Gardasil 9


human papillomavirus 9-valent vaccine (recombinant, adsorbed)

This medicine is authorised for use in the European Union.


This is a summary of the European public assessment report (EPAR) for Gardasil 9. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Gardasil 9.

For practical information about using Gardasil 9, patients should read the package leaflet or contact their doctor or pharmacist.

This EPAR was last updated on 08/03/2021

Authorisation details

Product details
Gardasil 9
Agency product number
Active substance
human papillomavirus vaccine [types 6, 11, 16, 18, 31, 33, 45, 52, 58] (recombinant, adsorbed)
International non-proprietary name (INN) or common name
human papillomavirus 9-valent vaccine (recombinant, adsorbed)
Therapeutic area (MeSH)
  • Condylomata Acuminata
  • Papillomavirus Infections
  • Immunization
  • Uterine Cervical Dysplasia
Anatomical therapeutic chemical (ATC) code
Publication details
Marketing-authorisation holder
Date of issue of marketing authorisation valid throughout the European Union
Contact address
162 avenue Jean Jaures
69007 Lyon

Product information

14/01/2021 Gardasil 9 - EMEA/H/C/003852 - II/0040


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Pharmacotherapeutic group

Papillomavirus vaccines

Therapeutic 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.

Assessment history

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