Cervarix: Withdrawal of the application to change the marketing authorisation

human papillomavirus vaccine [types 16, 18] (recombinant, adjuvanted, adsorbed)

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.

  • List item

    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

  • 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
    • human papillomavirus vaccine [types 16, 18] (recombinant, adjuvanted, adsorbed)
    Active substance
    • human papillomavirus1 type 16 L1 protein
    • human papillomavirus type 18 L1 protein
    Date of withdrawal
    22/10/2021
    Company making the application
    GlaxoSmithKline Biologicals S.A.
    Withdrawal type
    Post-authorisation

    All documents

    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    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 90').

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