Buccolam®

Oromucosal solution of buccal midazolam

Pre-filled oral midazolam syringe

For treatment of prolonged, acute, convulsive seizures in infants, toddlers, children and adolescents (from 3 months to < 18 years).

Buccolam was granted the first EMA Paediatric-Use Marketing Authorisation (PUMA).

Therakind was responsible for the regulatory strategy, design, management and sponsorship of clinical trial.

Marketing authorisation of product sold in 2010, currently marketed throughout Europe by Neuraxpharm.