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【第五十六批】仿制藥參比制劑目錄


【第五十六批】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
56-1吸入用乙酰半胱氨酸溶液Acetylcysteine ?Solution For Inhalation/Fluimucil(富露施)3ml:0.3gZambon Italia S.R.L國際公認的同種藥品國際公認進口
56-2注射用多特安肽藥盒Kit For The Preparation Of Gallium Ga 68 Dotatate Injection/ Netspot2.1~5.5mci/MlAdvanced Accelerator Applications Usa Inc未進口原研藥品美國橙皮書
56-3鎵[68Ga]多特安肽注射液Gallium[68Ga ] Dotatate Injection /Netspot2.1-5.5 Mci/MlAdvanced Accelerator Applications Usa Inc未進口原研藥品美國橙皮書
56-4醋酸亮丙瑞林注射用混懸劑Leuprolide Acetate For Injectable Suspension/Eligard7.5mgTolmar Pharmaceuticals, Inc.未進口原研藥品美國橙皮書
56-5艾曲泊帕乙醇胺干混懸劑Eltrombopag Lamine For Oral Suspension/ Promacta Kit25mgNovartis Pharmaceuticals Corporation未進口原研藥品美國橙皮書
56-6艾曲泊帕乙醇胺干混懸劑Eltrombopag Lamine For Oral Suspension/ Promacta Kit12.5mgNovartis Pharmaceuticals Corporation未進口原研藥品美國橙皮書
56-7鹽酸地爾硫卓緩釋片Diltiazem Hydrochloride Extended-Release Tablets/Cardizem La120mgBausch Health Us Llc未進口原研藥品美國橙皮書
56-8鹽酸地爾硫卓緩釋片Diltiazem Hydrochloride Extended-Release Tablets/Cardizem La180mgBausch Health Us Llc未進口原研藥品美國橙皮書
56-9鹽酸地爾硫卓緩釋片Diltiazem Hydrochloride Extended-Release Tablets/ Cardizem La240mgBausch Health Us Llc未進口原研藥品美國橙皮書
56-10鹽酸地爾硫卓緩釋片Diltiazem Hydrochloride Extended-Release Tablets/ Cardizem La300mgBausch Health Us Llc未進口原研藥品美國橙皮書
56-11鹽酸地爾硫卓緩釋片Diltiazem Hydrochloride Extended-Release Tablets/ Cardizem La360mgBausch Health Us Llc未進口原研藥品美國橙皮書
56-12美沙拉嗪緩釋膠囊Mesalamine Extended-Release Capsules / Apriso375mgValeant Pharmaceuticals International未進口原研藥品美國橙皮書
56-13盧非酰胺口服混懸液Rufinamide Oral Suspension/Banzel40mg/MlEisai Inc未進口原研藥品美國橙皮書
56-14壬二酸乳膏Azelaic Acid Cream/Azelex20%Almirall Llc未進口原研藥品美國橙皮書
56-15鹽酸毛果蕓香堿滴眼液Pilocarpine Hydrochloride Ophthalmic Solution /Vuity1.25%Abbvie Inc未進口原研藥品美國橙皮書
56-16異丙托溴銨沙丁胺醇吸入噴霧劑Ipratropium Bromide And Salbutamol Inhalation Spray20/100微克/撳Boehringer Ingelheim Pharmaceuticals,Inc.未進口原研藥品美國橙皮書
56-17布地奈德吸入粉霧劑Budesonide Inhalation Powder/Pulmicort Flexhaler0.16 Mg/吸(標定劑量0.18 Mg/吸)Astrazeneca LP未進口原研藥品美國橙皮書
56-18布地奈德吸入粉霧劑Budesonide Inhalation Powder/Pulmicort Flexhaler0.08 Mg/吸(標定劑量0.09 Mg/吸)Astrazeneca LP未進口原研藥品美國橙皮書
56-19噻托溴銨吸入噴霧劑Tiotropium Bromide Inhalation Spray/Spiriva Respimat1.25mcg/撳Boehringer Ingelheim Pharmaceuticals,Inc.未進口原研藥品美國橙皮書
56-20復合磷酸氫鉀注射液Potassium Phosphates Injection1.18GM/5ML?(236MG/ML);1.12GM/5ML?(224MG/ML)Fresenius Kabi USA LLC未進口原研藥品美國橙皮書
56-21氯化鉀注射液Potassium Chloride Injection20 Meq/10 MlHospira, Inc.國際公認的同種藥物美國橙皮書
56-22氯化鉀注射液Potassium Chloride Injection40 Meq/20 MlHospira, Inc.國際公認的同種藥物美國橙皮書
56-23乙酰半胱氨酸注射液Acetylcysteine Injection/ Hidonac AntíDoto25ml:5gZambon, S.A.U.未進口原研藥品歐盟上市
56-24對乙酰氨基酚布洛芬口服混懸液Paracetamol And Ibuprofen Oral Suspension / Tachifenekid每毫升含對乙酰氨基酚32mg,布洛芬9.6mgAziende Chimiche Riunite Angelini Francesco?–?A.C.R.A.F. S.P.A未進口原研藥品歐盟上市
56-25復方聚乙二醇(3350)電解質(zhì)散MOVICOL Paediatric Plain 6.9 G Sachet, Powder For Oral Solution6.9g/袋,含聚乙二醇3350 6.563g;氯化鈉0.1754g;碳酸氫鈉0.0893g;氯化鉀0.0251gNorgine Pharmaceuticals Limited未進口原研藥品歐盟上市
56-26復方聚乙二醇(3350)電解質(zhì)口服溶液MOVICOL Ready To Take Sachet, Powder For Oral Solution25ml/袋,每袋含:聚乙二醇3350 13.125 G;氯化鈉?0.3508 G;氯化鉀?0.0502 G;碳酸氫鈉?0.1786 GNorgine Pharmaceuticals Limited未進口原研藥品歐盟上市
56-27克林霉素磷酸酯凝膠Clindamycin Phosphate Gel / Dalacin T1%Pfizer Italia S.R.L.未進口原研藥品歐盟上市
56-28富馬酸酮替芬滴眼液Ketotifen Fumarate Ophthalmic Solution/Zaditen0.025%(0.4ml)Laboratoires Théa未進口原研藥品歐盟上市
56-29注射用培門冬酶Pegaspargase For Injection / Oncaspar3750U(750U/Ml)Les Laboratories Servier未進口原研藥品歐盟上市
56-30復方電解質(zhì)醋酸鈉注射液Multiple Electrolytes and Sodium Acetate Injection/Ionolyte500mlFresenius Kabi Nederland BV/Fresenius Kabi Pharma Portugal, Lda
歐盟上市
56-31西羅莫司外用凝膠Sirolimus Topical Gel /Rapalimus0.20%ノーベルファーマ株式會社未進口原研藥品日本上市
56-32醋酸葡萄糖維持液Acetate And Glucose ?Electrolytes Injection / Veen-3G Inj200ml扶桑薬品工業(yè)株式會社未進口原研藥品日本上市
56-33醋酸葡萄糖維持液Acetate And Glucose ?Electrolytes Injection / Veen-3G Inj500ml扶桑薬品工業(yè)株式會社未進口原研藥品日本上市
56-34碳酸氫鈉林格注射液Sodium Bicarbonate Ringer’s Injection/Bicanate500ml株式會社大塚製薬工場未進口原研藥品日本上市
56-35低鈣腹膜透析液(乳酸鹽- G1.76%)Low Calcium Peritoneal Dialysis Solution?(Lactate)/PERISATE360NL2000mlJMS株式會社未進口原研藥品日本上市
56-36低鈣腹膜透析液(乳酸鹽- G2.55%)Low Calcium Peritoneal Dialysis Solution?(Lactate)/PERISATE400NL2000mlJMS株式會社未進口原研藥品日本上市
56-37鹽酸普羅帕酮注射液Propafenone Hydrochloride Injection/Rytmonorm70mg/20mlMylan Healthcare Gmbh未進口原研藥品德國上市
56-38鹽酸丁卡因凝膠Tetracaine Hydrochloride Gel / Ametop4%(以丁卡因計)Alliance Pharmaceuticals Limited未進口原研藥品英國上市
56-39鹽酸奈福泮注射液Nefopam Hydrochloride Injection/Acupan2ml:20mgBiocodex未進口原研藥品法國上市
56-40他氟前列素滴眼液Tafluprost Eye Drops/Tapros(泰普羅斯)0.0015%(0.3ml:4.5μg)Santen Pharmaceutical Co., Ltd.國內(nèi)上市的原研藥品原研進口
56-41鹽酸奧洛他定滴眼液Olopatadine Hydrochloride Eye Drops0.2%(2.5ml:5mg,按C21H23NO3計)Novartis Pharmaceuticals Corporation國內(nèi)上市的原研藥品原研進口
56-42艾地骨化醇軟膠囊Eldecalcitol Soft Capsules0.5μgChugai Pharmaceutical Co.,Ltd國內(nèi)上市的原研藥品原研進口
56-43艾地骨化醇軟膠囊Eldecalcitol Soft Capsules0.75μgChugai Pharmaceutical Co.,Ltd國內(nèi)上市的原研藥品原研進口
56-44氨苯砜凝膠Dapsone Gel/Aczone7.50%Almirall, LLC未進口原研藥品美國橙皮書
56-45左卡尼汀注射液Levocarnitine Injection/ Carnitor200mg/mlLeadiant Biosciences Inc未進口原研藥品美國橙皮書
56-46瑞舒伐他汀鈣片Rosuvastatin Calcium Tables/Crestor5mgAstrazeneca Pharmaceuticals LP/ IPR Pharmaceuticals Inc未進口原研藥品美國橙皮書
56-47瑞舒伐他汀鈣片Rosuvastatin Calcium Tables/Crestor10mgAstrazeneca Pharmaceuticals LP/ IPR Pharmaceuticals Inc未進口原研藥品美國橙皮書
56-48左甲狀腺素鈉片Levothyroxine Sodium Tablets /Synthroid25μgAbbvie Inc.未進口原研藥品美國橙皮書
56-49左甲狀腺素鈉片Levothyroxine Sodium Tablets /Synthroid50μgAbbvie Inc.未進口原研藥品美國橙皮書
56-50左甲狀腺素鈉片Levothyroxine Sodium Tablets /Synthroid100μgAbbvie Inc.未進口原研藥品美國橙皮書
56-51左甲狀腺素鈉片Levothyroxine Sodium Tablets /Synthroid200μgAbbvie Inc.未進口原研藥品美國橙皮書
56-52左甲狀腺素鈉片Levothyroxine Sodium Tablets /Synthroid300μgAbbvie Inc.未進口原研藥品美國橙皮書
56-53左甲狀腺素鈉片Levothyroxine Sodium Tablets/Unithroid50 μgSTEVENS J未進口原研藥品美國橙皮書
56-54左甲狀腺素鈉片Levothyroxine Sodium Tablets/Unithroid100 μgSTEVENS J未進口原研藥品美國橙皮書
56-55左甲狀腺素鈉片Levothyroxine Sodium Tablets/Unithroid200 μgSTEVENS J未進口原研藥品美國橙皮書
56-56左甲狀腺素鈉片Levothyroxine Sodium Tablets/Unithroid300μgSTEVENS J未進口原研藥品美國橙皮書
56-57依折麥布瑞舒伐他汀鈣片Rosuvastatin And Ezetimibe Tablets/ ROSZET依折麥布10mg/瑞舒伐他汀10mgAlthera Pharmaceuticals LLC未進口原研藥品美國橙皮書
56-58依折麥布瑞舒伐他汀鈣片Rosuvastatin And Ezetimibe Tablets/ ROSZET依折麥布10mg/瑞舒伐他汀5mgAlthera Pharmaceuticals LLC未進口原研藥品美國橙皮書
56-59甲磺酸多沙唑嗪緩釋片Doxazosin Mesylate Extended Release Tablets/cardura xl4mgUPJOHN US 1 LLC未進口原研藥品美國橙皮書
56-60普瑞巴林膠囊Pregabalin Capsules/Lyrica200mgUPJOHN US 2 LLC未進口原研藥品美國橙皮書
56-61阿達帕林過氧苯甲酰凝膠Adapalene And Benzoyl Peroxide Gel/Epiduo0.1%;2.5%(包裝規(guī)格:2g、45g/管,45g/Pump)Galderma Laboratories LP未進口原研藥品美國橙皮書
56-62阿達帕林過氧苯甲酰凝膠Adapalene And Benzoyl Peroxide Gel/Epiduo0.1%;2.5%(包裝規(guī)格:5g、15g、30g、45g、60g、90g/管和15g、30g、45g、60g/Pump)Galderma Nordic AB未進口原研藥品歐盟上市
56-63泊沙康唑口服混懸液Posaconazole Oral Suspension/Noxafil40mg/mlMerck Sharp And Dohme B.V.未進口原研藥品歐盟上市?
56-64溴夫定片Brivudine Tablets/ Zostex125mgBerlin-Chemie AG未進口原研藥品歐盟上市
56-65達格列凈片Dapagliflozin Tablets /FORXIGA5mgAstra Zeneca AB未進口原研藥品歐盟上市
56-66精氨酸培哚普利片Perindopril Arginine Tablets/Coversyl5mgLes Laboratoires Servier未進口原研藥品歐盟上市?
56-67精氨酸培哚普利片Perindopril Arginine Tablets/Coversyl10mgLes Laboratoires Servier未進口原研藥品歐盟上市?
56-68美沙拉秦栓Mesalazine Suppositories/Salofalk1gDr. Falk Pharma Gmbh未進口原研藥品歐盟上市
56-69鹽酸依匹斯汀滴眼液Epinastine Hydrochloride Ophthalmic Solution/Aleison LX0.1%(5mg:5ml)Santen Pharmaceutical Co., Ltd.未進口原研藥品日本上市?
56-70卡絡(luò)磺鈉注射液Carbazochrome Sodium Sulfonate Injection/Adona2ml:10mgニプロ?ES?ファーマ株式會社未進口原研藥品日本上市
56-71倍他洛爾滴眼液Betaxolol Hydrochloride Ophthalmic Solution/Betoptic0.50%ノバルティスファーマ株式會社未進口原研藥品日本上市
56-72吡格列酮二甲雙胍片?Pioglitazone Hydrochloride And Metformin Hydrochloride Tablets?(15mg/500mg)/メタクト?配合錠LD15mg/500mg武田テバ薬品株式會社未進口原研藥品日本上市?
56-73注射用氟氯西林鈉Flucloxacillin Sodium For Injection/Floxapen500mg(以C19H17CLFN3O5S計)Teva Pharma AG,Basel未進口原研藥品瑞士上市
56-74注射用氟氯西林鈉Flucloxacillin Sodium For Injection/Floxapen1g(以C19H17CLFN3O5S計)Teva Pharma AG,Basel未進口原研藥品瑞士上市
27-465卡貝縮宮素注射液Carbetocin Injection/Pabal1ml:100μgFerring Pharmaceuticals Ltd/Ferring Arzneimittel Gmbh未進口原研藥品增加持證商Ferring Arzneimittel Gmbh
24- 38?注射用厄他培南Ertapenem For Injection/Invanz(怡萬之)1g(以厄他培南計)Merck Sharp & Dohme Limited/?Merck Sharp & Dohme B.V.國內(nèi)上市的原研藥品持證商發(fā)生變更,增加變更后的持證商Merck Sharp & Dohme B.V.


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