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PRODUCT DETAIL

HEPLISAV B 20 mikrogramov injekčný roztok v naplnenej injekčnej striekačke

Code 6939D
MA number EU/1/20/1503/001
Product Form: sol iru 5x0,5 ml/20 µg (striek.inj.napl.skl.)
MA Status: E - Valid centralised marketing authorisation
Type of procedure: EU
Therapeutic Class: 59 - IMMUNOPRAEPARATA
ATC:
J ANTIINFECTIVES FOR SYSTEMIC USE
J07 VACCINES
J07B VIRAL VACCINES
J07BC Hepatitis vaccines
J07BC01 Hepatitis B, purified antigen
Shelf life: 36
Route of admin.: Intramuscular use
Prescription Status: Medicinal product subject to medical prescription.
Legal basis: Article 8(3) application - new active substance
MA issued: 18.02.2021
Validity: 18.02.2026
SmPC + PL: European Medicines Agency's database
Safety feature Yes
Data update: 22.03.2021
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