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: |
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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 |