Adverse Drug Reaction (ADR)
Is a response to a medicinal product which is noxious and unintended. Response in this context means that a causal relationship between a medicinal product and an adverse event is at least a reasonable possibility
Serious adverse reaction; is an adverse reaction which:
- Results in death,
- Is life-threatening,
- Requires in-patient hospitalization or prolongation of existing hospitalization
- Is a congenital anomaly/birth defect