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PRODUCT DETAIL

Silodosin Mylan 4 mg

Code 1276D
MA number 77/0120/19-S
Product Form: cps dur 100x4 mg (blis.Al/PVC/PE/PVDC)
MA Status: R - Valid Marketing Authorisation
Type of procedure: Decentralised
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: 07.05.2019
Validity: 07.05.2024
MA renewed: Renewal application submitted
SPC: SPC_Silodosin Mylan 4 mg_03_2021.pdf  
PIL: PIL_Silodosin Mylan_cps dur_03_2023.pdf  
Safety feature Yes
Data update: 12.03.2021
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