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Epistatus 10mg oromucosal solution now authorized

20th June 2017

The Epistatus® brand of midazolam 10mg oromucosal solution for buccal administration has been authorized in the UK for the treatment of prolonged, acute seizures in children and adolescents aged 10 to <18 years. The NHS list price of one prefilled syringe is £60. This product was previously unauthorized but available as a special order product. The other strengths of Epistatus® oromucosal solutions remain unauthorized.

Note. The Epistatus® oromucosal solution is 10mg/mL; this is double the concentration of the other authorized formulation of midazolam oromucosal solution (Buccolam®) in the UK which is 5mg/mL and available as 2.5mg, 5mg, 7.5mg and 10mg prefilled oral syringes.

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