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ViroPharma's Buccolam® (Midazolam, Oromucosal Solution) Granted European Marketing Authorization for Treatment of Acute Seizures
Date:9/6/2011

nating pediatric convulsive seizures.

The approval of Buccolam follows the positive opinion adopted by the Committee for Medicinal Products for Human Use (CHMP) in June 2011. Buccolam is now approved 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 marketing authorization for Buccolam in Europe is an important step towards addressing the need of parents and carers in the community for a rapidly-acting, effective and socially acceptable rescue medication for emergency treatment to terminate prolonged, acute convulsive seizures in children and adolescents," commented Thierry Darcis, M.D., ViroPharma's vice president, general manager, Europe. "We look forward to providing for the evolving needs of patients, which is our priority throughout our global organization, and we look forward to working closely with physicians across Europe as we launch Buccolam into the European markets."

A Pediatric Use Marketing Authorization (PUMA) is a new type of centralized marketing authorization procedure requested for medicines already authorized but no longer covered by intellectual property rights and exclusively developed for use in children. Medicines awarded a PUMA benefit from 10 years of market protection.

About Buccolam® (Midazolam, Oromucosal Solution)

Buccolam is oral midazolam provided in an individual dose formulation for buccal delivery.  It is provided as a convenient, portable, ready to use, pre-filled syringe containing an age-specific dose. Buccolam is approved throughout the European Union and the EEA for treatment of prolonged, acute, convulsive seizures in infants, toddlers, children and adolescents, from three months to less than 18 years of age.  Buccolam should only be used by parents/carers where the patient has been diagnosed to have epilepsy.  For infants between 3-6 months of age, trea
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SOURCE ViroPharma Incorporated
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