Egranli: Withdrawal of the marketing authorisation application
Table of contents
Overview
On 4 November 2014, Teva Pharma 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 Egranli, for reduction in the duration of neutropenia and the occurrence of febrile neutropenia in adult cancer patients.
Key facts
Name |
Egranli |
Product number |
EMEA/H/C/002637 |
Date of withdrawal |
04/11/2014 |
Withdrawal type |
Initial authorisation |
All documents
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List item
Withdrawal assessment report for Egranli (PDF/2.16 MB)
Adopted
First published: 16/02/2015
Last updated: 16/02/2015
EMA/CHMP/453321/2014 -
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Withdrawal letter: Egranli (PDF/56.19 KB)
First published: 21/11/2014
Last updated: 21/11/2014 -
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Questions and answers on the withdrawal of the marketing authorisation application for Egranli (balugrastim) (PDF/72.42 KB)
First published: 21/11/2014
Last updated: 16/02/2015
EMA/705109/2014 -
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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').