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"1", "activesubstance": { "activesubstancename": "CALCIUM MONOETHYLFUMARATE\\DIMETHYL FUMARATE\\MAGNESIUM MONOETHYLFUMARATE\\ZINC MONOETHYLFUMARATE" } }, { "drugcharacterization": "1", "medicinalproduct": "NEOTIGASON", "drugbatchnumb": "Not Available", "drugseparatedosagenumb": "1", "drugadministrationroute": "065", "drugindication": "Psoriasis", "drugtreatmentduration": "2", "drugtreatmentdurationunit": "802", "actiondrug": "1", "drugadditional": "1", "activesubstance": { "activesubstancename": "ACITRETIN" } }, { "drugcharacterization": "2", "medicinalproduct": "CALCIPOTRIENE", "drugseparatedosagenumb": "1", "drugadministrationroute": "061", "drugindication": "Psoriasis", "drugstartdateformat": "602", "drugstartdate": "1993", "activesubstance": { "activesubstancename": "CALCIPOTRIENE" }, "openfda": { "application_number": [ "ANDA090633", "ANDA078468", "ANDA205772", "NDA022563", "NDA020273", "NDA020554" ], "brand_name": [ "CALCIPOTRIENE", "PELLIX", "SORILUX", "CALCITRENE" ], 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"drugindication": "RHEUMATOID ARTHRITIS", "drugstartdateformat": "102", "drugstartdate": "20100106", "drugenddateformat": "102", "drugenddate": "20100707", "actiondrug": "1", "drugrecurreadministration": "3", "activesubstance": { "activesubstancename": "ADALIMUMAB" }, "openfda": { "application_number": [ "BLA125057", "BLA761219", "BLA761071", "BLA761154" ], "brand_name": [ "HUMIRA", "ADALIMUMAB" ], "generic_name": [ "ADALIMUMAB", "ADALIMUMAB-AATY", "ADALIMUMAB-ADAZ", "ADALIMUMAB-FKJP" ], "manufacturer_name": [ "Cordavis Limited", "CELLTRION USA, Inc.", "AbbVie Inc.", "Sandoz Inc", "Biocon Biologics Inc" ], "product_ndc": [ "83457-124", "83457-554", "83457-243", "83457-616", "83457-817", "72606-022", "72606-040", "72606-041", "0074-0124", "0074-3799", "0074-4339", "0074-9374", "0074-0243", "0074-0554", "0074-0067", "0074-2540", "0074-1539", "0074-0616", "0074-0817", "61314-325", "61314-327", "61314-332", "61314-391", "83257-020", "83257-021", "83257-022" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "rxcui": [ "797544", "1726844", "1726846", "1872979", "1872980", "1921009", "1921010", "1921016", "1921017", "1921238", "1921240", "2639651", "2639659", "2668483", "2668485", "2668487", "2668489", "727703", "727705", "763564", "763565", "825169", "825170", "1594352", "1594357", "1594358", "1655726", "1655728", "1656703", "1801277", "1801278", "1855523", "1855524", "1855526", "1855527", "1872983", "1872984", "1872985", "1872986", "1873086", "1873087", "1921244", "1921245", "1921467", "1921468", "2531133", "2531134", "2641644", "2641653", "2641655", "2641660", "2641662", "2640404", "2640412", "2640417" ], "spl_id": [ "5fe81b1a-cc31-444e-a0f1-1ea4f7334b89", "4ba7057b-2495-42ba-9c35-95d87449259c", "8bf84b15-6763-41cf-bfa4-bcee9ad4ef9a", "ae54abc4-e9c5-4c5a-8fa7-968e5ad72050", "39c67c8f-7fbd-a17a-1535-5d41ece68818" ], "spl_set_id": [ "4977567e-3525-44ac-9ff5-f1e74b053950", "c44365e9-d470-4e35-978d-8565a9e3471e", "608d4f0d-b19f-46d3-749a-7159aa5f933d", "3468792f-63ef-4916-8ed1-8214f327d9dd", "5cde907d-6747-0e62-db25-1718ee717fe7" ], "package_ndc": [ "83457-554-02", "83457-553-01", "83457-927-01", "83457-124-02", "83457-123-01", "83457-243-02", "83457-242-01", "83457-616-02", "83457-615-01", "83457-817-02", "83457-816-01", "72606-022-01", "72606-022-02", "72606-022-03", "72606-022-04", "72606-022-05", "72606-022-06", "72606-022-07", "72606-022-08", "72606-022-09", "72606-022-10", "72606-022-11", "72606-022-12", "72606-040-01", "72606-040-02", "72606-040-03", "72606-040-04", "72606-040-05", "72606-040-06", "72606-041-01", "0074-3799-02", "0074-3799-71", "0074-3799-06", "0074-3799-03", "0074-4339-02", "0074-4339-07", "0074-4339-71", "0074-4339-73", "0074-4339-01", "0074-4339-74", "0074-9374-71", "0074-0243-02", "0074-0243-71", "0074-0554-01", "0074-0554-02", "0074-0554-04", "0074-0554-06", "0074-0554-71", "0074-0554-74", "0074-0554-73", "0074-0067-02", "0074-2540-01", "0074-2540-03", "0074-0124-74", "0074-0124-73", "0074-0124-01", "0074-0124-03", "0074-0124-02", "0074-0124-04", "0074-1539-03", "0074-0616-71", "0074-0616-02", "0074-0817-02", "61314-327-64", "61314-327-20", "61314-332-64", "61314-325-20", "61314-391-64", "83257-020-42", "83257-021-42", "83257-022-32" ], "route": [ "SUBCUTANEOUS" ], "substance_name": [ "ADALIMUMAB" ], "nui": [ "N0000175610", "N0000175451", "M0001357" ], "pharm_class_epc": [ "Tumor Necrosis Factor Blocker [EPC]" ], "pharm_class_moa": [ "Tumor Necrosis Factor Receptor Blocking Activity [MoA]" ], "pharm_class_cs": [ "Antibodies, Monoclonal [CS]" ], "unii": [ "FYS6T7F842" ] } }, { "drugcharacterization": "2", "medicinalproduct": "VOLTAREN", "drugadministrationroute": "048", "actiondrug": "4", "activesubstance": { "activesubstancename": "DICLOFENAC SODIUM" }, "openfda": { "application_number": [ "NDA022122" ], "brand_name": [ "VOLTAREN ARTHRITIS PAIN" ], "generic_name": [ "DICLOFENAC SODIUM" ], "manufacturer_name": [ "Haleon US Holdings LLC" ], "product_ndc": [ "0067-8152", "0067-8153", "0067-8154" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "TOPICAL" ], "substance_name": [ "DICLOFENAC SODIUM" ], "rxcui": [ "855633", "855635" ], "spl_id": [ "71ee74f6-1c1d-4ba8-95be-9b9aefc02d3c" ], "spl_set_id": [ "30a94282-0892-442a-aa10-6525cbd4fe88" ], "package_ndc": [ "0067-8152-01", "0067-8152-02", "0067-8152-03", "0067-8152-04", "0067-8152-05", "0067-8152-08", "0067-8152-09", "0067-8153-01", "0067-8154-01" ], "unii": [ "QTG126297Q" ] } } ], "summary": { "narrativeincludeclinical": "CASE EVENT DATE: 2013" } } }, { "safetyreportversion": "1", "safetyreportid": "10034673", "primarysourcecountry": "JP", "occurcountry": "JP", "transmissiondateformat": "102", "transmissiondate": "20141002", "reporttype": "1", "serious": "1", "seriousnessother": "1", "receivedateformat": "102", "receivedate": "20140325", "receiptdateformat": "102", "receiptdate": "20140325", "fulfillexpeditecriteria": "1", "companynumb": "JP-ASTELLAS-2014JP002581", "duplicate": "1", "reportduplicate": { 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