EMA — authorised 26 July 2023
- Marketing authorisation holder: Marinus Pharmaceuticals Emerald Limited
- Status: approved
🇪🇺 Ztalmy in European Union
EMA authorised Ztalmy on 26 July 2023
Marketing authorisations
EMA — authorised 26 July 2023
- Application: EMEA/H/C/005825
- Marketing authorisation holder: Marinus Pharmaceuticals Emerald Limited
- Local brand name: Ztalmy
- 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.
- Pathway: orphan
- Status: approved
Ztalmy in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Neuroscience approved in European Union
Frequently asked questions
Is Ztalmy approved in European Union?
Yes. EMA authorised it on 26 July 2023; EMA authorised it on 26 July 2023.
Who is the marketing authorisation holder for Ztalmy in European Union?
Marinus Pharmaceuticals Emerald Limited holds the EU marketing authorisation.