PRODUCT DETAIL

Ganirelix Theramex 0,25 mg/ 0,5 ml injekčný roztok v naplnenej injekčnej striekačke

Code

3664E

MA number

56/0136/23-S

Product Form:

sol iru 5x0,25 mg/0,5 ml (striek.inj.skl.napl.+ihly)

MA Status:

R - Valid Marketing Authorisation

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
H01C	HYPOTHALAMIC HORMONES
H01CC	Anti-gonadotropin-releasing hormones
H01CC01	Ganirelix

Shelf life:

Container:

pre-filled syringe

Route of admin.:

Subcutaneous use

Prescription Status:	Medicinal product subject to restricted medical prescription.
Legal basis:	Article 10(1) generic application
MA issued:	14.06.2023
Validity:	14.06.2028
PIL:	PIL_Ganirelix Theramex 0,25 mg_ 0,5 ml injekčný roztok v naplnenej injekčnej striekačke_05 2023.pdf
SPC:	SPC_Ganirelix Theramex 0,25 mg_ 0,5 ml injekčný roztok v naplnenej injekčnej striekačke_05 2023.pdf
Safety feature	Yes
Data update:	15.06.2023