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【第五十三批】仿制藥參比制劑目錄


【第五十三批】仿制藥參比制劑目錄


序號藥品通用名稱英文名稱/商品名規(guī)格持證商備注1備注2
53-1環(huán)孢素注射液Ciclosporin Injection/ Sandimmun5ml: 250mgNovartis Pharma Schweiz AG國內(nèi)上市的原研藥品原研進(jìn)口
53-2復(fù)方聚乙二醇電解質(zhì)散(III)Polyethylene Glycol Electrolytes Powder(III) /福靜清73.690g/袋IPSEN Consumer HealthCare國內(nèi)上市的原研藥品原研進(jìn)口
53-3阿舒瑞韋軟膠囊Asunaprevir Soft Capsules/Sunvepra(速維普)100mgBristol-Myers Squibb (Singapore) Pte. Ltd.國內(nèi)上市的原研藥品原研進(jìn)口
53-4多替阿巴拉米片Dolutegravir Sodium, Abacavir Sulfate and Lamivudine Tablets/Triumeq(綏美凱)每片含多替拉韋鈉(以多替拉韋計)50mg、硫酸阿巴卡韋(以阿巴卡韋計)600mg和拉米夫定300mgViiV Healthcare UK Limited/ViiV Healthcare BV國內(nèi)上市的原研藥品原研進(jìn)口
53-5西美瑞韋膠囊Simeprevir Capsules/Olysio(奧萊森)150mgJanssen-Cilag International NV國內(nèi)上市的原研藥品原研進(jìn)口
53-6奧比帕利片Ombitasvir,Paritaprevir and Ritonavir Tablets/Viekirax(維建樂)每片含奧比他韋12.5mg,帕立瑞韋75mg和利托那韋50mgAbbVie AG/AbbVie Ltd國內(nèi)上市的原研藥品原研進(jìn)口
53-7達(dá)塞布韋鈉片Dasabuvir Sodium Tablets/Exviera(易奇瑞)250mgAbbVie AG/AbbVie Ltd國內(nèi)上市的原研藥品原研進(jìn)口
53-8德拉馬尼片Delamanid Tablets/Deltyba(德爾巴)50mgOtsuka Pharmaceutical Co., Ltd國內(nèi)上市的原研藥品原研進(jìn)口
53-9拉替拉韋鉀干混懸劑Raltegravir Potassium For Oral Suspension/Isentress(艾生特)100mg(按拉替拉韋計)Merck Sharp & Dohme Corp.國內(nèi)上市的原研藥品原研進(jìn)口
53-10艾爾巴韋格拉瑞韋片Elbasvir and Grazoprevir Tablets/Zepatier(擇必達(dá))每片含艾爾巴韋50mg和格拉瑞韋100mgMerck Sharp & Dohme Australia Pty ltd/Merck Sharp & Dohme B.V.國內(nèi)上市的原研藥品原研進(jìn)口
53-11索磷布韋維帕他韋片Sofosbuvir and Velpatasvir Tablets/Epclusa(丙通沙)每片含400mg索磷布韋和100mg維帕他韋Gilead Sciences International Ltd/Gilead Sciences Ireland UC國內(nèi)上市的原研藥品原研進(jìn)口
53-12鹽酸阿來替尼膠囊Alectinib Hydrochloride Capsules/Alecensa(安圣莎)150mg(按C30H34N4O2計)Roche Registration GmbH國內(nèi)上市的原研藥品原研進(jìn)口
53-13精氨酸培哚普利片Perindopril Arginine Tablets/Acertil(雅施達(dá))10mgLes Laboratoires Servier國內(nèi)上市的原研藥品原研進(jìn)口
53-14地塞米松玻璃體內(nèi)植入劑Dexamethasone Intravitreal Implant/Ozurdex(傲迪適)0.7mgAllergan Pharmaceuticals Ireland國內(nèi)上市的原研藥品原研進(jìn)口
53-15甲硝唑氯化鈉注射液Metronidazole and Sodium Chloride Injection100ml:甲硝唑0.5g與氯化鈉0.8g上海百特醫(yī)療用品有限公司經(jīng)審核確定的國外原研企業(yè)在中國境內(nèi)生產(chǎn)的藥品原研地產(chǎn)化
53-16葡萄糖酸鈣氯化鈉注射液Calcium Gluconate in Sodium Chloride Injection1g/50ml(20mg/ml)HQ Specialty Pharma Corp未進(jìn)口原研藥品美國橙皮書
53-17葡萄糖酸鈣氯化鈉注射液Calcium Gluconate in Sodium Chloride Injection2g/100ml(20mg/ml)HQ Specialty Pharma Corp未進(jìn)口原研藥品美國橙皮書
53-18葡萄糖酸鈣氯化鈉注射液Calcium Gluconate in Sodium Chloride Injection1g/100ml(10mg/ml)HQ Specialty Pharma Corp未進(jìn)口原研藥品美國橙皮書
53-19甲硝唑陰道凝膠Metronidazole Vaginal Gel/Nuvessa1.30%Chemo Research Sl未進(jìn)口原研藥品美國橙皮書
53-20布比卡因美洛昔康緩釋溶液Bupivacaine And Meloxicam Extended-Release Solution/Zynrelef Kit2.3ml:布比卡因60mg與美洛昔康1.8mgHeron Therapeutics Inc未進(jìn)口原研藥品美國橙皮書
53-21布比卡因美洛昔康緩釋溶液Bupivacaine And Meloxicam Extended-Release Solution/Zynrelef Kit2.3ml:布比卡因60mg與美洛昔康1.8mgHeron Therapeutics Inc未進(jìn)口原研藥品美國橙皮書
53-22布比卡因美洛昔康緩釋溶液Bupivacaine And Meloxicam Extended-Release Solution/Zynrelef Kit2.3ml:布比卡因60mg與美洛昔康1.8mgHeron Therapeutics Inc未進(jìn)口原研藥品美國橙皮書
53-23布比卡因美洛昔康緩釋溶液Bupivacaine And Meloxicam Extended-Release Solution/Zynrelef Kit2.3ml:布比卡因60mg與美洛昔康1.8mgHeron Therapeutics Inc未進(jìn)口原研藥品美國橙皮書
53-24左氧氟沙星口服溶液Levofloxacin Oral Solution25mg/mlAkorn Operating Co LLC國際公認(rèn)的同種藥品美國橙皮書
53-25锝[Tc-99m]奧昔膦酸鹽注射液制備試劑盒Kit for the preparation of Technetim [Tc-99m] Oxidronate for Injection每瓶含3.0mg的奧昔膦酸鈉Curium LLC Company未進(jìn)口原研藥品美國橙皮書
53-26锝[Tc 99m]噴替酸鹽注射液制備試劑盒Kit for the preparation of Technetium[Tc-99m] Pentetate Injection每瓶含噴替酸(二乙基三胺五乙酸)20mgJubilant Draximage Inc Dba Jubilant Radiopharma未進(jìn)口原研藥品美國橙皮書
53-27注射用亞錫甲氧異腈Kit for the preparation of Technetium Tc99m Sestamibi for Injection/Cardiolite四(2-甲氧異腈)絡(luò)銅(I)氟硼酸鹽1.0mgLantheus Medical Imaging Inc未進(jìn)口原研藥品美國橙皮書
53-28氟[18F]美他酚注射液Flutemetamol (18F) Injection/Vizamyl4.05mCi/MLGE Healthcare Inc.未進(jìn)口原研藥品美國橙皮書
53-29氟[18F]脫氧葡糖注射液Fludeoxyglucose[18F] Injection20-200mCi/mLPETNET Solution INC國際公認(rèn)的同種藥品美國橙皮書
53-30鎵[68Ga]伊索曲肽注射液SomaKit TOC 40 Micrograms Solution For InjectionGallium (68ga) Edotreotide / SomaKit TOC31.63-266.8MBq/mL(即0.86-7.21mCi/mL)Advanced Accelerator Applications未進(jìn)口原研藥品歐盟上市
53-31鎵[68Ga]伊索曲肽注射液制備用藥盒SomaKit TOC 40 Micrograms Kit For Radiopharmaceutical PreparationEdotreotide / SomaKit TOCVial 1: 40μg;Vial 2: 1 mLAdvanced Accelerator Applications未進(jìn)口原研藥品歐盟上市
53-32注射用亞錫替曲膦Tetrofosmin and Stannous Chloride for Injection/Myoview每瓶含替曲膦230微克的注射用亞錫替曲膦GE Healthcare AS未進(jìn)口原研藥品歐盟上市
53-33锝[99mTc]替曲膦注射液Technetium [99mTc] Tetrofosmin Injection/Myoview≤1.5 GBq/mLGE Healthcare Limited未進(jìn)口原研藥品歐盟上市
53-34[177Lu]镥氧奧曲肽注射液Lutathera 370 MBq/mL solution for infusion Lutetium (177Lu) oxodotreotide/ Lutathera370 MBq/mLAdvanced Accelerator Applications未進(jìn)口原研藥品歐盟上市
53-35比索洛爾氨氯地平片Bisoprolol Fumarate and Amlodipine Besylate Tablets富馬酸比索洛爾5mg與苯磺酸氨氯地平(按氨氯地平計)5mgMerck Serono GmbH未進(jìn)口原研藥品歐盟上市
53-36多種微量元素注射液(Ⅲ)Concentrate for solution for infusion /Addaven10mlFresenius Kabi未進(jìn)口原研藥品歐盟上市
53-37多種微量元素注射液(Ⅰ)Concentrate for solution for infusion / Peditrace10mlFresenius Kabi未進(jìn)口原研藥品歐盟上市
53-38藥用炭膠囊Activated Charcoal Capsules0.2gCabot Norit Nederland B.V.
歐盟上市
53-39多潘立酮干混懸劑Domperidone for Suspension/ Nauzelin10mg協(xié)和キリン株式會社未進(jìn)口原研藥品日本上市
53-40中性腹膜透析液(乳酸鹽-G1.35%)Neutral Peritoneal Dialysis Solution(Lactate-G1.35%)/MIDPELIQ 135?腹膜透析液2000ml(1600ml /400ml)テルモ株式會社(泰爾茂株式會社)未進(jìn)口原研藥品日本上市
53-41中性腹膜透析液(乳酸鹽-G2.5%)Neutral Peritoneal Dialysis Solution(Lactate-G2.5%)/MIDPELIQ 250?腹膜透析液2000ml(1600ml /400ml)テルモ株式會社(泰爾茂株式會社)未進(jìn)口原研藥品日本上市
53-42中性低鈣腹膜透析液(乳酸鹽-G1.35%)Neutral Low Calcium Peritoneal Dialysis Solution(Lactate-G1.35%)/MIDPELIQ L135?腹膜透析液2000ml(1600ml /400ml)、2500ml(2000ml /500ml)テルモ株式會社(泰爾茂株式會社)未進(jìn)口原研藥品日本上市
53-43中性低鈣腹膜透析液(乳酸鹽-G2.5%)Neutral Low Calcium Peritoneal Dialysis Solution(Lactate-G2.5%)/MIDPELIQ L250?腹膜透析液2000ml(1600ml /400ml)、2500ml(2000ml /500ml)テルモ株式會社(泰爾茂株式會社)未進(jìn)口原研藥品日本上市
53-44中性低鈣腹膜透析液(乳酸鹽-G1.5%)Neutral Low Calcium Peritoneal Dialysis Solution(Lactate-G1.5%)/ダイアニール-N PD-4 1.5?腹膜透析液1000ml、1500ml、2000ml、2500ml、5000ml/袋バクスター株式會社未進(jìn)口原研藥品日本上市
53-45中性低鈣腹膜透析液(乳酸鹽-G2.5%)Neutral Low Calcium Peritoneal Dialysis Solution(Lactate-G2.5%)/ダイアニール-N PD-4 2.5?腹膜透析液1000ml、1500ml、2000ml、2500ml、5000ml/袋バクスター株式會社未進(jìn)口原研藥品日本上市
53-46復(fù)方維生素C鈉鉀散Compound Vitamin C, Sodium Sulfate and Potassium Sulfate Powder / MoviPrepA袋:氯化鈉5.382g,氯化鉀2.03g,無水硫酸鈉15.0g,聚乙二醇4000 200.0g;B袋:維生素C 9.4g,維生素C鈉11.8gEAファーマ株式會社未進(jìn)口原研藥品日本上市
53-47鹽酸伊格列敏片Imeglimin Hydrochloride Tablets/Twymeeg500mg日本住友制藥株式會社未進(jìn)口原研藥品日本上市
53-48孟魯司特鈉口崩片Montelukast Sodium Orally Disintegrating Tablets/Singulair10mgMSD株式會社未進(jìn)口原研藥品日本上市
53-49黃體酮栓Progesterone Suppositories/Cyclogest400mgL.D.Collins & Co.Ltd.
英國上市
53-50瑪巴洛沙韋片Baloxavir Marboxil Tablets/Xofluza(速福達(dá))20mgRoche Pharma (Schweiz) AG國內(nèi)上市的原研藥品原研進(jìn)口
53-51非諾貝特酸膽堿緩釋膠囊Choline Fenofibrate Sustained-release Capsules135mgAbbott Laboratories Limited國內(nèi)上市的原研藥品原研進(jìn)口
53-52小兒法羅培南鈉顆粒Pediatric Faropenem Sodium Granules/菲若姆0.05g(按C12H15NO5S計)Maruho Co.,Ltd.國內(nèi)上市的原研藥品原研進(jìn)口
53-53特立氟胺片Teriflunomide Tablets/Aubagio7mgSanofi Aventis US LLC未進(jìn)口原研藥品美國橙皮書
53-54特立氟胺片Teriflunomide Tablets/Aubagio14mgSanofi Aventis US LLC未進(jìn)口原研藥品美國橙皮書
53-55鹽酸納布啡注射液Nalbuphine Hydrochloride Injection10mg/ml(10ml)Hospira INC未進(jìn)口原研藥品美國橙皮書
53-56硫酸沙丁胺醇吸入氣霧劑Salbutamol Sulfate Inhalation Aerosol/Proair HFA90μg/撳(以沙丁胺醇計)Teva Branded Pharmaceutical Products R And D INC未進(jìn)口原研藥品美國橙皮書
53-57左甲狀腺素鈉口服溶液Levothyroxine Sodium Oral Solution /Tirosint-SOL1ml:13μgInstitut Biochimique SA (IBSA)未進(jìn)口原研藥品美國橙皮書
53-58左甲狀腺素鈉口服溶液Levothyroxine Sodium Oral Solution /Tirosint-SOL1ml:25μgInstitut Biochimique SA (IBSA)未進(jìn)口原研藥品美國橙皮書
53-59左甲狀腺素鈉口服溶液Levothyroxine Sodium Oral Solution /Tirosint-SOL1ml:50μgInstitut Biochimique SA (IBSA)未進(jìn)口原研藥品美國橙皮書
53-60左甲狀腺素鈉口服溶液Levothyroxine Sodium Oral Solution /Tirosint-SOL1ml:150μgInstitut Biochimique SA (IBSA)未進(jìn)口原研藥品美國橙皮書
53-61注射用鹽酸米諾環(huán)素Minocycline Hydrochloride For Injection/Minocin100mgRempex Pharmaceuticals未進(jìn)口原研藥品美國橙皮書
53-62白消安注射液Busulfan Injection/Busilvex10ml: 60mgPierre Fabre Médicament未進(jìn)口原研藥品歐盟上市
53-63多巴絲肼片Levodopa and Benserazide Hydrochloride Tablets/ Madopar125mgRoche Pharma AG未進(jìn)口原研藥品歐盟上市
53-64阿奇霉素膠囊Azithromycin Capsules/Sumamed0.25gPliva Hrvatska d.o.o.未進(jìn)口原研藥品歐盟上市
53-65注射用替考拉寧Teicoplanin for Injection/Targocid200 mgSanofi S.p.A未進(jìn)口原研藥品歐盟上市
53-66注射用替考拉寧Teicoplanin for Injection/Targocid400 mgSanofi-Aventis France未進(jìn)口原研藥品歐盟上市
53-67伊布替尼片Ibrutinib Tablets/Imbruvica140mgJanssen-Cilag International NV未進(jìn)口原研藥品歐盟上市
53-68伊布替尼片Ibrutinib Tablets/Imbruvica280mgJanssen-Cilag International NV未進(jìn)口原研藥品歐盟上市
53-69伊布替尼片Ibrutinib Tablets/Imbruvica420mgJanssen-Cilag International NV未進(jìn)口原研藥品歐盟上市
53-70伊布替尼片Ibrutinib Tablets/Imbruvica560mgJanssen-Cilag International NV未進(jìn)口原研藥品歐盟上市
53-71特立齊酮膠囊Terizidon Capsules250mgRiemser Pharma GmbH國際公認(rèn)的同種藥品歐盟上市
53-72尼可地爾片Nicorandil Tablets/Sigmart2.5mg中外製薬株式會社未進(jìn)口原研藥品日本上市
53-73鹽酸羥考酮緩釋片Oxycodone Hydrochloride Prolonged-release Tablets/Oxycontin20mgNapp Pharmaceuticals Limited未進(jìn)口原研藥品英國上市
53-74羥考酮納洛酮緩釋片Oxycodone Hydrochloride and Naloxone Hydrochloride Prolonged-release Tablets?/Targinact5mg/2.5mgNapp Pharmaceuticals Limited未進(jìn)口原研藥品英國上市
53-75羥考酮納洛酮緩釋片Oxycodone Hydrochloride and Naloxone Hydrochloride Prolonged-release Tablets?/Targinact10mg/5mgNapp Pharmaceuticals Limited未進(jìn)口原研藥品英國上市
53-76羥考酮納洛酮緩釋片Oxycodone Hydrochloride and Naloxone Hydrochloride Prolonged-release Tablets?/Targinact20mg/10mgNapp Pharmaceuticals Limited未進(jìn)口原研藥品英國上市
53-77羥考酮納洛酮緩釋片Oxycodone Hydrochloride and Naloxone Hydrochloride Prolonged-release Tablets?/Targinact40mg/20mgNapp Pharmaceuticals Limited未進(jìn)口原研藥品英國上市
53-78左甲狀腺素鈉片Levothyroxine Sodium Tablets / Eltroxin50μgMercury Pharma Group Ltd.未進(jìn)口原研藥品英國上市
53-79左甲狀腺素鈉片Levothyroxine Sodium Tablets / Eltroxin100μgMercury Pharma Group Ltd.未進(jìn)口原研藥品英國上市
53-80復(fù)方維生素C聚乙二醇(3350)鈉鉀散Vitamin C Polyethylene Glycol 3350 Sodium Potassium Powder /Moviprep聚乙二醇(3350)100g、氯化鈉2.691g、氯化鉀1.015g、硫酸鈉7.500g、維生素C4.700 g、維生素C鈉5.900 gSalix Pharmaceuticals,Inc.未進(jìn)口原研藥品美國橙皮書
53-81復(fù)方維生素C聚乙二醇(3350)鈉鉀散Vitamin C Polyethylene Glycol 3350 Sodium Potassium Powder /Moviprep聚乙二醇(3350)100g、氯化鈉2.691g、氯化鉀1.015g、硫酸鈉7.500g、維生素C4.700 g、維生素C鈉5.900 gNorgine Pharmaceuticals Limited未進(jìn)口原研藥品英國上市
1-18醋酸甲羥孕酮片Medroxyprogesterone Acetate Tablets/?Provera /Farlutal0.25gPfizer Italia s.r.l.歐盟上市增加商品名Farlutal,不限定產(chǎn)地
7-27呋塞米片Furosemide Tablets/LASIX20mgUS PHARMACEUTICAL HOLDINGS II LLC/Validus Pharmaceuticals Llc美國橙皮書增加持證商Validus Pharmaceuticals Llc
10-200氧氟沙星片Ofloxacin Tablets/TARIVID0.1gDaiichi Sankyo Co., Ltd/アルフレッサ ファーマ株式會社日本橙皮書增加持證商アルフレッサ?ファーマ株式會社
26-197歐米加-3-酸乙酯軟膠囊Omega-3-Acid Ethyl Esters Soft Capsules/Lovaza1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSSmithkline Beecham/GlaxoSmithKline/Woodward Pharma Services LLC未進(jìn)口原研藥品增加持證商Woodward Pharma Services LLC
10-229利伐沙班片Rivaroxaban Tablets/Xarelto10mgBayer Pharma AG/Bayer AG原研進(jìn)口持證商發(fā)生變更,增加變更后持證商Bayer AG
10-230利伐沙班片Rivaroxaban Tablets/Xarelto15mgBayer Pharma AG/Bayer AG原研進(jìn)口持證商發(fā)生變更,增加變更后持證商Bayer AG
10-231利伐沙班片Rivaroxaban Tablets/Xarelto20mgBayer Pharma AG/Bayer AG原研進(jìn)口持證商發(fā)生變更,增加變更后持證商Bayer AG
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