🇪🇺 Tritanrix-HepB in European Union

EMA authorised Tritanrix-HepB on 19 July 1996

Marketing authorisation

EMA — authorised 19 July 1996

  • Application: EMEA/H/C/000093
  • Marketing authorisation holder: GlaxoSmithKline Biologicals S.A.
  • Local brand name: Tritanrix HepB
  • Indication: Tritanrix HepB is indicated for active immunisation against diphtheria, tetanus, pertussis and hepatitis B (HBV) in infants from six weeks onwards (see section 4.2).
  • Status: withdrawn

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Other Infectious Diseases approved in European Union

Frequently asked questions

Is Tritanrix-HepB approved in European Union?

Yes. EMA authorised it on 19 July 1996.

Who is the marketing authorisation holder for Tritanrix-HepB in European Union?

GlaxoSmithKline Biologicals S.A. holds the EU marketing authorisation.