Cervarix
human papillomavirus vaccine [types 16, 18] (recombinant, adjuvanted, adsorbed)
Table of contents
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.
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Cervarix : EPAR - Summary for the public (PDF/93.81 KB)
First published: 23/12/2008
Last updated: 18/08/2016 -
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Cervarix : EPAR - Risk management plan summary (PDF/170.39 KB)
First published: 26/04/2022
Last updated: 23/05/2023
Authorisation details
Product details | |
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Name |
Cervarix
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Agency product number |
EMEA/H/C/000721
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Active substance |
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International non-proprietary name (INN) or common name |
human papillomavirus vaccine [types 16, 18] (recombinant, adjuvanted, adsorbed)
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Therapeutic area (MeSH) |
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Anatomical therapeutic chemical (ATC) code |
J07BM02
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Publication details | |
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Marketing-authorisation holder |
GlaxoSmithKline Biologicals S.A.
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Revision |
39
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Date of issue of marketing authorisation valid throughout the European Union |
20/09/2007
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Contact address |
Rue de l'Institut, 89
B-1330 Rixensart Belgium |
Product information
26/04/2023 Cervarix - EMEA/H/C/000721 - WS2365
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
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
News
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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 8-11 November 202112/11/2021
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24/06/2016
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20/11/2015
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05/11/2015
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13/07/2015
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13/07/2015
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22/02/2013
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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 17-20 October 201121/10/2011