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The First Paediatric Use Marketing Authorisation: A Case Study
John Watson1, Kulminder Nowacki2
11 NPS Pharma UK Ltd, Maidenhead, UK.
Therapeutic Innovation & Regulatory Science
|September 18, 2018
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)Committee for Medicinal Products for Human UseEuropean Medicines AgencyPaediatric Use Marketing Authorisationcentralized procedureefficacyepileptic seizuremarketing authorizationnonclinicalpediatric investigation planpediatric regulationpharmacodynamicpharmacokineticqualitysafetyRelated Concept Videos
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