| Code | 0927F | ||||||||||
| MA number | EU/1/25/1951/001 | ||||||||||
| Product Form: | dis inf 1x10 ml + 0-2x10 ml-20ml + 1-6x30 ml-70 ml (vak EVA) | ||||||||||
| MA Status: | Ex - Conditional centralised marketing authorisation | ||||||||||
| Type of procedure: | EU | ||||||||||
| MAH, country: | Autolus GmbH, Germany | ||||||||||
| Therapeutic Class: | 44 - CYTOSTATICA | ||||||||||
| ATC: |
|
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| Shelf life: | 6 | ||||||||||
| Container: | bag ethylene vinyl acetate (EVA) | ||||||||||
| 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: | 17.07.2025 |
| Validity: | 17.07.2026 |
| SmPC + PL: |
European Medicines Agency's database
|
| Safety feature | No |
| Data update: | 20.08.2025 |
