| Code | 9511E | ||||||||||
| MA number | 18/0116/25-S | ||||||||||
| Product Form: | tbl flm 14x25 mg (blis.PVC/PVDC/Al) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | MEDOCHEMIE Ltd., Cyprus | ||||||||||
| Therapeutic Class: | 18 - ANTIDIABETICA (VRÁTANE INZULÍNU) | ||||||||||
| 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: | 09.04.2025 |
| Validity: | 09.04.2030 |
| Pediatric indication: | Yes |
| Pediatric posology: | Yes |
| SPC: |
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| PIL: |
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| Safety feature | Yes |
| Data update: | 25.04.2025 |