Individual Case Safety Report

ANNEXURE-RA003/A01

    Date ICSR No. Patient Name Date of Birth Gender
    Weight Height Race Nationality Health Institution Medical Record No Type of Notification Action Taken


    Seriousness of ADR Tick all applicable


    Outcome of ADR (Tick all applicable)
    Patient


    Event subsided after stopping (de-challenge)


    Event reappears after reintroducing (re-challenge)


    Specific antagonist used


    Suspected Drug(s)
    Brand Name Dosage Form Strength Batch No. MFG EXP Route Used Dosage Regime Treatment Period
    FromTo Indication Concomitant Medicines Recently Discontinued Medications Work Environment in Which The Error Occurred Previous Allergic History The relationship between the suspected drug and the ADR is


    Reporter
    Reporter Name Profession (Specialty) Address E-mail Phone/Mobile Date Signature

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