PRODUCT DETAIL

DEXAMETHASONE GALENIKA 4 mg/ml injekčný/infúzny roztok

Code

1738F

MA number

56/0308/25-S

Product Form:

sol ijf 25x1 ml/4 mg (amp.skl.)

MA Status:

R - Valid Marketing Authorisation

Type of procedure:

Mutual recognition procedure

MAH, country:

Galenika International Kft., Hungary

Therapeutic Class:

56 - HORMONA (LIEČIVA S HORMONÁLNOU AKTIVITOU)

ATC:

H	SYSTEMIC HORMONAL PREPARATIONS, EXCL. SEX HORMONES AND INSULINS
H02	CORTICOSTEROIDS FOR SYSTEMIC USE
H02A	CORTICOSTEROIDS FOR SYSTEMIC USE, PLAIN
H02AB	Glucocorticoids
H02AB02	Dexamethasone

Shelf life:

Container:

glass ampoule

Prescription Status:	Medicinal product subject to medical prescription.
Legal basis:	Article 10(1) generic application
MA issued:	06.11.2025
Validity:	06.11.2030
Pediatric indication:	Yes
Pediatric posology:	Yes
Pediatric warnings:	Yes
SPC:	SPC_DEXAMETHASONE GALENIKA 4 mg/ml injekčný/infúzny roztok_sol ijf_10/2025_REG.pdf
PIL:	PIL_DEXAMETHASONE GALENIKA 4 mg/ml injekčný/infúzny roztok_sol ijf_10/2025_REG.pdf
Safety feature	Yes
Data update:	07.11.2025