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PRODUCT DETAIL

Alofisel 5 miliónov buniek/ml injekčná suspenzia

Code 7704C
MA number EU/1/17/1261/001
Product Form: sus inj 4x6 ml/30 miliónov buniek
MA Status: E - Valid centralised marketing authorisation
Type of procedure: EU Orphan
Therapeutic Class: 59 - IMMUNOPRAEPARATA
ATC:
L ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
L04 Immunosuppressants
L04A Immunosuppressants
L04AX Other immunosuppressants
L04AX08 Darvadstrocel
Shelf life: 72 hodín
Container: glass vial
Route of admin.: Intralesional use
Prescription Status: Medicinal product subject to restricted medical prescription.
Legal basis: Article 8(3) application - new active substance
MA issued: 23.03.2018
SmPC + PL: European Medicines Agency's database
Dokument: Alofisel_Potenciálna mikrobiálna kontaminácia (Príručka pre zdravotníckych pracovníkov).pdf  
Dokument: Alofisel_Spôsob podavania (Prirucka pre chirurgov).pdf  
Dokument: Alofisel_Pokyny na príjem a uchovávanie lieku (Príručka pre lekárnikov).pdf  
Safety feature No
Data update: 24.01.2023
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