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PRODUCT DETAIL

KAVIGALE 300 mg injekčný/infúzny roztok

Code 8986E
MA number EU/1/24/1900/001
Product Form: sol ijf 1x2 ml/300 mg (liek.inj.skl.)
MA Status: E - Valid centralised marketing authorisation
Type of procedure: EU
MAH, country: AstraZeneca AB, Sweden
Therapeutic Class: 59 - IMMUNOPRAEPARATA
ATC:
J ANTIINFECTIVES FOR SYSTEMIC USE
J06 IMMUNE SERA AND IMMUNOGLOBULINS
J06B IMMUNOGLOBULINS
J06BD Antiviral monoclonal antibodies
J06BD09 Sipavibart
Shelf life: 18
Container: glass vial
Route of admin.: Intramuscular or intravenous use
Prescription Status: Medicinal product subject to medical prescription.
Legal basis: Article 8(3) application - new active substance
MA issued: 20.01.2025
Validity: 20.01.2030
SmPC + PL: European Medicines Agency's database
Safety feature Yes
Data update: 12.02.2025
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