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Glossary

Serious Adverse Device Effect (SADE)

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Adverse Device Effect that has resulted in any of the consequences characteristic of a Serious Adverse Event.

Other glossary definitions

M

Market Exclusivity

The 10-year period after the marketing authorisation of an orphan medicine when similar medicines for…

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E

Emerging Safety Issue

A safety issue considered by a marketing authorization holder to require urgent attention by the…

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