仿制药参比制剂目录（第42批）

1、附件仿制药参比制剂目录（第四十二批）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242-1依折麦布辛伐他汀片Ezetimibe and Simvastatin Tablets/葆至能每片含依折麦布10mg，辛伐他汀20mgMerck Sharp & Dohme B.V.国内上市的原研药品原研进口42-2依折麦布辛伐他汀片Ezetimibe and Simvastatin Tablets/葆至能每片含依折麦布10mg，辛伐他汀40mgMerck Sharp & Dohme B.V.国内上市的原研药品原研进口42-3格拉司琼透皮贴片Granisetron Transderm

2、al Patches34.3mg/52cm2（释药量3.1mg/24h）ProStrakan国内上市的原研药品原研进口42-4-3鱼油脂肪乳注射液-3 Fish Oil Fat Emulsion Injection/Omegaven50ml:5g（精制鱼油）:0.6g （卵磷脂）Fresenius Kabi Austria GmbH国内上市的原研药品原研进口42-5盐酸奥布卡因滴眼液Oxybuprocaine Hydrochloride Eye Drops / Benoxil（倍诺喜）0.4%（0.5ml:2mg）Santen Pharmaceutical Co., Ltd.国内上市的原研药品

3、原研进口42-610%脂肪乳（OO）/5.5%氨基酸（15）/葡萄糖（20%）注射液10% Fat Emulsion（OO）/5.5% Amino Acids（15）/Glucose（20%） Injection/Oliclinomel（克林玫）1500ml:10%橄榄油脂肪乳300ml+5.5%复方氨基酸注射液（15）600ml+20%葡萄糖注射液600mlBaxter S.A.国内上市的原研药品原研进口42-710%脂肪乳（OO）/5.5%氨基酸（15）/葡萄糖（20%）注射液10% Fat Emulsion（OO）/5.5% Amino Acids（15）/Glucose（20%） In

4、jection/Oliclinomel（克林玫）1000ml:10%橄榄油脂肪乳200ml+5.5%复方氨基酸注射液（15）400ml+20%葡萄糖注射液400mlBaxter S.A.国内上市的原研药品原研进口42-8苯甲酸钠苯乙酸钠注射液Sodium Phenylacetate and Sodium Benzoate Injection /Ammonul10%；10%（5g/50mL；5g/50mL）Bausch Health Us LLC未进口原研药品美国橙皮书42-9苯丁酸甘油酯口服液Glycerol Phenylbutyrate Oral Liquid/Ravicti1.1 g/mL

5、Horizon Therapeutics LLC未进口原研药品美国橙皮书42-10盐酸西替利嗪注射液Cetirizine Hydrochloride Injection/Quzyttir10mg/mlJDP Therapeutics LLC未进口原研药品美国橙皮书42-11拉莫三嗪缓释片Lamotrigine Extended Release Tablets / Lamictal XR25mgGlaxoSmithKline LLC未进口原研药品美国橙皮书42-12拉莫三嗪缓释片Lamotrigine Extended Release Tablets / Lamictal XR50mgGlaxo

6、SmithKline LLC未进口原研药品美国橙皮书42-13拉莫三嗪缓释片Lamotrigine Extended Release Tablets / Lamictal XR100mgGlaxoSmithKline LLC未进口原研药品美国橙皮书42-14拉莫三嗪缓释片Lamotrigine Extended Release Tablets / Lamictal XR200mgGlaxoSmithKline LLC未进口原研药品美国橙皮书42-15拉莫三嗪缓释片Lamotrigine Extended Release Tablets / Lamictal XR250mgGlaxoSmithK

7、line LLC未进口原研药品美国橙皮书42-16拉莫三嗪缓释片Lamotrigine Extended Release Tablets / Lamictal XR300mgGlaxoSmithKline LLC未进口原研药品美国橙皮书42-17氢溴酸安非他酮缓释片Bupropion Hydrobromide Extended-Release Tablets/Aplenzin174mgValeant Pharmaceuticals North America LLC未进口原研药品美国橙皮书42-18氢溴酸安非他酮缓释片Bupropion Hydrobromide Extended-Releas

8、e Tablets/Aplenzin348mgValeant Pharmaceuticals North America LLC未进口原研药品美国橙皮书42-19氢溴酸安非他酮缓释片Bupropion Hydrobromide Extended-Release Tablets/Aplenzin522mgValeant Pharmaceuticals North America LLC未进口原研药品美国橙皮书42-20核黄素磷酸钠滴眼液Riboflavin 5-Phosphate Ophthalmic Solution/ Photrexa0.146%Glaukos Corporation未进口原

9、研药品美国橙皮书42-21壬二酸凝胶Azelaic Acid Gel / Finacea15%Leo Pharma AS未进口原研药品美国橙皮书42-22盐酸吉西他滨注射液Gemcitabine Hydrochloride Injection200mg/5.26ml （38 mg/ml）Hospira, Inc.未进口原研药品美国橙皮书42-23盐酸吉西他滨注射液Gemcitabine Hydrochloride Injection1g/26.3ml（38 mg/ml）Hospira, Inc.未进口原研药品美国橙皮书42-24盐酸伊达比星注射液Idarubicin Hydrochloride

10、 Injection/Idamycin Pfs1 mg/mlPfizer Inc未进口原研美国橙皮书42-25盐酸氟西汀口服溶液Fluoxetine Hydrochloride Oral Solution/ Prozac20mg/5mlLilly France未进口原研药品欧盟上市42-26曲安奈德益康唑乳膏Triamcinolone Acetonide and Econazole Nitrate Cream每克含硝酸益康唑10mg、曲安奈德1.0mgJanssen-Cilag未进口原研药品欧盟上市42-27特比萘芬凝胶Terbinafine Gel/Lamisil DermGel1%Glax

11、osmithkline Sante Grand Public未进口原研药品欧盟上市42-28-3鱼油中长链脂肪乳/氨基酸（16）/葡萄糖（16%）注射液-3 Fish Oil Medium and Long Chain Fat Emulsion/Amino Acids （16）/Glucose （16%） Injection / NuTRIflex Omega peri1250mlB.Braun Melsungen AG未进口原研药品欧盟上市42-29复方-酮酸片Compound -Ketoacid Tablets0.63gFresenius Kabi Deutschland GmbH未进口原

12、研药品欧盟上市42-30盐酸头孢卡品酯颗粒Cefcapene Pivoxil Hydrochloride Granules /Flomox10%（1g含盐酸盐水合物100mg，50mg/袋）塩野義製薬株式会社未进口原研药品日本上市42-31儿童褪黑素颗粒Melatonin granules for pediatric / Melatobel1g:2mg株式会社未进口原研药品日本上市42-32注射用盐酸尼非卡兰Nifekalant Hydrochloride for Injection / Shinbit50mg株式会社未进口原研药品日本上市42-33枸橼酸铁片Ferric Citrate Ta

13、blet/ Riona Tab 250mg250mg（以枸橼酸铁计）鳥居薬品株式会社未进口原研药品日本上市42-34巴氯芬口服溶液Baclofen Oral Solution/Lioresal5mg/5mlNovartis Pharmaceuticals UK Limited未进口原研药品英国上市42-35阿替洛尔注射液Atenolol Injection/Tenormin10ml:5mgAstraZeneca未进口原研药品英国上市42-36盐酸帕罗西汀片Paroxetine Hydrochloride Tablets/赛乐特20mg（以C19H20FNO3计）中美天津史克制药有限公司经审核确

14、定的国外原研企业在中国境内生产的药品原研地产化42-37硫酸沙丁胺醇吸入气雾剂Salbutamol Sulfate Inhalation Aerosol/Proventil-Hfa90g/揿（以沙丁胺醇计）Kindeva Drug Delivery LP/Merck Sharp & Dohme Corp./3M Drug Delivery Systems未进口原研药品美国橙皮书42-38注射用泮托拉唑钠Pantoprazole Sodium For Injection/ Pantoprazole Sodium40mgHikma Pharmaceuticals LLC未进口原研药品美国橙

15、皮书42-39别嘌醇片Allopurinol Tablets /Zyloprim0.3gCasper Parma LLC未进口原研药品美国橙皮书42-40马来酸依那普利片Enalapril Maleate Tablets/Vasotec5mgBausch Health US LLC未进口原研药品美国橙皮书42-41马来酸依那普利片Enalapril Maleate Tablets/Vasotec10mgBausch Health US LLC未进口原研药品美国橙皮书42-42马来酸依那普利片Enalapril Maleate Tablets/Vasotec20mgBausch Health U

16、S LLC未进口原研药品美国橙皮书42-43卡巴他赛注射液Cabazitaxel Injection/Jevtana60mg/1.5ml（40mg/ml）Sanofi-Aventis US INC未进口原研药品美国橙皮书42-44奥拉帕利片Olaparib Tablets/Lynparza100mgAstraZeneca Pharmaceuticals LP未进口原研药品美国橙皮书42-45奥拉帕利片Olaparib Tablets/Lynparza150mgAstraZeneca Pharmaceuticals LP未进口原研药品美国橙皮书42-46曲氟尿苷替匹嘧啶片Trifluridine

17、 and Tipiracil Hydrochloride Tablets/ Lonsurf曲氟尿苷15mg,盐酸替匹嘧啶7.065mg（相当于替匹嘧啶6.14mg）Taiho Oncology Inc.未进口原研药品美国橙皮书42-47曲氟尿苷替匹嘧啶片Trifluridine and Tipiracil Hydrochloride Tablets/ Lonsurf曲氟尿苷20mg,盐酸替匹嘧啶9.420mg（相当于替匹嘧啶8.19mg）Taiho Oncology Inc未进口原研药品美国橙皮书42-48盐酸帕罗西汀片Paroxetine Hydrochloride Tablets / Pa

18、xil10mgApotex Technologies Inc未进口原研药品美国橙皮书42-49盐酸帕罗西汀片Paroxetine Hydrochloride Tablets / Paxil30mgApotex Technologies Inc未进口原研药品美国橙皮书42-50布立西坦注射液Brivaracetam Solution for Injection/Briviact10mg/mlUCB Inc未进口原研药品美国橙皮书42-51丙酸氟替卡松乳膏Fluticasone Propionate Cream0.05%Perrigo Israel Pharmaceuticals Ltd国际公认的

19、同种药品美国橙皮书42-52拉坦前列素滴眼液Latanoprost Eye Drops/Xalatan0.005%Upjohn US 2 LLC未进口原研药品美国橙皮书42-53卡前列素氨丁三醇注射液Carboprost Tromethamine Injection/Hemabate1ml:250gPfizer Inc未进口原研药品美国橙皮书42-54枸橼酸托法替布缓释片Tofacitinib Citrate Extended Release tablets/Xeljanz Xr22mgPfizer Inc未进口原研药品美国橙皮书42-55注射用头孢哌酮钠舒巴坦钠Cefoperazone So

20、dium and Sulbactam Sodium for Injection/Sulperazon1g（头孢哌酮0.5g：舒巴坦0.5g）Pfizer Polska Sp. z o.o.未进口原研药品欧盟上市42-56依替巴肽注射液Eptifibatide Injection/Integrilin20mg/10mLGlaxoSmithKline （Ireland） Limited未进口原研药品欧盟上市42-57依替巴肽注射液Eptifibatide Injection/Integrilin75mg/100mLGlaxoSmithKline （Ireland） Limited未进口原研药品欧盟

21、上市42-58利伐沙班片Rivaroxaban Tablets/Xarelto2.5mgBayer AG未进口原研药品欧盟上市42-59利伐沙班片Rivaroxaban Tablets/Xarelto10mgBayer AG未进口原研药品欧盟上市42-60利伐沙班片Rivaroxaban Tablets/Xarelto15mgBayer AG未进口原研药品欧盟上市42-61利伐沙班片Rivaroxaban Tablets/Xarelto20mgBayer AG未进口原研药品欧盟上市42-62钆特酸葡胺注射液Gadoteric Acid Meglumine Salt Injection/Dota

22、rem0.5 mmol/mL（10ml、15ml、20ml/瓶）Guerbet未进口原研药品欧盟上市42-63盐酸伐地那非口崩片Vardenafil Hydrochloride Orally disintegrating Tablets/Levitra10mgBayer AG未进口原研药品欧盟上市42-64甲泼尼龙片Methylprednisolon /Medrol16mgPfizer Italia s.r.l未进口原研药品欧盟上市42-65卡络磺钠注射液Carbosulfan Sodium injection/Adona20ml：100mgES株式会社未进口原研药品日本上市42-66托拉塞米

23、片Torasemide Tablets/Torem5mgMylan Products Ltd.未进口原研药品英国上市42-67托拉塞米片Torasemide Tablets/Torem10mgMylan Products Ltd.未进口原研药品英国上市6-12硫酸羟氯喹片Hydroxychloroquine Sulfate Tablets/Plaquenil0.2gAventis Pharma Limited/ Sanofi-aventis Ireland Ltd. T/A SANOFI原研进口持证商变更，增加持证商Sanofi-aventis Ireland Ltd. T/A SANOFI1

24、0-223克唑替尼胶囊Crizotinib Capsules/XALKORI0.25gPfizer Ltd. /PFIZER EUROPE MA EEIG原研进口持证商变更，增加持证商PFIZER EUROPE MA EEIG10-224克唑替尼胶囊Crizotinib Capsules/XALKORI0.2gPfizer Ltd. /PFIZER EUROPE MA EEIG原研进口持证商变更，增加持证商PFIZER EUROPE MA EEIG17-7盐酸贝尼地平片Benidipine Hydrochloride Tablets/可力洛4mg协和发酵麒麟株式会社/Kyowa Kirin Co., Ltd.原研进口持证商变更，增加持证商Kyowa Kirin Co., Ltd.17-8盐酸贝尼地平片Benidipine Hydrochloride