PRODUCT DETAIL

Saizen 5,83 mg/ml injekčný roztok v náplni

Code

01932

MA number

56/0815/10-S

Product Form:

sol ise 1x1,03 ml/6 mg (náplň skl.)

MA Status:

D - Marketing Authorisation valid for an unlimited period

Type of procedure:

Decentralised

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 cartrige

Route of admin.:

Subcutaneous use

Prescription Status:	Medicinal product subject to medical prescription.
Legal basis:	Article 8(3) application - known active substance
MA issued:	19.11.2010
Pediatric indication:	Yes
Pediatric posology:	Yes
Pediatric contraindication:	Yes
Pediatric warnings:	Yes
PIL:	PIL_Saizen 5_83 mg_01_2022.pdf
SPC:	SPC_Saizen 5_83 mg_06_2023.pdf
Safety feature	Yes
Data update:	19.06.2023