| Code | 0864E | ||||||||||
| MA number | 18/0131/22-S | ||||||||||
| Product Form: | tbl flm 60x50 mg/1000 mg (blis.PVC/PVDC/Al) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | Zentiva, k.s., Czechia | ||||||||||
| Therapeutic Class: | 18 - ANTIDIABETICA (VRÁTANE INZULÍNU) | ||||||||||
| ATC: |
|
||||||||||
| Shelf life: | 24 | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 10(1) generic application |
| MA issued: | 18.05.2022 |
| Validity: | 18.05.2027 |
| SPC: |
SPC_Jamesi_05.2025.pdf
|
| PIL: |
PIL_Jamesi_05.2025.pdf
|
| Safety feature | Yes |
| Data update: | 16.02.2024 |
