Dexamethasone Taw: Withdrawal of the marketing authorisation application
dexamethasone phosphate
Table of contents
Overview
Taw Pharma (Ireland) Ltd withdrew its application for a marketing authorisation of Dexamethasone Taw for the treatment of several inflammatory and other conditions.
The company withdrew the application on 20 January 2021 because it was unable to remove preservatives from the medicine within the timeframe required by EMA.
Key facts
Name |
Dexamethasone Taw |
Product number |
EMEA/H/C/005740 |
International non-proprietary name (INN) or common name |
|
Active substance |
|
Date of withdrawal |
20/01/2021 |
Company making the application | |
Withdrawal type |
Initial authorisation |
All documents
-
List item
Withdrawal assessment report for Dexamethasone Taw (PDF/1.08 MB)
Adopted
First published: 19/03/2021
EMA/78138/2021 -
List item
Withdrawal letter: Dexamethasone Taw (PDF/108.71 KB)
First published: 29/01/2021 -
List item
Questions and answers on the withdrawal of application for the marketing authorisation of Dexamethasone Taw (dexamethasone phosphate) (PDF/139.71 KB)
First published: 29/01/2021
EMA/49981/2021 -
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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').