2 Information about ganaxolone

Marketing authorisation indication

2.1

Ganaxolone (Ztalmy, Orion and Marinus) 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'.

Dosage in the marketing authorisation

Price

2.3

The list price for ganaxolone is confidential and cannot be reported here.

2.4

The company has a commercial arrangement, which would have applied if ganaxolone had been recommended.