🇪🇺 Bivalent Vaccines in European Union

EMA authorised Bivalent Vaccines on 20 September 2007

Marketing authorisation

EMA — authorised 20 September 2007

  • Application: EMEA/H/C/000721
  • Marketing authorisation holder: GlaxoSmithKline Biologicals S.A.
  • Local brand name: Cervarix
  • Indication: Cervarix is a vaccine for use from the age of 9 years for the prevention of premalignant ano-genital lesions (cervical, vulvar, vaginal and anal) and cervical and anal cancers causally related to certain oncogenic Human Papillomavirus (HPV) types. See sections 4.4 and 5.1 for important information on the data that support this indication. The use of Cervarix should be in accordance with official recommendations.
  • Status: approved

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Bivalent Vaccines in other countries

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

Other Immunology approved in European Union

Frequently asked questions

Is Bivalent Vaccines approved in European Union?

Yes. EMA authorised it on 20 September 2007.

Who is the marketing authorisation holder for Bivalent Vaccines in European Union?

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