Levosimendan Kabi

Medicinal product

(Invented) name

Levosimendan Kabi

Active substance (s)

Levosimendanas

Strength

2,5 mg/ml

Pharmaceutical form

koncentratas infuziniam tirpalui

Route (s) of administration

leisti į veną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

C01CX08, Levosimendan

Marketing authorisation holder

Fresenius Kabi Polska Sp.z.o.o., Lenkija

Date of authorisation

2022-01-28

Date of renewal

Documents

4884 Pakuotės lapelis 2023 01 01.docx

4884 Levosimendan Kabi II PL 2023 01 01.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

AT/H/1130/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

1 ml koncentrato yra:	1 ml
Levosimendanas	2,5 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
107954	94059	1094059	flakonas	5 ml N1		Receptinis	LT/1/22/4884/001	Netiekiama	2024-11-03	-	No	-	-	Download
107955	94060	1094060	flakonas	5 ml N4		Receptinis	LT/1/22/4884/002	Netiekiama	-	-	No	-	-
107956	94061	1094061	flakonas	5 ml N10		Receptinis	LT/1/22/4884/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-01-28	Registruotas