| Code | 8588D | ||||||||||
| MA number | EU/1/21/1570/001 | ||||||||||
| Product Form: | plc ifc 1x200 mg (liek.inj.skl.) | ||||||||||
| MA Status: | Ex - Conditional centralised marketing authorisation | ||||||||||
| Type of procedure: | EU Orphan | ||||||||||
| MAH, country: | Incyte Biosciences Distribution B.V., Netherland | ||||||||||
| Therapeutic Class: | 44 - CYTOSTATICA | ||||||||||
| ATC: |
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| Shelf life: | 60 | ||||||||||
| Container: | glass vial | ||||||||||
| Route of admin.: | Intravenous use |
| Prescription Status: | Medicinal product subject to restricted medical prescription. |
| Legal basis: | Article 8(3) application - new active substance |
| MA issued: | 26.08.2021 |
| Validity: | 01.09.2026 |
| SmPC + PL: |
European Medicines Agency's database
|
| Safety feature | Yes |
| Data update: | 26.09.2025 |
