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PRODUCT DETAIL

JEMPERLI 500 mg koncentrát na infúzny roztok

Code 7504D
MA number EU/1/21/1538/001
Product Form: con inf 1x10 ml/500 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
L01FF07 Dostarlimab
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: 21.04.2021
Validity: 22.04.2024
SmPC + PL: European Medicines Agency's database
Dokument: Jemperli_Karta_pacienta.pdf  
Safety feature Yes
Data update: 21.12.2023
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