| Code | 8022D | ||||||||||
| MA number | EU/1/21/1553/003 | ||||||||||
| Product Form: | tbl flm 56x500 mg (blis.PVC/PE/PVDC//papier/Al - kalend.bal.) | ||||||||||
| MA Status: | E - Valid centralised marketing authorisation | ||||||||||
| Type of procedure: | EU | ||||||||||
| MAH, country: | KRKA, d.d., Novo mesto, Slovenia | ||||||||||
| Therapeutic Class: | 44 - CYTOSTATICA | ||||||||||
| ATC: |
|
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| Shelf life: | 24 | ||||||||||
| Container: | blister PVC/PE/PVDC/Al/paper | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 10(1) generic application |
| MA issued: | 24.06.2021 |
| Validity: | 24.06.2026 |
| SmPC + PL: |
European Medicines Agency's database
|
| Safety feature | Yes |
| Data update: | 01.07.2021 |
