Efgratin: Withdrawal of the marketing authorisation application
pegfilgrastim
Table of contents
Overview
On 16 November 2016, Gedeon Richter Plc officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Efgratin, for reducing neutropenia.
Key facts
Name |
Efgratin |
Product number |
EMEA/H/C/004023 |
International non-proprietary name (INN) or common name |
|
Active substance |
|
Date of withdrawal |
16/11/2016 |
Company making the application | |
Withdrawal type |
Initial authorisation |
All documents
-
List item
Withdrawal assessment report for Efgratin (PDF/2.86 MB)
Adopted
First published: 27/06/2017
Last updated: 27/06/2017
EMA/18691/2017 -
List item
Withdrawal letter: Efgratin (PDF/64.37 KB)
First published: 16/12/2016
Last updated: 16/12/2016 -
List item
Questions and answers on the withdrawal of the marketing authorisation application for Efgratin (pegfilgrastim) (PDF/74.15 KB)
First published: 16/12/2016
Last updated: 16/12/2016
EMA/822770/2016 -
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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').