Cervarix: Withdrawal of the application to change the marketing authorisation
human papillomavirus vaccine [types 16, 18] (recombinant, adjuvanted, adsorbed)
Table of contents
Overview
GlaxoSmithKline Biologicals SA withdrew its application to use Cervarix in individuals from the age of nine years for the prevention of head and neck cancers that are caused by certain types of human papillomavirus (HPV).
The company withdrew the application on 22 October 2021.
Key facts
Name |
Cervarix |
Product number |
EMEA/H/C/000721 |
Date of issue of market authorisation valid throughout the European Union (if applicable) |
20/09/2007 |
International non-proprietary name (INN) or common name |
|
Active substance |
|
Date of withdrawal |
22/10/2021 |
Company making the application | |
Withdrawal type |
Post-authorisation |
All documents
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List item
Withdrawal assessment report for Cervarix (PDF/4.58 MB)
Adopted
First published: 10/01/2022
EMA/612496/2021 -
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Withdrawal letter: Cervarix (PDF/175.93 KB)
First published: 12/11/2021 -
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Questions and answers on the withdrawal of application to change the marketing authorisation for Cervarix (human papillomavirus vaccine [types 16, 18] (recombinant, adjuvanted, adsorbed)) (PDF/106.06 KB)
First published: 12/11/2021
EMA/627371/2021 -
Related information on withdrawals
The question-and-answer (Q&A) document provides a summary of the CHMP's evaluation of the application at the time of the withdrawal, and includes a link to the company's formal withdrawal letter.
An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 90').
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