Influenza A/H1N1v: Pharmacovigilance in Europe

The European Medicines Agency (EMEA) issued, as part of the A/H1N1v influenza pandemic, the first report in the weekly update on the monitoring of adverse reactions related to vaccines and antiviral medicines used in Europe.

The European Medicines Agency has published on 3rd December the first in a series of weekly pandemic pharmacovigilance updates.

Successive reports can be found on the page: "European reports on pharmacovigilance for vaccines and antiviral drugs used as prevention and/of treatment of the A/H1N1v influenza pandemic”.

These weekly bulletins will provide information on adverse reactions reported after the use of centrally authorised pandemic influenza vaccines and antivirals in the European Union and complement the information the Agency has been publishing regularly on the development and approval of medicines for use during the pandemic.

“I am confident that the weekly updates will allow to further increase transparency in the field of pandemic and to provide up to date information in a timely manner to the public,” said Thomas Lönngren, Executive Director of the European Medicines Agency.

This information will support European institutions and Member States in their communications, and provide an additional resource when recommending the use of vaccines and antiviral treatments.

The information on adverse reactions in the update comes from EudraVigilance, the central European database on adverse reactions, managed by the Agency. It is based on reports from Member States and marketing authorisation holders.

The weekly update also provides an estimate of how many doses of pandemic vaccines and antivirals have been administered in the European Union, and other information that helps put adverse reaction reports in context.


1. Update of 3rd December 2009.

2. There are three pandemic vaccines, Celvapan, Focetria and Pandemrix, authorised by the European Commission, and one antiviral, Tamiflu.There are other pandemic vaccines and antivirals approved by Member States. Information on the Agency’s activities in relation to the influenza pandemic can be found on the EMEA's Pandemic influenza (H1N1) website.

3. All the information on the work of the European Medicines Agency, can be found on the EMEA's website.



Last updated on 11/12/2009