PRODUCT DETAIL

Kelzy 2 mg/0,02 mg tablety s predĺženým uvoľňovaním

Code

6838E

MA number

17/0177/24-S

Product Form:

tbl plg 13x28x2 mg/0,02 mg (blis. PVC/PE/PVDC/Al)

MA Status:

R - Valid Marketing Authorisation

Type of procedure:

Decentralised

MAH, country:

Exeltis Slovakia s.r.o., Slovakia

Therapeutic Class:

17 - ANTICONCIPIENTIA

ATC:

G	GENITO URINARY SYSTEM AND SEX HORMONES
G03	SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
G03A	HORMONAL CONTRACEPTIVES FOR SYSTEMIC USE
G03AA	Progestogens and estrogens, fixed combinations
G03AA16	Dienogest and ethinylestradiol

Shelf life:

Container:

blister PVC/PE/PVDC/Al

Route of admin.:

Oral use

Prescription Status:	Medicinal product subject to medical prescription.
Legal basis:	Article 8(3) application - known active substance
MA issued:	31.07.2024
Validity:	31.07.2029
SPC:	SPC_Kelzy 2 mg/0,02 mg tablety s predĺženým uvoľňovaním_tbl plg_07/2024_REG.pdf
PIL:	PIL_Kelzy 2 mg/0,02 mg tablety s predĺženým uvoľňovaním_tbl plg_07/2024_REG.pdf
Safety feature	Yes
Data update:	07.08.2024