Buccolam®: The first centralized paediatric use marketing authorization

The First Paediatric Use Marketing Authorisation: A Case Study

“…Therakind was responsible for regulatory development and strategy, including obtaining scientific advice, approval of the Paediatric Investigation Plan (PIP), clinical trial authorizations, and the PIP compliance check. 6 Scientific advice obtained from the Committee for Medicinal Products for Human Use (CHMP) in September 2008 established that the publically available clinical data and the proposed PK study were sufficiently robust to support the efficacy and safety of midazolam for the new indication and a new route of administration. [5][6][7] Furthermore, no new nonclinical data were required.…”

“…ViroPharma—which had recently established a European business and was seeking new, protected, medicines in therapeutic areas where there was a significant unmet need—acquired Auralis in May 2010, before submission of the PUMA application in August 2010. 6…”