Levosimendan Kalceks

Medicinal product

(Invented) name

Levosimendan Kalceks

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

AS Kalceks, Latvija

Date of authorisation

2022-03-02

Date of renewal

Documents

4916 Pakuotės lapelis 2024 10 01.docx

4916 Levosimendan Kalceks PL 2024 10 01, VRA rastas 17041.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

DK/H/3214/001/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
108194	94298	1094298	flakonas	5 ml N1		Receptinis	LT/1/22/4916/001	Netiekiama	-	-	No	-	-
108195	94299	1094299	flakonas	5 ml N4		Receptinis	LT/1/22/4916/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-03-02	Registruotas