Code | 1277D | ||||||||||
MA number | 77/0121/19-S | ||||||||||
Product Form: | cps dur 30x8 mg (blis.Al/PVC/PE/PVDC) | ||||||||||
MA Status: | R - Valid Marketing Authorisation | ||||||||||
Type of procedure: | Decentralised | ||||||||||
MAH, country: | Mylan Ireland Limited, Ireland | ||||||||||
Therapeutic Class: | 77 - SYMPATHOLYTICA | ||||||||||
ATC: |
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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 8 mg_03_2021.pdf |
PIL: | PIL_Silodosin Mylan_cps dur_03_2023.pdf |
Safety feature | Yes |
Data update: | 12.03.2021 |