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PRODUCT DETAIL

YESCARTA

Code 9269C
MA number EU/1/18/1299/001
Product Form: dis inf 1x68 ml (vak etylénvinylacetátový)
MA Status: E - Valid centralised marketing authorisation
Type of procedure: EU Orphan
MAH, country: Kite Pharma EU B.V, Netherland
Therapeutic Class: 44 - CYTOSTATICA
ATC:
L ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
L01 ANTINEOPLASTIC AGENTS
L01X OTHER ANTINEOPLASTIC AGENTS
L01XL ?
L01XL03 Axicabtagene ciloleucel
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: 23.08.2018
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: 16.08.2023
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