Prognia
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🇪🇺EU · EMAAuthorisedATC: N05CD08

Buccolam(midazolam)

Epilepsy

Marketing Authorisation Holder: Neuraxpharm Pharmaceuticals S.L.

EMA Authorisation: 04/09/2011

INN: midazolam

Indication

Treatment of prolonged, acute, convulsive seizures in infants from 3 months to adults.BUCCOLAM must only be used by parents/carers where the patient has been diagnosed to have epilepsy.For infants between 3-6 months of age treatment should be in a hospital setting where monitoring is possible and resuscitation equipment is available. See section 4.2.

Official EMA Resources

View on EMA (ema.europa.eu)

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Medical disclaimer: This information is intended for qualified healthcare professionals. Always verify with the official EMA Summary of Product Characteristics (SmPC) before clinical use.