Gardasil

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human papillomavirus vaccine [types 6, 11, 16, 18] (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. 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.

This EPAR was last updated on 27/06/2018

Authorisation details

Product details
Name
Gardasil
Agency product number
EMEA/H/C/000703
Active substance
  • human papillomavirus type 6 L1 protein
  • human papillomavirus type 11 L1 protein
  • human papillomavirus type 16 L1 protein
  • human papillomavirus type 18 L1 protein
International non-proprietary name (INN) or common name
human papillomavirus vaccine [types 6, 11, 16, 18] (recombinant, adsorbed)
Therapeutic area (MeSH)
  • Papillomavirus Infections
  • Uterine Cervical Dysplasia
  • Condylomata Acuminata
  • Immunization
Anatomical therapeutic chemical (ATC) code
J07BM01
Publication details
Marketing-authorisation holder
MSD VACCINS
Revision
38
Date of issue of marketing authorisation valid throughout the European Union
20/09/2006
Contact address
162 avenue Jean Jaurès
69007 Lyon Cedex 07
France

Product information

17/05/2018 Gardasil - EMEA/H/C/000703 - WS/1349/G

Contents

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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.

Assessment history

Changes since initial authorisation of medicine

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