Infanrix HepB (diphtheria, tetanus, acellular pertussis and hepatitis B recombinant, adsorbed vaccine)
- Region
- 🇪🇺 EU
- Active substance
- diphtheria, tetanus, acellular pertussis and hepatitis B recombinant, adsorbed vaccine
- Company
- GlaxoSmithKline Biologicals S.A.
- Status
- Withdrawn
- Therapeutic area
- Hepatitis B; Tetanus; Immunization; Whooping Cough; Diphtheria
- EU approval
- Wed 30 Jul 1997
- Application
- EMEA/H/C/000126
- ATC
- J07CA
- Official record
- www.ema.europa.eu
Indication
Infanrix HepB is indicated for active immunisation of all infants from the age of 2 months againstdiphtheria, tetanus, pertussis and hepatitis B.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Infanrix Hexa Authorised · GlaxoSmithKline Biologicals S.A.
- 🇪🇺 Hexacima Authorised · Sanofi Winthrop Industrie
- 🇪🇺 Hexyon Authorised · Sanofi Winthrop Industrie
- 🇪🇺 Vaxelis Authorised · MCM Vaccine B.V.
- 🇪🇺 Tritanrix HepB Lapsed · GlaxoSmithKline Biologicals S.A.
- 🇪🇺 Infanrix Penta Lapsed · GlaxoSmithKline Biologicals S.A.
- 🇪🇺 Hexavac Withdrawn · Sanofi Pasteur MSD, SNC
- 🇪🇺 Quintanrix Withdrawn · GlaxoSmithKline Biologicals S.A.
- 🇪🇺 Triacelluvax Withdrawn · Chiron S.p.A.
- 🇪🇺 Primavax Withdrawn · Pasteur Mà¨rieux MSD
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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.