| Code | 9980D | ||||||||||
| MA number | 18/0070/22-S | ||||||||||
| Product Form: | tbl flm 56x50 mg/850 mg (blis.Al/OPA/Al/PVC) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | Viatris Limited, Ireland | ||||||||||
| Therapeutic Class: | 18 - ANTIDIABETICA (VRÁTANE INZULÍNU) | ||||||||||
| ATC: |
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| Shelf life: | 36 | ||||||||||
| Container: | blister Al/OPA/Al/PVC | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 10(1) generic application |
| MA issued: | 01.04.2022 |
| Validity: | 01.04.2027 |
| PIL: |
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| SPC: |
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| Safety feature | Yes |
| Data update: | 13.04.2022 |