| Code | 4966E | ||||||||||
| MA number | 44/0256/23-S | ||||||||||
| Product Form: | tbl flm 28x1x40 mg (blis.PVC/PVDC//Al-jednotk.bal.) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Mutual recognition procedure | ||||||||||
| MAH, country: | Sandoz Pharmaceuticals d.d., Slovenia | ||||||||||
| Therapeutic Class: | 44 - CYTOSTATICA | ||||||||||
| 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: | 30.11.2023 |
| Validity: | 30.11.2028 |
| PIL: |
PIL_Enzalutamid Sandoz 40 mg filmom obalené tablety_03.2025.pdf
|
| SPC: |
SPC_Enzalutamid Sandoz 40 mg filmom obalené tablety_08.2025.pdf
|
| Safety feature | Yes |
| Data update: | 04.12.2023 |
