🇪🇺 HPV vaccine in European Union

EMA authorised HPV vaccine on 20 September 2006

Marketing authorisation

EMA — authorised 20 September 2006

  • Application: EMEA/H/C/000703
  • Marketing authorisation holder: Merck Sharp & Dohme B.V.
  • Local brand name: Gardasil
  • Indication: Gardasil is a vaccine for use from the age of 9 years for the prevention of: premalignant genital lesions (cervical, vulvar and vaginal), premalignant anal lesions, cervical cancers and anal cancers causally related to certain oncogenic Human Papillomavirus (HPV) types; genital warts (condyloma acuminata) causally related to specific HPV types. See sections 4.4 and 5.1 for important information on the data that support this indication. The use of Gardasil should be in accordance with official recommendations.
  • Status: approved

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Frequently asked questions

Is HPV vaccine approved in European Union?

Yes. EMA authorised it on 20 September 2006.

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

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