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Glossary

Off-label use

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Situations where a medicinal product is intentionally used for a medical purpose not in accordance with the terms of the marketing authorization. 

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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C

CE Marking

CE certification verifies to regulators in Europe that medical devices meet all quality, safety and…

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