Quviviq
daridorexant
Table of contents
Overview
Quviviq is a medicine for treating adults with insomnia (difficulty sleeping) that has lasted for at least 3 months and has a considerable impact on how they function during the day.
Quviviq contains the active substance daridorexant.
-
List item
Quviviq : EPAR - Medicine overview (PDF/104.23 KB)
First published: 03/05/2022
EMA/127096/2022 -
-
List item
Quviviq : EPAR - Risk-management-plan summary (PDF/178.28 KB)
First published: 03/05/2022
Authorisation details
Product details | |
---|---|
Name |
Quviviq
|
Agency product number |
EMEA/H/C/005634
|
Active substance |
daridorexant hydrochloride
|
International non-proprietary name (INN) or common name |
daridorexant
|
Therapeutic area (MeSH) |
Sleep Initiation and Maintenance Disorders
|
Anatomical therapeutic chemical (ATC) code |
N05
|
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. |
Publication details | |
---|---|
Marketing-authorisation holder |
Idorsia Pharmaceuticals Deutschland GmbH
|
Revision |
5
|
Date of issue of marketing authorisation valid throughout the European Union |
29/04/2022
|
Contact address |
Marie-Curie-Strasse 8 |
Product information
12/05/2023 Quviviq - EMEA/H/C/005634 - II/0009/G
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
Psycholeptics
Therapeutic 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.