Ztalmy (ganaxolone)
OrphanAdditional monitoring
- Region
- 🇪🇺 EU
- Active substance
- ganaxolone
- Company
- Marinus Pharmaceuticals Emerald Limited
- Status
- Authorised
- Therapeutic area
- Epileptic Syndromes; Spasms, Infantile
- CHMP opinion
- Thu 25 May 2023
- EU approval
- Wed 26 Jul 2023
- Designations
- Orphan, Additional monitoring
- Application
- EMEA/H/C/005825
- ATC
- N03AX
- Official record
- www.ema.europa.eu
Indication
Ztalmy is indicated for the adjunctive treatment of epileptic seizures associated with cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder (CDD) in patients 2 to 17 years of age. Ztalmy may be continued in patients 18 years of age and older.
Regulatory milestones
No milestones recorded in the last year.
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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.