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【第四十一批】仿制药参比制剂目录


【第四十一批】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
41-1拉坦噻吗滴眼液Latanoprost and Timolol Maleate Eye Drops
每1ml溶液含50μg拉坦前列素和6.8mg马来酸噻吗洛尔Pfizer SA国内上市的原研药品原研进口
41-2甲磺酸奥希替尼片Osimertinib Mesylate Tablets Tagrisso(泰瑞沙)80mgAstraZeneca AB国内上市的原研药品原研进口
41-3枸橼酸伊沙佐米胶囊Ixazomib Citrate CapsulesNinlaro(恩莱瑞)2.3mg(按C14H19BCl2N2O4计)Takeda Pharma A/S国内上市的原研药品原研进口
41-4枸橼酸伊沙佐米胶囊Ixazomib Citrate CapsulesNinlaro(恩莱瑞)3mg(按C14H19BCl2N2O4计)Takeda Pharma A/S国内上市的原研药品原研进口
41-5枸橼酸伊沙佐米胶囊Ixazomib Citrate CapsulesNinlaro(恩莱瑞)4mg(按C14H19BCl2N2O4计)Takeda Pharma A/S国内上市的原研药品原研进口
41-6吲哚美辛凝胶Indometacin GelVantelinkowa(万特力)每克含吲哚美辛0.01克与l-薄荷醇0.03克Kowa Company,Ltd.国内上市的原研药品原研进口
41-7醋酸阿比特龙片(II)Abiraterone Acetate TabletsYonsa125mgSun Pharma Global FZE未进口原研药品美国橙皮书
41-8丁酸氯维地平注射用乳剂Clevidipine Injectable EmulsionCleviprex25mg/50ml(0.5mg/ml)Chiesi USA INC未进口原研药品美国橙皮书
41-9丁酸氯维地平注射用乳剂Clevidipine Injectable EmulsionCleviprex50mg/100ml(0.5mg/ml)Chiesi USA INC未进口原研药品美国橙皮书
41-10碳酸司维拉姆干混悬剂Sevelamer Carbonate Powder for oral suspension Renvela2.4gGenzyme Corporation未进口原研药品美国橙皮书
41-11碳酸司维拉姆干混悬剂Sevelamer Carbonate Powder for oral suspension Renvela0.8gGenzyme Corporation未进口原研药品美国橙皮书
41-12钆贝葡胺注射液Gadobenate dimeglumine Injection Multihance15ml:7.935g(529mg/ml)Bracco Diagnostics Inc未进口原研药品美国橙皮书
41-13琥珀酸舒马普坦萘普生钠片Sumatriptan and Naproxen Sodium TabletsTreximet85/500mgCurrax Pharmaceuticals LLC未进口原研药品美国橙皮书
41-14盐酸达克罗宁局部溶液剂Dyclonine Topical SolutionDyclopro0.005Novocol Inc国际公认的同种药品美国橙皮书
41-15盐酸达克罗宁局部溶液剂Dyclonine Topical SolutionDyclopro0.01Novocol Inc国际公认的同种药品美国橙皮书
41-16克霉唑含片Clotrimazole Troche
10mgHikma Pharmaceuticals USA INC国际公认的同种药品美国橙皮书
41-17蒙脱石混悬液Montmorillonite Suspension
3gIpsen Pharma / Ipsen Consumer Healthcare未进口原研药品欧盟上市
41-18ω-3鱼油中长链脂肪乳/氨基酸(16)/葡萄糖(30%)注射液ω-3 Fish Oil Medium and Long Chain Fat Emulsion/Amino Acids (16)Glucose (30%) Injection1250mlB.Braun Melsungen AG未进口原研药品欧盟上市
41-19甲磺酸奥希替尼片Osimertinib Mesylate Tablets Tagrisso40mgAstraZeneca AB未进口原研药品欧盟上市
41-20肠内营养乳剂(SP)Enteral Nutritional Emulsion(SP) Survimed OPD500mlFresenius Kabi Deutschland GmbH未进口原研药品欧盟上市
41-21匹可硫酸钠滴剂Sodium Picosulfate Drops
7.5 mg/ml帝人ファーマ株式会社未进口原研药品日本上市
41-22布美他尼注射液Bumetanide Injection
1ml:0.5mg第一三共株式会社未进口原研药品日本上市
41-23盐酸纳呋拉啡口崩片Nalfurafine Hydrochloride OD TabletsRemitch OD Tablets2.5μg東レ株式会社未进口原研药品日本上市
41-24来特莫韦注射液Letermovir InjectionPrevymis20mg/ml(240mg:12ml)MSD株式会社未进口原研药品日本上市
41-25来特莫韦片Letermovir TabletsPrevymis240mgMSD株式会社未进口原研药品日本上市
41-26克立硼罗软膏Crisaborole OintmentStaquis(舒坦明)2%(30g、60g)Anacor Pharmaceuticals, Inc.国内上市的原研药品原研进口
41-27司来帕格片Selexipag TabletsUptravi(优拓比)0.4mgActelion Pharmaceuticals Ltd国内上市的原研药原研进口
41-28曲安奈德注射液Triamcinolone Acetonide Injectable SuspensionKenalog-1010mg/mlApothecon Inc Div Bristol Myers Squibb未进口原研药品美国橙皮书
41-29坎地沙坦酯氢氯噻嗪片Candesartan Cilexetil and Hydrochlorothiazide TabletsAtacand HCT16mg/12.5mgANI Pharmaceuticals INC/Astrazeneca未进口原研药品美国橙皮书
41-30注射用米卡芬净钠Micafungin Sodium for Injection Mycamine50mgAstellas Pharma US Inc未进口原研药品美国橙皮书
41-31注射用哌拉西林钠他唑巴坦钠Piperacillin And TazobactamZosyn4.5gWyeth Pharmaceuticals LLC未进口原研药品美国橙皮书
41-32盐酸托莫西汀胶囊Atomoxetine Hydrochloride CapsulesStrattera10mg(以托莫西汀碱计)Eli Lilly And Co未进口原研药品美国橙皮书
41-33盐酸托莫西汀胶囊Atomoxetine Hydrochloride CapsulesStrattera25mg(以托莫西汀碱计)Eli Lilly And Co未进口原研药品美国橙皮书
41-34盐酸托莫西汀胶囊Atomoxetine Hydrochloride CapsulesStrattera40mg(以托莫西汀碱计)Eli Lilly And Co未进口原研药品美国橙皮书
41-35熊去氧胆酸胶囊Ursodeoxycholic Acid Capsules  Actigall300mgAllergan Sales LLC未进口原研药品美国橙皮书
41-36碳酸镧咀嚼片Lanthanum Carbonate Chewable TabletsFosrenolEq 500mg BaseShire Development LLC/Takeda Pharmaceuticals USA INC未进口原研药品美国橙皮书
41-37钆布醇注射液Gadobutrol InjectionGadavist6.0472g/10ml (604.72mg/ml)Bayer Healthcare Pharmaceuticals Inc未进口原研药品美国橙皮书
41-38阿昔洛韦胶囊Aciclovir Capsules
0.2gApotex Inc国际公认的同种药品美国橙皮书
41-39他达拉非片Tadalafil TabletsAdcirca20mgEli Lilly CO未进口原研药品美国橙皮书
41-40他达拉非片Tadalafil TabletsCialis2.5mgEli Lilly Nederland B.V.未进口原研药品欧盟上市
41-41米氮平片Mirtazapine Tablets  Norset15mgMSD France未进口原研药品欧盟上市
41-42醋酸阿托西班注射液Atosiban Acetate Injection Tractocile0.9ml:7.5mg/ml(以阿托西班计)Ferring Pharmaceuticals A/S未进口原研药品欧盟上市
41-43醋酸阿托西班注射液Atosiban Acetate Injection Tractocile5ml:7.5mg/ml(以阿托西班计)Ferring Pharmaceuticals A/S未进口原研药品欧盟上市
41-44盐酸普拉克索片Pramipexole Dihydrochloride TabletsSifrol0.5mgBoehringer Ingelheim International GmbH未进口原研药品欧盟上市
41-45中长链脂肪乳/氨基酸(16)/葡萄糖(16%)注射液Medium and Long Chain Fat Emulsion/Amino Acids(16)Glucose(16%)Injection1250mlB.Braun Melsungen AG未进口原研药品欧盟上市
41-46二甲双胍维格列汀片(III)Metformin Hydrochloride and Vildagliptin Tablets  Eucreas每片含盐酸二甲双胍1000mg和维格列汀50mgNovartis Europharm Limited未进口原研药品欧盟上市
41-47伊立替康脂质体注射液Irinotecan Liposome injectionOnivyde43mg/10mlLes Laboratoires Servier未进口原研药品欧盟上市
41-48吡拉西坦注射液Piracetam Injection
12g/60mlUCB Pharma未进口原研药品欧盟上市
41-49阿加曲班注射液Argatroban InjectionNovastan2mL:10mg田辺三菱製薬株式会社未进口原研药品日本上市
41-50玻璃酸钠滴眼液Sodium Hyaluronate Eye Drops Hyalein0.1%(0.4ml:0.4mg)参天制药株式会社未进口原研药品日本上市
41-51苯甲酸阿格列汀片Alogliptin Benzoate Oral TabletNesina6.25mg武田薬品工業株式会社未进口原研药品日本上市
41-52苯甲酸阿格列汀片Alogliptin Benzoate Oral TabletNesina25mg武田薬品工業株式会社未进口原研药品日本上市
41-53马来酸曲美布汀片Trimebutine Maleate Tablets  Cerekinon100 mg田边三菱制药株式会社未进口原研药品日本上市
41-54盐酸昂丹司琼片Ondansetron Hydrochloride TabletsZofran4mgNovartis Pharmaceuticals Corp未进口原研药品德国上市
41-55盐酸昂丹司琼片Ondansetron Hydrochloride TabletsZofran8mgNovartis Pharmaceuticals Corp未进口原研药品德国上市
1-33阿立哌唑口崩片Aripiprazole Orally Disintegrating tabletsAbilify10mgOtsuka Pharmaceutical Europe Ltd./Otsuka Pharmaceutical Netherlands B.V.欧盟上市持证商发生变更,增加持证商Otsuka Pharmaceutical Netherlands B.V.
10-6氨酚双氢可待因片Paracetamol and Dihydrocodeine Tartrate TabletsCo-dydramol对乙酰氨基酚500mg;酒石酸双氢可待因10mgActavis UK Limited/Accord UK Ltd欧盟上市(上市国家:英国;产地:英国)持证商发生变更,增加变更后持证商Accord UK Ltd
10-220枸橼酸托法替布片Tofacitinib Citrate Tablets Xeljanz5mgPF Prism C.V./Pfizer Limited/Pfizer Europe MA EEIG原研进口持证商发生变更,增加变更后持证商Pfizer Limited/Pfizer Europe MA EEIG
12-4交沙霉素片Josamycin Tablets
50mgAstellasPharma Inc./LTL ファーマ株式会社未进口原研药品持证商发生变更,增加持证商LTL ファーマ株式会社
12-5交沙霉素片Josamycin Tablets
200mgAstellasPharma Inc./LTL ファーマ株式会社未进口原研药品持证商发生变更,增加持证商LTL ファーマ株式会社
22-104羟乙基淀粉130/0.4电解质注射液Hydroxyethyl Starch 130/0.4 and Electrolyte Injection/Volulyte 6% Soluzione per Infusione
500mlFresenius Kabi Deutschland GmbH/Fresenius Kabi ltaliaS.r.l.未进口原研药品持证商发生变更,增加持证商Fresenius Kabi ltaliaS.r.l.,不限定上市国
23-267注射用头孢哌酮钠Cefoperazone Sodium For InjectionCefobid2.0g(以头孢哌酮计)Pfizer Italia S.R.L./Pfizer, Spol. S R.O/Pfizer, Austria Ges.m.b.H未进口原研药品持证商发生变更,增加持证商Pfizer, Spol. S R.O; Pfizer, Austria Ges.m.b.H
23-284碳酸镧咀嚼片Lanthanum Carbonate Chewable TabletsFosrenolEq 750mg BaseShire Development LLC/Takeda Pharmaceuticals USA INC未进口原研药品持证商发生变更,增加持证商Takeda Pharmaceuticals USA INC
23-286碳酸镧咀嚼片Lanthanum Carbonate Chewable TabletsFosrenolEq 1gm BaseShire Development LLC/Takeda Pharmaceuticals USA INC未进口原研药品持证商发生变更,增加持证商Takeda Pharmaceuticals USA INC
27-249氨己烯酸口服溶液用散Vigabatrin Powder for Oral Solution Sabril;Sabrilex500mgSanofi未进口原研药品药品通用名称更正为氨己烯酸口服溶液用散,英文名称更正为Vigabatrin Powder for Oral Solution。


1、参比制剂选择原则:有原研进口的应选择原研进口药作为参比制剂首选。
2、本网站所有仿制药参比制剂目录数据源自国家药品监督管理局官方网站,如有纰漏请以国家官网为准。


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