Infinia: Withdrawal of the marketing authorisation application
Table of contents
Overview
On 21 June 2017, Kamada BioPharma Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Infinia, for the treatment of adults with lung disease due to congenital deficiency of alpha-1-antitrypsin.
Key facts
Name |
Infinia |
Product number |
EMEA/H/C/003934 |
Active substance |
|
Date of withdrawal |
21/06/2017 |
Company making the application | |
Withdrawal type |
Initial authorisation |
All documents
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List item
Withdrawal letter: Infinia (PDF/287.37 KB)
First published: 21/07/2017
Last updated: 21/07/2017 -
List item
Questions and answers on the withdrawal of the marketing authorisation application for Infinia (alpha-1-antitrypsin) (PDF/75.2 KB)
First published: 21/07/2017
Last updated: 16/02/2018
EMA/440995/2017 -
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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').