Pioglitazone Teva Generics: Withdrawal of the marketing authorisation application
pioglitazone
Table of contents
Overview
On 26 January 2012, Teva Generics B.V. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Pioglitazone Teva Generics, for the treatment of type-2 diabetes.
Key facts
Name |
Pioglitazone Teva Generics |
Product number |
EMEA/H/C/002448 |
International non-proprietary name (INN) or common name |
|
Active substance |
|
Date of withdrawal |
26/01/2012 |
Company making the application | |
Withdrawal type |
Initial authorisation |
All documents
-
List item
Withdrawal assessment report for Pioglitazone Teva Generics (PDF/282.31 KB)
Adopted
First published: 03/07/2012
Last updated: 03/07/2012
EMA/252892/2012 -
List item
Withdrawal letter: Pioglitazone ratio (PDF/80.16 KB)
First published: 30/04/2012
Last updated: 30/04/2012 -
List item
Questions and answers on the withdrawal of the marketing authorisation application for Pioglitazone Teva Generics (PDF/54.08 KB)
First published: 30/04/2012
Last updated: 30/04/2012
EMA/282199/2012 -
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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').