仿制药参比制剂目录（第44批）

1、 附件仿制药参比制剂目录（第四十四批）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244-1十一酸睾酮软胶囊Testosterone Undecanoate Soft Capsules/Andriol Testocaps（安特尔）40mgN.V.Organon国内上市的原研药品原研进口44-2氯苯唑酸葡胺软胶囊Tafamidis Meglumine Soft Capsules/Vyndaqel（维达全）20mg（按C14H7Cl2NO3·C7H17NO5计）Pfizer Europe MA EEIG国内上市的原研药品原研进口44-3阿帕他胺片Apalutamide Table

2、ts60mgJanssen Biotech Inc未进口原研药品美国橙皮书44-4咪达唑仑鼻用喷雾剂Midazolam Nasal Spray/Nayzilam5 mg/喷UCB Inc未进口原研药品美国橙皮书44-5注射用达巴万星Dalbavancin For Injection/Dalvance500mgAllergan Sales LLC未进口原研药品美国橙皮书44-6克林霉素磷酸酯阴道乳膏Clindamycin Phosphate Vaginal Cream/ Cleocin2%Pfizer Inc未进口原研药品美国橙皮书44-7注射用硫酸多黏菌素BPolymyxin B sulfat

3、e for Injection50万单位/瓶Gland Pharma LTD国际公认的同种药品美国橙皮书44-8呋塞米口服溶液Furosemide Oral Solution10mg/mlHikma Pharmaceuticals USA INC国际公认的同种药品美国橙皮书44-9右酮洛芬氨丁三醇片Dexketoprofen Trometamol Tablets12.5mg（按C16H14O3计）Laboratorios Menarini，S.A.未进口原研药品欧盟上市44-10间苯三酚口崩片Phloroglucinol Orally Disintegrating Tablets80mgTev

4、a Sante未进口原研药品欧盟上市44-11注射用坎格雷洛Cangrelor for Injection/Kengrexal50mgChiesi Farmaceutici S.p.A.未进口原研药品欧盟上市44-12伊拉地平缓释胶囊Isradipine Sustained-release Capsules/Vascal2.5mgCheplapharm Arzneimittel GmbH未进口原研药品欧盟上市44-13伊拉地平缓释胶囊Isradipine Sustained-release Capsules/Vascal5mgCheplapharm Arzneimittel GmbH未进口原研

5、药品欧盟上市44-14达芦那韦片Darunavir Tablets/Prezista600mgJanssen-Cilag International NV未进口原研药品欧盟上市44-15恩那司他片Enarodustat Tablets/Enaroy2mg日本産業株式会社未进口原研药品日本上市44-16恩那司他片Enarodustat Tablets/Enaroy4mg日本産業株式会社未进口原研药品日本上市44-17二硫化硒洗剂Selenium Sulfide Lotion/Selsun2.5%Sanofi未进口原研药品英国上市44-18注射用阿莫西林钠Amoxicillin Sodium fo

6、r Injection500mgBeecham Group plc未进口原研药品英国上市44-19注射用阿莫西林钠Amoxicillin Sodium for Injection1.0gBeecham Group plc未进口原研药品英国上市44-20美沙拉秦肠溶片Mesalazine Enteric-coated Tablets400mgTillotts Pharma AG国内上市的原研药品原研进口44-21美沙拉秦肠溶片Mesalazine Enteric-coated Tablets800mgTillotts Pharma AG国内上市的原研药品原研进口44-22甲氨蝶呤注射液Metho

7、trexate Injection/美素生10ml:1gHospira Australia Pty Ltd国内上市的原研药品原研进口44-23甲氨蝶呤注射液Methotrexate Injection/美素生20ml:0.5gHospira Australia Pty Ltd国内上市的原研药品原研进口44-24-3鱼油脂肪乳注射液-3 Fish Oil Fat Emulsion Injection/ Omegaven100ml:10g（精制鱼油）:1.2g（卵磷脂）Fresenius Kabi Austria GmbH国内上市的原研药品原研进口44-25卡贝缩宫素注射液Carbetocin I

8、njection1ml: 100g辉凌制药（中国）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44-26依折麦布辛伐他汀片Ezetimibe and Simvastatin Tablets/Vytorin10mg/10mgOrganon Llc A Sub Of Organon And Co未进口原研药品美国橙皮书44-27依折麦布辛伐他汀片Ezetimibe and Simvastatin Tablets/Vytorin10mg/20mgOrganon Llc A Sub Of Organon And Co未进口原研药品美国橙皮书44-28依折麦布辛伐他汀片Ezetimib

9、e and Simvastatin Tablets/Vytorin10mg/40mgOrganon Llc A Sub Of Organon And Co未进口原研药品美国橙皮书44-29盐酸西替利嗪滴眼液Cetirizine Ophthalmic Solution/Zerviate0.24%（0.2ml）Eyevance Pharmaceuticals Llc未进口原研药品美国橙皮书44-30盐酸氯普鲁卡因注射液Chloroprocaine Hydrochloride Injection/Nesacaine-MPF2%Fresenius Kabi USA LLC未进口原研药品美国橙皮书44-

10、31盐酸氯普鲁卡因注射液Chloroprocaine Hydrochloride Injection/Nesacaine-MPF3%Fresenius Kabi USA LLC未进口原研药品美国橙皮书44-32赛洛多辛胶囊Silodosin Capsules/Rapaflo4mgAllergan Sales LLC未进口原研药品美国橙皮书44-33西洛他唑片Cilostazol Tablets50mgTeva Pharmaceuticals USA Inc国际公认的同种药品美国橙皮书44-34格列吡嗪片Glipizide Tablets/Minidiab5mgPfizer Italia s.r

11、.l.未进口原研药品欧盟上市44-35注射用醋酸奥曲肽微球Octreotide Acetate Microspheres for Injection /Sandostatin LAR10mgNovartis Pharma GmbH未进口原研药品欧盟上市44-36注射用醋酸奥曲肽微球Octreotide Acetate Microspheres for Injection /Sandostatin LAR20mgNovartis Pharma GmbH未进口原研药品欧盟上市44-37注射用醋酸奥曲肽微球Octreotide Acetate Microspheres for Injection /

12、Sandostatin LAR30mgNovartis Pharma GmbH未进口原研药品欧盟上市44-38培唑帕尼片Pazopanib Tablets /Votrient200mg（按培唑帕尼计）Novartis Europharm Limited未进口原研药品欧盟上市44-39培唑帕尼片Pazopanib Tablets /Votrient400mg（按培唑帕尼计）Novartis Europharm Limited未进口原研药品欧盟上市44-40-3鱼油中长链脂肪乳氨基酸（16）葡萄糖（30%）注射液-3 Fish Oil Medium and Long Chain Fat Emuls

13、ion/Amino Acids （16）/Glucose（30%） Injection1875mlB.Braun Melsungen AG未进口原研药品欧盟上市44-41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%）Injection1875mlB.Braun Melsungen AG未进口原研药品欧盟上市44-42艾曲泊帕乙醇胺片Eltrombopag Olamine Tablets/Revolade50mgNovartis Europharm Limited未

14、进口原研药品欧盟上市44-43盐酸溴己新口服溶液Bromhexine Hydrochloride Oral Solution/Bisolvon2mg/ml（40ml、100ml）Sanofi未进口原研产品欧盟上市44-44苯丁酸甘油酯口服液Glycerol phenylbutyrate oral liquid/Ravicti1.1g/mlImmedica Pharma AB未进口原研药品欧盟上市44-45氟尿嘧啶注射液Fluorouracil Injection 10ml:0.25gHospira UK Limited国际公认的同种药品欧盟上市44-46头孢氨苄胶囊Cefalexin Caps

15、ules0.25g共和薬品工業株式会社未进口原研药品日本上市44-47那格列奈片Nateglinide Tablets/ Fastic30mgEA制药株式会社未进口原研药品日本上市44-48洛索洛芬钠贴剂Loxoprofen Sodium Patches/Loxonin100mg/贴（10cm×14cm）株式会社未进口原研药品日本上市44-49依折麦布片Ezetimibe Tablets/Zetia10mgMSD株式会社未进口原研药品日本上市44-50阿糖胞苷注射液Cytarabine Injection/Cytosar5ml:100mgPfizer PFE Switzerland

16、GmbH/Pfizer AG未进口原研药品瑞士上市44-51阿糖胞苷注射液Cytarabine Injection/Cytosar25ml:500mgPfizer AG未进口原研药品瑞士上市44-52腺苷注射液Adenosine Injection/Adenoscan10ml:30mgAventis Pharma Limited未进口原研药品英国上市44-53腺苷注射液Adenosine Injection/Adenocor2ml:6mgAventis Pharma Limited未进口原研药品英国上市44-54盐酸倍他司汀片Betahistine Dihydrochloride Tablet

17、s / Serc8mgMylan Products Ltd未进口原研药品英国上市9-3双氯芬酸钠缓释片Diclofenac Sodium Sustained-release Tablets/VOLTAREN0.1gNovartis Pharma GmbH欧盟上市不限定上市国及产地12-7尼麦角林片Nicergoline Tablets/Sermion5mgPfizer Italia S.r.l./Upjohn EESV欧盟上市增加持证商Upjohn EESV12-8尼麦角林片Nicergoline Tablets/Sermion10mgPfizer Italia S.r.l./Upjohn E

18、ESV欧盟上市增加持证商Upjohn EESV12-9尼麦角林片Nicergoline Tablets/Sermion30mgPfizer Italia S.r.l./Pfizer Europe MA EEIG/Upjohn EESV欧盟上市增加持证商Pfizer Europe MA EEIG、Upjohn EESV23-204依托泊苷注射液Etoposide Injection/Vepesid5ml:100mg 株式会社/株式会社未进口原研药品持证商变更，增加持证商株式会社10-233磷酸西格列汀片Sitagliptin Phosphate Tablets/JANUVIA100mgMerck

19、 Sharp & Dohme Ltd./ Merck Sharp & Dohme B.V.原研进口持证商变更，增加持证商Merck Sharp & Dohme B.V.27-441富马酸依美斯汀滴眼液Emedastine Difumarate Eye Drops/Emadine（埃美丁）5ml:2.5mg（0.05%，以依美斯汀计）Novartis Europharm Limited/ Novartis Pharma Schweiz AG国内上市的原研药品持证商变更，增加持证商Novartis Pharma Schweiz AG31-82钆特酸葡胺注射液Gadoteric Acid Meglumine Salt Injection/Dotarem376.9mg/mlGuerbet LLC未进口原研药品规格更新为376.9mg/ml42-610%脂肪乳（OO）/5.5%氨基酸（15）/葡萄糖（2