Desloratadine Krka: Withdrawal of the marketing authorisation application

desloratadine

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
  • desloratadine
Active substance
  • desloratadine
Date of withdrawal
14/10/2011
Company making the application
Krka, d.d., Novo mesto
Withdrawal type
Initial authorisation

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 (withdrawal letter Doc. type, leave the 'Author' in properties blank).

An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

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