| Code | 8419C | ||||||||||
| MA number | 50/0223/18-S | ||||||||||
| Product Form: | tbl flm 20x1x25 mg (blis.PVC/PVDC/Al-perf.) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| 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 |
