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Glossary

Market Exclusivity

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The 10-year period after the marketing authorisation of an orphan medicine when similar medicines for the same indication cannot be placed on the market.

Other glossary definitions

I

Integrated summary of efficacy (or effectiveness) (ISE)

Comprehensive integrated analysis of the effectiveness of a study drug, recommended to be submitted to…

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I

Important identified risk and Important potential risk

An identified risk or potential risk that could have an impact on the risk-benefit balance…

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