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Glossary

Unexpected adverse reaction

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An adverse reaction, the nature, severity or outcome of which is not consistent with the summary of product characteristics 

Other glossary definitions

A

Adverse Drug Reaction (ADR)

Single or repeated drug administration as well as combination of different drugs administration can cause…

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R

Real World Data (RWD)

An umbrella term for data regarding the effects of health interventions (e.g. safety, effectiveness, resource…

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