| Code | 7375E | ||||||||||
| MA number | 44/0227/24-S | ||||||||||
| Product Form: | tbl flm 56x1x80 mg (blis.OPA/Al/PVC/Al - jednotk.bal.) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | AGmed s.r.o., Czechia | ||||||||||
| Therapeutic Class: | 44 - CYTOSTATICA | ||||||||||
| 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: | 12.10.2024 |
| Validity: | 12.10.2029 |
| SPC: |
SPC_Enzalutamide AGmed 80 mg filmom obalené tablety_11.2024.pdf
|
| PIL: |
PIL_Enzalutamide AGmed 80 mg filmom obalené tablety_11.2024.pdf
|
| Safety feature | Yes |
| Data update: | 09.01.2025 |
