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PRODUCT DETAIL

LIBTAYO 350 mg infúzny koncentrát

Code 2200D
MA number EU/1/19/1376/001
Product Form: con inf 1x7 ml/350 mg (liek.inj.skl.)
MA Status: E - Valid centralised marketing authorisation
Type of procedure: EU
Therapeutic Class: 44 - CYTOSTATICA
ATC:
L ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
L01 ANTINEOPLASTIC AGENTS
L01F MONOCLONAL ANTIBODIES AND ANTIBODY DRUG CONJUGATES
L01FF PD-1/PDL-1 (Programmed cell death protein 1/death ligand 1) inhibitors
L01FF06 Cemiplimab
Shelf life: 36
Container: glass vial
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: 28.06.2019
Validity: 01.07.2027
SmPC + PL: European Medicines Agency's database
Dokument: LIBTAYO_Karta pacienta.pdf  
Dokument: LIBTAYO_Príručka pre pacienta.pdf  
Safety feature Yes
Data update: 24.10.2022
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