9. Glossary

alert ; alert

Signal validated after risk assessment, requiring the implementation of precautionary measures and/or preventive or corrective actions.

base nationale de pharmacovigilance; french pharmacovigilance database

A database managed by ANSM (the French National Agency for Medicines and Health Products) containing adverse reaction observations reported by healthcare professionals and entered by CRPVs after evaluation, validation and attribution.

adverse effect; effet indésirable

Any noxious and unintended reaction occurring at dosages normally used in humans, for all conditions of use.

serious adverse effect; effet indésirable grave

A lethal or life-threatening effect, or one resulting in significant or lasting...