Desloratadine Krka: Withdrawal of the marketing authorisation application
desloratadine
Table of contents
Overview
On 14 October 2011, Krka, d.d., Novo mesto officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Desloratadine Krka, for the relief of symptoms of allergic rhinitis or urticaria.
Key facts
Name |
Desloratadine Krka |
Product number |
EMEA/H/C/002461 |
International non-proprietary name (INN) or common name |
|
Active substance |
|
Date of withdrawal |
14/10/2011 |
Company making the application | |
Withdrawal type |
Initial authorisation |
All documents
-
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Withdrawal assessment report for Desloratadine Krka (PDF/198.65 KB)
Adopted
First published: 26/01/2012
Last updated: 26/01/2012
EMA/32973/2012 -
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Withdrawal letter: Desloratadine Krka (PDF/37.86 KB)
First published: 17/11/2011
Last updated: 17/11/2011 -
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Krka, d.d., Novo mesto withdraws its marketing authorisation application for Desloratadine Krka (desloratadine) (PDF/56.62 KB)
First published: 19/10/2011
Last updated: 19/10/2011
EMA/840073/2011 -
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Questions and answers on the withdrawal of the marketing authorisation application for Desloratadine Krka (PDF/58.21 KB)
First published: 17/11/2011
Last updated: 17/11/2011
EMA/CHMP/839195/2011
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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').