| Code | 8935C | ||||||||||
| MA number | EU/1/18/1297/001 | ||||||||||
| Product Form: | dis inf 1-3 (vak etylénvinylacetátový (EVA)) | ||||||||||
| MA Status: | E - Valid centralised marketing authorisation | ||||||||||
| Type of procedure: | EU Orphan | ||||||||||
| MAH, country: | Novartis Europharm Limited, Ireland | ||||||||||
| Therapeutic Class: | 87 - VARIA I | ||||||||||
| 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: | 23.08.2018 |
| SmPC + PL: |
European Medicines Agency's database
|
| Dokument: |
Kymriah_Prirucka pre pacienta.pdf
|
| Dokument: |
Kymriah_Karta Pacienta.pdf
|
| Dokument: |
Kymriah_Edu_mat_lekaren_bunkove lab_inf_cen.pdf
|
| Dokument: |
Kymriah_skoliaci materiaal pre zdravotnickych pracovnikov.pdf
|
| Dokument: |
DHPC_CAR-T cells_18.07.2024.pdf
|
| Safety feature | No |
| Data update: | 18.05.2023 |
