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PRODUCT DETAIL

Aristissa 5 mg filmom obalené tablety

Code 9991D
MA number 73/0072/22-S
Product Form: tbl flm 30x5 mg (blis.PVC/Al)
MA Status: R - Valid Marketing Authorisation
Type of procedure: Mutual recognition procedure
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)
G04BD08 Solifenacin
Shelf life: 48
Container: blister PVC/Al
Route of admin.: Oral use
Prescription Status: Medicinal product subject to medical prescription.
Legal basis: Article 10(1) generic application
MA issued: 22.04.2022
Validity: 22.04.2027
MA renewed: Renewal application submitted
PIL: PIL_Aristissa 5 mg 10 mg tbl flm_08_2022.pdf  
SPC: SPC_Aristissa 5 mg 10 mg tbl flm_12_2022.pdf  
Safety feature Yes
Data update: 09.12.2022
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