PRODUCT DETAIL

Skytrofa 11 mg prášok a rozpúšťadlo na injekčný roztok v náplni

Code

9578D

MA number

EU/1/21/1607/008

Product Form:

plv iol 4x11 mg+4x0,479 ml solv.+6xihla (náplň dvojkom.skl.)

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
H01AC09	Lonapegsomatropin

Shelf life:

Container:

double-chamber glass cartrige

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:	11.01.2022
Validity:	11.01.2027
SmPC + PL:	European Medicines Agency's database
Safety feature	Yes
Data update:	08.09.2022