🇪🇺 Rotavirus vaccine in European Union

EMA authorised Rotavirus vaccine on 21 February 2006

Marketing authorisations

EMA — authorised 21 February 2006

  • Application: EMEA/H/C/000639
  • Marketing authorisation holder: GlaxoSmithKline Biologicals S.A.
  • Local brand name: Rotarix
  • Indication: Rotarix is indicated for the active immunisation of infants aged 6 to 24 weeks for prevention of gastroenteritis due to rotavirus infection. The use of Rotarix should be based on official recommendation.
  • Status: approved

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EMA

  • Application: EMEA/H/C/000192
  • Local brand name: Rotashield
  • Status: withdrawn

Rotavirus vaccine in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Other Immunology / Infectious Disease approved in European Union

Frequently asked questions

Is Rotavirus vaccine approved in European Union?

Yes. EMA authorised it on 21 February 2006; EMA has authorised it.

Who is the marketing authorisation holder for Rotavirus vaccine in European Union?

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