reporttype1Version of Safety Report ID2receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10049763serious1Date Last Updated01/04/2014receiptdateformat102companynumbUS-SA-POMP-1003147occurcountryUSseriousnessother1duplicate1Date Received01/04/2014seriousnesshospitalization1transmissiondate12/12/2014primarysourcecountryUS
Primary Source
reportercountryUSqualification1
Patient
Onset Age17Unit of Onset AgeyearsWeight45SexFemale
drugcharacterization1medicinalproductLUMIZYMEdrugbatchnumbUNKNOWNdrugauthorizationnumb125291drugstructuredosagenumb8.8drugstructuredosageunit007drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition803drugdosagetext8.8 MG/KG, QWdrugdosageformPOWDER FOR SOLUTION FOR INFUSIONdrugadministrationroute042drugindicationGLYCOGEN STORAGE DISEASE TYPE IIdrugstartdateformat102drugstartdate31/12/2010actiondrug4
drugcharacterization1medicinalproductLUMIZYMEdrugbatchnumbUNKNOWNdrugauthorizationnumb125291drugstructuredosagenumb8drugstructuredosageunit007drugseparatedosagenumb1drugintervaldosageunitnumb2drugintervaldosagedefinition803drugdosageformPOWDER FOR SOLUTION FOR INFUSIONdrugadministrationroute042drugindicationGLYCOGEN STORAGE DISEASE TYPE IIdrugstartdateformat610drugstartdate/01/2013actiondrug4
drugcharacterization2medicinalproductSERTRALINEdrugstructuredosagenumb50drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext50 MG, QDdrugindicationPRODUCT USED FOR UNKNOWN INDICATION