Gardasil
human papillomavirus vaccine [types 6, 11, 16, 18] (recombinant, adsorbed)
Table of contents
Overview
This is a summary of the European public assessment report (EPAR) for Gardasil. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Gardasil.
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Gardasil : EPAR - Summary for the public (PDF/81.54 KB)
First published: 15/09/2008
Last updated: 04/08/2014 -
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Gardasil : EPAR - Risk-management-plan summary (PDF/2.15 MB)
First published: 30/04/2019
Last updated: 06/06/2019
Authorisation details
Product details | |
---|---|
Name |
Gardasil
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Agency product number |
EMEA/H/C/000703
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Active substance |
|
International non-proprietary name (INN) or common name |
human papillomavirus vaccine [types 6, 11, 16, 18] (recombinant, adsorbed)
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Therapeutic area (MeSH) |
|
Anatomical therapeutic chemical (ATC) code |
J07BM01
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Publication details | |
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Marketing-authorisation holder |
MSD VACCINS
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Revision |
43
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Date of issue of marketing authorisation valid throughout the European Union |
20/09/2006
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Contact address |
162 avenue Jean Jaurès
69007 Lyon Cedex 07 France |
Product information
06/11/2020 Gardasil - EMEA/H/C/000703 - II/0087
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
Vaccines
Therapeutic indication
Gardasil is a vaccine for use from the age of 9 years for the prevention of:
- premalignant genital lesions (cervical, vulvar and vaginal), premalignant anal lesions, cervical cancers and anal cancers causally related to certain oncogenic Human Papillomavirus (HPV) types;
- genital warts (condyloma acuminata) causally related to specific HPV types.
See sections 4.4 and 5.1 for important information on the data that support this indication.
The use of Gardasil should be in accordance with official recommendations.