Draft guidance consultation
Closed for comments This consultation ended on at Request commenting lead permission
2 Information about daridorexant
Marketing authorisation indication
2.1 Daridorexant (QUVIVIQ, Idorsia) is indicated for 'the treatment of adult patients with insomnia characterised by symptoms present for at least 3 months and considerable impact on daytime functioning'.
Dosage in the marketing authorisation
2.2 The dosage schedule is available in the summary of product characteristics for daridorexant.
Price
2.3 The list price of daridorexant has not yet been approved. The company have provided an anticipated list price, which is considered confidential until it has been approved.
How are you taking part in this consultation?
You will not be able to change how you comment later.
You must be signed in to answer questions