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附件1化学仿制药参比制剂目录（第三十二批）（征求意见稿）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2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醋酸阿比特龙片Abiraterone Acetate Tablets/ Zytiga250mgJanssen Biotech Inc未进口原研药品美国橙皮书盐酸乐卡地平片Lercanidipine Hydrochloride Tablets/Zanidip（再宁平）20mgRecordati S.P.A.国内上市的原研药品原研进口法莫替丁钙镁咀嚼片Famotidine，Calcium Carbonate and Magnesium Hydroxide Chewable 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地高辛注射液Digoxin Injection/Lanoxin2mL:0.5mgAspen Pharma Trading Limited未进口原研药品欧盟上市依非韦伦片Efavirenz Tablets/Sustiva600mgBristol-Myers Squibb Pharma Compay未进口原研药品美国橙皮书奥氮平片Olanzapine Tablets/Zyprexa2.5mgEli Lilly Nederland B.V.未进口原研药品欧盟上市黄体酮注射液Progesterone Injection/Lubion1.112ml:25mgIBSA Farmaceutici Italia Srl未进口原研药品欧盟上市阿普司特片Apremilast Tablets/Otezla10mgCelgene Europe B.V.未进口原研药品欧盟上市阿普司特片Apremilast Tablets/Otezla30mgCelgene Europe B.V.未进口原研药品欧盟上市来迪派韦索磷布韦片Ledipasvir and Sofosbuvir Tablets/ Harvoni（夏帆宁）90mg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利福平胶囊Rifampicin Capsules/RIFADIN150mgSanofi未进口原研药品欧盟上市倍他米松磷酸钠注射液Betamethasone phosphate sodium injection/Celestone4mg/ml（以倍他米松计）（1ml）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50μgTeva UK Limited未进口原研药品 欧盟上市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50μgTeva UK Limited未进口原研药品 日本上市丙酸倍氯米松吸入气雾剂Beclometasone Dipropionate Inhalation Aerosol /Clenil Modulite 每瓶200揿，每揿含丙酸倍氯米松250μgChiesi Limited/ Chiesi Farmaceutici S.p.A.未进口原研药品 欧盟上市阿立哌唑口崩片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复方磺胺甲噁唑片Compound Sulfamethoxazole Tablets/Bactrim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伏立康唑片Voriconazole Tablets/Vfend50mgPF Prism CV未进口原研药品美国橙皮书盐酸法舒地尔注射液Fasudil Hydrochloride Injection/Eril2ml:30mgAsahi Kasei Pharma Corporatio未进口原研药品日本上市氯化锰口服溶液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ファルマ株式会社未进口原研药品日本上市利多卡因凝胶贴膏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注射用德拉沙星Delafloxacin for Injection / Baxdela300mgMelinta Subsidiary Corp未进口原研药品美国橙皮书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盐酸托莫西汀口服溶液Atomoxetine Hydrochloride Oral Solution /Strattera100ml∶0.4g日本イーライリリー株式会社未进口原研药品 日本上市艾曲泊帕乙醇胺片Eltrombopag Olamine Tablets/Promacta25mgNovartis Pharmaceuticals Corporation未进口原研药品美国橙皮书硫酸亚铁缓释片Ferrous Sulfate Extended-release Tablets/Fero-Gradumet105mg（以铁元素计）マイランEPD合同会社未进口原研药品日本上市克霉唑乳膏Clotrimazole Cream/Canesten1%Bayer Inc未进口原研药品加拿大上市曲安奈德乳膏Triamcinolone Acetonide Cream0.1%Fougera Pharmaceuticals Inc国际公认的同种药品美国橙皮书注射用伏立康唑Voriconazole for Injection/Vfend200mgPF Prism CV未进口原研药品美国橙皮书碳酸司维拉姆片Sevelamer Carbonate Tablets / Renvela800mgSanofi Genzyme未进口原研药品美国橙皮书盐酸咪达普利片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未进口原研药品瑞士上市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硝呋太尔片Nifuratel Tablets/ Macmiror200mgPolichem S.R.L./ Polichem SA未进口原研药品欧盟上市美沙拉秦灌肠液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氟尿嘧啶注射液Fluorouracil Injection/Fluorouracil 1g/20mlFresenius Kabi USA LLC国际公认的同种药品美国橙皮书氟尿嘧啶注射液Fluorouracil Injection/Fluorouracil 1g/20mlAccord Healthcare INC国际公认的同种药品美国橙皮书注射用替加环素Tigecycline for Injection/Tygacil50mgPF Prism CV未进口原研药品美国橙皮书他克莫司胶囊Tacrolimus Capsules/ Prograf5mgAstellas Pharma US Inc未进口原研药品美国橙皮书他克莫司胶囊Tacrolimus Capsules/ Prograf1mgAstellas Pharma US Inc未进口原研药品美国橙皮书他克莫司胶囊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盐酸氮卓斯汀丙酸氟替卡松鼻喷雾剂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137μg和50μgMEDA Pharma GmbH & Co. KG未进口原研药品欧盟上市盐酸格拉司琼片Granisetron Hydrochloride Tablets/Kytril1mgAtnahs Pharma Netherlands B.V.未进口原研药品欧盟上市硝酸甘油片Nitroglycerin Sublingual Tablets/ Nitrostat0.6mgPfizer Pharmaceuticals LTD未进口原研药品美国橙皮书拉莫三嗪片Lamotrigine Tablets/LAMICTAL100mgThe Wellcome Foundation Ltd国内上市的原研药品原研进口米拉贝隆缓释片Mirabegron Sustained-release Tablets/Myrbetriq25mgAstellas Pharma Global Development Inc未进口原研药品美国橙皮书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头孢地尼干混悬剂Cefdinirfor Suspension250mg/5mlSandoz Inc国际公认的同种药品美国橙皮书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盐酸去氧肾上腺素注射液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磷酸特地唑胺片Tedizolid Phosphate Tablets/Sivextro200mgMSD PHARMA（SINGAPORE）PTE. LTD.未进口原研药品新加坡上市注射用二丁酰环磷腺苷钠Bucladesine Sodium Injection/アクトシン300mgアルフレッサ ファーマ株式会社未进口原研药品日本上市环孢素眼用乳剂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马来酸米达唑仑片Midazolam Maleate Tablets/Dormicum7.5mg（以咪达唑仑计）CPS Cito Pharma Services未进口原研药品瑞士上市醋酸去氨加压素注射液Desmopressin Acetate Injection/Minirin1ml:4μg（按去氨加压素计3.56μg）Ferring AG未进口原研药品瑞士上市醋酸去氨加压素注射液Desmopressin Acetate Injection/Octostim1ml:15μg（按去氨加压素计13.4μg）Ferring AG未进口原研药品瑞士上市盐酸屈他维林片Drotaverine Hydrochloride Tablets/ NO-SPA40mgSanofi-Aventis未进口原研药品欧盟上市米库氯铵注射液Mivacurium Chloride Injection/Mivacron10ml:20mgAspen Pharma Trading Limited未进口原研药品英国上市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盐酸罗哌卡因注射液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萘普生钠片Naproxen Sodium Tablets /Apranax275mgAtnahs Pharma Netherlands B.V.未进口原研药品法国上市替米沙坦片Telmisartan Tablets/Micardis40mgBoehringer Ingelheim未进口原研药品美国橙皮书替米沙坦片Telmisartan Tablets/Micardis80mgBoehringer Ingelheim未进口原研药品美国橙皮书10-66卡维地洛片Carvedilol Tablets/Dilatrend6.25mgRoche Pharma 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 Gmbh备注1.未在国内上市品种，需参照原总局2015年第230号公告等的相关要求开展研究，通用名、剂型等经药典委核准后为准。2.参比制剂目录公示后，未正式发布的品种将进行专题研究，根据研究结果另行发布。3.欧盟上市的参比制剂包括其在英国上市的同一药品。附件2未通过审议品种目录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2遴选情况说明氨氯地平阿托伐他汀钙AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM/CADUET5mg/80mgPfizer Inc未进口原研药品美国橙皮书经一致性评价专家委员会专家审议，80mg规格的阿托伐他汀对于中国人群的有效性获益增加有限、安全性风险可能增加。审议未通过。艾拉莫德片Iguratimod Tablets /Careram25 mgエーザイ株式会社／富士フイルム富山化学株式会社未进口原研药品日本上市经一致性评价专家委员会专家审议，国内上市的艾拉莫德片已完成临床研究批准上市，用法用量与此次推荐的参比制剂不同。审议未通过。吉法酯片Gefarnate Tablets/惠加强-G(WYCAKON-G)50mgSeiko Eiyo Yakuhin Co.,LTD日本上市经一致性评价专家委员会专家审议，本品原研地位暂不明确。审议未通过。萘普生艾司奥美拉唑镁肠溶片Naproxen and esomeprazole magnesium delayed-release tablets/Vimovo萘普生375mg/艾司奥美拉唑20mgHorizon Medicines LLC未进口原研药品美国橙皮书经一致性评价专家委员会专家审议，萘普生在国内为非主流非甾体抗炎药，该复方暂不符合国内临床实践及复方制剂的要求。审议未通过。萘普生艾司奥美拉唑镁肠溶片Naproxen and esomeprazole magnesium delayed-release tablets/Vimovo萘普生500mg/艾司奥美拉唑20mgHorizon Medicines LLC未进口原研药品美国橙皮书同上。酚磺乙胺注射液Etamsylate Injection/ Dicynone2ml：250mgOM Pharma SA未进口原研产品瑞士上市经一致性评价专家委员会专家审议，申请资料未提供支持该产品在瑞士上市完整、充分安全性及有效性数据。审议未通过。美他多辛口服溶液Metadoxine Oral Solutiong/METADOXIL500mg/15mlLaboratori Baldacci S.P.A.未进口原研药品欧盟上市经一致性评价专家委员会专家审议，申请的参比制剂与国内已上市该品种规格、适应症不同；基于遴选资料，无法对其安全、有效性进行评价。审议未通过。骨化三醇口服溶液Calcitriol Oral Solution15μg:15mgValidus Pharmaceuticals LLC未进口原研药品美国橙皮书经一致性评价专家委员会专家审议，国内已有多种活性维生素D类口服制剂，本品如在国内申请上市属改剂型品种，建议提供较目前已上市剂型的临床优势证据。审议未通过。 ................
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