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【第七十五批】仿制藥參比制劑目錄


【第七十五批】仿制藥參比制劑目錄


序號(hào)藥品通用名稱(chēng)英文名規(guī)格上市許可持有人備注1備注2劑型
75-1奧特康唑膠囊Oteseconazole Capsules0.15geVENUS PHARMACEUTICAL LABORATORIES INC.國(guó)內(nèi)上市的原研藥品原研進(jìn)口膠囊劑
75-2右美沙芬安非他酮緩釋片Dextromethorphan Hydrobromide and Bupropion Hydrochloride Extended-Release Tablets /Auvelity45mg（以C18H25NO·HBr·H2O計(jì)）/105mg（以C13H18ClNO·HCl計(jì)）Axsome Therapeutics Inc未進(jìn)口原研藥品美國(guó)橙皮書(shū)緩釋片
75-3美沙拉嗪腸溶膠囊Mesalamine delayed-release capsules400mgAbbvie Inc未進(jìn)口原研藥品美國(guó)橙皮書(shū)膠囊劑
75-4雙氯芬酸鉀軟膠囊Diclofenac Potassium Soft Capsules/ ZIPSOR25mgASSERTIO THERAPEUTICS INC未進(jìn)口原研藥品美國(guó)橙皮書(shū)膠囊劑
75-5萬(wàn)古霉素注射液Vancomycin Injection500mg/100ml、1g/200ml、（5mg/ml）XELLIA PHARMACEUTICALS APS未進(jìn)口原研藥品美國(guó)橙皮書(shū)注射劑
75-6碘[123I]化鈉膠囊Sodium Iodide（123I）?Capsules / SODIUM IODIDE I-123100μCi、200μCiCARDINAL HEALTH 418 INC未進(jìn)口原研藥品美國(guó)橙皮書(shū)膠囊劑
75-7依巴斯汀口崩片Ebastine Orally Disintegrating Tablets / Ebastel Flas；Kestine Flash；Kestine Lyo；Kestine；Estivan Lyo；Kestine Smelt；10mgAlmirall未進(jìn)口原研藥品歐盟上市口崩片
75-8依巴斯汀口崩片Ebastine Orally Disintegrating Tablets / Ebastel Flas；Kestine Flash；Kestine Lyo；Kestine；Estivan Lyo；Kestine Smelt；20mgAlmirall未進(jìn)口原研藥品歐盟上市口崩片
75-9雙氯芬酸鈉鹽酸利多卡因注射液Diclofenacum natricum +Lidocaini hydrochloridum2ml：?雙氯芬酸鈉75mg、鹽酸利多卡因20mgTeva B.V.未進(jìn)口原研藥品歐盟上市注射劑
75-10锝[99mTc]雙半胱乙酯注射液Neurolite Injection Daiichi/ニューロライト注射液第一400MBq/2ml, 600MBq/3mlPDRファーマ株式會(huì)社未進(jìn)口原研藥品日本上市注射劑
75-11二巰丙磺鈉注射液Sodium Dimercaptopropane Sulfonate Injection/Dimaval250mg/5mlHeyl Chemical Pharmaceutical Factory GmbH & Co. KG
德國(guó)上市注射劑
75-12口服用苯丁酸甘油酯Glycerol phenylbutyrate oral25mlImmedica Pharma AB國(guó)內(nèi)上市的原研藥品原研進(jìn)口口服液
75-13注射用雙羥萘酸曲普瑞林Triptorelin Pamoate For Injection22.5mgIPSEN PHARMA國(guó)內(nèi)上市的原研藥品原研進(jìn)口注射劑
75-14腹膜透析液（乳酸鹽-G1.35%）Peritoneal Dialysis Solution（Lactate-G1.35%）2000ml（1600ml /400ml）威高泰爾茂（威海）醫(yī)療制品有限公司經(jīng)審核確定的國(guó)外原研企業(yè)在中國(guó)境內(nèi)生產(chǎn)的藥品原研地產(chǎn)化透析液
75-15腹膜透析液（乳酸鹽-G2.5%）Peritoneal Dialysis Solution（Lactate-G2.5%）2000ml（1600ml /400ml）威高泰爾茂（威海）醫(yī)療制品有限公司經(jīng)審核確定的國(guó)外原研企業(yè)在中國(guó)境內(nèi)生產(chǎn)的藥品原研地產(chǎn)化透析液
75-16低鈣腹膜透析液（乳酸鹽-G1.35%）Low Calcium Peritoneal Dialysis Solution（Lactate-G1.35%）2000ml（1600ml /400ml）、2500ml（2000ml /500ml）威高泰爾茂（威海）醫(yī)療制品有限公司經(jīng)審核確定的國(guó)外原研企業(yè)在中國(guó)境內(nèi)生產(chǎn)的藥品原研地產(chǎn)化透析液
75-17低鈣腹膜透析液（乳酸鹽-G2.5%）Low Calcium Peritoneal Dialysis Solution（Lactate-G2.5%）2000ml（1600ml /400ml）、2500ml（2000ml /500ml）威高泰爾茂（威海）醫(yī)療制品有限公司經(jīng)審核確定的國(guó)外原研企業(yè)在中國(guó)境內(nèi)生產(chǎn)的藥品原研地產(chǎn)化透析液
75-18結(jié)構(gòu)脂肪乳注射液（C6～24）Structural Fat Emulsion Injection（C6~24）250ml:結(jié)構(gòu)甘油三酯50g費(fèi)森尤斯卡比華瑞制藥有限公司經(jīng)審核確定的國(guó)外原研企業(yè)在中國(guó)境內(nèi)生產(chǎn)的藥品原研地產(chǎn)化注射液
75-19阿貝西利片Abemaciclib Tablets/ Verzenios（唯擇）100mgEli Lilly Nederland B.V.國(guó)內(nèi)上市的原研藥品原研進(jìn)口片劑
75-20阿貝西利片Abemaciclib Tablets /Verzenios50mgEli Lilly Nederland B.V.未進(jìn)口原研藥品歐盟上市片劑
75-21阿貝西利片Abemaciclib Tablets /Verzenios100mgEli Lilly Nederland B.V.未進(jìn)口原研藥品歐盟上市片劑
75-22阿貝西利片Abemaciclib Tablets /Verzenios150mgEli Lilly Nederland B.V.未進(jìn)口原研藥品歐盟上市片劑
75-23復(fù)方氨基酸注射液（20AA）Compound Amino Acid Injection/Aminoplasmal Hepa-10%500ml:50gB.Braun Melsungen AG未進(jìn)口原研藥品歐盟上市注射液
75-24巴瑞替尼片Baricitinib Tablets/Olumiant2mgEli Lilly Nederland B.V.未進(jìn)口原研藥品歐盟上市片劑
75-25巴瑞替尼片Baricitinib Tablets/Olumiant4mgEli Lilly Nederland B.V.未進(jìn)口原研藥品歐盟上市片劑
75-26復(fù)方聚乙二醇（3350）電解質(zhì)散MOVICOL Plain 13.7g sachet, powder for oral solution13.7g/袋，含聚乙二醇3350 13.1250g；氯化鈉0.3508g；碳酸氫鈉0.1786g；氯化鉀0.0502gNorgine Pharmaceuticals Limited未進(jìn)口原研藥品歐盟上市口服溶液
75-27馬來(lái)酸茚達(dá)特羅吸入粉霧劑Indacaterol Maleate Powder for Inhalation/Onbrez150μg（以C24H28N2O3計(jì)）Novartis Europharm Limited未進(jìn)口原研藥品歐盟上市吸入粉霧劑
75-28注射用頭孢他啶Ceftazidime for Injection/Fortum、Glazidim1gLaboratoire GlaxoSmithKline/Glaxosmithkline S.p.A.未進(jìn)口原研藥品歐盟上市注射劑
75-29硫酸阿巴卡韋片Abacavir Sulfate Tablets/Ziagen300mgViiV Healthcare B.V.未進(jìn)口原研藥品歐盟上市片劑
75-30注射用鹽酸地爾硫?Diltiazem Hydrochloride For Injection/Herbesser50mg田辺三菱製薬株式會(huì)社未進(jìn)口原研藥品日本上市注射劑
75-31異麥芽糖酐鐵注射液Ferric Derisomaltose Injection/ MONOFERRIC1GM/10ML?（100MG/ML）Pharmacosmos AS未進(jìn)口原研藥品美國(guó)橙皮書(shū)注射劑
75-32腹膜透析液（乳酸鹽-G1.5%）Dianeal Pd-2 W/ Dextrose 1.5%In Plastic Container5000mlBaxter Healthcare Corporation未進(jìn)口原研藥品美國(guó)橙皮書(shū)透析液
75-33腹膜透析液（乳酸鹽-G2.5%）Dianeal Pd-2 W/ Dextrose 2.5%In Plastic Container5000mlBaxter Healthcare Corporation未進(jìn)口原研藥品美國(guó)橙皮書(shū)透析液
75-34腹膜透析液（乳酸鹽-G4.25%）Dianeal Pd-2 W/ Dextrose 4.5%In Plastic Container5000mlBaxter Healthcare Corporation未進(jìn)口原研藥品美國(guó)橙皮書(shū)透析液
75-35罌粟乙碘油注射液/碘化油注射液Ethiodized Oil Injection/LIPIODOL10ml（含碘480mg/ml）GUERBET LLC未進(jìn)口原研藥品美國(guó)橙皮書(shū)注射液
75-36多替拉韋鈉片Dolutegravir Sodium Tablets /TIVICAY10mgVIIV HEALTHCARE CO未進(jìn)口原研藥品美國(guó)橙皮書(shū)片劑
75-37多替拉韋鈉片Dolutegravir Sodium Tablets /TIVICAY25mgVIIV HEALTHCARE CO未進(jìn)口原研藥品美國(guó)橙皮書(shū)片劑
75-38多替拉韋鈉片Dolutegravir Sodium Tablets /TIVICAY50mgVIIV HEALTHCARE CO未進(jìn)口原研藥品美國(guó)橙皮書(shū)片劑
75-39蔗糖鐵注射液Iron Sucrose Injection/VENOFER50mg鐵/2.5mlAMERICAN REGENT INC未進(jìn)口原研藥品美國(guó)橙皮書(shū)注射劑
75-40蔗糖鐵注射液Iron Sucrose Injection/VENOFER100mg鐵/5mlAMERICAN REGENT INC未進(jìn)口原研藥品美國(guó)橙皮書(shū)注射劑
75-41蔗糖鐵注射液Iron Sucrose Injection/VENOFER200mg鐵/10mlAMERICAN REGENT INC未進(jìn)口原研藥品美國(guó)橙皮書(shū)注射劑
75-42格拉司瓊透皮貼片Granisetron Transdermal Patches/SANCUSO3.1mg/24h?Kyowa Kirin, Inc??未進(jìn)口原研藥品美國(guó)橙皮書(shū)貼片
75-43醋酸潑尼松龍滴眼液Prednisolone Acetate Ophthalmic Suspension/PRED FORTE1%（5ml:50mg/10ml:100mg）ABBVIE INC未進(jìn)口原研藥品美國(guó)橙皮書(shū)滴眼液
75-44那他霉素滴眼液Natamycin Ophthalmic Suspension/NATACYN5%（15ml:0.75g）Eyevance Pharmaceuticals，?LLC未進(jìn)口原研藥品美國(guó)橙皮書(shū)滴眼液
75-45鹽酸阿來(lái)替尼膠囊Alectinib Hydrochloride Capsules/Alecensa150mgRoche Registration GmbH未進(jìn)口原研藥品歐盟上市膠囊劑
75-46異氟烷Isoflurane/FORANE100mlBaxter Healthcare Corporation未進(jìn)口原研藥品美國(guó)橙皮書(shū)吸入劑
75-47氯雷他定口服溶液Loratadine oral solution5mg/5mlBayer HealthCare LLC未進(jìn)口原研藥品美國(guó)橙皮書(shū)口服溶液
75-48硫酸阿托品滴眼液Atropine Sulfate Ophthalmic Solution1%BAUSCH AND LOMB INC未進(jìn)口原研藥品美國(guó)橙皮書(shū)滴眼液
75-49氯雷他定口腔崩解片Loratadine Orally Disintegrating Tablets /Claritin Reditabs5mgBayer HealthCare LLC未進(jìn)口原研藥品美國(guó)橙皮書(shū)片劑
75-50噻托溴銨吸入噴霧劑Tiotropium Bromide Inhalation Spray/Spiriva Respimat2.5mcg/撳Boehringer Ingelheim Pharmaceuticals,Inc.未進(jìn)口原研藥品美國(guó)橙皮書(shū)吸入噴霧劑
75-51鹽酸雷洛昔芬片Raloxifene Hydrochloride Tablets/EVISTA60mgEli Lilly and Company未進(jìn)口原研藥品美國(guó)橙皮書(shū)片劑
75-52碘克沙醇注射液Iodixanol Injection/Visipaque200ml：64g（I）Ge HEALTHCARE未進(jìn)口原研藥品美國(guó)橙皮書(shū)注射劑
75-53鹽酸氮?斯汀鼻噴霧劑Azelastine Hydrochloride Nasal Spray/Children's Astepro Allergy每噴含205.5mcg鹽酸氮?斯汀Bayer Health Care LLC未進(jìn)口原研藥品美國(guó)橙皮書(shū)噴霧劑
75-54硫酸阿巴卡韋片Abacavir Sulfate Tablets/ZIAGEN300mg/片ViiV Healthcare Co.未進(jìn)口原研藥品美國(guó)橙皮書(shū)片劑
75-55蘭索拉唑口崩片Lansoprazole delayed-release orally disintegrating tablets/ PREVACID SoluTabTM30mg/片Takeda Pharmaceuticals USA Inc.未進(jìn)口原研藥品美國(guó)橙皮書(shū)口崩片
75-56鹽酸曲馬多片TRAMADOL HYDROCHLORIDE50mgSUN PHARMACEUTICAL INDUSTRIES LTD國(guó)際公認(rèn)同種藥品美國(guó)橙皮書(shū)片劑
75-57魯比前列酮膠囊Lubiprostone Capsules/Amitiza8μgSucampo Pharma Americas, LLC.未進(jìn)口原研藥品美國(guó)橙皮書(shū)膠囊劑
75-58來(lái)特莫韋注射液Letermovir Injection/ PREVYMIS240mg/12mL?（20mg/mL）MERCK SHARP AND DOHME CORP未進(jìn)口原研藥品美國(guó)橙皮書(shū)注射劑
75-59來(lái)特莫韋注射液Letermovir Injection/ PREVYMIS480mg/24mL?（20mg/mL）MERCK SHARP AND DOHME CORP未進(jìn)口原研藥品美國(guó)橙皮書(shū)注射劑
75-60高锝[99mTc]酸鈉注射液Sodium Pertechnetate [99mTc] Injection / Tekcis20GBq（99Mo-99mTc發(fā)生器）CIS bio international未進(jìn)口原研藥品歐盟上市注射劑
75-61伊維菌素乳膏Ivermectin Cream /Soolantra1%GALDERMA International未進(jìn)口原研藥品歐盟上市乳膏劑
75-62注射用哌拉西林鈉他唑巴坦鈉Piperacillin Sodium And Tazobactam Sodium For Injection/TAZOCILLINE4.5gPFIZER HOLDING FRANCE未進(jìn)口原研藥品歐盟上市注射劑
75-63注射用哌拉西林鈉他唑巴坦鈉Piperacillin Sodium And Tazobactam Sodium For Injection/TAZOCILLINE2.25gPFIZER HOLDING FRANCE未進(jìn)口原研藥品歐盟上市注射劑
75-64利格列汀二甲雙胍片Linagliptin and Metformin Hydrochloride Tablets/Jentadueto每片含利格列汀2.5mg與鹽酸二甲雙胍850mgBoehringer Ingelheim International GmbH未進(jìn)口原研藥品歐盟上市片劑
75-65磷酸蘆可替尼乳膏.Ruxolitinib Phosphate Cream /Opzelura1.5%（以蘆可替尼計(jì)）Incyte Biosciences Distribution B.V.未進(jìn)口原研藥品歐盟上市乳膏劑
75-66單硝酸異山梨酯片Isosorbide Mononitrate Tablets /Monoket20mgMerus Labs Luxco II, S.à.r.l.未進(jìn)口原研藥品歐盟上市片劑
75-67尿素[13C]呼氣試驗(yàn)診斷試劑盒Helicobacter Test Infai45mg/瓶?Infai GmbH未進(jìn)口原研藥品歐盟上市顆粒劑
75-68布美他尼注射液Bumetanide Injection/Burinex1mg/2mlKaro Pharma AB未進(jìn)口原研藥品歐盟上市注射劑
75-69鹽酸雷洛昔芬片Raloxifene Hydrochloride Tablets/Evista60mgSUBSTIPHARM未進(jìn)口原研藥品歐盟上市片劑
75-70注射用嗎替麥考酚酯Mycophenolate Mofetil for Injection/ CELLCEPT500mgRoche Products Limited未進(jìn)口原研藥品英國(guó)上市注射劑
75-71對(duì)乙酰氨基酚注射液/對(duì)乙酰氨基酚甘露醇注射液Acetaminophen Injection/acelio100ml:1g（10mg/ml）TERUMO?株式會(huì)社未進(jìn)口原研藥品日本上市注射劑
75-72比拉斯汀口腔崩解片Bilastine Orally disintegrating Tablets / Bilanoa20mg大鵬薬品工業(yè)株式會(huì)社未進(jìn)口原研藥品日本上市片劑
75-73丙戊酸鈉緩釋微片Sodium valproate Sustained-release mini-tablets/Orfiril long150mgDesitin Arzneimittel GmbH未進(jìn)口原研藥品歐盟上市緩釋片
75-74丙戊酸鈉緩釋微片Sodium valproate Sustained-release mini-tablets/Orfiril long300mgDesitin Arzneimittel GmbH未進(jìn)口原研藥品歐盟上市緩釋片
75-75丙戊酸鈉緩釋微片Sodium valproate Sustained-release mini-tablets/Orfiril long1000mgDesitin Arzneimittel GmbH未進(jìn)口原研藥品歐盟上市緩釋片
75-76茚達(dá)特羅格隆溴銨吸入粉霧劑Indacaterol Maleate and Glycopyrronium Bromide Powder for Inhalation / Ultibro Breezhaler每粒含馬來(lái)酸茚達(dá)特羅110μg（以C24H28N2O3計(jì)）和格隆溴銨50μg（以C19H28NO3計(jì)）Novartis Europharm Limited未進(jìn)口原研藥品歐盟上市吸入粉霧劑
75-77中性腹膜透析液（碳酸氫鹽-G1.5%）Reguneal Hca 1.5 Peritoneal Dialysis Solution2500ml（906ml/1594ml）バクスター株式會(huì)社未進(jìn)口原研藥品日本上市透析液
75-78中性腹膜透析液（碳酸氫鹽-G2.5%）Reguneal Hca 2.5 Peritoneal Dialysis Solution5000ml（1812ml/3188ml）バクスター株式會(huì)社未進(jìn)口原研藥品日本上市透析液
75-79中性低鈣腹膜透析液（碳酸氫鹽-G1.5%）Reguneal Lca 1.5 Peritoneal Dialysis Solution/レギュニール?Lca 1.5?腹膜透析液2500ml（906ml/1594ml）バクスター株式會(huì)社未進(jìn)口原研藥品日本上市透析液
75-80中性低鈣腹膜透析液（碳酸氫鹽-G1.5%）Reguneal Lca 1.5 Peritoneal Dialysis Solution/レギュニール?Lca 1.5?腹膜透析液5000ml（1812ml/3188ml）バクスター株式會(huì)社未進(jìn)口原研藥品日本上市透析液
75-81中性低鈣腹膜透析液（碳酸氫鹽-G2.5%）Reguneal Lca 2.5 Peritoneal Dialysis Solution/レギュニール?Lca 1.5?腹膜透析液2500ml（906ml/1594ml）バクスター株式會(huì)社未進(jìn)口原研藥品日本上市透析液
75-82中性低鈣腹膜透析液（碳酸氫鹽-G2.5%）Reguneal Lca 2.5 Peritoneal Dialysis Solution/レギュニール?Lca 2.5腹膜透析液5000ml（1812ml/3188ml）バクスター株式會(huì)社未進(jìn)口原研藥品日本上市透析液
27-241達(dá)肝素鈉注射液Dalteparin Sodium Injection/Fragmin0.3ml:7500I.E.Pfizer Pharma Pfe GmbH/Pfizer Pharma GmbH未進(jìn)口原研藥品增加上市許可持有人Pfizer Pharma GmbH?注射劑
30-49鹽酸卡利拉嗪膠囊Cariprazine hydrochloride Capsules/Vraylar1.5mgAllergan Sales LLC/ABBVIE INC未進(jìn)口原研藥品增加上市許可持有人ABBVIE INC膠囊劑
30-50鹽酸卡利拉嗪膠囊Cariprazine hydrochloride Capsules/Vraylar3mgAllergan Sales LLC/ABBVIE INC未進(jìn)口原研藥品增加上市許可持有人ABBVIE INC膠囊劑
30-51鹽酸卡利拉嗪膠囊Cariprazine hydrochloride Capsules/Vraylar4.5mgAllergan Sales LLC/ABBVIE INC未進(jìn)口原研藥品增加上市許可持有人ABBVIE INC膠囊劑
30-52鹽酸卡利拉嗪膠囊Cariprazine hydrochloride Capsules/Vraylar6mgAllergan Sales LLC/ABBVIE INC未進(jìn)口原研藥品增加上市許可持有人ABBVIE INC膠囊劑
45-30雷貝拉唑鈉腸溶片Rabeprazole Sodium Enteric-coated Tablets/ Aciphex20mgEisai INC/WOODWARD PHARMA SERVICES LLC未進(jìn)口原研藥品增加上市許可持有人WOODWARD PHARMA SERVICES LLC片劑
26-63氨溴特羅口服溶液Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral Solution1ml:鹽酸氨溴索1.5mg與鹽酸克侖特羅1μg（包裝規(guī)格100ml、250ml）Sanofi-Aventis Deutschland GmbH./ A.Nattermann & Cie. GmbH未進(jìn)口原研藥品增加上市許可持有人A.Nattermann & Cie. GmbH口服溶液
21-214頭孢呋辛酯片Cefuroxime Axetil Tablets/Zinnat按頭孢呋辛（C16H16N4O8S）計(jì)0.125gGlaxo SmithKline/ Glaxo Wellcome UK Limited/Sandoz Pharmaceuticals d.d.未進(jìn)口原研藥品增加上市許可持有人Sandoz Pharmaceuticals d.d.片劑
60-67二硫化硒洗劑Selenium Sulfide Lotion/Selsun25mg/ml（2.5%）Sanofi-Aventis Netherlands B.V./Opella Healthcare France SAS/Genzyme Europe B.V./A. Nattermann & Cie. GmbH/Pharma Developpement/Sanofi-Aventis Deutschland GmbH未進(jìn)口原研藥品增加上市許可持有人Sanofi-Aventis Deutschland GmbH洗劑
50-64聚甲酚磺醛陰道栓Policresulen Vaginal Suppositories90mgTakeda GmbH/Orifarm Healthcare A/S未進(jìn)口原研藥品增加上市許可持有人Orifarm Healthcare A/S栓劑
64-11鹽酸米諾環(huán)素泡沫劑Minocycline foam/ AMZEEQ4%JOURNEY MEDICAL CORP/Foamix Pharmaceuticals Inc./VYNE Pharmaceuticals Inc.未進(jìn)口原研藥品增加上市許可持有人Foamix Pharmaceuticals Inc./VYNE Pharmaceuticals Inc.泡沫劑
64-12鹽酸米諾環(huán)素泡沫劑Minocycline foam/??ZILXI1.50%JOURNEY MEDICAL CORP/Foamix Pharmaceuticals Inc./VYNE Pharmaceuticals Inc.未進(jìn)口原研藥品增加上市許可持有人Foamix Pharmaceuticals Inc./VYNE Pharmaceuticals Inc.泡沫劑
29-25地諾孕素片Dienogest Tablets/Visannette/Visanne2mgJenapharm GmbH & Co. KG/Bayer HealthCare/Bayer Hispania, S.L.未進(jìn)口原研藥品增加商品名Visanne和上市許可持有人Bayer Hispania, S.L.片劑
31-88注射用紫杉醇（白蛋白結(jié)合型）Paclitaxel For Injection（Albumin Bound）/ Abraxane100mgAbraxis Bioscience/BRISTOL-MYERS SQUIBB CO未進(jìn)口原研藥品增加上市許可持有人BRISTOL-MYERS SQUIBB CO注射劑
23-197依折麥布瑞舒伐他汀鈣片Ezetimibe rosuvastatin calcium film-coated tablet依折麥布10mg/瑞舒伐他汀10mgSanofi-Aventis, S.R.O./Sanofi-Aventis Deutschland GmbH/Sanofi-Aventis Ireland Limited T/A SANOFI /SANOFI-AVENTIS FRANCE未進(jìn)口原研藥品增加上市許可持有人SANOFI-AVENTIS FRANCE片劑
22-96唑來(lái)膦酸注射液Zoledronic Acid Injection/Zometa4mg:100mlNovartis Europharm Limited/Phoenix Labs Unlimited Company未進(jìn)口原研藥品增加上市許可持有人Phoenix Labs Unlimited Company注射劑
8-48厄貝沙坦氫氯噻嗪片Irbesartan and Hydrochlorothiazide Tablets/COAPROVEL每片含厄貝沙坦0.15g，氫氯噻嗪12.5mgSanofi Clir SNC/Sanofi-aventis groupe原研進(jìn)口增加變更后的上市許可持有人Sanofi-aventis groupe片劑
22-188注射用替考拉寧Teicoplanin for Injection/Targocid（他格適）200mgSanofi S.p.A /Sanofi S.r.l.國(guó)內(nèi)上市的原研藥品增加變更后的上市許可持有人Sanofi S.r.l.注射劑
24-125特立氟胺片Teriflunomide Tablets/Aubagio（奧巴捷）7mgSanofi Aventis U.S. Inc./ Sanofi-Aventis U.S. LLC國(guó)內(nèi)上市的原研藥品增加變更后的上市許可持有人Sanofi-Aventis U.S. LLC片劑
24-126特立氟胺片Teriflunomide Tablets/Aubagio（奧巴捷）14mgSanofi Aventis U.S. Inc./ Sanofi-Aventis U.S. LLC國(guó)內(nèi)上市的原研藥品增加變更后的上市許可持有人Sanofi-Aventis U.S. LLC片劑
1-28硫酸氫氯吡格雷片Clopidogrel Hydrogen Sulphate Tablets（Clopidogrel Bisulfate Tablets）/Plavix75mgSanofi Clir SNC/Sanofi-aventis groupe/Sanofi Winthrop Industrie原研進(jìn)口增加變更后上市許可持有人Sanofi-aventis groupe/Sanofi Winthrop Industrie片劑
2-17硫酸氫氯吡格雷片Clopidogrel Hydrogen Sulphate Tablets（Clopidogrel Bisulfate Tablets）/Plavix300mgSanofi Clir SNC/Sanofi-aventis groupe/Sanofi Winthrop Industrie原研進(jìn)口增加變更后上市許可持有人Sanofi-aventis groupe/Sanofi Winthrop Industrie片劑
52-3比索洛爾氨氯地平片Bisoprolol Fumarate and Amlodipine Besilate Tablets富馬酸比索洛爾5mg與苯磺酸氨氯地平（按氨氯地平計(jì)）5mgMerck Kft國(guó)內(nèi)上市的原研藥品英文名由Bisoprolol Fumarate and Amlodipine Besylate Tablets更新為Bisoprolol Fumarate and Amlodipine Besilate Tablets片劑
52-43歐米加-3-酸乙酯軟膠囊Omega-3-Acid Ethyl Esters Soft Capsules/Omacor1g Contains at least 900mg of the Ethyl Esters of Omega-3 Fattay AcidsBASF AS未進(jìn)口原研藥品修改規(guī)格為1g Contains at least 900mg of the Ethyl Esters of Omega-3 Fattay Acids膠囊劑
備注1.目錄中所列尚未在國(guó)內(nèi)上市品種的通用名、劑型等，以藥典委核準(zhǔn)的為準(zhǔn)。
2.參比制劑目錄公示后，未正式發(fā)布的品種將進(jìn)行專(zhuān)題研究，根據(jù)研究結(jié)果另行發(fā)布。
3.歐盟上市的參比制劑包括其在英國(guó)上市的同一藥品。
4.選擇未進(jìn)口參比制劑開(kāi)展仿制藥研究除滿(mǎn)足其質(zhì)量要求外，還需滿(mǎn)足現(xiàn)行版《中國(guó)藥典》和相關(guān)指導(dǎo)原則要求。
5.放射性藥物不同于普通化學(xué)藥物，具有一定的特殊性如放射性、時(shí)效性、按放射性活度給藥等特點(diǎn)，參比制劑主要用于明確其研發(fā)目標(biāo)和基本要求，可根據(jù)其藥物特性同時(shí)結(jié)合參比制劑的可獲得性進(jìn)行研究。??
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