Ketipinor

Medicinal product

(Invented) name

Ketipinor

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

Orion Corporation, Suomija

Date of authorisation

2014-12-23

Date of renewal

2020-01-24

Documents

Ketipinor mokomoji medziaga sveikatos prieziuros specialistams.pdf

3670 Ketipinor pailg atpal PCS PL 2024 07 01.docx

3670 Pakuotės lapelis 2024 07 01.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

FI/H/1166/005/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
56420	70518	1070518	lizdinė plokštelė	N60		Receptinis	LT/1/14/3670/023	Netiekiama	-	-	No	-	-
61038	75349	1075349	lizdinė plokštelė	N100		Receptinis	LT/1/14/3670/024	Netiekiama	2025-05-09	2025-10-06	No	-	-	Download
61039	75350	1075350	buteliukas	N60		Receptinis	LT/1/14/3670/025	Netiekiama	-	-	No	-	-
61040	75351	1075351	buteliukas	N100		Receptinis	LT/1/14/3670/026	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2020-01-24	Perregistruotas
2014-12-23	Registruotas