仿制药参比制剂目录（第32批）

1、附件仿制药参比制剂目录（第三十二批）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232-1比克恩丙诺片Bictegravir Sodium, Emtricitabine and Tenofovir Alafenamide Fumarate Tablets/ Biktarvy（必妥维）比克替拉韦钠（以比克替拉韦计）50mg，恩曲他滨200mg，富马酸丙酚替诺福韦（以丙酚替诺福韦计）25mgGilead Sciences Ireland UC国内上市的原研药品原研进口32-2来迪派韦索磷布韦片Ledipasvir and Sofosbuvir Tablets/ Harvoni（夏帆宁）90

2、mg来迪派韦,400mg索磷布韦Gilead Sciences International Ltd.国内上市的原研药品原研进口32-3卡泊三醇搽剂Calcipotriol Scalp Solution/ Daivonex（达力士）0.005%（30ml:1.50mg）LEO Pharma A/S国内上市的原研药品原研进口32-4溴夫定片Brivudine Tablets/ Zostex（左代）125mgBerlin-Chemie AG国内上市的原研药品原研进口32-5法莫替丁钙镁咀嚼片Famotidine，Calcium Carbonate and Magnesium Hydroxide Ch

3、ewable Tablets/Pepcid Complete法莫替丁10mg，碳酸钙800mg，氢氧化镁165mgJohnson And Johnson Consumer Inc Mcneil Consumer Healthcare Division未进口原研药品美国橙皮书32-6利多卡因凝胶贴膏Lidocaine Cataplasms/ Lidoderm5%Teikoku Pharma Usa Inc未进口原研药品美国橙皮书32-7注射用德拉沙星Delafloxacin for Injection / Baxdela300mgMelinta Subsidiary Corp未进口原研药品美国橙

4、皮书32-8美沙拉秦灌肠液Mesalazine Enemas/ Rowasa4g/60mlMylan Specialty LP未进口原研药品美国橙皮书32-9蔗糖氢氧化氧铁咀嚼片Sucroferric oxyhydroxide Chewable Tablet/ Velphoro500mgVifor Fresenius Medical Care Renal Pharma France未进口原研药品美国橙皮书32-10眼用丝裂霉素溶液用粉末Mitomycin for Solution/Mitosol0.2mgMobius Therapeutics LLC未进口原研药品美国橙皮书32-11盐酸去氧肾

5、上腺素注射液Phenylephrine Hydrochloride Injection/ Biorphen5ml:0.5mgEton Pharmaceuticals 未进口原研药品美国橙皮书32-12盐酸去氧肾上腺素注射液Phenylephrine Hydrochloride Injection1mL:10mgWest Ward Pharmaceutical Corp未进口原研药品美国橙皮书32-13马来酸阿伐曲泊帕片Avatrombopag Tablets/ Doptelet20mgAkaRx, Inc未进口原研药品美国橙皮书32-14曲安奈德乳膏Triamcinolone Acetonid

6、e Cream0.1%Fougera Pharmaceuticals Inc国际公认的同种药品美国橙皮书32-15头孢地尼干混悬剂Cefdinir for Suspension250mg/5mlSandoz Inc国际公认的同种药品美国橙皮书32-16丙戊酸钠缓释片Compound Sodium Valproate and Valproic Acid Sustained Release Tablets/ Depakine Chrono500mg（以丙戊酸钠计）Sanofi Aventis France未进口原研药品欧盟上市32-17倍他米松磷酸钠注射液Betamethasone Sodium

7、Phosphate Injection/Celestone; Celestan; Celeston4mg/ml（以倍他米松计）MSD Belgium BVBA/SPRL/MSD Sharp & Dohme GmbH/Merck Sharp & Dohme BV/MSD Polska Sp. z o.o.未进口原研药品欧盟上市32-18盐酸氯米帕明注射液Clomipramine Hydrochloride Injection / Anafranil25mg/2mlAlfasigma France/Alfasigma S.p.A.未进口原研药品欧盟上市32-19盐酸氮卓斯汀丙酸氟替

8、卡松鼻喷雾剂Azelastine hydrochloride Fluticasone Propionate Nasal Spray/ Dymista每瓶120喷，每喷含盐酸氮卓斯汀和丙酸氟替卡松137g和50gMEDA Pharma GmbH & Co. KG未进口原研药品欧盟上市32-20盐酸格拉司琼片Granisetron Hydrochloride Tablets/Kytril1mgAtnahs Pharma Netherlands B.V.未进口原研药品欧盟上市32-21盐酸屈他维林片Drotaverine Hydrochloride Tablets/ NO-SPA40mgSa

9、nofi-Aventis未进口原研药品欧盟上市32-22氯化锰口服溶液Manganese Chloride Oral Solution / Bothdel Oral Solution 10250mL/袋，含有36mg氯化锰四水合物（相当于锰10mg）Meiji Seika株式会社未进口原研药品日本上市32-23洛索洛芬钠凝胶Loxoprofen sodium hydrate gel1%第一三共株式会社未进口原研药品日本上市32-24硫酸亚铁缓释片Ferrous Sulfate Extended-release Tablets/Fero-Gradumet105mg（以铁元素计）EPD合同会社未进

10、口原研药品日本上市32-25注射用二丁酰环磷腺苷钠Bucladesine Sodium Injection/300mg 株式会社未进口原研药品日本上市32-26盐酸乐卡地平片Lercanidipine Hydrochloride Tablets/Zanidip（再宁平）20mgRecordati S.P.A.国内上市的原研药品原研进口32-27拉莫三嗪片Lamotrigine Tablets/Lamictal100mgThe Wellcome Foundation Ltd国内上市的原研药品原研进口32-28依非韦伦片Efavirenz Tablets/Sustiva600mgBristol-M

11、yers Squibb Pharma Compay未进口原研药品美国橙皮书32-29阿立哌唑口崩片Aripiprazole Orally Disintegrating tablets/Abilify10mgOtsuka Pharmaceutical Co.Ltd未进口原研药品美国橙皮书32-30阿立哌唑口崩片Aripiprazole Orally Disintegrating tablets/Abilify15mgOtsuka Pharmaceutical Co.Ltd未进口原研药品美国橙皮书32-31复方磺胺甲噁唑片Compound Sulfamethoxazole Tablets/Bact

12、rim磺胺甲噁唑800g，甲氧苄啶 160mgSun Pharmaceutical Industries Inc未进口原研药品美国橙皮书32-32艾曲泊帕乙醇胺片Eltrombopag Olamine Tablets/Promacta25mgNovartis Pharmaceuticals Corp未进口原研药品美国橙皮书32-33注射用替加环素Tigecycline for Injection/Tygacil50mgPF Prism CV未进口原研药品美国橙皮书32-34他克莫司胶囊Tacrolimus Capsules/ Prograf5mgAstellas Pharma US Inc未进

13、口原研药品美国橙皮书32-35他克莫司胶囊Tacrolimus Capsules/ Prograf1mgAstellas Pharma US Inc未进口原研药品美国橙皮书32-36他克莫司胶囊Tacrolimus Capsules/ Prograf0.5mgAstellas Pharma US Inc未进口原研药品美国橙皮书32-37硝酸甘油片Nitroglycerin Sublingual Tablets/ Nitrostat0.6mgPfizer Pharmaceuticals LTD未进口原研药品美国橙皮书32-38米拉贝隆缓释片Mirabegron Extended-release

14、Tablets/Myrbetriq25mgAstellas Pharma Global Development Inc未进口原研药品美国橙皮书32-39盐酸伊立替康注射液Irinotecan Hydrochloride Injection/Camptosar5ml:0.1gPfizer Inc未进口原研药品美国橙皮书32-40盐酸伊立替康注射液Irinotecan Hydrochloride Injection/Camptosar2ml:40mgPfizer Inc未进口原研药品美国橙皮书32-41替米沙坦片Telmisartan Tablets/Micardis40mgBoehringer

15、Ingelheim未进口原研药品美国橙皮书32-42替米沙坦片Telmisartan Tablets/Micardis80mgBoehringer Ingelheim未进口原研药品美国橙皮书32-43伏立康唑片Voriconazole Tablets/Vfend50mgPF Prism CV未进口原研药品美国橙皮书32-44注射用伏立康唑Voriconazole for Injection/Vfend200mgPF Prism CV未进口原研药品美国橙皮书32-45碳酸司维拉姆片Sevelamer Carbonate Tablets / Renvela800mgSanofi Genzyme未进

16、口原研药品美国橙皮书32-46注射用磷酸特地唑胺Tedizolid Phosphate For Injection/Sivextro200mgCubist Pharmaceuticals LLC/Merck & CO.,INC未进口原研药品美国橙皮书32-47氟尿嘧啶注射液Fluorouracil Injection/Fluorouracil1g/20mlFresenius Kabi USA LLC国际公认的同种药品美国橙皮书32-48地高辛注射液Digoxin Injection/Lanoxin2mL:0.5mgAspen Pharma Trading Limited未进口原研药品欧

17、盟上市32-49奥氮平片Olanzapine Tablets/Zyprexa2.5mgEli Lilly Nederland B.V.未进口原研药品欧盟上市32-50黄体酮注射液Progesterone Injection1.112ml:25mgIBSA Farmaceutici Italia Srl未进口原研药品欧盟上市32-51阿普司特片Apremilast Tablets/Otezla10mgCelgene Europe B.V.未进口原研药品欧盟上市32-52阿普司特片Apremilast Tablets/Otezla30mgCelgene Europe B.V.未进口原研药品欧盟上市

18、32-53利福平胶囊Rifampicin Capsules/Rifadin150mgSanofi未进口原研药品欧盟上市32-54丙酸倍氯米松吸入气雾剂Beclometasone Dipropionate Inhalation Aerosol /Qvar 每瓶200揿，每揿含丙酸倍氯米松50gTeva UK Limited未进口原研药品 欧盟上市32-55丙酸倍氯米松吸入气雾剂Beclometasone Dipropionate Inhalation Aerosol /Qvar 每瓶200揿，每揿含丙酸倍氯米松50gTeva UK Limited未进口原研药品 日本上市32-56丙酸倍氯米松吸入

19、气雾剂Beclometasone Dipropionate Inhalation Aerosol /Clenil Modulite/ Clenil每瓶200揿，每揿含丙酸倍氯米松250gChiesi Limited/ Chiesi Farmaceutici S.p.A.未进口原研药品 欧盟上市32-57苯磺顺阿曲库铵注射液Cisatracurium Besylate Injection/Nimbex2.5ml:5mgAspen Pharma Trading Limited未进口原研药品欧盟上市32-58硝呋太尔片Nifuratel Tablets/ Macmiror200mgPolichem

20、S.R.L./ Polichem SA未进口原研药品欧盟上市32-59马尿酸乌洛托品片Methenamine Hippurate Tablets/ Hippex1gMylan Products Ltd未进口原研药品欧盟上市32-60环孢素眼用乳剂Ciclosporin Eye Drops Emulsion/ Verkazia0.10%Santen Oy未进口原研药品欧盟上市32-61盐酸罗哌卡因注射液Ropivacaine Hydrochloride Injection/Naropin10ml:75mgAspen Pharma Trading Limited未进口原研药品欧盟上市32-62盐酸

21、罗哌卡因注射液Ropivacaine Hydrochloride Injection/Naropin10ml:100mgAspen Pharma Trading Limited未进口原研药品欧盟上市32-63马来酸阿法替尼片Afatinib Dimaleate Tablets/Giotrif50mgBoehringer Ingelheim International GmbH未进口原研药品欧盟上市32-64盐酸阿罗洛尔片Arotinolol Hydrochloride Tablets5mg大日本住友製薬株式会社未进口原研药品日本上市32-65盐酸法舒地尔注射液Fasudil Hydrochlo

22、ride Injection/Eril2ml:30mgAsahi Kasei Pharma Corporatio未进口原研药品日本上市32-66盐酸托莫西汀口服溶液Atomoxetine Hydrochloride Oral Solution /Strattera100ml0.4g日本株式会社未进口原研药品 日本上市32-67盐酸咪达普利片Imidapril Hydrochloride Tablets/ Tanatril2.5mg田辺三菱製薬株式会社 未进口原研药品日本上市32-68米库氯铵注射液Mivacurium Chloride Injection/Mivacron10ml:20mgAs

23、pen Pharma Trading Limited未进口原研药品英国上市32-69萘普生钠片Naproxen Sodium Tablets /Apranax275mgAtnahs Pharma Netherlands B.V.未进口原研药品法国上市32-70克霉唑乳膏Clotrimazole Cream/Canesten1%Bayer Inc未进口原研药品加拿大上市32-71注射用阿莫西林钠克拉维酸钾Amoxicillin Sodium and Clavulanate Potassium for injection（10:1）550mg（500/50）GlaxoSmithKline AG未进

24、口原研药品瑞士上市32-72注射用阿莫西林钠克拉维酸钾Amoxicillin Sodium and Clavulanate Potassium for injection（10:1）1.1g（1000/100）GlaxoSmithKline AG未进口原研药品瑞士上市32-73注射用阿莫西林钠克拉维酸钾Amoxicillin Sodium and Clavulanate Potassium for injection（10:1）2.2g（2000/200）GlaxoSmithKline AG未进口原研药品瑞士上市32-74马来酸咪达唑仑片Midazolam Maleate Tablets/Do

25、rmicum7.5mg（以咪达唑仑计）CPS Cito Pharma Services未进口原研药品瑞士上市32-75醋酸去氨加压素注射液Desmopressin Acetate Injection/Minirin1ml:4g（按去氨加压素计3.56g）Ferring AG未进口原研药品瑞士上市32-76醋酸去氨加压素注射液Desmopressin Acetate Injection/Octostim1ml:15g（按去氨加压素计13.4g）Ferring AG未进口原研药品瑞士上市10-66卡维地洛片Carvedilol Tablets/Dilatrend6.25mgRoche Pharma

26、 AG/Cheplapharm Arzneimittel GmbH欧盟上市持证商发生变更，增加持证商Cheplapharm Arzneimittel GmbH10-68卡维地洛片Carvedilol Tablets/Dilatrend12.5mgRoche Pharma AG/Cheplapharm Arzneimittel GmbH欧盟上市持证商发生变更，增加持证商Cheplapharm Arzneimittel GmbH30-86磷酸特地唑胺片Tedizolid Phosphate Tablets/Sivextro200mgCubist Pharmaceuticals LLC/MSD Pharma（Singapore）Pte. Ltd.未进口原研药品增加持证商MSD Pharma（Singapore）Pte. Ltd21-