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PRODUCT DETAIL

Spevigo 450 mg koncentrát na infúzny roztok

Code 2651E
MA number EU/1/22/1688/001
Product Form: con inf 2x7,5 ml/450 mg (liek.inj.skl.)
MA Status: Ex - Conditional centralised marketing authorisation
Type of procedure: EU
Therapeutic Class: 59 - IMMUNOPRAEPARATA
ATC:
L ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
L04 Immunosuppressants
L04A Immunosuppressants
L04AC Interleukin inhibitors
L04AC22 Spesolimab
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: 09.12.2022
Validity: 12.12.2024
SmPC + PL: European Medicines Agency's database
Safety feature Yes
Data update: 26.09.2023
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