🇪🇺 Prepandrix™ in European Union

EMA authorised Prepandrix™ on 14 May 2008

Marketing authorisation

EMA — authorised 14 May 2008

  • Application: EMEA/H/C/000822
  • Marketing authorisation holder: GlaxoSmithKline Biologicals S.A.
  • Local brand name: Prepandrix
  • Indication: Active immunisation against H5N1 subtype of influenza-A virus. This indication is based on immunogenicity data from healthy subjects from the age of 18 years onwards following administration of two doses of vaccine prepared with H5N1 subtype strains. Prepandrix should be used in accordance with official guidance.
  • Pathway: accelerated assessment
  • Status: withdrawn

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Other Immunology / Infectious Disease approved in European Union

Frequently asked questions

Is Prepandrix™ approved in European Union?

Yes. EMA authorised it on 14 May 2008.

Who is the marketing authorisation holder for Prepandrix™ in European Union?

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