Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: Idorsia Pharmaceuticals Deutschland GmbH, Marie-Curie-Strasse 8, 79539 Lörrach, Germany
QUVIVIQ 25 mg film-coated tablets.
QUVIVIQ 50 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet (tablet). QUVIVIQ 25 mg film-coated tablets: Light purple arc-triangle shaped film-coated tablets, debossed with ‘25’ on one side, and ‘i’ on the other side. QUVIVIQ 50 mg film-coated tablets: Light orange arc-triangle shaped film-coated tablets, debossed with ‘50’ on one side, and ‘i’ on the other side. |
QUVIVIQ 25 mg film-coated tablets: Each film-coated tablet contains daridorexant hydrochloride equivalent to 25 mg of daridorexant.
QUVIVIQ 50 mg film-coated tablets: Each film-coated tablet contains daridorexant hydrochloride equivalent to 50 mg of daridorexant.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Daridorexant |
Daridorexant is a dual orexin receptor antagonist, acting on both orexin 1 and orexin 2 receptors and equipotent on both. The orexin neuropeptides (orexin A and orexin B) act on orexin receptors to promote wakefulness. Daridorexant antagonises the activation of orexin receptors by the orexin neuropeptides and consequently decreases the wake drive, allowing sleep to occur, without altering the proportion of sleep stages. |
| List of Excipients |
|---|
|
Tablet core: Mannitol (E421) Film coat: Hypromellose (E464) |
Polyvinyl chloride (PVC) coated with polyvinylidene chloride (PVdC) and laminated with PVC film blister sealed with an aluminium foil blister, packed in a carton box.
Pack size of 10 or 30 film-coated tablets.
Not all pack sizes may be marketed.
Idorsia Pharmaceuticals Deutschland GmbH, Marie-Curie-Strasse 8, 79539 Lörrach, Germany
EU/1/22/1638/001
EU/1/22/1638/002
EU/1/22/1638/003
EU/1/22/1638/004
| Drug | Countries | |
|---|---|---|
| QUVIVIQ | Austria, Estonia, Spain, Croatia, Ireland, Italy, Lithuania, Poland, United Kingdom, United States |
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