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.
Glossary
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.
A substantial amendment (SA) is a change to the conduct of the clinical trial that…
View definitionIn periodic benefit-risk evaluation reports for medicinal products, all relevant safety information contained in the…
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