Ztalmy
ganaxolone
Table of contents
Overview
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.
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Ztalmy : EPAR - Medicine Overview (PDF/103.91 KB)
First published: 31/07/2023
EMA/314982/2023 -
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Ztalmy : EPAR - Risk management plan summary (PDF/661.72 KB)
First published: 31/07/2023
Authorisation details
| Product details | |
|---|---|
| Name |
Ztalmy
|
| Agency product number |
EMEA/H/C/005825
|
| Active substance |
Ganaxolone
|
| International non-proprietary name (INN) or common name |
ganaxolone
|
| Therapeutic area (MeSH) |
|
| Anatomical therapeutic chemical (ATC) code |
N03AX
|
Additional 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. |
Orphan |
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 |
26/07/2023
|
| Contact address |
10 Earlsfort Terrace |
Product information
Ztalmy - EMEA/H/C/005825 -
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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
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.