Gardasil 9
human papillomavirus 9-valent vaccine (recombinant, adsorbed)
Table of contents
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.
-
List item
Gardasil 9 : EPAR - Summary for the public (PDF/88.67 KB)
First published: 03/07/2015
Last updated: 17/05/2016 -
-
List item
Gardasil 9 : EPAR - Risk-management-plan summary (PDF/92.86 KB)
First published: 03/07/2015
Last updated: 25/07/2023
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) |
|
Anatomical therapeutic chemical (ATC) code |
J07BM03
|
Publication details | |
---|---|
Marketing-authorisation holder |
Merck Sharp & Dohme B.V.
|
Revision |
22
|
Date of issue of marketing authorisation valid throughout the European Union |
10/06/2015
|
Contact address |
Waarderweg 39 |
Product information
12/05/2023 Gardasil 9 - EMEA/H/C/003852 - II/0063
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:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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
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.