Quetiapine Accord

Medicinal product

(Invented) name

Quetiapine Accord

Active substance (s)

Kvetiapinas

Strength

400 mg

Pharmaceutical form

pailginto atpalaidavimo tabletės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

N05AH04, Quetiapine

Marketing authorisation holder

Accord Healthcare B.V., Nyderlandai

Date of authorisation

2011-09-15

Date of renewal

2021-10-26

Documents

Quetiapine Accord mokomoji medziaga sveikatos prieziuros specialistams.pdf

2620 Pakuotės lapelis 50,200,300,400 atpal 2025 03 11.docx

2620 Quetiapine Accord 50,200,300,400 pailg atp II PL 2025 03 11.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

NL/H/4781/003

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Tabletėje yra:	1 vnt.
Kvetiapinas	400 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
38426	52103	1052103	lizdinė plokštelė	N10		Receptinis	LT/1/11/2620/011	Netiekiama	-	-	No	-	-
48556	62385	1062385	lizdinė plokštelė	N30		Receptinis	LT/1/11/2620/012	Netiekiama	-	-	No	-	-
48557	62386	1062386	lizdinė plokštelė	N50		Receptinis	LT/1/11/2620/013	Netiekiama	-	-	No	-	-
48558	62387	1062387	lizdinė plokštelė	N60		Receptinis	LT/1/11/2620/014	Netiekiama	-	-	No	-	-
48559	62388	1062388	lizdinė plokštelė	N100		Receptinis	LT/1/11/2620/015	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2021-10-26	Perregistruotas
2011-09-15	Registruotas