2022仿制药参比制剂目录第五十批

1、仿制药参比制剂目录（第五十批）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250-1阿法骨化醇滴剂Alfacalcidol Drops2%/ml （10ml/瓶，20ml/ 瓶）LEO Pharma A/S国内上市的原研 药品原研进口50-2枸橼酸钠血滤置 换液Hemofiltratio nReplaceme nt Soluti on of Sodium Citrate Hemofiltratio n Replaceme nt Fluid ofSodium Citrate5000mlBaxter Holdi ng B.V./Gambro Lun dia AB国内上市的原研 药品原研进口

2、50-3水飞蓟素胶囊Silymari n Capsules/Legal on（利加隆）140mgMEDA PHARMA GMBH & CO.KG国内上市的原研 药品原研进口50-4盐酸普萘洛尔缓 释胶囊Propra nolol Hydrochloride Exte nded-release Cap sules/INDERAL LA60 mgANI Pharmaceuticals Inc.未进口原研药品美国橙皮书50-5盐酸普萘洛尔缓 释胶囊Propra nolol Hydrochloride Exte nded-releaseCap sules/INDERAL LA80 mgANI P

3、harmaceuticals Inc.未进口原研药品美国橙皮书50-6奈拉滨注射液Nelarab ine injection/ Arranon250mg/50mL （5mg/mL）NovartisPharmaceuticals Corp未进口原研药品美国橙皮书50-7复方硫酸钠片Sodium sulfate, magn esiur sulfate, and potassium chloride Tablets每片含硫酸钠1.479g硫酸镁0.225g氯化钾0.188gBrain tree Laboratories Inc.未进口原研药品美国橙皮书序号药品通用名称英文名称/商品名规格持证商备注1

4、备注250-8聚乙二醇3350散Polyethylene Glycol 3350/MiraLAX17g/袋Bayer Healthcare LLC未进口原研药品美国橙皮书50-9二十二醇乳膏Docosa nol cream10%GlaxoSmithKli ne未进口原研药品美国橙皮书50-10醋酸亮丙瑞林注 射液Leuprolide Acetate for Injectio n/LEUPROLIDE ACETATE1mg/0.2ml(14mg/2.8ml)San doz Inc国际公认的同种 药品美国橙皮书50-11盐酸维纳卡兰注 射液Vern akala nt Hydrochloride f

5、or In jecti on/Brin avess25ml:500mgCorrevioe未进口原研药品欧盟上市50-12盐酸维纳卡兰注 射液Vern akala nt Hydrochloride for In jecti on/Brin avess10ml:200mgCorrevioe未进口原研药品欧盟上市50-13盐酸氨酮戊酸口 服溶液用粉末Gliola n 30 mg/ml powder for oral soluti on5- ami nolevuli nic acid hydrochloride/ Gliola n1.5g (以 5-ALA HCl计)Medac GmbH未进口原研药品

6、欧盟上市50-14马来酸甲麦角新 碱注射液Methylerg onovine Maleate In jecti on/ Methergin1ml:0.2mgNovartis Pharma GmbH未进口原研药品欧盟上市50-15昂丹司琼口崩片Ondan setr on Orally Disin tegrat ing Tablets4mgNovartis未进口原研药品欧盟上市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250-16昂丹司琼口崩片Ondan setr on Orally Disin tegrat ing Tablets8mgNovartis未进口原研药品欧盟上市50-17盐

7、酸多奈哌齐口 服凝胶Don epezil Hydrochloride Oral Jelly/Aricept3mg工一廿'彳株式会社未进口原研药品日本上市50-18盐酸多奈哌齐口 服凝胶Don epezil Hydrochloride Oral Jelly/Aricept5mg工一廿'彳株式会社未进口原研药品日本上市50-19盐酸多奈哌齐口 服凝胶Don epezil Hydrochloride Oral Jelly/Aricept10mg工一廿'彳株式会社未进口原研药品日本上市50-20阿仑膦酸钠水合 物口服凝胶Ale ndron ate Sodium Hydrate

8、Oral Jelly/Bo nalon35mg帝人77-V株式会 社未进口原研药品日本上市50-21辛酸拉尼米韦吸 入粉雾剂Lanin amivir Octa no ate Dry Powder In haler/I navir20mg （按辛酸拉尼 米韦计）第一二共株式会社未进口原研药品日本上市50-22氟比洛芬贴剂Flurbiprofe n Patches/Zepolas20mg/贴二笠製楽株式会社未进口原研药品日本上市50-23氟比洛芬贴剂Flurbiprofe n Patches/Zepolas40mg/贴二笠製楽株式会社未进口原研药品日本上市序号药品通用名称英文名称/商品名规格持证商

9、备注1备注250-24氢溴酸依他佐辛 注射液Eptazoc ine Hydrobromide Injection/Sedapa in1ml:15mg （以依他 佐辛计）日医工株式会社未进口原研药品日本上市50-25乌拉地尔缓释胶 囊Urapidil Sustai ned-release Capsules30mgTakeda GmbH未进口原研药品德国上市50-26乌拉地尔缓释胶 囊Urapidil Sustai ned-release Capsules60mgTakeda GmbH未进口原研药品德国上市50-27乌拉地尔缓释胶 囊Urapidil Sustai ned-release Caps

10、ules90mgTakeda GmbH未进口原研药品德国上市50-28曲氟尿苷替匹嘧 啶片Triflurid ine and Tipiracil Hydrochloride Tablets/L on surf曲氟尿苷15mg盐酸替匹嘧啶7.065mg （相当于替匹嘧啶6.14mg）Taiho Pharmaceutical Co.,Ltd.国内上市的原研 药品原研进口50-29曲氟尿苷替匹嘧 啶片Triflurid ine and Tipiracil Hydrochloride Tablets/L on surf曲氟尿苷20mg盐酸替匹嘧啶9.420mg （相当于替匹嘧啶8.19mg）Taiho

11、 Pharmaceutical Co.,Ltd.国内上市的原研 药品原研进口50-30托伐普坦片Tolvapta n Tablets/Samsca（办麦卡）15mg浙江大冢制药有限公 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50-31替格瑞洛片Ticagrelor Tablets/Brili nta60mg阿斯利康制药有限公 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250-32替格瑞洛片Ticagrelor Tablets/Brili nta90mg阿斯利康制药有限公 司经审核确定的国 外原研企业在

12、中 国境内生产的药 品原研地产化50-33瑞卢戈利片Relugolix Tablets/Orgovyx120mgMyova nt Scien ces GmbH未进口原研药品美国橙皮书50-34盐酸文拉法辛缓 释胶囊Venlafaxine Hydrochloride Susta in ed-Release Capsules/Efexor XREq 75mg BaseUPJOHN US 2 LLC未进口原研药品美国橙皮书50-35盐酸文拉法辛缓 释胶囊Venlafaxine Hydrochloride Susta in ed-Release Capsules/Efexor XREq 150mg B

13、aseUPJOHN US 2 LLC未进口原研药品美国橙皮书50-36肾上腺素注射液Epin ephri ne Injection/ Symjepi0.3ml:0.3mgAdamis Pharms Corp未进口原研药品美国橙皮书50-37肾上腺素注射液Epin ephri ne Injection/ Symjepi0.3ml:0.15mgAdamis Pharms Corp未进口原研药品美国橙皮书50-38达肝素钠注射液Daltepari n Sodium Injectio n/Fragmin2,500IU/0.2ML(12,500IU/ML)Pfizer Inc未进口原研药品美国橙皮书50

14、-39酒石酸托特罗定 缓释胶囊Tolterod ine Tartrate Exte nded Release Cap sules/Detrol LA2mgUPJOHN US 2 LLC未进口原研药品美国橙皮书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250-40酒石酸托特罗定 缓释胶囊Tolterod ine Tartrate Exte nded Release Cap sules/Detrol LA4mgUPJOHN US 2 LLC未进口原研药品美国橙皮书50-41阿瑞匹坦胶囊Aprepita nt Capsules/ Eme nd80mgMerck And Co Inc未进口原

15、研药品美国橙皮书50-42阿瑞匹坦胶囊Aprepita nt Capsules/ Eme nd125mgMerck And Co Inc未进口原研药品美国橙皮书50-43氟哌啶醇片Haloperidol Tablets2mgMyla n Pharmaceutical Incs国际公认的同种 药品美国橙皮书50-44氯化钾缓释片Potassium Chloride Exte nded-Release Tablets USP/ Klor-C on M,20mEqUpsher Smith Laboratories LLC国际公认的同种 药品美国橙皮书50-45氯化钾缓释片Potassium Chlo

16、ride Exte nded-Release Tablets USP/ Klor-C on M,10mEqUpsher Smith Laboratories LLC美国橙皮书50-46盐酸二甲双胍缓 释片（川）Metformin Hydrochloride Exte nded-Release Tablets500mgLUPIN LTD美国橙皮书50-47雷贝拉唑钠肠溶 片Rabeprazole Sodium En teric-coated Tablets/Pariet10mgEisai Ltd.未进口原研药品欧盟上市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250-48雷贝拉唑钠肠溶

17、 片Rabeprazole Sodium En teric-coated Tablets/Pariet20mgEisai Ltd.未进口原研药品欧盟上市50-49注射用硼替佐米Bortezomib For Injectio n/Velcade3.5mgJan sse n-Cilag International NV未进口原研药品欧盟上市50-50尼洛替尼胶囊Nilot inib Capsules/Tasig na50mgNovartis Europharm Limited未进口原研药品欧盟上市50-51尼洛替尼胶囊Nilot inib Capsules/Tasig na150mgNovarti

18、s Europharm Limited未进口原研药品欧盟上市50-52尼洛替尼胶囊Nilot inib Capsules/Tasig na200mgNovartis Europharm Limited未进口原研药品欧盟上市50-53注射用醋酸地加 瑞克Degarelix Acetate for Injectio n/Firmago n80mgFerri ngPharmaceuticals A/S未进口原研药品欧盟上市50-54注射用醋酸地加 瑞克Degarelix Acetate for Inject ion/ Firmag on120mgFerri ngPharmaceuticals A/S

19、未进口原研药品欧盟上市50-55磷酸芦可替尼片Ruxoliti nib Phosphate Tablets /Jakavi15mgNovartis Europharm Limited未进口原研药品欧盟上市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250-56磷酸芦可替尼片Ruxoliti nib Phosphate Tablets /Jakavi20mgNovartis Europharm Limited未进口原研药品欧盟上市50-57盐酸齐拉西酮胶 囊Ziprasid one Hydrochloride Capsules/Zeldox20mg （按齐拉西酮 计）Pfizer未进口原

20、研药品欧盟上市50-58加巴喷丁口服溶 液Gabape nti n Oral Solutio n/Neur ontin5%富士製薬工業株式会 社未进口原研药品日本上市50-59卢立康唑乳膏Lulic on azole Cream/Lulico n1% (5g)株式会 社未进口原研药品日本上市50-60卢立康唑乳膏Lulic on azole Cream/Lulico n1% (10g)株式会 社未进口原研药品日本上市50-61聚卡波非钙片Polycarbophil Calcium Tablets / Colo nel500mg製薬株式 会社未进口原研药品日本上市50-62注射用盐酸吡柔 比星P

21、irarubici n Hydrochloride for Injection /Therarubicin10mg(按C32H37NO 12 计)Meiji Seika 7株式会社未进口原研药品日本上市50-63注射用盐酸吡柔 比星Pirarubici n Hydrochloride for Injection /Therarubicin20mg (按C32H37NO 12 计)Meiji Seika 7株式会社未进口原研药品日本上市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250-64聚甲酚磺醛阴道 栓Policresule n Vagi nal Suppositories /Al

22、bothyl90mgTakeda GmbH未进口原研药品德国上市8-94门冬氨酸钾片Potassium Aspartate Tablets/ASPARA Potassium0.3gMitsubishi Tan abe Pharma Corporatio n/ 二九 ES "一 它株式会社(Nipro ES Pharma Co., Ltd).日本橙皮书持证商变更， 增加变更后持 证商二口ES 77-V 株式会社(Nipro ESPharma Co., Ltd.)8-190吲哚布芬片In dobufe n Tablets/ Ibustri n0.2gPfizer Italia S.r.l /Laborat drios Pfizer, Lda.未进口原研药品增加持证商Laborat drios Pfizer, Lda,不限定上市国22419盐酸文拉法辛缓 释胶囊Venlafaxine Hydrochloride Susta in ed-