| Code | 0817F | ||||||||||
| MA number | 18/0265/25-S | ||||||||||
| Product Form: | tbl flm 60x10 mg (blis.OPA/Al/PVC/Al) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | PharmaPath S.A. , Greece | ||||||||||
| Therapeutic Class: | 18 - ANTIDIABETICA (VRÁTANE INZULÍNU) | ||||||||||
| ATC: |
|
||||||||||
| 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 |
| SPC: |
SPC_Dagetia 10 mg filmom obalené tablety_tbl flm_08/2025_REG.pdf
|
| PIL: |
PIL_Dagetia 10 mg filmom obalené tablety_tbl flm_08/2025_REG.pdf
|
| Safety feature | Yes |
| Data update: | 17.09.2025 |
