From 1 October 2008 and two years onwards, the Danish Medicines Agency implements special monitoring of side effects (adverse reactions) from the Gardasil® cervical cancer vaccine.
On a monthly basis, we will extract data from both the Danish and European adverse reactions databases. In this connection, we encourage everyone to report all suspected side effects from the Gardasil® vaccine via meldenbivirkning.dk.
Doctors, healthcare professionals, medicine users and relatives can report side effects directly to the Danish Medicines Agency.
Part of the child vaccination programme from 1 October
The special monitoring activities are implemented because the Gardasil® vaccine becomes part of the child vaccination programme from 1 October 2008.
Gardasil® is approved in the EU for the prevention of cervical cancer and other diseases caused by human papillomavirus (HPV) types 6, 11, 16 and 18 in women.
Doctors have been informed separately
The Danish Medicines Agency has urged all general practitioners to stay alert to suspected adverse reactions from Gardasil® in an information package distributed by the National Board of Health in mid-September.
Via the factbox to the right, you can see the National Board of Health’s information communicated to doctors and girls (/parents) covered by the programme (in Danish only).
Danish Medicines Agency, 30 September 2008
