Code | 8412C | ||||||||||
MA number | 50/0223/18-S | ||||||||||
Product Form: | tbl flm 20x25 mg (blis.PVC/PVDC/Al) | ||||||||||
MA Status: | R - Valid Marketing Authorisation | ||||||||||
Type of procedure: | Decentralised | ||||||||||
MAH, country: | KRKA, d.d., Novo mesto, Slovenia | ||||||||||
Therapeutic Class: | 50 - DIURETICA | ||||||||||
ATC: |
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Shelf life: | 36 | ||||||||||
Container: | blister PVC/PVDC/Al | ||||||||||
Route of admin.: | Oral use |
Prescription Status: | Medicinal product subject to medical prescription. |
Legal basis: | Article 10(1) generic application |
MA issued: | 13.07.2018 |
Validity: | 13.07.2023 |
MA renewed: | Renewal application submitted |
PIL: | PIL_Apleria 25 mg_tbl_flm_07/2018_REG.docx |
SPC: | SPC_Apleria 25 mg_tbl flm_09_2019.docx |
Safety feature | Yes |
Data update: | 09.09.2019 |