Quviviq

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daridorexant

Authorised
This medicine is authorised for use in the European Union.

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.

This EPAR was last updated on 08/06/2022

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 monitoringAdditional 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
1
Date of issue of marketing authorisation valid throughout the European Union
29/04/2022
Contact address

Marie-Curie-Strasse 8
79539 Lörrach
Germany

Product information

02/06/2022 Quviviq - EMEA/H/C/005634 - IAIN/0002

Product information documents contain:

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.

Assessment history

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