Quetiapine Torrent

Medicinal product

(Invented) name

Quetiapine Torrent

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

Torrent Pharma GmbH, Vokietija

Date of authorisation

2013-02-28

Date of renewal

2016-09-09

Documents

3237_1-16 Quetiapine_Torrent_pat_perr0909.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

DE/H/2912/005/DC

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
41495	55253	1055253	lizdinė plokštelė	N10		Receptinis	LT/1/13/3237/013	Netiekiama	-	-	No	-	-
55495	69543	1069543	lizdinė plokštelė	N50		Receptinis	LT/1/13/3237/014	Netiekiama	-	-	No	-	-
55496	69544	1069544	lizdinė plokštelė	N60		Receptinis	LT/1/13/3237/015	Netiekiama	-	-	No	-	-
55497	69545	1069545	lizdinė plokštelė	N100		Receptinis	LT/1/13/3237/016	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2017-11-10	Išregistruotas
2016-09-09	Perregistruotas
2013-02-28	Registruotas