Leponex

Medicinal product

(Invented) name

Leponex

Active substance (s)

Klozapinas

Strength

100 mg

Pharmaceutical form

tabletės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

N05AH02, Clozapine

Marketing authorisation holder

Viatris SIA, Latvija

Date of authorisation

1994-03-31

Date of renewal

2007-12-20

Documents

Klozapinas_laiškas gydytojams DHCP.pdf

0949 Leponex RPP 2023 09 01.docx

0949 Pakuotės lapelis 2023 09 01.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Nacionalinė procedūra

Qualitative and quantitative composition

Tabletėje yra	1 vnt.
Klozapinas	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
2187	1176	1001176	lizdinė plokštelė	N50		Receptinis	LT/1/94/0949/002	Tiekiama	-	-	No	-	-	Download

Stadijos

Data	Stadija
2007-12-20	Perregistruotas
1994-03-31	Registruotas