QUVIVIQ

Medicinal product

(Invented) name

QUVIVIQ

Active substance (s)

Daridoreksantas

Strength

50 mg

Pharmaceutical form

plėvele dengtos tabletės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

N05CJ03, daridorexant

Marketing authorisation holder

Idorsia Pharmaceuticals Deutschland GmbH, Vokietija

Date of authorisation

2022-04-29

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Film-coated tablet	1 vnt.
Daridoreksantas	50 mg

Packages

PAKID	NPAKID	NPAKID-7	Pack type	Pack size	Type of packaging	Proposed dispensing/classification	Marketing authorisation no.	Supply status	From	To	Package is in foreign language	From	To	Mock-up
108556	94660	1094660	lizdinė plokštelė	N10		Receptinis	EU/1/22/1638/003	Netiekiama	-	-	No	-	-
108557	94661	1094661	lizdinė plokštelė	N30		Receptinis	EU/1/22/1638/004	Netiekiama	2025-01-03	2025-12-31	Yes	2025-01-22	2025-12-31
108768	94874	1094874	lizdinė plokštelė	N20		Receptinis	EU/1/22/1638/006	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-04-29	Registruotas