This medicine is authorised for use in the European Union.


Ztalmy is a medicine used to treat epileptic seizures in children from 2 to 17 years of age who have a condition known as cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder. These patients can continue taking Ztalmy when they become adults if a clear benefit has been observed.

The medicine is used in combination with other anti-epileptic medicines.

CDKL5 deficiency disorder is rare, and Ztalmy was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 13 November 2019. Further information on the orphan designation can be found on the EMA website.

Ztalmy contains the active substance ganaxolone.

This EPAR was last updated on 31/07/2023

Authorisation details

Product details
Agency product number
Active substance
International non-proprietary name (INN) or common name
Therapeutic area (MeSH)
  • Epileptic Syndromes
  • Spasms, Infantile
Anatomical therapeutic chemical (ATC) code
Additional monitoringAdditional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.


This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.

Publication details
Marketing-authorisation holder
Marinus Pharmaceuticals Emerald Limited
Date of issue of marketing authorisation valid throughout the European Union
Contact address

10 Earlsfort Terrace
Dublin D02 T380

Product information

Ztalmy - EMEA/H/C/005825 -

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Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

Other antiepileptics

Therapeutic 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.

Assessment history

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