Cervarix

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human papillomavirus vaccine [types 16, 18] (recombinant, adjuvanted, 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 Cervarix. 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 Cervarix.

This EPAR was last updated on 26/06/2018

Authorisation details

Product details
Name
Cervarix
Agency product number
EMEA/H/C/000721
Active substance
  • human papillomavirus1 type 16 L1 protein
  • human papillomavirus type 18 L1 protein
International non-proprietary name (INN) or common name
human papillomavirus vaccine [types 16, 18] (recombinant, adjuvanted, adsorbed)
Therapeutic area (MeSH)
  • Papillomavirus Infections
  • Uterine Cervical Dysplasia
  • Immunization
Anatomical therapeutic chemical (ATC) code
J07BM02
Publication details
Marketing-authorisation holder
GlaxoSmithKline Biologicals S.A.
Revision
31
Date of issue of marketing authorisation valid throughout the European Union
19/09/2007
Contact address
Rue de l'Institut, 89
B-1330 Rixensart
Belgium

Product information

16/05/2018 Cervarix - EMEA/H/C/000721 - II/0094

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

Cervarix is a vaccine for use from the age of 9 years for the prevention of premalignant ano-genital lesions (cervical, vulvar, vaginal and anal) and cervical and anal cancers causally related to certain oncogenic Human Papillomavirus (HPV) types. See sections 4.4 and 5.1 for important information on the data that support this indication.

The use of Cervarix should be in accordance with official recommendations.

Assessment history

Changes since initial authorisation of medicine

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