The Report of the Agency for Medicinal Products and Medical Devices and the European Medicines Agency on adverse reactions to the pandemic vaccine Focetria
The Agency for Medicinal Products and Medical Devices, together with the Croatian National Institute of Public Health, collects and analyses adverse reactions to all vaccines. In the period since the start of the vaccination campaign with the vaccine Focetria (from 27.11. until 28.12.2009.), two adverse reaction reports have been received. Both these reports related to mild and known adverse reactions that were stated in the Patient Information Leaflet.
Tabular presentation of the reports (28th December 2009) can be seen here (available in Croatian).
Tabular presentation of the reports (30th December 2009) can be seen here (available in Croatian).
As of 3 December 2009, the European Medicines Agency (EMA), which has authorised the vaccine Focetria for all EU members through the centralised procedure, has been publishing weekly pandemic influenza pharmacovigilance update reports on its website.
The EMA reports comprise the latest information on the spread of pandemic influenza, number of doses of vaccine and antivirotics distributed or received in Europe, summaries of the vaccine- and antivirotics-induced adverse reactions that were reported to EMA, as well as other information on the benefits and risks of the use of vaccines and antivirotics. For the purposes of the EMA reports, the centrally-authorised medicinal products for pandemic influenza are the vaccines Celvapan, Focetria and Pandemrix, as well as the antiviral medicine Tamiflu.
The EMA reports are available at the link below: