| Code | 3100E | ||||||||||
| MA number | 18/0065/23-S | ||||||||||
| Product Form: | tbl flm 100x5 mg (blis.OPA/Al/PVC//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: | 36 | ||||||||||
| 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: | 23.02.2023 |
| Validity: | 23.02.2028 |
| PIL: |
PIL_Sansik_12.2023.pdf
|
| SPC: |
SPC_Sansik_12.2023.pdf
|
| Safety feature | Unknown |
| Data update: | 27.02.2023 |
