🇪🇺 human papillomavirus vaccine, recombinant in European Union

EMA authorised human papillomavirus vaccine, recombinant on 10 June 2015

Marketing authorisation

EMA — authorised 10 June 2015

  • Application: EMEA/H/C/003852
  • Marketing authorisation holder: Merck Sharp & Dohme B.V.
  • Local brand name: Gardasil 9
  • Indication: Gardasil 9 is indicated for active immunisation of individuals from the age of 9 years against the following HPV diseases: Premalignant lesions and cancers affecting the cervix, vulva, vagina and anus caused by vaccine HPV types Genital warts (Condyloma acuminata) caused by specific HPV types. See sections 4.4 and 5.1 for important information on the data that support these indications. The use of Gardasil 9 should be in accordance with official recommendations.
  • Status: approved

Read official source →

human papillomavirus vaccine, recombinant 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 human papillomavirus vaccine, recombinant approved in European Union?

Yes. EMA authorised it on 10 June 2015.

Who is the marketing authorisation holder for human papillomavirus vaccine, recombinant in European Union?

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