Desloratadine Krka: Withdrawal of the marketing authorisation application



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

Desloratadine Krka
Product number
International non-proprietary name (INN) or common name
  • desloratadine
Active substance
  • desloratadine
Date of withdrawal
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.

An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

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