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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

D

Dysbiosis

Imbalance between the types/amounts of microorganisms present in a person’s natural flora, potentially leading to…

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C

Clinical Study Report (CSR)

Upon completion of a clinical trial, the sponsor is required to prepare a detailed report…

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