Gastromotal: Withdrawal of the marketing authorisation application
Table of contents
Overview
On 5 November 2007, INFAI, Institut für biomedizinische Analytik & NMR-Imaging GmbH officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Gastromotal, for in vivo diagnosis of solid-phase gastric half emptying time in gastric motility disorders.
Key facts
Name |
Gastromotal |
Product number |
EMEA/H/C/000724 |
Date of withdrawal |
05/11/2007 |
Company making the application | |
Withdrawal type |
Initial authorisation |
All documents
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Withdrawal assessment report for Gastromotal (PDF/122.08 KB)
Adopted
First published: 10/03/2008
Last updated: 10/03/2008
EMEA/111865/2008 -
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INFAI withdraws its marketing authorisation application for Gastromotal (PDF/31.02 KB)
First published: 16/11/2007
Last updated: 16/11/2007
EMEA/521472/2007 -
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Withdrawal letter : Gastromotal (PDF/35.38 KB)
First published: 05/11/2007
Last updated: 05/11/2007 -
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Questions and answers on the withdrawal of the marketing application for Gastromotal (PDF/50.7 KB)
First published: 16/11/2007
Last updated: 16/11/2007
EMEA/519568/2007 -
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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').