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 -
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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.
An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').