Hedonin

Medicinal product

(Invented) name

Hedonin

Active substance (s)

Kvetiapinas

Strength

100 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)

N05AH04, Quetiapine

Marketing authorisation holder

G.L. Pharma GmbH, Austrija

Date of authorisation

2007-10-03

Date of renewal

2013-02-08

Documents

0840 Hedonin PCS PL 2024 08 30.docx

0840 Pakuotės lapelis 2024 08 30.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

DK/H/1103/002/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Tabletėje yra	1 vnt.
Kvetiapinas	100 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
20630	23612	1023612	lizdinė plokštelė	N30		Receptinis	LT/1/07/0840/004	Netiekiama	-	-	No	-	-
24162	5123	1005123	lizdinė plokštelė	N60		Receptinis	LT/1/07/0840/005	Tiekiama	-	-	No	-	-	Download
24163	26831	1026831	lizdinė plokštelė	N90		Receptinis	LT/1/07/0840/006	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2013-02-08	Perregistruotas
2007-10-03	Registruotas