| Code | 7766E | ||||||||||
| MA number | EU/1/24/1864/002 | ||||||||||
| Product Form: | plc ifc 1x420 mg (liek.inj.skl.) | ||||||||||
| MA Status: | E - Valid centralised marketing authorisation | ||||||||||
| Type of procedure: | EU | ||||||||||
| MAH, country: | Prestige Biopharma Belgium BVBA, Belgium | ||||||||||
| Therapeutic Class: | 44 - CYTOSTATICA | ||||||||||
| ATC: |
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| Shelf life: | 48 | ||||||||||
| Container: | glass vial | ||||||||||
| Route of admin.: | Intravenous use |
| Prescription Status: | Medicinal product subject to restricted medical prescription. |
| Legal basis: | Article 10(4) similar biological application |
| MA issued: | 19.09.2024 |
| Validity: | 19.09.2029 |
| SmPC + PL: |
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| Safety feature | Yes |
| Data update: | 16.10.2024 |