| Code | 6826D | ||||||||||
| MA number | 18/0076/21-S | ||||||||||
| Product Form: | tbl flm 14x50 mg/850 mg (blis.PVC/PE/PVDC/Al) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | Sandoz Pharmaceuticals d.d., Slovenia | ||||||||||
| Therapeutic Class: | 18 - ANTIDIABETICA (VRÁTANE INZULÍNU) | ||||||||||
| ATC: |
|
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| Shelf life: | 24 | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 10(1) generic application |
| MA issued: | 31.03.2021 |
| Validity: | 31.03.2026 |
| MA renewed: | Renewal application submitted |
| SPC: |
SPC_Eprocliv filmom obalené tablety_08.2022.pdf
|
| PIL: |
PIL_Eprocliv filmom obalené tablety_05.2023.pdf
|
| Safety feature | Yes |
| Data update: | 16.04.2021 |
