QUVIVIQ

Medicinal product

(Invented) name

QUVIVIQ

Active substance (s)

Daridoreksantas

Strength

25 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	25 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
108554	94658	1094658	lizdinė plokštelė	N10		Receptinis	EU/1/22/1638/001	Netiekiama	-	-	No	-	-
108555	94659	1094659	lizdinė plokštelė	N30		Receptinis	EU/1/22/1638/002	Netiekiama	2025-01-03	2025-12-31	Yes	2025-01-22	2025-12-31
108767	94873	1094873	lizdinė plokštelė	N20		Receptinis	EU/1/22/1638/005	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-04-29	Registruotas