Tuzodi (midazolam)
- Region
- 🇪🇺 EU
- Active substance
- midazolam
- Company
- Regulatory Pharma Net S.r.l.
- Status
- Application withdrawn
- Therapeutic area
- Seizures
- Application
- EMEA/H/C/005658
- ATC
- N05CD08
- Official record
- www.ema.europa.eu
Indication
Treatment of prolonged, acute, convulsive seizures in adults, adolescents, children and toddlers (from 2 years of age).
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Omforro Application withdrawn · Regulatory Pharma Net S.r.l.
- 🇪🇺 Buccolam Authorised · Neuraxpharm Pharmaceuticals S.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.