舒巴坦钠Cefoperazone Sodium and Sulbactam Sodium for Injection/舒普深1.0g(C25H27N9O8S2 0.5g与C8H11NO5S 0.5g)辉瑞制药有限公司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
60-53尼洛替尼胶囊 Nilotinib Capsules/Tasigna50mgNovartis Pharmaceuticals Corp未进口原研药品美国橙皮书
60-54尼洛替尼胶囊 Nilotinib Capsules/Tasigna150mgNovartis Pharmaceuticals Corp未进口原研药品美国橙皮书
60-55尼洛替尼胶囊 Nilotinib Capsules/Tasigna200mgNovartis Pharmaceuticals Corp未进口原研药品美国橙皮书
60-56酮咯酸氨丁三醇注射液Ketorolac Tromethamine Injection15mg/ml(1ml:15mg)Hospira INC.国际公认的同种药品美国橙皮书
60-57环孢素软胶囊Ciclosporin Soft Capsules/100mgNovartis Pharmaceuticals Corporation未进口原研药品美国橙皮书
 Neoral
60-58吸入用布地奈德混悬液Budesonide Suspension For Inhalation/ Pulmicort Respules2ml:0.5mgAstrazeneca Pharmaceuticals LP未进口原研药品美国橙皮书
60-59吸入用布地奈德混悬液Budesonide Suspension For Inhalation/ Pulmicort Respules2ml:1mgAstrazeneca Pharmaceuticals LP未进口原研药品美国橙皮书
60-60奥美沙坦酯氢氯噻嗪片Hydrochlorothiazide;Olmesartan Medoxomil /Benicar Hct20mg/12.5mgDaiichi Sankyo Inc未进口原研药品美国橙皮书
60-61布洛芬注射液※Ibuprofen Injection/Caldolor800MG/8ML (100MG/ML)Cumberland Pharmaceuticals Inc未进口原研药品美国橙皮书
60-62氟维司群注射液Faslodex 250 mg solution for injection/Faslodex5ml:0.25gAstraZeneca AB/AstraZeneca UK Limited未进口原研药品欧盟上市
60-63氯苯唑酸葡胺软胶囊Tafamidis Meglumine Soft Capsules/Vyndaqel20mgPfizer Europe MA EEIG未进口原研药品欧盟上市
60-64恩他卡朋片Entacapone Tablets /Comtess200mgOrion Pharma GmbH未进口原研药品欧盟上市
60-65卡格列净片Canagliflozin Tablets/Invokana300mgJanssen-Cilag International NV,未进口原研药品欧盟上市
60-66硫酸羟氯喹片Hydroxychloroquine Sulfate Tablets/Plaquenil0.2gSanofi-Aventis未进口原研药品欧盟上市
60-67二硫化硒洗剂Selenium Sulfide Lotion/Selsun2.50%Sanofi-Aventis Netherlands B.V./ Opella Healthcare France SAS未进口原研药品欧盟上市
60-68碳酸司维拉姆干混悬剂Sevelamer Carbonate Powder for oral suspension/Renvela0.8gGenzyme Europe B.V.未进口原研药品欧盟上市
60-69碳酸司维拉姆干混悬剂Sevelamer Carbonate Powder for oral suspension/Renvela2.4gGenzyme Europe B.V.未进口原研药品欧盟上市
60-70达肝素钠注射液Dalteparin Sodium Injection/Fragmin0.2ml:2500IUPfizer Pharma Pfe GmbH未进口原研药品欧盟上市
60-71比沙可啶肠溶片Bisacodyl Enteric-coated Tablets/Dulcolax5mgOpella Healthcare France SAS未进口原研药品欧盟上市
60-72盐酸文拉法辛缓释胶囊Venlafaxine Hydrochloride Sustained-Release Capsules/Efexor XL75mg(以文拉法辛计)Upjohn UK Limited未进口原研药品欧盟上市
60-73盐酸文拉法辛缓释胶囊Venlafaxine Hydrochloride Sustained-Release Capsules/Efexor XL150mg(以文拉法辛计)Upjohn UK Limited未进口原研药品欧盟上市
60-74骨化三醇注射液Calcitriol Injection/Rocaltrol1ml:0.5μg協和キリン株式会社未进口原研药品日本上市
60-75骨化三醇注射液Calcitriol Injection/Rocaltrol1ml:1μg協和キリン株式会社未进口原研药品日本上市
5-43盐酸帕罗西汀片Paroxetine Hydrochloride Tablets/Paxil20mgApotex Technologies Inc/Apotex Inc未进口原研药品增加持证商Apotex Inc
10-132普伐他汀钠片Pravastatin Sodium Tablet/Sanaprav40mgDAIICHI SANKYO ITALIA S.p.A./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
10-194盐酸曲唑酮片Trazodone Hydrochloride Tablets/RESLIN25mgMSD 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
10-195盐酸曲唑酮片Trazodone Hydrochloride Tablets/RESLIN50mgMSD 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
23-166盐酸利多卡因注射液Lidocaine Hydrochloride Injection2%(以C14H22N2O• HCL计)(5ml、10ml、20ml)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
26-167盐酸多巴胺注射液Dopamine Hydrochloride Injection/Inovan2.5ml:50mg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
26-168盐酸多巴胺注射液Dopamine Hydrochloride Injection/Inovan5ml:100mg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
26-1丙酸氟替卡松乳膏Fluticasone Propionate Cream/Cutivate0.05% (包装规格15、30、50、100g)Glaxo Wellcome/GlaxoSmithKline/GlaxoSmithKline(Ireland)Limited未进口原研药品增加持商:GlaxoSmithKline(Ireland)Limited
26-106依折麦布阿托伐他汀钙片Ezetimibe and Atorvastatin Calcium Trihydrate Tablets10mg/10mgMerck Sharp & Dohme/Organon Healthcare GmbH /Organon France未进口原研药品增加持证商Organon France
26-107依折麦布阿托伐他汀钙片Ezetimibe and Atorvastatin Calcium Trihydrate Tablets10mg/20mgMerck Sharp & Dohme/Organon Healthcare GmbH /Organon France未进口原研药品增加持证商Organon France
27-237羟乙基淀粉130/0.4氯化钠注射液Hydroxyethyl Starch 130/0.4 and Sodium Chloride Injection/Voluven Fresenius羟乙基淀粉130/0.4:60g/L,氯化钠:9.0g/L(250ml,500ml)Fresenius Kabi Deutschland GmbH/Fresenius Kabi Italia S.r.l./Fresenius Kabi Pharma Portugal, Lda未进口原研药品增加持证商Fresenius Kabi Pharma Portugal, Lda,
27-268氯硝西泮注射液Clonazepam Injection1ml:1mgRoche 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
27-372盐酸帕罗西汀片Paroxetine Hydrochloride Tablets/Paxil40mgApotex Technologies Inc/Apotex Inc未进口原研药品增加持证商Apotex Inc
30-149盐酸肾上腺素注射液/肾上腺素注射液Epinephrine Injection/ADRENALIN1ml:1mgPar Pharmaceutical, Inc/Par Sterile Products Llc未进口原研药品增加持证商 Par Sterile Products Llc
33-24乙酰半胱氨酸口服溶液Acetylcysteine Oral Solution2%(50ml、100ml、200ml)Zambon GmbH未进口原研药品不限定商品名
42-48盐酸帕罗西汀片Paroxetine Hydrochloride Tablets/Paxil10mgApotex Technologies Inc/Apotex Inc未进口原研药品增加持证商Apotex Inc
42-49盐酸帕罗西汀片Paroxetine Hydrochloride Tablets/Paxil30mgApotex Technologies Inc/Apotex Inc未进口原研药品增加持证商Apotex Inc
42-51丙酸氟替卡松乳膏Fluticasone Propionate Cream0.05%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


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