Information arising from one or multiple sources, including observations and experiments, which suggests a new potentially causal association, or a new aspect of a known association between an intervention and an event or set of related events, either adverse or beneficial, that is judged to be of sufficient likelihood to justify verificatory action.
Sources may include spontaneous reports, clinical studies and the scientific literature. New aspects of a known association may include changes in the frequency, distribution (e.g. gender, age and country), duration, severity or outcome of the adverse reaction.
A signal may concern any medicinal product. A signal generally involves an active substance regardless of its indication, strength or route of administration and applies to all brand names / medicinal products containing the active substance, including fixed combinations. However, in some instances, a signal may be relevant only to a particular indication, strength or route of administration. On the other hand, a signal may encompass all active substances of a therapeutic class.
Information arising from one or multiple sources, including observations and experiments, which suggests a new potentially causal association, or a new aspect of a known association between an intervention and an event or set of related events, either adverse or beneficial, that is judged to be of sufficient likelihood to justify verificatory action.
Sources may include spontaneous reports, clinical studies and the scientific literature. New aspects of a known association may include changes in the frequency, distribution (e.g. gender, age and country), duration, severity or outcome of the adverse reaction.
A signal may concern any medicinal product. A signal generally involves an active substance regardless of its indication, strength or route of administration and applies to all brand names / medicinal products containing the active substance, including fixed combinations. However, in some instances, a signal may be relevant only to a particular indication, strength or route of administration. On the other hand, a signal may encompass all active substances of a therapeutic class.
