Code | 5205D | ||||||||||
MA number | 50/0167/20-S | ||||||||||
Product Form: | tbl flm 100x50 mg (blis.Al/papier/PES/PVC) | ||||||||||
MA Status: | R - Valid Marketing Authorisation | ||||||||||
Type of procedure: | Decentralised | ||||||||||
MAH, country: | Medreg s.r.o., Czechia | ||||||||||
Therapeutic Class: | 50 - DIURETICA | ||||||||||
ATC: |
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Shelf life: | 36 | ||||||||||
Route of admin.: | Oral use |
Prescription Status: | Medicinal product subject to medical prescription. |
Legal basis: | Article 10(1) generic application |
MA issued: | 03.08.2020 |
Validity: | 03.08.2025 |
MA renewed: | Renewal application submitted |
SPC: | SPC_Eplerenon Medreg_tbl flm_03_2023.pdf |
PIL: | PIL_Eplerenon Medreg_tbl flm_02_2023.pdf |
Safety feature | Yes |
Data update: | 16.03.2023 |