🇪🇺 Pentavalent rotavirus vaccine in European Union

EMA authorised Pentavalent rotavirus vaccine on 26 June 2006

Marketing authorisation

EMA — authorised 26 June 2006

  • Application: EMEA/H/C/000669
  • Marketing authorisation holder: Merck Sharp & Dohme B.V.
  • Local brand name: RotaTeq
  • Indication: RotaTeq is indicated for the active immunisation of infants from the age of six weeks to 32 weeks for prevention of gastroenteritis due to rotavirus infection. RotaTeq is to be used on the basis of official recommendations.
  • Status: approved

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Other Immunology / Infectious Disease approved in European Union

Frequently asked questions

Is Pentavalent rotavirus vaccine approved in European Union?

Yes. EMA authorised it on 26 June 2006.

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

Merck Sharp & Dohme B.V. holds the EU marketing authorisation.