Neffy: Withdrawal of the marketing authorisation application
epinephrine
Table of contents
Overview
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.
Key facts
Name |
Neffy |
Product number |
EMEA/H/C/005584 |
International non-proprietary name (INN) or common name |
|
Active substance |
|
Date of withdrawal |
04/04/2022 |
Company making the application | |
Withdrawal type |
Initial authorisation |
All documents
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List item
Withdrawal assessment report for Neffy (PDF/10.04 MB)
Adopted
First published: 20/05/2022
EMA/204348/2022 -
List item
Withdrawal letter: Neffy (PDF/16.92 KB)
First published: 22/04/2022 -
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
EMA/222587/2022 -
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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').