Gallimune Flu H5N9 (i)

Application withdrawn

The application for this medicine has been withdrawn

Overview

An application for the granting of a Community marketing authorisation of Gallimune Flu H5N9(i) was submitted to the European Medicines Agency on 1 December 2009 by Merial in accordance with Regulation (EC) No. 726/2004. The product was eligible for the centralised procedure under Article 3(2) last paragraph of Regulation (EC) No 726/2004 since avian influenza is a disease subject to Community prophylactic measures. Gallimune Flu H5N9(i) contains 0.3 ml dose and is presented in packs/containers of 300 ml. It is indicated for active immunisation of chickens to reduce mortality, clinical signs and viral excretion caused by avian influenza virus type A, highly pathogenic subtype H5N1. The route of administration is intramuscular use. The target species is chickens. The letter of intent was sent in 2006. At that time, outbreaks of Asian Influenza H5N1 in poultry were regarded as being of high risk in Europe. Currently, the disease situation in Europe can be regarded as quiet. There are no reported infections with HPAIV H5N1, neither in poultry or wild birds. Currently high risks are only expected from illegal trade from Asia and Africa. The introduction by wild birds, travellers, vehicles and waterfowl trade is regarded as being low. The introduction by legal trade with third countries and within Europe as well as by travellers and vehicles is regarded as negligible (Source: Friedrich-Löffler-Institut, February 2010). The application was validated on 15 December 2009 and the assessment was carried out by the CVMP in line with its normal timetable. A List of Questions was adopted at day 120 of the procedure on 14 April 2010 and communicated to Merial. Merial then informed the European Medicines Agency on 30 September 2010 that it withdraws the application for Gallimune Flu H5N9 (i). This withdrawal report therefore reflects the CVMP assessment at that stage.

Withdrawal assessment report for Gallimune Flu H5N9(i)

AdoptedReference Number: EMA/675117/2010

Key facts

• Name of medicine:
  Gallimune Flu H5N9 (i)
• EMA product number:
  EMEA/V/C/002229
• Withdrawal of application:
  05/10/2010

All Documents

Withdrawal letter : Gallimune Flu H5N9(i)