Patient’s initials:

    Check the adequate box below:

    THE ADVERSE REACTION DETERMINED:

    the patient’s deathdisability/ significant or long-lasting incapacityjeopardized the patient’s lifeanomaly/ congenital malformationhospitalization/prolonged hospitalization

    YESNO

    YESNO

    YESNO

    YESNO

    YESNO

    YESNO
    SECTION FILLED-IN BY THE PHARMACOVIGILANCE OFFICER FURTHER TO ASSESSING CAUSALITY
    certainlyprobablylikelyless likelyunclassifiedunclassifiable


    * all fields are compulsory