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ViroPharma Announces Positive CHMP Opinion for Buccolam® (Midazolam, Oromucosal Solution) in the European Union
Date:6/24/2011

thorization Applications (MAAs) for medicines for human use. Their positive opinion forms the scientific basis for the European Commission to issue a binding decision for an MAA or a PUMA, a centralized marketing authorization which is valid throughout all the Member States of the European Union (EU) as well as in the European Economic Area (EEA), namely Norway, Iceland and Liechtenstein. The anticipated timeframe for the European Commission decision is by the fourth quarter of 2011.  A summary of the CHMP opinion will be available here: http://tinyurl.com/2am4ubc.  Please select "B" to access the Buccolam summary opinion.  

"This positive CHMP opinion - the first for a product seeking centralized authorization through a PUMA - is a great step towards the European marketing authorization for Buccolam, a product that addresses significant unmet need for families and caregivers – namely the quick and effective termination of prolonged, acute convulsive seizures in children and adolescents," commented Thierry Darcis, M.D., ViroPharma's vice president, general manager, Europe.  "We will work closely with physicians across Europe on improving the seizure treatment paradigm, and bringing this much-needed emergency medication to market as soon as possible this year."

A Pediatric Use Marketing Authorization (PUMA) is a new type of centralized marketing authorization procedure for medicines that are developed specifically for children and may already be authorized for other indications or routes of administration in adults but are not patented. These medicines benefit from 10 years of market protection as an incentive.  In August 2010, the EMA's Pediatric Committee (PDCO) confirmed that the required Pediatric Investigation Plan (PIP) for Buccolam had been fully completed.  

About Buccolam® (Midazolam, Oromucosal Solution)

Buccolam is oral midazolam prov
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SOURCE ViroPharma Incorporated
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