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Glossary

Overdose

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Administration of a quantity of a medicinal product given per administration or cumulatively which is above the maximum recommended dose according to the authorized product information.

Other glossary definitions

U

Unanticipated Serious Adverse Device Effect (USADE)

A Serious Adverse Device Effect which by its nature, incidence, severity, or outcome has not…

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R

Real World Evidence (RWE)

Real World Evidence (RWE) is the evidence derived from the analysis and/or synthesis of real-world…

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