Fendrix (hepatitis B (rDNA) vaccine (adjuvanted, adsorbed))
- Region
- 🇪🇺 EU
- Active substance
- hepatitis B (rDNA) vaccine (adjuvanted, adsorbed)
- Company
- GlaxoSmithKline Biologicals S.A.
- Status
- Authorised
- Therapeutic area
- Hepatitis B; Immunization
- EU approval
- Wed 02 Feb 2005
- Application
- EMEA/H/C/000550
- ATC
- J07BC01
- Official record
- www.ema.europa.eu
Indication
Fendrix is indicated in adolescents and adults from the age of 15 years onwards for active immunisation against hepatitis B virus infection (HBV) caused by all known subtypes for patients with renal insufficiency (including pre-haemodialysis and haemodialysis patients).
Regulatory milestones
No milestones recorded in the last year.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.