Neffy: Withdrawal of the marketing authorisation application



ARS Pharmaceuticals IRL, Limited withdrew its application for a marketing authorisation of Neffy for the emergency treatment of allergic reactions, including anaphylaxis.

The company withdrew the application on 4 April 2022.

  • List item

    Questions and answers on the withdrawal of application for the marketing authorisation of Neffy (adrenaline) (PDF/97.03 KB)

    First published: 22/04/2022
    Last updated: 20/05/2022

  • Key facts

    Product number
    International non-proprietary name (INN) or common name
    • epinephrine
    Active substance
    • epinephrine
    Date of withdrawal
    Company making the application
    Ars Pharmaceuticals Irl Limited
    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    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

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