Hedonin

Medicinal product

(Invented) name

Hedonin

Active substance (s)

Kvetiapinas+Kvetiapinas

Strength

25 mg + 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(3)

Procedure number

DK/H/1103/005/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Tabletėje (25 mg) yra	1 vnt.
Kvetiapinas	25 mg
Tabletėje (100 mg) 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
20627	23610	1023610	lizdinė plokštelė	N6 (25 mg) + N5 (100 mg)		Receptinis	LT/1/07/0840/012	Netiekiama	-	-	No	-	-

Stadijos

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