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PRODUCT DETAIL

Ronapreve 300 mg + 300 mg injekčný/infúzny roztok

Code 8988D
MA number EU/1/21/1601/001
Product Form: sol ijf 1x2,5 ml/300 mg + 1x2,5 ml/300 mg (liek.inj.skl.jednoráz.)
MA Status: E - Valid centralised marketing authorisation
Type of procedure: EU
Therapeutic Class: 59 - IMMUNOPRAEPARATA
ATC:
J ANTIINFECTIVES FOR SYSTEMIC USE
J06 IMMUNE SERA AND IMMUNOGLOBULINS
J06B IMMUNOGLOBULINS
J06BD Antiviral monoclonal antibodies
J06BD07 Casirivimab and imdevimab
Shelf life: 24
Container: glass vial
Route of admin.: Subcutaneous and intravenous use
Prescription Status: Medicinal product subject to medical prescription.
Legal basis: Article 8(3) application - new active substance
MA issued: 12.11.2021
Validity: 12.11.2026
SmPC + PL: European Medicines Agency's database
Safety feature Yes
Data update: 21.07.2023
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