Ogivri: Withdrawal of the marketing authorisation application
Table of contents
Overview
On 3 August 2017, Mylan S.A.S. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Ogivri, for the treatment of breast cancer and gastric cancer.
Key facts
Name |
Ogivri |
Product number |
EMEA/H/C/004346 |
Date of withdrawal |
03/08/2017 |
Withdrawal type |
Initial authorisation |
All documents
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List item
Withdrawal assessment report for Ogivri (PDF/4.75 MB)
Adopted
First published: 28/11/2017
Last updated: 28/11/2017
EMA/305022/2017 -
List item
Withdrawal letter: Ogivri (PDF/46.44 KB)
First published: 15/09/2017
Last updated: 15/09/2017 -
List item
Questions and answers on the withdrawal of the marketing authorisation application for Ogivri (trastuzumab) (PDF/68.17 KB)
First published: 15/09/2017
Last updated: 15/09/2017
EMA/564631/2017 -
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 (withdrawal letter Doc. type, leave the 'Author' in properties blank).
An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').