PRODUCT DETAIL

INCRELEX 10 mg/ml, injekčný roztok

Code

44951

MA number

EU/1/07/402/001

Product Form:

sol inj 1x4 ml/40 mg (liek.skl.)

MA Status:

Ev - Valid centralised marketing authorisation under exceptional circumstances

Type of procedure:

MAH, country:

ESTEVE PHARMACEUTICALS, S.A., Spain

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
H01AC03	Mecasermin

Shelf life:

Container:

glass container

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:	03.08.2007
SmPC + PL:	European Medicines Agency's database
Dokument:	DHPC Increlex 7 1 2014.pdf
Dokument:	Increlex_Informácia pre lekára.pdf
Dokument:	Increlex_Informácie o hypoglykémii.pdf
Dokument:	Increlex_Dôležite informácie a minimalizacii rizika pre pacientov.pdf
Safety feature	Yes
Data update:	06.05.2021