| Code | 9795E | ||||||||
| MA number | EU/1/25/1917/002 | ||||||||
| Product Form: | con inf 1x10 ml/200 mg (liek.inj.skl.) | ||||||||
| MA Status: | Ex - Conditional centralised marketing authorisation | ||||||||
| Type of procedure: | EU | ||||||||
| MAH, country: | Regeneron Ireland Designated Activity Company (DAC), Ireland | ||||||||
| Therapeutic Class: | 44 - CYTOSTATICA | ||||||||
| ATC: |
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| Shelf life: | 18 | ||||||||
| 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: | 23.04.2025 |
| Validity: | 23.04.2026 |
| SmPC + PL: |
European Medicines Agency's database
|
| Safety feature | Yes |
| Data update: | 30.10.2025 |
