PRODUCT DETAIL

Mirabegron STADA 50 mg tablety s predĺženým uvoľňovaním

Code

0194F

MA number

73/0207/25-S

Product Form:

tbl plg 200x50 mg (blis.Al/OPA/Al/PVC)

MA Status:

R - Valid Marketing Authorisation

Type of procedure:

Decentralised

MAH, country:

STADA Arzneimittel AG, Germany

Therapeutic Class:

73 - SPASMOLYTICA

ATC:

G	GENITO URINARY SYSTEM AND SEX HORMONES
G04	UROLOGICALS
G04B	UROLOGICALS (OTHER UROLOGICALS, INCL. ANTISPASMODICS-delete WHO)
G04BD	Drugs for urinary frequency and incontinence (Urinary antispasmodics-delete-WHO)
G04BD12	Mirabegron

Shelf life:

Container:

blister Al/OPA/Al/PVC

Route of admin.:

Oral use

Prescription Status:	Medicinal product subject to medical prescription.
Legal basis:	Article 10(1) generic application
MA issued:	13.06.2025
Validity:	13.06.2030
SPC:	SPC_Mirabegron STADA 50 mg tablety s predĺženým uvoľňovaním_tbl plg_06/2025_REG.pdf
PIL:	PIL_Mirabegron STADA 50 mg tablety s predĺženým uvoľňovaním_tbl plg_06/2025_REG.pdf
Safety feature	Yes
Data update:	20.06.2025