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news.ViroPharma's Pediatric Use Marketing Authorization (PUMA) for Buccolam (midazolam, oromucosal solution) has received a positive opinion from European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP).
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Buccolam is an oral midazolam provided in a pre-measured, age-specific dose formulation for convenient buccal (i.e. via the cavity between the cheek and gum line) delivery which is used to treat prolonged, acute, convulsive seizures in infants, toddlers, children and adolescents, from 3 months to less than 18 years.
University of London School of Pharmacy Paediatric Pharmacy Research Centre director Ian Wong said the approval of Buccolam would address a challenge for physicians who prescribe rectally-administered diazepam for acute seizures.
ViroPharma vice president and general manager Thierry Darcis said this positive CHMP opinion through a PUMA for Buccolam addresses unmet need for families and caregivers and terminates prolonged, acute convulsive seizures in children and adolescents.