ADR | Adverse Drug Reaction |
EEA | European Economic Area |
EMA | European Medicines Agency |
EU | European Union |
EV | EudraVigilance |
FDA | United States Food and Drug Administration agency |
mAb | monoclonal antibody |
MedDRA | Medical Dictionary for Regulatory Activities |
PT | Preferred term |
RP | reference product |
ROR | Reporting Odds Ratio |
SPC | Summary of the Product Characteristic |