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【第六十批】仿制藥參比制劑目錄


【第六十批】仿制藥參比制劑目錄


序號(hào)藥品通用名稱英文名稱/商品名規(guī)格持證商備注1備注2
60-1拉米夫定多替拉韋片Lamivudine and Dolutegravir Sodium Tablets/多偉托每片含拉米夫定300mg和多替拉韋鈉（以多替拉韋計(jì)）50mgViiV Healthcare B.V.國內(nèi)上市的原研藥品原研進(jìn)口
60-2磷/碳酸氫鈉血濾置換液Hemofiltration Replacement Fluid of Sodium Bicarbonate and Phosphate5000ml（250ml/4750ml）Gambro Lundia AB國內(nèi)上市的原研藥品原研進(jìn)口
60-3咪康唑口腔貼片Miconazole Buccal Tablet/?諾彌可50 mgVECTANS PHARMA國內(nèi)上市的原研藥品原研進(jìn)口
60-4甲苯磺酸盧美哌隆膠囊Lumateperone tosylate capsule/Caplyta42 mg（以盧美哌隆計(jì)）Intra-Cellular Therapies Inc未進(jìn)口原研藥品美國橙皮書
60-5復(fù)方電解質(zhì)注射液Multiple Electrolytes Injection/Plasma-Lyte A500mlBaxter Healthcare Corp未進(jìn)口原研藥品美國橙皮書
60-6碳酸氫鈉注射液Sodium Bicarbonate Injection0.9MEQ/ML（7.5%）Exela Pharma Sciences LLC國際公認(rèn)的同種藥品美國橙皮書
60-7碳酸氫鈉注射液Sodium Bicarbonate Injection1MEQ/ML（8.4%）Exela Pharma Sciences LLC國際公認(rèn)的同種藥品美國橙皮書
60-8非奈利酮片Finerenone Tablets/Kerendia10mgBayer Healthcare Pharmaceuticals INC未進(jìn)口原研藥品美國橙皮書
60-9非奈利酮片Finerenone Tablets/Kerendia20mgBayer Healthcare Pharmaceuticals INC未進(jìn)口原研藥品美國橙皮書
60-10氯苯唑酸軟膠囊Tafamidis soft Capsules /Vyndamax61mgFoldrx Pharmaceuticals LLC A Wholly Owned Sub Of Pfizer INC未進(jìn)口原研藥品美國橙皮書
60-11氨基己酸口服溶液Aminocaproic Acid Oral Solution /Amicar0.25 g/mlAkorn Operating CO LLC未進(jìn)口原研藥品美國橙皮書
60-12維利西呱片Vericiguat Tablets/Verquvo2.5mgMerck Sharp And Dohme Corp未進(jìn)口原研藥品美國橙皮書
60-13維利西呱片Vericiguat Tablets/Verquvo5mgMerck Sharp And Dohme Corp未進(jìn)口原研藥品美國橙皮書
60-14維利西呱片Vericiguat Tablets/Verquvo10mgMerck Sharp And Dohme Corp未進(jìn)口原研藥品美國橙皮書
60-15度骨化醇軟膠囊Doxercalciferol Capsules /Hectorol2.5μgSanofi Genzyme未進(jìn)口原研藥品美國橙皮書
60-16度骨化醇軟膠囊Doxercalciferol Capsules /Hectorol1μgSanofi Genzyme未進(jìn)口原研藥品美國橙皮書
60-17度骨化醇軟膠囊Doxercalciferol Capsules /Hectorol0.5μgSanofi Genzyme未進(jìn)口原研藥品美國橙皮書
60-18潑尼松龍磷酸鈉口服溶液Prednisolone Sodium phosphate Oral solution/ Pediapred5mg/5mlSeton Pharmaceutical LLC未進(jìn)口原研藥品美國橙皮書
60-19環(huán)磷酰胺注射液Cyclophosphamide Injection500mg/2.5ml（200mg/ml）Ingenus Pharmaceuticals,LLC未進(jìn)口原研藥品美國橙皮書
60-20環(huán)磷酰胺注射液Cyclophosphamide Injection1g/5ml（200mg/ml）Ingenus Pharmaceuticals,LLC未進(jìn)口原研藥品美國橙皮書
60-21環(huán)磷酰胺注射液Cyclophosphamide Injection2g/10ml（200mg/ml）Ingenus Pharmaceuticals,LLC未進(jìn)口原研藥品美國橙皮書
60-22枸櫞酸托法替布口服溶液Tofacitinib Citrate Oral Solution1mg/ml，240mlPfizer Inc.未進(jìn)口原研藥品美國橙皮書
60-23非那雄胺他達(dá)拉非膠囊Finasteride and Tadalafil Capsules / Entadfi5mg/5mgVeru Inc未進(jìn)口原研藥品美國橙皮書
60-24依托咪酯注射液Etomidate Injection/Amidate10ml∶20mgHospira INC未進(jìn)口原研藥品美國橙皮書
60-25瑪巴洛沙韋干混懸劑Baloxavir Marboxil for Suspension/Xofluza2mg/mlGenentech Inc.未進(jìn)口原研藥品美國橙皮書
60-26鹽酸沙瑞環(huán)素片?Sarecycline Hydrochloride Tablet/Seysara60mgAlmirall LLC未進(jìn)口原研藥品美國橙皮書
60-27鹽酸沙瑞環(huán)素片?Sarecycline Hydrochloride Tablet/Seysara100mgAlmirall LLC未進(jìn)口原研藥品美國橙皮書
60-28鹽酸沙瑞環(huán)素片?Sarecycline Hydrochloride Tablet/Seysara150mgAlmirall LLC未進(jìn)口原研藥品美國橙皮書
60-29注射用鹽酸替拉凡星Telavancin Hydrochloride for Injection/Vibativ750 mgCumberland Pharmaceuticals Inc.未進(jìn)口原研藥品美國橙皮書
60-30托吡卡胺滴眼液Tropicamide Ophthalmic Solution/ Mydriacyl0.50%Sandoz INC未進(jìn)口原研藥品美國橙皮書
60-31磷酸二氨基吡啶片Amifampridine phosphate tablets/Firdapse10mgSERB S.A.未進(jìn)口原研藥品歐盟上市
60-32比拉斯汀口服溶液Bilastine Oral Solution2.5mg/mlMenarini International Operations Luxembourg S.A./FAES Farma, S.A.未進(jìn)口原研藥品歐盟上市
60-33鹽酸巴尼地平緩釋膠囊Barnidipine Hydrochloride ?Sustained-Release Capsules / Libradin10mgAlfasigma S.p.A.未進(jìn)口原研藥品歐盟上市
60-34鹽酸喹高利特片Quinagolide Hydrochloride Tablets/Norprolac25μg（按C20H33N3O3S計(jì)）Ferring Arzneimittel GmbH未進(jìn)口原研藥品歐盟上市
60-35鹽酸喹高利特片Quinagolide Hydrochloride Tablets/Norprolac50μg（按C20H33N3O3S計(jì)）Ferring Arzneimittel GmbH未進(jìn)口原研藥品歐盟上市
60-36鹽酸喹高利特片Quinagolide Hydrochloride Tablets/Norprolac75μg（按C20H33N3O3S計(jì)）Ferring Arzneimittel GmbH未進(jìn)口原研藥品歐盟上市
60-37鹽酸喹高利特片Quinagolide Hydrochloride Tablets/Norprolac150μg（按C20H33N3O3S計(jì)）Ferring Arzneimittel GmbH未進(jìn)口原研藥品歐盟上市
60-38枸櫞酸托法替布口服溶液Tofacitinib Citrate Oral Solution1mg/ml，240mlPfizer Europe MA EEIG未進(jìn)口原研藥品歐盟上市
60-39亞甲藍(lán)腸溶緩釋片Methylthioninium Chloride Enteric-coated Sustained-Release Tablets / Lumeblue25mgAlfasigma S.p.A.
歐盟上市
60-40異康唑二氟可龍乳膏Isoconazole Nitrate and Diflucortolone Valerate Cream /Travocort?Cream1%,0.1%LEO Pharma A/S
歐盟上市
60-41鹽酸美貝維林片?Mebeverine Hydrochloride Tablets / Colofac135mgMylan Products Ltd.未進(jìn)口原研藥品歐盟上市
60-42水合氯醛灌腸劑Chloral Hydrate Enemas/ Escre1.34g：0.5g久光製薬株式會(huì)社未進(jìn)口原研藥品日本上市
60-43復(fù)方聚乙二醇電解質(zhì)散（Ⅱ）Polyethylene Glycol Electrolytes Powder (II)/Niflec137.155g/袋EAファーマ株式會(huì)社未進(jìn)口原研藥品日本上市
60-44硝酸異康唑乳膏Isoconazole Nitrate Cream/Adestan Cream1%バイエル薬品株式會(huì)社未進(jìn)口原研藥品日本上市
60-45醋酸蘭瑞肽緩釋注射液（預(yù)充式）Lanreotide Acetate Sustained-release Injection (a pre-filled syringe)60mgIpsen Pharma國內(nèi)上市的原研藥品原研進(jìn)口
60-46醋酸蘭瑞肽緩釋注射液（預(yù)充式）Lanreotide Acetate Sustained-release Injection (a pre-filled syringe)90mgIpsen Pharma國內(nèi)上市的原研藥品原研進(jìn)口
60-47醋酸蘭瑞肽緩釋注射液（預(yù)充式）Lanreotide Acetate Sustained-release Injection (a pre-filled syringe)120mgIpsen Pharma國內(nèi)上市的原研藥品原研進(jìn)口
60-48阿法骨化醇軟膠囊Alfacalcidol Soft Capsules / Etalpha1μgCHEPLAPHARM Arzneimittel GmbH國內(nèi)上市的原研藥品原研進(jìn)口
60-49瑪巴洛沙韋片?Baloxavir Marboxil Tablets/Xofluza(速福達(dá))40mgRoche Pharma (Schweiz) AG國內(nèi)上市的原研藥品原研進(jìn)口
60-50硫酸氫氯吡格雷片Clopidogrel Hydrogen Sulphate Tablets/Plavix75mg賽諾菲（杭州）制藥有限公司?經(jīng)審核確定的國外原研企業(yè)在中國境內(nèi)生產(chǎn)的藥品原研地產(chǎn)化
60-51注射用頭孢哌酮鈉舒巴坦鈉Cefoperazone Sodium and Sulbactam Sodium for Injection/舒普深1.5g（C25H27N9O8S2?1.0g與C8H11NO5S 0.5g）輝瑞制藥有限公司經(jīng)審核確定的國外原研企業(yè)在中國境內(nèi)生產(chǎn)的藥品原研地產(chǎn)化
60-52注射用頭孢哌酮鈉舒巴坦鈉Cefoperazone Sodium and Sulbactam Sodium for Injection/舒普深1.0g（C25H27N9O8S2?0.5g與C8H11NO5S 0.5g）輝瑞制藥有限公司經(jīng)審核確定的國外原研企業(yè)在中國境內(nèi)生產(chǎn)的藥品原研地產(chǎn)化
60-53尼洛替尼膠囊?Nilotinib Capsules/Tasigna50mgNovartis Pharmaceuticals Corp未進(jìn)口原研藥品美國橙皮書
60-54尼洛替尼膠囊?Nilotinib Capsules/Tasigna150mgNovartis Pharmaceuticals Corp未進(jìn)口原研藥品美國橙皮書
60-55尼洛替尼膠囊?Nilotinib Capsules/Tasigna200mgNovartis Pharmaceuticals Corp未進(jìn)口原研藥品美國橙皮書
60-56酮咯酸氨丁三醇注射液Ketorolac Tromethamine Injection15mg/ml（1ml:15mg）Hospira INC.國際公認(rèn)的同種藥品美國橙皮書
60-57環(huán)孢素軟膠囊Ciclosporin Soft Capsules/100mgNovartis Pharmaceuticals Corporation未進(jìn)口原研藥品美國橙皮書
?Neoral
60-58吸入用布地奈德混懸液Budesonide Suspension For Inhalation/ Pulmicort Respules2ml：0.5mgAstrazeneca Pharmaceuticals LP未進(jìn)口原研藥品美國橙皮書
60-59吸入用布地奈德混懸液Budesonide Suspension For Inhalation/ Pulmicort Respules2ml：1mgAstrazeneca Pharmaceuticals LP未進(jìn)口原研藥品美國橙皮書
60-60奧美沙坦酯氫氯噻嗪片Hydrochlorothiazide;Olmesartan Medoxomil /Benicar Hct20mg/12.5mgDaiichi Sankyo Inc未進(jìn)口原研藥品美國橙皮書
60-61布洛芬注射液※Ibuprofen Injection/Caldolor800MG/8ML (100MG/ML)Cumberland Pharmaceuticals Inc未進(jìn)口原研藥品美國橙皮書
60-62氟維司群注射液Faslodex 250 mg solution for injection/Faslodex5ml:0.25gAstraZeneca AB/AstraZeneca UK Limited未進(jìn)口原研藥品歐盟上市
60-63氯苯唑酸葡胺軟膠囊Tafamidis Meglumine Soft Capsules/Vyndaqel20mgPfizer Europe MA EEIG未進(jìn)口原研藥品歐盟上市
60-64恩他卡朋片Entacapone Tablets /Comtess200mgOrion Pharma GmbH未進(jìn)口原研藥品歐盟上市
60-65卡格列凈片Canagliflozin Tablets/Invokana300mgJanssen-Cilag International NV,未進(jìn)口原研藥品歐盟上市
60-66硫酸羥氯喹片Hydroxychloroquine Sulfate Tablets/Plaquenil0.2gSanofi-Aventis未進(jìn)口原研藥品歐盟上市
60-67二硫化硒洗劑Selenium Sulfide Lotion/Selsun2.50%Sanofi-Aventis Netherlands B.V./ Opella Healthcare France SAS未進(jìn)口原研藥品歐盟上市
60-68碳酸司維拉姆干混懸劑Sevelamer Carbonate Powder for oral suspension/Renvela0.8gGenzyme Europe B.V.未進(jìn)口原研藥品歐盟上市
60-69碳酸司維拉姆干混懸劑Sevelamer Carbonate Powder for oral suspension/Renvela2.4gGenzyme Europe B.V.未進(jìn)口原研藥品歐盟上市
60-70達(dá)肝素鈉注射液Dalteparin Sodium Injection/Fragmin0.2ml:2500IUPfizer Pharma Pfe GmbH未進(jìn)口原研藥品歐盟上市
60-71比沙可啶腸溶片Bisacodyl Enteric-coated Tablets/Dulcolax5mgOpella Healthcare France SAS未進(jìn)口原研藥品歐盟上市
60-72鹽酸文拉法辛緩釋膠囊Venlafaxine Hydrochloride Sustained-Release Capsules/Efexor XL75mg（以文拉法辛計(jì)）Upjohn UK Limited未進(jìn)口原研藥品歐盟上市
60-73鹽酸文拉法辛緩釋膠囊Venlafaxine Hydrochloride Sustained-Release Capsules/Efexor XL150mg（以文拉法辛計(jì)）Upjohn UK Limited未進(jìn)口原研藥品歐盟上市
60-74骨化三醇注射液Calcitriol Injection/Rocaltrol1ml:0.5μg協(xié)和キリン株式會(huì)社未進(jìn)口原研藥品日本上市
60-75骨化三醇注射液Calcitriol Injection/Rocaltrol1ml:1μg協(xié)和キリン株式會(huì)社未進(jìn)口原研藥品日本上市
5-43鹽酸帕羅西汀片Paroxetine Hydrochloride Tablets/Paxil20mgApotex Technologies Inc/Apotex Inc未進(jìn)口原研藥品增加持證商Apotex Inc
10-132普伐他汀鈉片Pravastatin Sodium Tablet/Sanaprav40mgDAIICHI SANKYO ITALIA S.p.A./Daiichi Sankyo Belgium S.A/Daiichi Sankyo Europe Gmbh歐盟上市增加持證商Daiichi Sankyo Belgium S.A/Daiichi Sankyo Europe Gmbh，不限定上市國和產(chǎn)地
10-194鹽酸曲唑酮片Trazodone Hydrochloride Tablets/RESLIN25mgMSD K.K./オルガノン株式會(huì)社日本橙皮書增加持證商オルガノン株式會(huì)社
10-195鹽酸曲唑酮片Trazodone Hydrochloride Tablets/RESLIN50mgMSD K.K./オルガノン株式會(huì)社日本橙皮書增加持證商オルガノン株式會(huì)社
23-166鹽酸利多卡因注射液Lidocaine Hydrochloride Injection2%（以C14H22N2O? HCL計(jì)）（5ml、10ml、20ml）Aspen/Aspen Pharma Trading Limited未進(jìn)口原研藥品增加持商：Aspen Pharma Trading Limited，不限定商品名
26-167鹽酸多巴胺注射液Dopamine Hydrochloride Injection/Inovan2.5ml:50mg協(xié)和発酵キリン株式會(huì)社/協(xié)和キリン株式會(huì)社未進(jìn)口原研藥品增加持證商協(xié)和キリン株式會(huì)社
26-168鹽酸多巴胺注射液Dopamine Hydrochloride Injection/Inovan5ml:100mg協(xié)和発酵キリン株式會(huì)社/協(xié)和キリン株式會(huì)社未進(jìn)口原研藥品增加持證商協(xié)和キリン株式會(huì)社
26-1丙酸氟替卡松乳膏Fluticasone Propionate Cream/Cutivate0.05%?（包裝規(guī)格15、30、50、100g）Glaxo Wellcome/GlaxoSmithKline/GlaxoSmithKline（Ireland）Limited未進(jìn)口原研藥品增加持商：GlaxoSmithKline（Ireland）Limited
26-106依折麥布阿托伐他汀鈣片Ezetimibe and Atorvastatin Calcium Trihydrate Tablets10mg/10mgMerck Sharp & Dohme/Organon Healthcare GmbH /Organon France未進(jìn)口原研藥品增加持證商Organon France
26-107依折麥布阿托伐他汀鈣片Ezetimibe and Atorvastatin Calcium Trihydrate Tablets10mg/20mgMerck Sharp & Dohme/Organon Healthcare GmbH /Organon France未進(jìn)口原研藥品增加持證商Organon France
27-237羥乙基淀粉130/0.4氯化鈉注射液Hydroxyethyl Starch 130/0.4 and Sodium Chloride Injection/Voluven Fresenius羥乙基淀粉130/0.4:60g/L，氯化鈉:9.0g/L（250ml，500ml）Fresenius Kabi Deutschland GmbH/Fresenius Kabi Italia S.r.l./Fresenius Kabi Pharma Portugal, Lda未進(jìn)口原研藥品增加持證商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未進(jìn)口原研藥品增加持證商CPS Cito Pharma Services GmbH
27-372鹽酸帕羅西汀片Paroxetine Hydrochloride Tablets/Paxil40mgApotex Technologies Inc/Apotex Inc未進(jìn)口原研藥品增加持證商Apotex Inc
30-149鹽酸腎上腺素注射液/腎上腺素注射液Epinephrine Injection/ADRENALIN1ml:1mgPar Pharmaceutical, Inc/Par Sterile Products Llc未進(jìn)口原研藥品增加持證商?Par Sterile Products Llc
33-24乙酰半胱氨酸口服溶液Acetylcysteine Oral Solution2%（50ml、100ml、200ml）Zambon GmbH未進(jìn)口原研藥品不限定商品名
42-48鹽酸帕羅西汀片Paroxetine Hydrochloride Tablets/Paxil10mgApotex Technologies Inc/Apotex Inc未進(jìn)口原研藥品增加持證商Apotex Inc
42-49鹽酸帕羅西汀片Paroxetine Hydrochloride Tablets/Paxil30mgApotex Technologies Inc/Apotex Inc未進(jìn)口原研藥品增加持證商Apotex Inc
42-51丙酸氟替卡松乳膏Fluticasone Propionate Cream0.05%Perrigo Israel Pharmaceuticals Ltd / Padagis Israel Pharmaceuticals Ltd國際公認(rèn)的同種藥品增加持證商Padagis Israel Pharmaceuticals Ltd
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