Abstract
The first Paediatric Use Marketing Authorisation was approved in Europe in 2011. This article describes the assessment procedure and the key regulatory issues that were addressed.
Keywords
Buccolam (midazolam oromucosal solution)pediatric regulationPaediatric Use Marketing Authorisationepileptic seizureEuropean Medicines Agencynonclinicalpharmacokineticpharmacodynamicmarketing authorizationpediatric investigation planqualitysafetyefficacyCommittee for Medicinal Products for Human Usecentralized procedure
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References
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