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PRODUCT DETAIL

SARCLISA 20 mg/ml infúzny koncentrát

Code 4904D
MA number EU/1/20/1435/001
Product Form: con inf 1x5 ml/100 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
L01FC CD38 (Clusters of Differentiation 38) inhibitors
L01FC02 Isatuximab
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: 30.05.2020
Validity: 30.05.2025
SmPC + PL: European Medicines Agency's database
Safety feature Yes
Data update: 18.05.2023
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