REPORT ON ADVERSE REACTION ( AR) OR LACK OF EFFICACY ( LE)

INFORMATION ABOUT PATIENT


MF

INFORMATION ABOUT AR/LE


Death of patientLife-threateningHospitalization of ambulatory patient or prolongation of hospitalizationTemporary or considerable disability, invalidityCongenital malformationsNone of the above

INFORMATION ABOUT SUSPECTED MEDICINAL PRODUCT (SMP)


MedicalSelf-medication

INFORMATION ABOUT SOURCE


Health workerMedical representativePatientOther