Blectifor: Withdrawal of the marketing authorisation application
caffeine citrate
Table of contents
Overview
On 9 March 2017, Viridian Pharma Ltd officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Blectifor, for the prevention of bronchopulmonary dysplasia.
Key facts
Name |
Blectifor |
Product number |
EMEA/H/C/004100 |
International non-proprietary name (INN) or common name |
|
Active substance |
|
Date of withdrawal |
09/03/2017 |
Company making the application | |
Withdrawal type |
Initial authorisation |
All documents
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Withdrawal assessment report for: Blectifor (PDF/1.21 MB)
Adopted
First published: 16/05/2017
Last updated: 16/05/2017
EMA/CHMP/41570/2017 -
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Withdrawal letter: Blectifor (PDF/47.75 KB)
First published: 24/03/2017
Last updated: 24/03/2017 -
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Questions and answers on the withdrawal of the marketing authorisation application for Blectifor (caffeine citrate) (PDF/74.71 KB)
First published: 24/03/2017
Last updated: 24/03/2017
EMA/188385/2017 -
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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').