2022年仿制药参比制剂目录(第五十九批).docx

化学仿制药参比制剂目录（第五十九批）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259-1异麦芽糖酐铁注射 液Iron IsomaltosideInjection/ MonoFer按Fe计1ml : 1mgPharmacosmosA/S国内上市的原研 药品原研进59-2异麦芽糖酐铁注射 液Iron IsomaltosideInjection/ MonoFer按Fe计5ml : 5mgPharmacosmosA/S国内上市的原研 药品原研进59-3异麦芽糖酐铁注射 液Iron IsomaltosideInjection/ MonoFer按 Fe 计 10ml : 10mgPharmacosmosA/S国内上市的原研 药品原研进59-4氘丁苯那嗪片DeutetrabenazineTablets/安 泰坦6mgTeva Branded Pharmaceutical Products R&D Inc.国内上市的原研 药品原研进59-5氘丁苯那嗪片DeutetrabenazineTablets/安 泰坦9mgTeva Branded Pharmaceutical Products R&D Inc.国内上市的原研 药品原研进59-6氘丁苯那嗪片DeutetrabenazineTablets/安 泰坦12mgTeva Branded Pharmaceutical Products R&D Inc.国内上市的原研 药品原研进59-7多拉韦林片DoravirineTablets/Pifeltrd 沛卓）1mgMerck Sharp & Dohme B.V.国内上市的原研 药品原研进59-8多拉米替片Doravirine, Lamivudine and Tenofovir Disoproxil Fumarate Tablets/Delstrigo母片含多拉韦林 1mg、拉米夫定 3mg 和富马酸 替诺福韦二吡呋酯 3mgMerck Sharp & Dohme B.V.国内上市的原研 药品原研进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259-9聚乙二醇钠钾散Macrogol Sodium Potassium Powder/Movicol (默维 可)13.8g/包Bridging PharmaLimited国内上市的原研 药品原研进59-10复方电解质注射液(II)Multiple Electrolytes Injection(II)5mlB. Braun Melsungen AG国内上市的原研 药品原研进59-11乙琥胺软胶囊Ethosuximide Capsules / Zarontin250mgParke Davis Div Warner Lambert Co未进原研药品美国橙皮书59-12盐酸帕罗西汀混悬 剂ParoxetineHydrochloride Oral Suspension/Paxil10mg/5mlApotex Corp.未进原研药品美国橙皮书59-13卡泊三醇乳膏Calcipotriol Cream /Dovonex0.5%Leo Pharma As未进原研药品美国橙皮书59-14盐酸羟甲唑琳滴眼 液OxymetazolineHydrochlorideOphthalmic Solution/Upneeq0.1%(0.3ml:0.3mg )RvlPharmaceuticalsInc未进原研药品美国橙皮书59-15乳酸钠林格注射液Lactated RingersInjection/LactatedRingers In PlasticContainer5mlBaxter HealthcareCorp未进原研药品美国橙皮书59-16非奈利酮片FinerenoneTablet/Kerendia10mgBayer Healthcare Pharmaceuticals Inc未进原研药品美国橙皮书59-17非奈利酮片FinerenoneTablet/Kerendia20mgBayer Healthcare Pharmaceuticals Inc未进原研药品美国橙皮书59-18环索奈德吸入气雾 剂Ciclesonide InhalationAerosol/Alvesco0.08MG/INHCovis PharmaGmbh未进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259-19环索奈德吸入气雾 剂Ciclesonide InhalationAerosol/Alvesco0.16MG/INHCovis PharmaGmbh未进原研药品美国橙皮书59-20盐酸万古霉素胶囊VancomycinHydrochlorideCapsules/Vancocin125mgANIPharmaceuticalInc未进原研药品美国橙皮书59-21盐酸万古霉素胶囊VancomycinHydrochlorideCapsules/Vancocin250mgANIPharmaceuticalInc未进原研药品美国橙皮书59-22山梨醇甘露醇冲洗 剂Sorbitol MannitolIrrigation Solution30mlIcu Medical Inc未进原研药品美国橙皮书59-23碳酸氢钠注射液Sodium BicarbonateInjection0.5MEQ/MLExela PharmaSciences Llc国际公认的同种 药品美国橙皮书59-24磷/碳酸氢钠血滤 置换液Biphozyl Solution for haemodialysis / haemofiltration/Biphozyl 22 mmol/l50ml (250ml/4750ml )Baxter HoldingB.V.未进原研药品欧盟上市59-25碳酸氢钠血滤置换 液Prismasol 2 mmol/lPotassium solution for haemodialysis/haemofilt ration/Prismasol 2 mmol/l Potassium50ml (250ml/4750ml )Baxter HoldingB.V.未进原研药品欧盟上市59-26多替拉韦利匹韦林 片Dolutegravir andRilpivirine Tablets50mg/25mgViiV Healthcare BV未进原研药品欧盟上市59-27复方电解质注射液(II)Sterofundin ISO solution for infusion/ SterofundinISO250mlB. Braun Melsungen AG未进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259-28尿素13C呼气试验 诊断试剂盒Helicobacter Test Infai75mg/ 瓶Infai GmbH未进原研药品欧盟上市59-29克霉唑阴道乳膏Clotrimazole Vaginal Cream/ Canesten10%Bayer plc未进原研药品欧盟上市59-30去铁酮服溶液Deferiprone Oral Solution/Ferriprox1ml : 1mgChiesi FarmaceuticiS.p.A.未进原研药品欧盟上市59-31氢澳酸加兰他敏 服溶液GalanthamineHydrobromide OralSolution/Reminyl4mg/mlJanssen-Cilag AB未进原研药品欧盟上市59-32酮洛芬喷雾剂Ketoprofen 10% Cutaneous Spray/ Ketospray1mg/ml ；12.5ml/瓶和25ml/ 瓶CyathusExquirere Pharmaforschung s GmbH欧盟上市59-33艾氟洛芬贴剂Esflurbiprofen Patches/Loqoa Tape40 mg/ 贴 (10cm x14cm )大正株式会社未进原研药品日本上市59-34注射用阿糖腺苷Arasena-A For Intravenous Infusion 3mg3mg/ 瓶持田株式会社未进原研药品日本上市59-35盐酸阿拉莫林片AnamorelinHydrochloride Tablets /Adlumiz50mg小野品工株式 会社未进原研药品日本上市59-36布瑞哌唑崩片Brexpiprazole Orally Disintegrating Tablets/Rexulti OD Tablets0.5mg大株式会社(Otsuka PharmaceuticalCo., Ltd.)未进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259-37布瑞哌唑崩片Brexpiprazole Orally Disintegrating Tablets/Rexulti OD Tablets1mg大株式会社(Otsuka PharmaceuticalCo., Ltd.)未进原研药品日本上市59-38布瑞哌唑崩片Brexpiprazole Orally Disintegrating Tablets/Rexulti OD Tablets2mg大株式会社(Otsuka PharmaceuticalCo., Ltd.未进原研药品日本上市59-39醋酸钠林格注射液Sodium Acetate Ringers Injection/Veen F Inj.5ml :氯化钠 3.0g，氯化钾 0.15g，氯化钙 （二水合物） 0.10g，醋酸钠 （三水合物） 1.90g扶桑品工株式 会社未进原研药品日本上市59-40钠钾镁钙葡萄糖注 射液/复方醋酸钠 林格注射液Sodium Potassium Magnesium Calcium and Glucose Injection/Physio 140250ml株式会社大 工未进原研药品日本上市59-41碳酸氢钠林格注射 液Sodium BicarbonateRingers Injection/Bicanate10ml大株式会社未进原研药品日本上市59-42两性霉素B 服混 悬剂Amphotericin B for Oral Suspension /Fungizone1mg/mL9二株式 会社未进原研药品日本上市59-43富马酸氯马斯汀糖 浆ClemastineFumarate/Tavegal0.01%日新 株式会社未进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259-44注射用乳糖酸克拉 霉素Powder for Concentrate for Solution for Infusion Clarithromycin/ Klaricidi5mgMylan ProductsLimited英国上市59-45利多卡因喷雾剂LidocaineSpray/Xylocaine 10mg Spray10mg/ 喷，50ml/ 瓶Aspen Pharma Trading Limited未进原研药品英国上市59-46聚乙二醇钠钾散/ 复方聚乙二醇（ 3350）电解质 散Movicol Paediatric Chocolate Flavour 6.9g Sachet, Powder For OralSolution / Movicol6.9g/袋，含聚乙二 醇 3350 6.563g ；氯化钠： 0.1754g ；碳酸氢 钠：0.0893g ；氯 化钾：0.0159gNorgine Pharmaceuticals Limited未进原研药品英国上市59-47唑尼沙胺服混悬 液Zonisamide Oral Suspension/Desizon20mg/ml（250ml:5g ）Desitin Arzneimittel GmbH英国上市59-48氯化锶89Sr注射 液Strontium 89SrChloride Injection/Metastron （美他特龙）150MBq （4mCi ） /4mLGe HealthcareLimited国内上市的原研 药品原研进59-49盐酸曲唑酮缓释片TrazodoneHydrochlorideSustained-releaseTablets150mgAChim.Riun.Ang elini Francesco Acraf S.PA.国内上市的原研 药品原研进59-50利托那韦片Ritonavir Tablets/Norvir1mgAbbvie Inc未进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259-51平衡盐溶液（供灌 注用）Sterile Irrigating Soluti (balanced salt solution) / BSS15mL/支每毫升含 氯化钠0.64%，氯 化钾 0.075%，二 on 水合氯化钙0.048%，六水合氯 化镁0.030%，三水合醋酸钠 0.39%，二水合枸橼酸钠0.17%AlconLaboratories, Inc未进原研药品美国橙皮书59-52达沙替尼片Dasatinib Tablets/Sprycel70mgBristol MyersSquibb Co未进原研药品美国橙皮书59-53盐酸奥洛他定滴眼 液OlopatadineHydrochlorideOphthalmic solution/Pataday0.70%AlconLaboratories Inc未进原研药品美国橙皮书59-54二甲双胍恩格列净 片Empagliflozin andMetforminHydrochlorideTablets/Synjardy每片含盐酸二甲双 胍5mg和恩格 列净12.5mgBoehringerIngelheim Pharmaceuticals Inc未进原研药品美国橙皮书59-55氟18F脱氧葡糖注 射液Fludeoxyglucose F18 Injection20-4mCi/mlFeinstein InstitutMedical Researche未进原研药品美国橙皮书59-56萘普生钠片Naproxen SodiumTablets /Aleve2mg （以萘普生 计）Bayer Vital Gmbh/ Bayer BV / Bayer(Schweiz ) AG未进原研药品欧盟上市59-57多索茶碱注射液Doxofylline Injection10ml:0.1gAbc FarmaceuticiSP A未进原研产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259-58复方聚乙二醇 3350电解质散Polyethylene Glycol 3350 ElectrolytesPowder/MoviprepOrange抗坏血酸4.7g、聚 乙二醇33501g、氯化钾 1.015g、抗坏血酸 钠5.9g、氯化钠 2.691g、无水硫酸钠 7.5gNorgine B.V.未进原研药品欧盟上市59-59利培酮服溶液Risperidone Oral Solution/Risperdal0.1%(1mL:1mg)Janssen CilagSpA未进原研药品欧盟上市59-60注射液用盐酸伊达 比星Idarubicin HydrochlorideFor Injection5mg77/株式会 社（辉瑞公司）未进原研药品日本上市59-61哌柏西利片Palbociclib Tablets/ 725mg77/株式会 社未进原研药品日本上市59-62哌柏西利片Palbociclib Tablets/ T7125mg77/株式会 社未进原研药品日本上市59-63度他雄胺软胶囊Dutasteride Soft Capsules/Zagallo Capsules0.1mg/77 ；7/株式会社未进原研药品日本上市59-64头胞特仑新戊酯片Cefteram Pivoxil Tablets/Tomiron1mg富士7/儿山富山 化学株式会社未进原研药品日本上市59-65头胞特仑新戊酯片Cefteram Pivoxil Tablets/Tomiron50mg富士7/儿山富山 化学株式会社未进原研药品日本上市59-66乙酰半胱氨酸注射 液AcetylcysteineInjection/Fluimucil25ml : 5gZambonSwitzerland Ltd未进原研药品瑞士上市59-67乙酰半胱氨酸注射 液AcetylcysteineInjection/Fluimucil3ml : 3mgZambon Switzerland Ltd/ZambonSvizzera SA未进原研药品瑞士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210-132普伐他汀钠片Pravastatin SodiumTablets/Sanaprav /Prareduct40mgDaiichi SankyoItaliaS.P A./DaiichiSankyo BelgiumS.A.欧盟上市增加持证商DaiichiSankyoBelgiumS.A.,不限定上市国和产地10-272青霉素V钾片PhenoxymethylpenicillinPotassium Tablets0.5g（80万单位）Sandoz GmbH/Sandoz Inc美国橙皮书增加持证商Sandoz Inc23-167盐酸利多卡因局部 溶液Lidocaine Hydrochloride Topical Solution/Xylocaine Solution4% （以C14H22N2O HCl 计）（20ml、 1ml ）7株式会社/K7了 株式会社未进原研药品增加持证商K7T -r株式会社25-10布立西坦注射液Brivaracetam Solution for Injection/Briviact10mg/ml （ 5ml ）UCB PharmaS.A./UCB Pharma Limited未进原研药品增加持证商UCB Pharma Limited27-231二甲磺酸利右苯丙 胺胶囊LisdexamfetamineDimesylate capsules/Vyvanse30mgShireDevelopmentINC/Takeda Pharmaceuticals USA INC未进原研药品增加持证商 Takeda Pharmaceuti cals USA INC27-232二甲磺酸利右苯丙 胺胶囊LisdexamfetamineDimesylate capsules/Vyvanse50mgShireDevelopmentINC/Takeda Pharmaceuticals USA INC未进原研药品增加持证商 Takeda Pharmaceuti cals USA INC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227-233二甲磺酸利右苯丙 胺胶囊LisdexamfetamineDimesylate capsules/Vyvanse70mgShireDevelopmentINC/Takeda Pharmaceuticals USA INC未进原研药品增加持证商 Takeda Pharmaceuti cals USA INC27-269氯硝西泮注射液ClonazepamInjection/Rivotril1ml:1mgRoche Pharma AG /Roche/Cheplaph arm ArzneimittelGmbh未进原研药品增加持证商CheplapharmArzneimittelGmbh29-125阿莫西林克拉维酸 钾片Amoxicillin andClavulanate PotassiumTablets/Augmentin0.625g(C16H19N3O5S0.5g： C8H9NO 50.125g)Beecham Group /Beecham Group Plc未进原研药品增加持证商BeechamGroup Plc32-16丙戊酸钠缓释片Compound SodiumValproate and Valproic Acid Sustained Release Tablets/ DepakineChrono/Ergenyl chrono5mg （以丙戊酸 钠计）Sanofi Aventis France/Sanofi- Aventis Deutschland GmbH/SanofiS.p.A.未进原研药品增加持证商Sanofi-Aventis Deutschland GmbH/Sanofi S.p.A.47-21青霉素V钾片PhenoxymethylpenicillinPotassium Tablets250mgSandoz GmbH/Sandoz Inc美国橙皮书增加持证商Sandoz Inc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210-15巴氯芬片Baclofen Tablets/Lioresal10mgNovartis PharmaSchweizAG/Hemony PharmaceuticalSwitzerlandGmbH原研进持证商变更， 增加变更后持 证商Hemony Pharmaceuti cal SwitzerlandGmbH23-76噻托澳铵粉吸入剂 /噻托澳铵吸入粉 雾剂Tiotropium Bromide Powder For Inhalation/Spiriva（思力 华）18田（按噻托铵 计，相当于噻托澳铵 一水合物22.5田）BoehringerIngelheim InternationalGmbH国内上市的原研 药品修订规格及药 品通用名称备注1. 目录中所列尚未在国内上市品种的通用名、剂型2. 参比制剂目录公示后，未正式发布的品种将进行3. 欧盟上市的参比制剂包括其在英国上市的同一药4. 选择未进参比制剂开展仿制药研究除满足其成5. 放射性药物不同于普通化学药物，具有一定的特 研发目标和基本要求，可根据其药物特性同时结4等，以药典委核准的为准。亍专题研究，根据研究结果另行发布。5品。E量要求外，还需满足现行版中国药典和相关指导原则要求。字殊性如放射性、时效性、按放射性活度给药等特点，参比制剂主要用于明确其 4参比制剂的可获得性进行研究。