| Code | 0375C | ||||||||||
| MA number | 49/0330/16-S | ||||||||||
| Product Form: | tbl flm 20x50 mg (blis.PVC/PE/PVDC/Al) | ||||||||||
| MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | MEDOCHEMIE Ltd., Cyprus | ||||||||||
| Therapeutic Class: | 49 - DIGESTIVA, ADSORBENTIA, ACIDA | ||||||||||
| ATC: |
|
||||||||||
| Shelf life: | 36 | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 10(1) generic application |
| MA issued: | 12.07.2016 |
| PIL: |
PIL_ITOCAN_tbl flm_11_2024.pdf
|
| SPC: |
SPC_ITOCAN_tbl flm_11_2024.pdf
|
| PIL: |
PIL_GASTRIX_03_2025.pdf
|
| SPC: |
SPC_GASTRIX_03_2025.pdf
|
| Safety feature | Yes |
| Data update: | 20.03.2025 |
