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PRODUCT DETAIL

ENGERIX-B 10 µg

Code 96068
MA number 59/0170/87-CS
Product Form: sus inj 1x0,5 ml (liek.inj.skl.)
MA Status: D - Marketing Authorisation valid for an unlimited period
Type of procedure: National
MAH, country: GlaxoSmithKline Biologicals S.A., Belgium
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: 18.02.1988
Pediatric indication: Yes
Pediatric posology: Yes
SPC: SPC_ENGERIX-B 10 mcg_06.2023.pdf  
PIL: PIL_ENGERIX-B 10 mcg_ ENGERIX-B 20 mcg_06.2023.pdf  
Safety feature Yes
Data update: 22.05.2018
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