Gardasil 9

RSS

human papillomavirus 9-valent vaccine (recombinant, adsorbed)

Authorised
This medicine is authorised for use in the European Union.

Overview

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 23/08/2018

Authorisation details

Product details
Name
Gardasil 9
Agency product number
EMEA/H/C/003852
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
J07BM
Additional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Publication details
Marketing-authorisation holder
MSD VACCINS
Revision
8
Date of issue of marketing authorisation valid throughout the European Union
09/06/2015
Contact address
162 avenue Jean Jaures
69007 Lyon
France

Product information

26/07/2018 Gardasil 9 - EMEA/H/C/003852 - II/0024/G

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

Suspension for injection

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

How useful was this page?

Add your rating
Average
1 rating