Buccolam (midazolam)
- Region
- 🇪🇺 EU
- Active substance
- midazolam
- Company
- Neuraxpharm Pharmaceuticals S.L.
- Status
- Authorised
- Therapeutic area
- Epilepsy
- CHMP opinion
- Thu 23 Jun 2011
- EU approval
- Sun 04 Sep 2011
- Application
- EMEA/H/C/002267
- ATC
- N05CD08
- Official record
- www.ema.europa.eu
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.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Omforro Application withdrawn · Regulatory Pharma Net S.r.l.
- 🇪🇺 Tuzodi Application withdrawn · Regulatory Pharma Net S.r.l.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.