Off-label use of orphan medicinal products: a Belgian qualitative study

Off-label use of orphan medicinal products: a Belgian qualitative study

Abstract Background Off-label use of (orphan) medicinal products for (rare) diseases is quite common but not underpinned by clinical studies to confirm efficacy and safety. No risk-analyses by regulatory agencies are carried out. The objective of this study was to map off-label use of orphan medicin...

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Bibliographic Details
Main Authors: Marc Dooms, David Cassiman, Steven Simoens
Format: Article
Language:English
Published: BMC 2016-10-01
Series:Orphanet Journal of Rare Diseases
Subjects:
Off-label use
Unlicensed use
Orphan medicinal products
Rare diseases
Safety
Efficacy
Online Access:http://link.springer.com/article/10.1186/s13023-016-0507-y

Internet

http://link.springer.com/article/10.1186/s13023-016-0507-y

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