PRODUCT DETAIL

Norditropin FlexPro 5 mg/1,5 ml injekčný roztok v naplnenom pere

Code

1542F

MA number

56/0277/25-S

Product Form:

sol ira 1x1,5 ml/5 mg (náplň skl. v napln.pere)

MA Status:

R - Valid Marketing Authorisation

Type of procedure:

Mutual recognition procedure

MAH, country:

Novo Nordisk A/S, Denmark

Therapeutic Class:

56 - HORMONA (LIEČIVA S HORMONÁLNOU AKTIVITOU)

ATC:

H	SYSTEMIC HORMONAL PREPARATIONS, EXCL. SEX HORMONES AND INSULINS
H01	PITUITARY AND HYPOTHALAMIC HORMONES AND ANALOGUES
H01A	ANTERIOR PITUITARY LOBE HORMONES AND ANALOGUES
H01AC	Somatropin and somatropin agonists
H01AC01	Somatropin

Shelf life:

Container:

glass cartridge in pre-filled pen

Route of admin.:

Subcutaneous use

Prescription Status:	Medicinal product subject to medical prescription.
Legal basis:	Article 8(3) application - known active substance
MA issued:	23.10.2025
Validity:	23.10.2030
Pediatric indication:	Yes
Pediatric posology:	Yes
Pediatric contraindication:	Yes
Pediatric warnings:	Yes
SPC:	SPC_Norditropin FlexPro 5 mg/1,5 ml injekčný roztok v naplnenom pere_sol ira_10/2025_REG.pdf
PIL:	PIL_Norditropin FlexPro 5 mg/1,5 ml injekčný roztok v naplnenom pere_sol ira_10/2025_REG.pdf
Safety feature	Yes
Data update:	29.10.2025