| Code | 7961D | ||||||||||
| MA number | 44/0187/21-S | ||||||||||
| Product Form: | tbl flm 90x1(3x30x1)x1000 mg (blis.Al/OPA/Al/PVC-multibal.jednotliv.dáv.) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | Sandoz Pharmaceuticals d.d., Slovenia | ||||||||||
| Therapeutic Class: | 44 - CYTOSTATICA | ||||||||||
| ATC: |
|
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| Shelf life: | 36 | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 10(3) hybrid application |
| MA issued: | 23.07.2021 |
| Validity: | 23.07.2026 |
| MA renewed: | Renewal application submitted |
| SPC: |
SPC_Abiraterón Sandoz 1000 mg filmom obalené tablety_10.2025.pdf
|
| PIL: |
PIL_Abiraterón Sandoz 1000 mg filmom obalené tablety_10.2025.pdf
|
| Safety feature | Yes |
| Data update: | 17.06.2025 |
