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[EPC]" ], "pharm_class_pe": [ "Central Nervous System Stimulation [PE]" ], "unii": [ "207ZZ9QZ49", "4B3SC438HI" ] } }, { "drugcharacterization": "2", "medicinalproduct": "PREDNISONE ACETATE", "drugdosagetext": "UNK", "drugindication": "Product used for unknown indication", "drugrecurreadministration": "3", "activesubstance": { "activesubstancename": "PREDNISONE ACETATE" } }, { "drugcharacterization": "2", "medicinalproduct": "REMICADE", "drugdosagetext": "UNK", "drugindication": "Product used for unknown indication", "drugstartdateformat": "102", "drugstartdate": "20170124", "activesubstance": { "activesubstancename": "INFLIXIMAB" }, "openfda": { "application_number": [ "BLA103772" ], "brand_name": [ "REMICADE" ], "generic_name": [ "INFLIXIMAB" ], "manufacturer_name": [ "Janssen Biotech, Inc." ], "product_ndc": [ "57894-030" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "INTRAVENOUS" ], "substance_name": [ "INFLIXIMAB" ], "rxcui": [ "213361", "310994" ], "spl_id": [ "36afec96-dd29-9328-e063-6294a90af8e4" ], "spl_set_id": [ "a0a046c1-056d-45a9-bfd9-13b47c24f257" ], "package_ndc": [ "57894-030-01" ], "nui": [ "N0000175610", "N0000175451" ], "pharm_class_epc": [ "Tumor Necrosis Factor Blocker [EPC]" ], "pharm_class_moa": [ "Tumor Necrosis Factor Receptor Blocking Activity [MoA]" ], "unii": [ "B72HH48FLU" ] } }, { "drugcharacterization": "2", "medicinalproduct": "ENTYVIO", "drugdosagetext": "UNK", "drugindication": "Product used for unknown indication", "drugstartdateformat": "102", "drugstartdate": "20230201", "activesubstance": { "activesubstancename": "VEDOLIZUMAB" }, "openfda": { "application_number": [ "BLA761133", "BLA125476" ], "brand_name": [ "ENTYVIO" ], "generic_name": [ "VEDOLIZUMAB" ], "manufacturer_name": [ "Takeda Pharmaceuticals America, Inc." ], "product_ndc": [ "64764-107", "64764-300", "64764-108" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "SUBCUTANEOUS", "INTRAVENOUS" ], "substance_name": [ "VEDOLIZUMAB" ], "rxcui": [ "1538137", "1538142", "2667332", "2667336", "2667339", "2667342" ], "spl_id": [ "266293d6-dd28-4e38-81c2-4f518d95ef5d" ], "spl_set_id": [ "6e94621c-1a95-4af9-98d1-52b9e6f1949c" ], "package_ndc": [ "64764-300-20", "64764-108-20", "64764-108-21", "64764-107-10", "64764-107-11" ], "nui": [ "N0000175775", "N0000175774" ], "pharm_class_epc": [ "Integrin Receptor Antagonist [EPC]" ], "pharm_class_moa": [ "Integrin Receptor Antagonists [MoA]" ], "unii": [ "9RV78Q2002" ] } }, { "drugcharacterization": "2", "medicinalproduct": "RINVOQ", "drugdosagetext": "UNK", "drugdosageform": "Tablet", "drugindication": "Product used for unknown indication", "drugstartdateformat": "102", "drugstartdate": "20231001", "activesubstance": { "activesubstancename": "UPADACITINIB" }, "openfda": { "application_number": [ "NDA211675", "NDA218347" ], "brand_name": [ "RINVOQ" ], "generic_name": [ "UPADACITINIB" ], "manufacturer_name": [ "AbbVie Inc." ], "product_ndc": [ "0074-1043", "0074-2306", "0074-2310", "0074-2320" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "UPADACITINIB" ], "rxcui": [ "2196894", "2196900", "2590051", "2590054", "2596957", "2596960", "2681015", "2681019" ], "spl_id": [ "6c4bad0a-5930-4bb7-8509-6a8c6f279082" ], "spl_set_id": [ "2966aec7-2ef0-923c-d8ff-fe1a957bf095" ], "package_ndc": [ "0074-2306-30", "0074-2306-70", "0074-2310-30", "0074-2310-20", "0074-1043-28", "0074-1043-14", "0074-2320-01", "0074-2320-70" ], "nui": [ "N0000190858", "N0000190857" ], "pharm_class_epc": [ "Janus Kinase Inhibitor [EPC]" ], "pharm_class_moa": [ "Janus Kinase Inhibitors [MoA]" ], "unii": [ "4RA0KN46E0" ] } } ], "summary": { "narrativeincludeclinical": "CASE EVENT DATE: 20130601" } } } ] }