PRODUCT DETAIL

Ngenla 60 mg injekčný roztok v naplnenom pere

Code

9752D

MA number

EU/1/21/1617/002

Product Form:

sol inj 1x1,2 ml/60 mg (pero napl.)

MA Status:

E - Valid centralised marketing authorisation

Type of procedure:

EU Orphan

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
H01AC08	Somatrogon

Shelf life:

Container:

pre-filled pen

Route of admin.:

Subcutaneous use

Prescription Status:	Medicinal product subject to restricted medical prescription.
Legal basis:	Article 8(3) application - new active substance
MA issued:	14.02.2022
Validity:	14.02.2027
SmPC + PL:	European Medicines Agency's database
Safety feature	Yes
Data update:	07.04.2022