Code | 6267D | ||||||||||
MA number | EU/1/20/1492/001 | ||||||||||
Product Form: | dis inf 1x68 ml (vak EVA) | ||||||||||
MA Status: | Ex - Conditional centralised marketing authorisation | ||||||||||
Type of procedure: | EU Orphan | ||||||||||
MAH, country: | Kite Pharma EU B.V, Netherland | ||||||||||
Therapeutic Class: | 44 - CYTOSTATICA | ||||||||||
ATC: |
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Shelf life: | 12 | ||||||||||
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: | 14.12.2020 |
Validity: | 15.12.2024 |
SmPC + PL: | European Medicines Agency's database |
Dokument: | Karta pacienta SK.pdf |
Dokument: | Pokyny pre zaobchádzanie s liekom SK.pdf |
Dokument: | Príručka pre zdravotníckych pracovníkov SK.pdf |
Dokument: | DHPC_CAR-T cells_18.07.2024.pdf |
Safety feature | No |
Data update: | 18.12.2023 |