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Ganaxolone for treating seizures caused by CDKL5 deficiency disorder in people 2 years and over

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2 Information about ganaxolone

Anticipated marketing authorisation indication

2.1 Ganaxolone (Ztalmy, Orion) does not have a marketing authorisation in Great Britain yet. The Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product ganaxolone intended 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

2.2 The dosage schedule will be available in the summary of product characteristics for ganaxolone.

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.