Miplyffa : Withdrawal of the marketing authorisation application
arimoclomol
Table of contents
Overview
Orphazyme A/S withdrew its application for a marketing authorisation of Miplyffa for the treatment of Niemann-Pick disease type C (NPC) in patients aged 2 years and older in combination with miglustat (another medicine to treat NPC).
The company withdrew the application on 22 March 2022.
Key facts
Name |
Miplyffa |
Product number |
EMEA/H/C/005203 |
International non-proprietary name (INN) or common name |
|
Active substance |
|
Date of withdrawal |
22/03/2022 |
Company making the application | |
Withdrawal type |
Initial authorisation |
All documents
-
List item
Withdrawal assessment report for Miplyffa (PDF/6.74 MB)
Adopted
First published: 07/02/2023
EMA/177363/2022 -
List item
Withdrawal letter: Miplyffa (PDF/87.92 KB)
First published: 22/04/2022 -
List item
Questions and answers on the withdrawal of application for the marketing authorisation of Miplyffa (arimoclomol) (PDF/115.83 KB)
First published: 22/04/2022
EMA/219136/2022 -
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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').