| Code | 8729D | ||||||||||
| MA number | 18/0256/21-S | ||||||||||
| Product Form: | tbl flm 180x50 mg/1000 mg (blis.OPA/Al/PVC/Al) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | STADA Arzneimittel AG, Germany | ||||||||||
| Therapeutic Class: | 18 - ANTIDIABETICA (VRÁTANE INZULÍNU) | ||||||||||
| ATC: |
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| Shelf life: | 30 | ||||||||||
| Container: | blister OPA/Al/PVC/Al | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 10(1) generic application |
| MA issued: | 04.11.2021 |
| Validity: | 04.11.2026 |
| MA renewed: | Renewal application submitted |
| SPC: |
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| PIL: |
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| Safety feature | Yes |
| Data update: | 05.11.2021 |