PRODUCT DETAIL

Norditropin SimpleXx 5 mg/1,5 ml

Code

92276

MA number

56/0202/05-S

Product Form:

sol inj 3x1,5 ml/5 mg (náplň skl.)

MA Status:

D - Marketing Authorisation valid for an unlimited period

Type of procedure:

Mutual recognition procedure

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:	19.07.2005
Pediatric indication:	Yes
Pediatric posology:	Yes
Pediatric contraindication:	Yes
Pediatric warnings:	Yes
SPC:	SPC_Norditropin SimpleXx_5 mg_10 mg_12_2022.pdf
PIL:	PIL_Norditropin_SimpleXx_5 mg_12_2022.pdf
Safety feature	Yes
Data update:	06.06.2018