Date of Receipt: Patient Details: Patient Initials: Age: Date of Birth: Ethnicity: —Please choose an option—AsianBlackCaucasianNative AmericanNative Hawaiian / Other Pacific IslanderAboriginalTorres Strait IslanderAboriginal & Torres Strait IslanderIndigenous MaoriNon-Maori Pacific Islander Gender: MaleFemaleOther Weight (kg): Height (cm): Pregnant? YesNo If Pregnant, Date of Last Menstrual Period: Current Week of Gestation Period: Expected Date of Delivery: Event Description: Event Start Date: Event End Date: Did the adverse event(s) result in any of the following? HospitalizationProlongation of existing hospitalization (treatment received during existing hospitalization)Life threatening illness (immediate risk of death from the event)Disability or permanent damagePatient diedCongenital anomaly or birth defectNone of the above Was treatment received for the adverse events? Outcome of the Event: Recovered/resolvedRecovering/resolvingNot recovered/not resolvedRecovered with sequelaeUnknownNot applicable Please specify, if there is any action taken with the product due to the event: Drug withdrawnDose increasedDose decreasedDose not changedNot applicableUnknown Product Details: Product Name: Dosage Form: Form Strength: Dose: Route of Administration: Frequency: Product Start Date: Product End Date: Indication: Batch Number: Expiry Date: Medical History of the Patient: Was the patient taking any other medication along with the Nova’s product?: Reporter Causality to the Product: SuspectedNot suspectedUnknown Reporter Details: Full Name: Occupation: Email Address: Contact Number: State: Country: Does the consumer/reporter provide consent for Nova Pharmaceuticals to contact back for further information? YesNo Does the consumer/reporter provide consent for Nova Pharmaceuticals to provide this information to the Regulatory authority? YesNo
