Quviviq (daridorexant)
Additional monitoring
- Region
- 🇪🇺 EU
- Active substance
- daridorexant
- Company
- Idorsia Pharmaceuticals Deutschland GmbH
- Status
- Authorised
- Therapeutic area
- Sleep Initiation and Maintenance Disorders
- CHMP opinion
- Thu 24 Feb 2022
- EU approval
- Fri 29 Apr 2022
- Designations
- Additional monitoring
- Application
- EMEA/H/C/005634
- ATC
- N05CJ03
- Official record
- www.ema.europa.eu
Indication
Quviviq 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.
Regulatory milestones
No milestones recorded in the last year.
Follow Quviviq
Get VigiEye Daily: approvals, opinions, safety actions and PDUFA dates every morning.
Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.