Fluad Paediatric: Withdrawal of the marketing authorisation application


On 10 February 2012, Novartis Vaccines and Diagnostics officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Fluad Paediatric, for the prevention of seasonal influenza in infants and children.

  • List item

    Questions and answers on the withdrawal of the marketing authorisation application for Fluad Paediatric (influenza vaccine, surface antigen, inactivated, adjuvanted) (PDF/63.98 KB)

    First published: 21/02/2012
    Last updated: 24/04/2012

  • Key facts

    Fluad Paediatric
    Product number
    Date of withdrawal
    Company making the application
    Novartis Vaccines and Diagnostics S.r.l.
    Withdrawal type
    Initial authorisation

    All documents

    Related information on withdrawals

    A question-and-answer (Q&A) document provides a summary of the CHMP's evaluation of the medicine at the time of the withdrawal of the application, 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    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

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