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Contact Us 第三十二批

【第三十二批】仿制藥參比制劑目錄


【第三十二批】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
32-1比克恩丙諾片Bictegravir Sodium, Emtricitabine and Tenofovir Alafenamide Fumarate Tablets?Biktarvy（必妥維）比克替拉韋鈉（以比克替拉韋計）50mg，恩曲他濱200mg，富馬酸丙酚替諾福韋（以丙酚替諾福韋計）25mgGilead Sciences Ireland UC國內(nèi)上市的原研藥品原研進口
32-2來迪派韋索磷布韋片Ledipasvir and Sofosbuvir Tablets?Harvoni（夏帆寧）90mg來迪派韋,400mg索磷布韋Gilead Sciences International Ltd.國內(nèi)上市的原研藥品原研進口
32-3卡泊三醇搽劑Calcipotriol Scalp Solution?Daivonex（達力士）0.005%（30ml:1.50mg）LEO Pharma A/S國內(nèi)上市的原研藥品原研進口
32-4溴夫定片Brivudine Tablets?Zostex（左代）125mgBerlin-Chemie AG國內(nèi)上市的原研藥品原研進口
32-5法莫替丁鈣鎂咀嚼片Famotidine，Calcium Carbonate and Magnesium Hydroxide Chewable TabletsPepcid Complete法莫替丁10mg，碳酸鈣800mg，氫氧化鎂165mgJohnson And Johnson Consumer Inc Mcneil Consumer Healthcare Division未進口原研藥品美國橙皮書
32-6利多卡因凝膠貼膏Lidocaine Cataplasms?Lidoderm0.05Teikoku Pharma Usa Inc未進口原研藥品美國橙皮書
32-7注射用德拉沙星Delafloxacin for Injection??Baxdela300mgMelinta Subsidiary Corp未進口原研藥品美國橙皮書
32-8美沙拉秦灌腸液Mesalazine Enemas?Rowasa4g/60mlMylan Specialty LP未進口原研藥品美國橙皮書
32-9蔗糖氫氧化氧鐵咀嚼片Sucroferric oxyhydroxide Chewable Tablet?Velphoro500mgVifor Fresenius Medical Care Renal Pharma France未進口原研藥品美國橙皮書
32-10眼用絲裂霉素溶液用粉末Mitomycin for SolutionMitosol0.2mgMobius Therapeutics? LLC未進口原研藥品美國橙皮書
32-11鹽酸去氧腎上腺素注射液Phenylephrine Hydrochloride Injection?Biorphen5ml:0.5mgEton Pharmaceuticals未進口原研藥品美國橙皮書
32-12鹽酸去氧腎上腺素注射液Phenylephrine Hydrochloride Injection
1mL:10mgWest Ward Pharmaceutical Corp未進口原研藥品美國橙皮書
32-13馬來酸阿伐曲泊帕片Avatrombopag Tablets?Doptelet20mgAkaRx, Inc未進口原研藥品美國橙皮書
32-14曲安奈德乳膏Triamcinolone Acetonide Cream
0.001Fougera Pharmaceuticals Inc國際公認(rèn)的同種藥品美國橙皮書
32-15頭孢地尼干混懸劑Cefdinir for Suspension
250mg/5mlSandoz Inc國際公認(rèn)的同種藥品美國橙皮書
32-16丙戊酸鈉緩釋片Compound Sodium Valproate and Valproic Acid Sustained Release Tablets?Depakine Chrono500mg（以丙戊酸鈉計）Sanofi Aventis France未進口原研藥品歐盟上市
32-17倍他米松磷酸鈉注射液Betamethasone Sodium Phosphate?InjectionCelestone; Celestan; Celeston4mg/ml（以倍他米松計）MSD Belgium BVBA/SPRL/MSD Sharp & Dohme GmbH/Merck Sharp & Dohme BV/MSD Polska Sp. z o.o.未進口原研藥品歐盟上市
32-18鹽酸氯米帕明注射液Clomipramine Hydrochloride Injection??Anafranil25mg/2mlAlfasigma France/Alfasigma S.p.A.未進口原研藥品歐盟上市
32-19鹽酸氮卓斯汀丙酸氟替卡松鼻噴霧劑Azelastine hydrochloride Fluticasone Propionate Nasal Spray?Dymista每瓶120噴，每噴含鹽酸氮卓斯汀和丙酸氟替卡松137μg和50μgMEDA Pharma GmbH & Co. KG未進口原研藥品歐盟上市
32-20鹽酸格拉司瓊片Granisetron Hydrochloride TabletsKytril1mgAtnahs Pharma Netherlands B.V.未進口原研藥品歐盟上市
32-21鹽酸屈他維林片Drotaverine Hydrochloride Tablets?NO-SPA40mgSanofi-Aventis未進口原研藥品歐盟上市
32-22氯化錳口服溶液Manganese Chloride Oral Solution??Bothdel Oral Solution 10250mL/袋，含有36mg氯化錳四水合物（相當(dāng)于錳10mg）Meiji Seikaファルマ株式會社未進口原研藥品日本上市
32-23洛索洛芬鈉凝膠Loxoprofen sodium hydrate gel
0.01第一三共株式會社未進口原研藥品日本上市
32-24硫酸亞鐵緩釋片Ferrous Sulfate Extended-release TabletsFero-Gradumet105mg（以鐵元素計）マイランEPD合同會社未進口原研藥品日本上市
32-25注射用二丁酰環(huán)磷腺苷鈉Bucladesine Sodium? Injectionアクトシン300mgアルフレッサ ファーマ株式會社未進口原研藥品日本上市
32-26鹽酸樂卡地平片Lercanidipine Hydrochloride TabletsZanidip（再寧平）20mgRecordati S.P.A.國內(nèi)上市的原研藥品原研進口
32-27拉莫三嗪片Lamotrigine TabletsLamictal100mgThe Wellcome Foundation Ltd國內(nèi)上市的原研藥品原研進口
32-28依非韋倫片Efavirenz TabletsSustiva600mgBristol-Myers Squibb Pharma Compay未進口原研藥品美國橙皮書
32-29阿立哌唑口崩片Aripiprazole Orally Disintegrating tabletsAbilify10mgOtsuka?Pharmaceutical?Co.Ltd未進口原研藥品美國橙皮書
32-30阿立哌唑口崩片Aripiprazole Orally Disintegrating tabletsAbilify15mgOtsuka?Pharmaceutical?Co.Ltd未進口原研藥品美國橙皮書
32-31復(fù)方磺胺甲噁唑片Compound Sulfamethoxazole TabletsBactrim磺胺甲噁唑800g，甲氧芐啶?160mgSun Pharmaceutical Industries Inc未進口原研藥品美國橙皮書
32-32艾曲泊帕乙醇胺片Eltrombopag Olamine TabletsPromacta25mgNovartis Pharmaceuticals Corp未進口原研藥品美國橙皮書
32-33注射用替加環(huán)素Tigecycline for InjectionTygacil50mgPF Prism CV未進口原研藥品美國橙皮書
32-34他克莫司膠囊Tacrolimus Capsules?Prograf5mgAstellas Pharma US Inc未進口原研藥品美國橙皮書
32-35他克莫司膠囊Tacrolimus Capsules?Prograf1mgAstellas Pharma US Inc未進口原研藥品美國橙皮書
32-36他克莫司膠囊Tacrolimus Capsules?Prograf0.5mgAstellas Pharma US Inc未進口原研藥品美國橙皮書
32-37硝酸甘油片Nitroglycerin Sublingual Tablets?Nitrostat0.6mgPfizer Pharmaceuticals LTD未進口原研藥品美國橙皮書
32-38米拉貝隆緩釋片Mirabegron Extended-release TabletsMyrbetriq25mgAstellas Pharma Global Development Inc未進口原研藥品美國橙皮書
32-39鹽酸伊立替康注射液Irinotecan Hydrochloride InjectionCamptosar5ml:0.1gPfizer Inc未進口原研藥品美國橙皮書
32-40鹽酸伊立替康注射液Irinotecan Hydrochloride InjectionCamptosar2ml:40mgPfizer Inc未進口原研藥品美國橙皮書
32-41替米沙坦片Telmisartan TabletsMicardis40mgBoehringer Ingelheim未進口原研藥品美國橙皮書
32-42替米沙坦片Telmisartan TabletsMicardis80mgBoehringer Ingelheim未進口原研藥品美國橙皮書
32-43伏立康唑片Voriconazole TabletsVfend50mgPF Prism CV未進口原研藥品美國橙皮書
32-44注射用伏立康唑Voriconazole for InjectionVfend200mgPF Prism CV未進口原研藥品美國橙皮書
32-45碳酸司維拉姆片Sevelamer Carbonate Tablets??Renvela800mgSanofi Genzyme未進口原研藥品美國橙皮書
32-46注射用磷酸特地唑胺Tedizolid Phosphate For InjectionSivextro200mgCubist Pharmaceuticals LLC/Merck & CO.,INC未進口原研藥品美國橙皮書
32-47氟尿嘧啶注射液Fluorouracil InjectionFluorouracil1g/20mlFresenius Kabi USA LLC國際公認(rèn)的同種藥品美國橙皮書
32-48地高辛注射液Digoxin InjectionLanoxin2mL:0.5mgAspen Pharma Trading Limited未進口原研藥品歐盟上市
32-49奧氮平片Olanzapine TabletsZyprexa2.5mgEli Lilly Nederland B.V.未進口原研藥品歐盟上市
32-50黃體酮注射液Progesterone Injection
1.112ml:25mgIBSA Farmaceutici Italia Srl未進口原研藥品歐盟上市
32-51阿普司特片Apremilast TabletsOtezla10mgCelgene Europe B.V.未進口原研藥品歐盟上市
32-52阿普司特片Apremilast TabletsOtezla30mgCelgene Europe B.V.未進口原研藥品歐盟上市
32-53利福平膠囊Rifampicin CapsulesRifadin150mgSanofi未進口原研藥品歐盟上市
32-54丙酸倍氯米松吸入氣霧劑Beclometasone Dipropionate Inhalation Aerosol?Qvar每瓶200撳，每撳含丙酸倍氯米松50μgTeva UK Limited未進口原研藥品歐盟上市
32-55丙酸倍氯米松吸入氣霧劑Beclometasone Dipropionate Inhalation Aerosol?Qvar每瓶200撳，每撳含丙酸倍氯米松50μgTeva UK Limited未進口原研藥品日本上市
32-56丙酸倍氯米松吸入氣霧劑Beclometasone Dipropionate Inhalation Aerosol?Clenil Modulite每瓶200撳，每撳含丙酸倍氯米松250μgChiesi Limited/ Chiesi Farmaceutici S.p.A.未進口原研藥品歐盟上市
32-57苯磺順阿曲庫銨注射液Cisatracurium Besylate InjectionNimbex2.5ml:5mgAspen Pharma Trading Limited未進口原研藥品歐盟上市
32-58硝呋太爾片Nifuratel Tablets?Macmiror200mgPolichem S.R.L./ Polichem SA未進口原研藥品歐盟上市
32-59馬尿酸烏洛托品片Methenamine Hippurate Tablets?Hippex1gMylan Products Ltd未進口原研藥品歐盟上市
32-60環(huán)孢素眼用乳劑Ciclosporin Eye Drops Emulsion?Verkazia0.001Santen Oy未進口原研藥品歐盟上市
32-61鹽酸羅哌卡因注射液Ropivacaine Hydrochloride InjectionNaropin10ml:75mgAspen Pharma Trading Limited未進口原研藥品歐盟上市
32-62鹽酸羅哌卡因注射液Ropivacaine Hydrochloride InjectionNaropin10ml:100mgAspen Pharma Trading Limited未進口原研藥品歐盟上市
32-64鹽酸阿羅洛爾片Arotinolol Hydrochloride Tablets
5mg大日本住友製薬株式會社未進口原研藥品日本上市
32-65鹽酸法舒地爾注射液Fasudil Hydrochloride InjectionEril2ml:30mgAsahi Kasei Pharma Corporatio未進口原研藥品日本上市
32-66鹽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會社未進口原研藥品日本上市
32-67鹽酸咪達普利片Imidapril Hydrochloride Tablets?Tanatril2.5mg田辺三菱製薬株式會社未進口原研藥品日本上市
32-68米庫氯銨注射液Mivacurium Chloride InjectionMivacron10ml:20mgAspen Pharma Trading Limited未進口原研藥品英國上市
32-69萘普生鈉片Naproxen Sodium Tablets?Apranax275mgAtnahs Pharma Netherlands B.V.未進口原研藥品法國上市
32-70克霉唑乳膏Clotrimazole CreamCanesten0.01Bayer Inc未進口原研藥品加拿大上市
32-71注射用阿莫西林鈉克拉維酸鉀Amoxicillin Sodium and Clavulanate Potassium for injection（10:1）
550mg（500/50）GlaxoSmithKline AG未進口原研藥品瑞士上市
32-72注射用阿莫西林鈉克拉維酸鉀Amoxicillin Sodium and Clavulanate Potassium for injection（10:1）
1.1g（1000/100）GlaxoSmithKline AG未進口原研藥品瑞士上市
32-73注射用阿莫西林鈉克拉維酸鉀Amoxicillin Sodium and Clavulanate Potassium for injection（10:1）
2.2g（2000/200）GlaxoSmithKline AG未進口原研藥品瑞士上市
32-74馬來酸咪達唑侖片Midazolam Maleate TabletsDormicum7.5mg（以咪達唑侖計）CPS Cito Pharma Services未進口原研藥品瑞士上市
32-75醋酸去氨加壓素注射液Desmopressin Acetate InjectionMinirin1ml:4μg（按去氨加壓素計3.56μg）Ferring AG未進口原研藥品瑞士上市
32-76醋酸去氨加壓素注射液Desmopressin Acetate InjectionOctostim1ml:15μg（按去氨加壓素計13.4μg）Ferring AG未進口原研藥品瑞士上市
10-66卡維地洛片Carvedilol TabletsDilatrend6.25mgRoche Pharma AG/Cheplapharm Arzneimittel GmbH歐盟上市持證商發(fā)生變更，增加持證商Cheplapharm Arzneimittel GmbH
10-68卡維地洛片Carvedilol TabletsDilatrend12.5mgRoche Pharma AG/Cheplapharm Arzneimittel GmbH歐盟上市持證商發(fā)生變更，增加持證商Cheplapharm Arzneimittel GmbH
30-86磷酸特地唑胺片Tedizolid Phosphate TabletsSivextro200mgCubist Pharmaceuticals LLC/MSD Pharma（Singapore）Pte. Ltd.未進口原研藥品增加持證商MSD Pharma（Singapore）Pte. Ltd
21-93鹽酸羅哌卡因注射液Ropivacaine hydrochloride injectionNaropin（耐樂品）20mg/10mlAstraZeneca AB/Aspen Pharmacare Australia Pty Ltd國內(nèi)上市的原研藥品持證商發(fā)生變更，增加持證商Aspen Pharmacare Australia Pty Ltd
21-94鹽酸羅哌卡因注射液Ropivacaine hydrochloride injectionNaropin（耐樂品）50mg/10mlAstraZeneca AB/Aspen Pharmacare Australia Pty Ltd國內(nèi)上市的原研藥品持證商發(fā)生變更，增加持證商Aspen Pharmacare Australia Pty Ltd
21-95鹽酸羅哌卡因注射液Ropivacaine hydrochloride injectionNaropin（耐樂品）75mg/10mlAstraZeneca AB/Aspen Pharmacare Australia Pty Ltd國內(nèi)上市的原研藥品持證商發(fā)生變更，增加持證商Aspen Pharmacare Australia Pty Ltd
21-96鹽酸羅哌卡因注射液Ropivacaine hydrochloride injectionNaropin（耐樂品）100mg/10mlAstraZeneca AB/Aspen Pharmacare Australia Pty Ltd國內(nèi)上市的原研藥品持證商發(fā)生變更，增加持證商Aspen Pharmacare Australia Pty Ltd


1、參比制劑選擇原則：有原研進口的應(yīng)選擇原研進口藥作為參比制劑首選。

2、本網(wǎng)站所有仿制藥參比制劑目錄數(shù)據(jù)源自國家藥品監(jiān)督管理局官方網(wǎng)站，如有紕漏請以國家官網(wǎng)為準(zhǔn)。
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