| Code | 7763E | ||||||||||
| MA number | EU/1/24/1843/003 | ||||||||||
| Product Form: | con inf 1x16 ml/320 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: | 36 | ||||||||||
| 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: | 22.08.2024 |
| Validity: | 23.08.2026 |
| SmPC + PL: |
European Medicines Agency's database
|
| Safety feature | Yes |
| Data update: | 11.08.2025 |
