Adverse Drug Reaction Reporting Form Informant Data Adverse Drug Reaction Reporting Form. Please use this form to report any suspected adverse reactions observed when using medicinal products of Biopharm Engineering AD. Feel free to send a message, even if you don’t have all the necessary information to fill out the form! The information you will provide us is extremely important for detecting unknown adverse reactions to medicinal products authorized for use by Biopharm Engineering AD. We will need your contact details for the purpose of: feedback to confirm receipt of the message; if we need to request additional information in order to evaluate the submitted signal with a view to the safety of the medicinal product and assessing the possibilities to minimize or prevent the risk; to inform you about the measures taken. We assure you that the personal data of the reporter/patient is treated in accordance with the Personal Data Protection Act. Address: Sopharma AD, Drug Safety Department 5 Lachezar Stanchev St., 1797, Sofia Phone: +359 700 47474; +359 800 20222; E-mail: safety@sopharma.bg Please enable JavaScript in your browser to complete this form.Please enable JavaScript in your browser to complete this form.Health-care professional? *YesNoLayoutName: *Contact phone number: *Address:Email: *Data about the patientInitials: *LayoutSex: *MaleFemaleAge:Suspected drug productSuspected drug product Product name: *LayoutPharmaceutical formulation:Batch number of the medicinal product:Daily dose:LayoutStart date:Stop date:Route of administration:LayoutIndications:Has the suspected drug been discontinued?YesNoReduced doseDid the patient use the suspected drug before?YesNoUnknownWere measures taken to treat the reaction and what?YesNoUnknownDescription of the measures (if the enterprises are such): + Add suspected drug - RemoveAdverse drug reactionAdverse drug reactionDescription of the adverse drug reaction: *LayoutStart date:Result:Recovered Recovered with sequelaeImprovedWorsenedNo changeFatal outcomeUnknownDid the adverse reaction abate after drug use stopped?YesNoUnknownStop date:Causal relationship:CertainProbablePossibleUnlikely ConditionalUnclassifiedDid the adverse reaction reappear after the drug reintroduction?YesNoUnknownDid the adverse reaction cause: Hospitalization or prolonged hospitalization?Life-threatening condition?Disability?Congenital anomaly or birth defect?Medically significant reaction?Death?If you agree for us to seek additional information on this case from your attending physician, please indicate his contact details. + Add an adverse reaction - RemoveMore information: *I am familiar with the Privacy Policy of Sopharma ADИзпрати
