PRODUCT DETAIL

Levosimendan FMK 2,5 mg/ml koncentrát na infúzny roztok

Code

0166F

MA number

41/0199/25-S

Product Form:

con inf 1x5 ml/12,5 mg (liek.inj.skl.)

MA Status:

R - Valid Marketing Authorisation

Type of procedure:

Decentralised

MAH, country:

Farmak International Sp. z o.o., Poland

Therapeutic Class:

41 - CARDIACA

ATC:

C	CARDIOVASCULAR SYSTEM
C01	CARDIAC THERAPY
C01C	CARDIAC STIMULANTS EXCL. CARDIAC GLYCOSIDES
C01CX	Other cardiac stimulants
C01CX08	Levosimendan

Shelf life:

Container:

glass vial

Route of admin.:

Intravenous use

Prescription Status:	Medicinal product subject to restricted medical prescription.
Legal basis:	Article 10(1) generic application
MA issued:	20.06.2025
Validity:	20.06.2030
Pediatric warnings:	Yes
PIL:	PIL_Levosimendan FMK 2,5 mg_ml koncentrát na infúzny roztok_06.2025.pdf
SPC:	SPC_Levosimendan FMK 2,5 mg_ml koncentrát na infúzny roztok_06.2025.pdf
Safety feature	Yes
Data update:	23.06.2025