Desloratadine Krka

Application withdrawn

The application for this medicine has been withdrawn

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.

What is Desloratadine Krka?

Desloratadine Krka is a medicine containing the active substance desloratadine. It was to be available as tablets.

Desloratadine Krka was developed as a 'generic medicine'. This means that Desloratadine Krka was intended to be similar to a 'reference medicine' already authorised in the European Union called Aerius. For more information on generic medicines, see the question-and-answer document here.

What was Desloratadine Krka expected to be used for?

Desloratadine Krka was to be used to relieve the symptoms of allergic rhinitis (inflammation of the nasal passages caused by an allergy, for example, hay fever or allergy to dust mites) or urticaria (a skin condition caused by an allergy, with symptoms including itching and hives).

How is Desloratadine Krka expected to work?

The active substance in Desloratadine Krka, desloratadine, is an antihistamine. It works by blocking the receptors on which histamine, a substance in the body that causes allergic symptoms, normally fixes itself. When the receptors are blocked, histamine cannot have its effect, and this leads to a decrease in the symptoms of allergy.

What did the company present to support its application?

Because Desloratadine Krka was developed as a generic medicine, the company presented the results of studies carried out to investigate whether it is 'bioequivalent' to the reference medicine. Two medicines are bioequivalent when they produce the same levels of the active substance in the body.

How far into the evaluation was the application when it was withdrawn?

The evaluation had finished and the CHMP had given a positive opinion. The company withdrew before the European Commission had issued a decision on this opinion.

What was the recommendation of the CHMP at that time?

Based on the review of the data and the company's response to the CHMP lists of questions, at the time of the withdrawal, the CHMP had given a positive opinion, recommending that a marketing authorisation be granted for Desloratadine Krka for the relief of symptoms of allergic rhinitis or urticaria.

What were the reasons given by the company for withdrawing the application?

The letter from the company notifying the Agency of the withdrawal of the application is available under the tab 'All documents'.

Questions and answers on the withdrawal of the marketing authorisation application for Desloratadine Krka

Reference Number: EMA/CHMP/839195/2011

Key facts

• Name of medicine:
  Desloratadine Krka
• Active substance:
  desloratadine
• International non-proprietary name (INN) or common name:
  desloratadine
• Therapeutic area (MeSH):
  • Rhinitis, Allergic, Perennial
  • Rhinitis, Allergic, Seasonal
• Anatomical therapeutic chemical (ATC) code:
  R06AX27
• EMA product number:
  EMEA/H/C/002461
• Generic:

  This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic and hybrid medicines.

• Marketing authorisation applicant:
  Krka, d.d., Novo mesto
• Withdrawal of application:
  14/10/2011

All documents

Withdrawal assessment report for Desloratadine Krka

Adopted Reference Number: EMA/32973/2012

Withdrawal letter: Desloratadine Krka