| Code | 0802F | ||||||||||
| MA number | 18/0264/25-S | ||||||||||
| Product Form: | tbl flm 56x5 mg (blis.OPA/Al/PVC/Al) - kalend.bal. | ||||||||||
| 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: | 24 | ||||||||||
| 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: | 04.09.2025 |
| Validity: | 04.09.2030 |
| Pediatric indication: | Yes |
| Pediatric posology: | Yes |
| PIL: |
PIL_DAGETIA tbl flm_10_2025.pdf
|
| SPC: |
SPC_DAGETIA tbl flm_10_2025.pdf
|
| Safety feature | Yes |
| Data update: | 17.09.2025 |
