Quetiapine Accord

Medicinal product

(Invented) name

Quetiapine Accord

Active substance (s)

Kvetiapinas

Strength

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

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

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

NL/H/4781/001

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Tabletėje yra:	1 vnt.
Kvetiapinas	200 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
38424	52101	1052101	lizdinė plokštelė	N10		Receptinis	LT/1/11/2620/001	Netiekiama	-	-	No	-	-
48548	62377	1062377	lizdinė plokštelė	N30		Receptinis	LT/1/11/2620/002	Netiekiama	-	-	No	-	-
48549	62378	1062378	lizdinė plokštelė	N50		Receptinis	LT/1/11/2620/003	Netiekiama	-	-	No	-	-
48550	62379	1062379	lizdinė plokštelė	N60		Receptinis	LT/1/11/2620/004	Netiekiama	2025-09-04	2025-12-29	No	-	-
48551	62380	1062380	lizdinė plokštelė	N100		Receptinis	LT/1/11/2620/005	Netiekiama	-	-	No	-	-

Stadijos

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