Report form

on adverse reaction and/or lack of efficacy of a medicinal product during its medical use.

  1. General information

    Gender: Outcome of an adverse reaction/lack of efficacy: Onset of an adverse reaction/lack of efficacy:
    Resolution of an adverse reaction/lack of efficacy:
    Category of an adverse reaction/lack of efficacy:
  2. Information on suspected medicinal product

  3. Information on concomitant medicinal products

    (Except for medicinal products used for management of consequences of the adverse reaction)

  4. Adverse reaction management methods

    Was withdrawal of the suspected medicinal product associated with resolution of the adverse reaction?
    Was the adverse reaction re-occurrence reported after re-initiation of the suspected medicinal product?
    Was the adverse reaction re-occurrence/lack of efficacy reported after change of dosage regimen of the suspected medicinal product?
  5. Information on reporter

    The report is submitted by: