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 08/11/2022

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
J07BM03
Publication details
Marketing-authorisation holder
Merck Sharp & Dohme B.V.
Revision
20
Date of issue of marketing authorisation valid throughout the European Union
10/06/2015
Contact address

Waarderweg 39
2031 BN Haarlem
NETHERLANDS

Product information

13/10/2022 Gardasil 9 - EMEA/H/C/003852 - WS2336

This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.

 

Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

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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