🇪🇺 Rotarix vaccine in European Union

EMA authorised Rotarix vaccine on 7 May 1999

Marketing authorisation

EMA — authorised 7 May 1999

  • Application: EMEA/H/C/000192
  • Marketing authorisation holder: Wyeth Lederle Vaccines S.A.
  • Local brand name: Rotashield
  • Indication: RotaShield is indicated for active immunisation of infants aged 6 weeks to 30 weeks for prevention of severe clinical manifestations of gastro-enteritis caused by rotavirus serotypes 1, 2, 3 and 4 of group A.
  • Status: withdrawn

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Rotarix vaccine in other countries

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

Frequently asked questions

Is Rotarix vaccine approved in European Union?

Yes. EMA authorised it on 7 May 1999.

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

Wyeth Lederle Vaccines S.A. holds the EU marketing authorisation.