Confirmed signal

For the signal management process in the EU, a validated signal entered in the European Pharmacovigilance Issues Tracking Tool (EPITT) that requires further analysis and prioritisation by the Pharmacovigilance Risk Assessment Committee (PRAC), according to the PRAC Rapporteur or (lead) Member State.

See also Validated signal, Signal management process, Signal confirmation by the PRAC Rapporteur or (lead) Member State, Signal analysis and prioritisation by the PRAC, Non-confirmed signal