SecreFlo: Withdrawal of the marketing authorisation application
Table of contents
Overview
On 15 August 2012, Repligen Europe Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for SecreFlo, intended for use in the detection of duct abnormalities in the pancreas.
Key facts
Name |
SecreFlo |
Product number |
EMEA/H/C/002027 |
Date of withdrawal |
15/08/2012 |
Company making the application | |
Withdrawal type |
Initial authorisation |
All documents
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Withdrawal assessment report for SecreFlo (PDF/592.36 KB)
Adopted
First published: 30/11/2012
Last updated: 30/11/2012
EMA/482305/2012 -
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Withdrawal letter: SecreFlo (secretin human) (PDF/24.39 KB)
First published: 24/09/2012
Last updated: 24/09/2012 -
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RepliGen Europe Limited withdraws its marketing authorisation application for SecreFlo (secretin human) (PDF/70.1 KB)
First published: 14/09/2012
Last updated: 14/09/2012
EMA/597126/2012 -
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Questions and answers on the withdrawal of the marketing authorisation application for SecreFlo (secretin human) (PDF/56.64 KB)
First published: 24/09/2012
Last updated: 24/09/2012
EMA/CHMP/602611/2012 -
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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').