Code | 8459D | ||||||||||
MA number | 73/0216/21-S | ||||||||||
Product Form: | tbl plg 28x4 mg (blis.OPA/Al/PVC/Al) | ||||||||||
MA Status: | R - Valid Marketing Authorisation | ||||||||||
Type of procedure: | Decentralised | ||||||||||
MAH, country: | Aristo Pharma GmbH, Germany | ||||||||||
Therapeutic Class: | 73 - SPASMOLYTICA | ||||||||||
ATC: |
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Shelf life: | 24 | ||||||||||
Container: | blister OPA/Al/PVC/Al | ||||||||||
Route of admin.: | Oral use |
Prescription Status: | Medicinal product subject to medical prescription. |
Legal basis: | Article 10(1) generic application |
MA issued: | 19.09.2021 |
Validity: | 19.09.2026 |
PIL: | PIL_Fesoterodine Aristo_08_2021.pdf |
SPC: | SPC_Fesoterodine Aristo 4_8 mg tablety s predlzenym uvolnovanim_05_2023.pdf |
Safety feature | Yes |
Data update: | 27.09.2021 |