| Code | 3496E | ||||||||||
| MA number | EU/1/23/1721/008 | ||||||||||
| Product Form: | tbl flm 98x5 mg (blis.OPA/Al/PVC/Al - kalend.bal.) | ||||||||||
| MA Status: | E - Valid centralised marketing authorisation | ||||||||||
| Type of procedure: | EU | ||||||||||
| MAH, country: | Viatris Limited, Ireland | ||||||||||
| 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: | 24.03.2023 |
| Validity: | 24.03.2028 |
| SmPC + PL: |
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| Safety feature | Yes |
| Data update: | 14.04.2023 |