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PRODUCT DETAIL

Silodosin FMK 8 mg tvrdé kapsuly

Code 1901D
MA number 77/0206/19-S
Product Form: cps dur 10x8 mg (blis.Al/PVC/PE/PVDC)
MA Status: D - Marketing Authorisation valid for an unlimited period
Type of procedure: Decentralised
MAH, country: Farmak International Sp. z o.o., Poland
Therapeutic Class: 77 - SYMPATHOLYTICA
ATC:
G GENITO URINARY SYSTEM AND SEX HORMONES
G04 UROLOGICALS
G04C DRUGS USED IN BENIGN PROSTATIC HYPERTROPHY
G04CA Alpha-adrenoreceptor antagonists
G04CA04 Silodosin
Shelf life: 36
Container: blister Al/PVC/PE/PVDC
Route of admin.: Oral use
Prescription Status: Medicinal product subject to medical prescription.
Legal basis: Article 10(1) generic application
MA issued: 08.07.2019
SPC: SPC_Silodosin FMK tvrdé kapsuly_08_2023.pdf  
PIL: PIL_Silodosin FMK tvrdé kapsuly_08_2023.pdf  
Safety feature Yes
Data update: 10.01.2024
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