Quetiapine Polpharma

Medicinal product

(Invented) name

Quetiapine Polpharma

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

Pharmaceutical Works POLPHARMA S.A., Lenkija

Date of authorisation

2010-04-16

Date of renewal

2017-07-27

Documents

1960 Pakuotės lapelis 2024 07 01.docx

1960 Quetiapine Polpharma PCS PL 2024 07 01.docx

Quetiapine Polpharma mokomoji medziaga sveikatos prieziuros specialistams.pdf

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

LV/H/0170/002

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
30955	5515	1005515	lizdinė plokštelė	N60		Receptinis	LT/1/10/1960/002	Tiekiama	-	-	No	-	-	Download
40658	54395	1054395	lizdinė plokštelė	N90		Receptinis	LT/1/10/1960/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2017-07-27	Perregistruotas
2010-04-16	Registruotas