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Glossary

Compassionate Use

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The use of an unauthorised medicine outside a clinical study in individual patients under strictly controlled conditions. This helps to make medicines that are still under development available to patients.

Other glossary definitions

R

Reference safety information

In periodic benefit-risk evaluation reports for medicinal products, all relevant safety information contained in the…

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S

Serious incident (MDR definition)

Any incident that directly or indirectly led, might have led or might lead to any…

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