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【第七十八批】仿制藥參比制劑目錄


【第七十八批】仿制藥參比制劑目錄


序號(hào)藥品通用名稱英文名規(guī)格持證商備注1備注2劑型
78-1硫酸沙丁胺醇吸入粉霧劑Salbutamol Sulfate Inhalation Powder200μg/吸（按C13H21NO3計(jì)），200吸/支Orion Corporation國(guó)內(nèi)上市的原研藥品原研進(jìn)口吸入粉霧劑
78-2乳酸鈉林格沖洗液LACTATED RINGER'S IN PLASTIC CONTAINER20mg/100ml; 30mg/100ml; 600mg/100ml; 310mg/100mlB BRAUN MEDICAL INC未進(jìn)口原研藥品美國(guó)橙皮書沖洗液
78-3鹽酸特泊替尼片Tepotinib Hydrochloride Tablets /Tepmetko225mg（以特泊替尼計(jì)）Merck Europe B.V.未進(jìn)口原研藥品歐盟上市片劑
78-4鹽酸奧洛他定口崩片Olopatadine Hydrochloride OD Tablets/ALLELOCK?OD Tablets5mg協(xié)和キリン株式會(huì)社未進(jìn)口原研藥品日本上市口崩片
78-5注射用絲裂霉素?Mitomycin for Injection10mg協(xié)和キリン株式會(huì)社未進(jìn)口原研藥品日本上市注射劑
78-6
阿替卡因腎上腺素注射液Articaine Hydrochloride and Epinephrine Tartrate Injection1.7ml：鹽酸阿替卡因68mg?與酒石酸腎上腺素17μg（按腎上腺素計(jì)）SEPTODONT國(guó)內(nèi)上市的原研藥品原研進(jìn)口注射劑
78-7達(dá)格列凈二甲雙胍緩釋片（Ⅰ）Dapagliflozin and Metformin Hydrochloride Sustained-release Tablets (Ⅰ)達(dá)格列凈10mg（以C??H??ClO?計(jì)）和鹽酸二甲雙胍1000mgAstraZeneca AB國(guó)內(nèi)上市的原研藥品原研進(jìn)口緩釋片
78-8達(dá)格列凈二甲雙胍緩釋片（Ⅰ）Dapagliflozin and Metformin Hydrochloride Sustained-release Tablets (Ⅰ)達(dá)格列凈5mg（以C??H??ClO?計(jì)）和鹽酸二甲雙胍500mgAstraZeneca AB國(guó)內(nèi)上市的原研藥品原研進(jìn)口緩釋片
78-9達(dá)格列凈二甲雙胍緩釋片（Ⅱ）Dapagliflozin and Metformin Hydrochloride Sustained-release Tablets (Ⅱ)達(dá)格列凈2.5 mg（以C??H??ClO?計(jì)）和鹽酸二甲雙胍1000 mgAstraZeneca AB國(guó)內(nèi)上市的原研藥品原研進(jìn)口緩釋片
78-10達(dá)格列凈二甲雙胍緩釋片（Ⅲ）Dapagliflozin and Metformin Hydrochloride Sustained-release Tablets (Ⅲ)達(dá)格列凈5mg（以C??H??ClO?計(jì)）和鹽酸二甲雙胍1000mgAstraZeneca AB國(guó)內(nèi)上市的原研藥品原研進(jìn)口緩釋片
78-11達(dá)格列凈二甲雙胍緩釋片（Ⅳ）Dapagliflozin and Metformin Hydrochloride Sustained-release Tablets (Ⅳ)達(dá)格列凈10mg（以C??H??ClO?計(jì)）和鹽酸二甲雙胍500mgAstraZeneca AB國(guó)內(nèi)上市的原研藥品原研進(jìn)口緩釋片
78-12氫溴酸替格列汀片Teneligliptin Hydrobromide Tablets /Tenelia20mgMitsubishi Tanabe Pharma Corporation國(guó)內(nèi)上市的原研藥品原研進(jìn)口片劑
78-13碘美普爾注射液Iomeprol Injection/Iomeron（典邁倫）500ml:175g（I）Bracco Imaging Italia S.r.L.國(guó)內(nèi)上市的原研藥品原研進(jìn)口注射劑
78-14碘美普爾注射液Iomeprol Injection/Iomeron（典邁倫）500ml:200g（I）Bracco Imaging Italia S.r.L.國(guó)內(nèi)上市的原研藥品原研進(jìn)口注射劑
78-15
甘油磷酸鈉注射液Sodium Glycerophosphate Injection /Glycophos（格利福斯）10ml : 2.16g費(fèi)森尤斯卡比華瑞制藥有限公司經(jīng)審核確定的國(guó)外原研企業(yè)在中國(guó)境內(nèi)生產(chǎn)的藥品原研地產(chǎn)化注射劑
78-16
艾司唑侖片Estazolam Tablets2mgDr Reddys Laboratories SA國(guó)際公認(rèn)的同種藥品美國(guó)橙皮書片劑
78-17碘佛醇注射液Ioversol Injection/OPTIRAY 350350 mg iodine/mL (ioversol 74%)LIEBEL-FLARSHEIM CO LLC未進(jìn)口原研藥品美國(guó)橙皮書注射劑
78-18碘佛醇注射液Ioversol Injection/OPTIRAY 320320 mg iodine/mL (ioversol 68%)LIEBEL-FLARSHEIM CO LLC未進(jìn)口原研藥品美國(guó)橙皮書注射劑
78-19鹽酸特比萘芬片Terbinafine Hydrochloride Tablets/Lamisil0.125gNovartis Poland Sp. z o.o.未進(jìn)口原研藥品歐盟上市片劑
78-20甲巰咪唑片ThiamazoleTablets/Thyrozol5mgMerck HealthcareGermany GmbH未進(jìn)口原研藥品歐盟上市片劑
78-21鹽酸賽庚啶片Cyproheptadine Hydrochloride Tablets/Periactin4mgAlfasigma S.p.A/Alfasigma Espa?a, S.L未進(jìn)口原研藥品歐盟上市片劑
78-22利伐沙班干混懸劑Rivaroxaban for suspension/ Xarelto51.7mgBayer AG未進(jìn)口原研藥品歐盟上市混懸劑
78-23利伐沙班干混懸劑Rivaroxaban for suspension/ Xarelto103.4mgBayer AG未進(jìn)口原研藥品歐盟上市混懸劑
78-24乙酰半胱氨酸片Acetylcysteine Tablets/Fluimucil600mgZambon Svizzera SA未進(jìn)口原研藥品瑞士上市片劑
78-25利培酮口服溶液Risperidone Oral Solution/Risperdal0.1%（0.5ml:0.5mg）ヤンセンファーマ株式會(huì)社未進(jìn)口原研藥品日本上市口服溶液
78-26利培酮口服溶液Risperidone Oral Solution/Risperdal0.1%（1ml:1mg）ヤンセンファーマ株式會(huì)社未進(jìn)口原研藥品日本上市口服溶液
78-27利培酮口服溶液Risperidone Oral Solution/Risperdal0.1%（2ml:2mg）ヤンセンファーマ株式會(huì)社未進(jìn)口原研藥品日本上市口服溶液
78-28利培酮口服溶液Risperidone Oral Solution/Risperdal0.1%（3ml:3mg）ヤンセンファーマ株式會(huì)社未進(jìn)口原研藥品日本上市口服溶液
8-202西格列汀二甲雙胍片(Ⅰ）Sitagliptin Phosphate/metformin Hydrochloride Tablets/JANUMET磷酸西格列汀50mg（以游離堿計(jì)）/鹽酸二甲雙胍500mgMSD Pharma (Singapore) Pte.Ltd/MSD Merck Sharp & Dohme AG原研進(jìn)口增加變更后上市許可持有人MSD Merck Sharp & Dohme AG片劑
8-203西格列汀二甲雙胍片(Ⅱ）Sitagliptin Phosphate/metformin Hydrochloride Tablets/JANUMET磷酸西格列汀50mg（以游離堿計(jì)）/鹽酸二甲雙胍850mgMSD Pharma (Singapore) Pte.Ltd/MSD Merck Sharp & Dohme AG原研進(jìn)口增加變更后上市許可持有人MSD Merck Sharp & Dohme AG片劑
10--15巴氯芬片Baclofen Tablets/Lioresal10mgNovartis Pharma Schweiz AG/Future Health Pharma GmbH/Hemony Pharmaceutical Switzerland GmbH原研進(jìn)口增加變更后上市許可持有人Future Health Pharma GmbH片劑
10--23單硝酸異山梨酯緩釋片Isosorbide Mononitrate Sustained-release Tablets/Ismo retard40mgRiemser Pharma GmbH/Esteve Pharmaceuticals Gmbh歐盟上市（上市國(guó)家：德國(guó)；產(chǎn)地：西班牙）增加變更后上市許可持有人Esteve Pharmaceuticals Gmbh緩釋片
10-281枸櫞酸坦度螺酮片Tandospirone Citrate Tablets/Sediel10mgSumitomo Dainippon Pharma Co., Ltd./ Sumitomo Pharma Co., Ltd.原研進(jìn)口增加變更后上市許可持有人Sumitomo Pharma Co., Ltd.片劑
10-282枸櫞酸坦度螺酮片Tandospirone Citrate Tablets/Sediel5mgSumitomo Dainippon Pharma Co., Ltd./ Sumitomo Pharma Co., Ltd.原研進(jìn)口增加變更后上市許可持有人Sumitomo Pharma Co., Ltd.片劑
21-157注射用美羅培南Meropenem For Injection/Mepem（美平）0.5gSumitomo Dainippon Pharma Co.，Ltd./?Sumitomo Pharma Co., Ltd.國(guó)內(nèi)上市的原研藥品增加變更后上市許可持有人Sumitomo Pharma Co., Ltd.注射劑
23-169羅庫(kù)溴銨注射液Rocuronium Bromide Injection/Esmeron（愛可松）5ml：50mgN.V. Organon/Merck Sharp & Dohme B.V.國(guó)內(nèi)上市的原研藥品增加變更后上市許可持有人Merck Sharp & Dohme B.V.注射劑
23-264注射用頭孢呋辛鈉Cefuroxime Sodium For Injection/CUROXIM1g?（以頭孢呋辛計(jì)）（靜脈注射，溶劑為注射用水）Glaxosmithkline S.P.A./Sandoz S.p.A未進(jìn)口原研藥品增加變更后的上市許可持有人Sandoz S.p.A注射劑
25-30注射用亞胺培南西司他丁鈉Imipenem and Cilastatin Sodium for Injection/Tienam（泰能）亞胺培南500mg和西司他丁500mgMerck Sharp & Dohme Corp./Merck Sharp & Dohme LLC國(guó)內(nèi)上市的原研藥品增加變更后上市許可持有人Merck Sharp & Dohme LLC注射劑
26-218依折麥布片Ezetimibe Tablets/Zetia10mgMSP Distribution Services (C) LLC/ORGANON LLC, A SUB OF ORGANON AND CO未進(jìn)口原研藥品增加變更后的上市許可持有人ORGANON LLC, A SUB OF ORGANON AND CO片劑
27-426氨氯地平貝那普利膠囊Amlodipine and Benazepril Hydrochloride Capsules /Lotrel氨氯地平5mg;鹽酸貝那普利10mgNovartis Pharmaceuticals Corp/SANDOZ INC未進(jìn)口原研藥品增加變更后上市許可持有人SANDOZ INC膠囊劑
30-40氨氯地平阿托伐他汀鈣片Amlodipine Besylate and Atorvastatin Calcium Tablets/Caduet氨氯地平5mg和阿托伐他汀20mgPFIZER INC/Pharmacia And Upjohn Co LLC未進(jìn)口原研藥品增加變更后上市許可持有人Pharmacia And Upjohn Co LLC片劑
34-23鹽酸特比萘芬片Terbinafine Hydrochloride Tablets/Lamisil0.25gNovatis Farma–Produtos Farmacêeuticos,S.A/Novartis Poland Sp. z o.o.未進(jìn)口原研藥品增加上市許可持有人Novartis Poland Sp. z o.o.片劑
38-13鹽酸環(huán)丙沙星滴眼液Ciprofloxacin ophthalmic solution/CILOXAN0.30%NOVARTIS PHARMACEUTICALS CORP / SANDOZ INC未進(jìn)口原研藥品增加變更后上市許可持有人SANDOZ INC滴眼液
39-5鹽酸美金剛多奈哌齊緩釋膠囊Memantine Hydrochloride Extended-release and Donepezil Hydrochloride Capsules/Namzaric7mg/10mgAllergan Sales LLC/ABBVIE INC未進(jìn)口原研藥品增加變更后上市許可持有人ABBVIE INC膠囊劑
39-6鹽酸美金剛多奈哌齊緩釋膠囊Memantine Hydrochloride Extended-release and Donepezil Hydrochloride Capsules/Namzaric14mg/10mgAllergan Sales LLC/ABBVIE INC未進(jìn)口原研藥品增加變更后上市許可持有人ABBVIE INC膠囊劑
39-7鹽酸美金剛多奈哌齊緩釋膠囊Memantine Hydrochloride Extended-release and Donepezil Hydrochloride Capsules/Namzaric21mg/10mgAllergan Sales LLC/ABBVIE INC未進(jìn)口原研藥品增加變更后上市許可持有人ABBVIE INC膠囊劑
39-8鹽酸美金剛多奈哌齊緩釋膠囊Memantine Hydrochloride Extended-release and Donepezil Hydrochloride Capsules / Namzaric28mg/10mgAllergan Sales LLC/ABBVIE INC未進(jìn)口原研藥品增加變更后上市許可持有人ABBVIE INC膠囊劑
41-14鹽酸達(dá)克羅寧局部溶液劑Dyclonine Topical Solution/Dyclopro0.50%Novocol Inc/SEPTODONT INC國(guó)際公認(rèn)的同種藥品增加變更后上市許可持有人SEPTODONT INC溶液劑
41-15鹽酸達(dá)克羅寧局部溶液劑Dyclonine Topical Solution/Dyclopro1%Novocol Inc/SEPTODONT INC國(guó)際公認(rèn)的同種藥品增加變更后上市許可持有人SEPTODONT INC溶液劑
41-54鹽酸昂丹司瓊片Ondansetron Hydrochloride Tablets/Zofran4mgNovartis Pharmaceuticals Corp/Novartis Pharma GmbH/未進(jìn)口原研藥品增加上市許可持有人Novartis FARMA S.P.A/ Hexal AG片劑
41-55鹽酸昂丹司瓊片Ondansetron Hydrochloride Tablets/Zofran8mgNovartis Pharmaceuticals Corp/Novartis Pharma GmbH/未進(jìn)口原研藥品增加上市許可持有人Novartis FARMA S.P.A片劑
60-23非那雄胺他達(dá)拉非膠囊Finasteride and Tadalafil Capsules / Entadfi5mg/5mgVeru Inc/BLUE WATER BIOTECH INC未進(jìn)口原研藥品增加變更后上市許可持有人:BLUE WATER BIOTECH INC膠囊劑
60-68碳酸司維拉姆干混懸劑Sevelamer Carbonate Powder for oral suspension/Renvela0.8gGenzyme Europe B.V./Sanofi B.V.未進(jìn)口原研藥品增加變更后上市許可持有人Sanofi B.V.干混懸劑
63-19氨氯地平貝那普利膠囊Amlodipine besylate and benazepril hydrochloride capsules/Lotrel氨氯地平2.5mg;鹽酸貝那普利10mgNovartis Pharmaceuticals Corp/SANDOZ INC未進(jìn)口原研藥品增加變更后上市許可持有人SANDOZ INC膠囊劑
64-50培哚普利氨氯地平片（I）Perindopril arginine and amlodipine besylate tablets/COVERAM/COVERLAM/Procoversyl/Prestance/Presteram每片含精氨酸培哚普利5mg和苯磺酸氨氯地平（以氨氯地平計(jì)）5mgLes Laboratoires Servier/Servier Pharma d.o.o.未進(jìn)口原研藥品增加上市許可持有人Servier Pharma d.o.o.片劑
64-51培哚普利氨氯地平片（III）Perindopril arginine and amlodipine besylate tablets/COVERAM/COVERLAM/Procoversyl/Prestance/Presteram每片含精氨酸培哚普利10mg和苯磺酸氨氯地平（以氨氯地平計(jì)）5mgLes Laboratoires Servier/Servier Pharma d.o.o.未進(jìn)口原研藥品增加上市許可持有人Servier Pharma d.o.o.片劑
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