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PRODUCT DETAIL

Epysqli 300 mg koncentrát na infúzny roztok

Code 3691E
MA number EU/1/23/1735/001
Product Form: con inf 1x30 ml/300 mg (liek.inj.skl.)
MA Status: E - Valid centralised marketing authorisation
Type of procedure: EU
MAH, country: Samsung Bioepis NL B.V., Netherland
Therapeutic Class: 59 - IMMUNOPRAEPARATA
ATC:
L ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
L04 Immunosuppressants
L04A Immunosuppressants
L04AA Selective immunosuppressants
L04AA25 Eculizumab
Shelf life: 36
Container: glass vial
Route of admin.: Intravenous use
Prescription Status: Medicinal product subject to restricted medical prescription.
Legal basis: Article 10(4) similar biological application
MA issued: 26.05.2023
Validity: 26.05.2028
SmPC + PL: European Medicines Agency's database
Safety feature Yes
Data update: 02.06.2023
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