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.
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 |
33
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Date of issue of marketing authorisation valid throughout the European Union |
20/09/2007
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Contact address |
Product information
14/05/2020 Cervarix - EMEA/H/C/000721 - II/0106
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
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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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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