| Code | 1147E | ||||||||||
| MA number | EU/1/22/1648/001 | ||||||||||
| Product Form: | dis inf 1x30 ml - 1x50 ml (vak EVA) | ||||||||||
| MA Status: | E - Valid centralised marketing authorisation | ||||||||||
| Type of procedure: | EU Orphan | ||||||||||
| MAH, country: | Janssen - Cilag International N.V., Belgium | ||||||||||
| Therapeutic Class: | 44 - CYTOSTATICA | ||||||||||
| ATC: |
|
||||||||||
| Shelf life: | 9 | ||||||||||
| 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: | 25.05.2022 |
| Validity: | 19.04.2029 |
| SmPC + PL: |
European Medicines Agency's database
|
| Dokument: |
DHPC_CAR-T cells_18.07.2024.pdf
|
| Safety feature | No |
| Data update: | 25.04.2024 |
