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药智数据企业版注册数据库:增设了"联合申报"、"临床试验默认许可日期"等搜索条件,让搜索页面纬度更加全面,还有热点搜索和高级条件组合检索等检索功能 等你来体验!
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1.查询FDA历年批准新分子实体和生物制品请访问FDA历年批准NMEs和Biologics


2. 更多药品说明书和标签信息访问美国NDC及药品标签


3.数据库新增中文名称,依据INN命名原则翻译而来,“*”号部分翻译还有待商榷!

导出数据
申请号 申请类型 商品名 活性成分 中文活性成分 剂型/给药途径 批准日期 申请机构
761122 BLA NUCALA MEPOLIZUMAB 美泊珠单抗 INJECTABLE;SUBCUTANEOUS 2019-06-06 GLAXOSMITHKLINE
761121 BLA POLIVY POLATUZUMAB VEDOTIN-PIIQ INJECTABLE;INJECTION 2019-06-10 GENENTECH
761116 BLA ELZONRIS TAGRAXOFUSP-ERZS * SOLUTION;INJECTION 2018-12-21 STEMLINE THERAPEEUTICS INC
761112 BLA CABLIVI CAPLACIZUMAB-YHDP 卡拉西组单抗-YHDP INJECTABLE;INJECTION 2019-02-06 ABLYNX NV
761108 BLA ULTOMIRIS RAVULIZUMAB-CWVZ 长春夫利*-CWVZ INJECTABLE;INJECTION 2018-12-21 ALEXION PHARM
761107 BLA GAMIFANT EMAPALUMAB-LZSG 依马利人单抗-LZSG INJECTABLE;INJECTION 2018-11-20 NOVIMMUNE S.A.
761106 BLA HERCEPTIN HYLECTA TRASTUZUMAB;HYALURONIDASE-OYSK 曲司珠单抗;曲司珠单抗 INJECTABLE;SUBCUTANEOUS 2019-02-28 GENENTECH INC
761105 BLA SKYRIZI RISANKIZUMAB-RZAA 利生奇组单抗 INJECTABLE;INJECTION 2019-04-23 ABBVIE INC
761104 BLA LUMOXITI MOXETUMOMAB PASUDOTOX-TDFK 帕西妥莫单抗-TDFK INJECTABLE;INJECTION 2018-09-13 ASTRAZENECA AB
761102 BLA ASPARLAS CALASPARGASE PEGOL-MKNL 培戈卡门冬酶-MKNL INJECTABLE;INTRAVENOUS 2018-12-20 SERVIER PHARMA LLC
761100 BLA ONTRUZANT TRASTUZUMAB-DTTB 曲司珠单抗-DTTB INJECTABLE;INJECTION 2019-01-18 SAMSUNG BIOEPIS CO LTD
761097 BLA LIBTAYO CEMIPLIMAB-RWLC -RWLC* INJECTABLE;INTRAVENOUS 2018-09-28 REGENERON PHARMACEUTICALS
761094 BLA OXERVATE CENEGERMIN-BKBJ 塞奈吉明-BKBJ SOLUTION;OPHTHALMIC 2018-08-22 DOMPE FARMACEUTICI
761092 BLA REVCOVI ELAPEGADEMASE-LVLR 依拉培加酶-LVLR INJECTABLE;INJECTION 2018-10-05 LEADIANT BIOSCI INC
761091 BLA HERZUMA TRASTUZUMAB-PKRB 曲司珠单抗-PKRB INJECTABLE;INJECTION 2018-12-14 CELLTRION INC
761090 BLA TAKHZYRO LANADELUMAB (SHP643) 拉那芦人单抗* INJECTABLE;INJECTION 2018-08-23 DYAX CORP.
761089 BLA AJOVY FREMANEZUMAB-VFRM 夫瑞奈组单抗-VFRM INJECTABLE;INJECTION 2018-09-14 TEVA PHARMS USA
761088 BLA TRUXIMA RITUXIMAB-ABBS 利妥昔单抗-ABBS INJECTABLE;INJECTION 2018-11-28 CELLTRION INC
761085 BLA JEUVEAU PRABOTULINUMTOXINA-XVFS 肉毒杆菌 INJECTABLE;INJECTION 2019-02-01 EVOLUS INC
761083 BLA HEMLIBRA EMICIZUMAB 依米赛珠单抗* INJECTABLE;INJECTION 2017-11-16 GENENTECH INC