Dear European Medicines Agency,
Under the right of access to documents in the EU treaties, as developed in Regulation 1049/2001, I am requesting documents which contain the following information:
We urgently need the following data from the EudraVigilance database:
Number of reported cases of Progressive Multifocal Leukencephalopathy (PML) related to
1. Rituximab AND
AND clustered as follows:
a) By year (if possible cumulative for 2005 and earlier) AND
b) By the following regions:
• Reported for the whole EU
• Reported for the USA
This means 72 data sets:
2 drugs x 12 periods of time x 3 regions
This is a life-threatening situation as a patient is highly concerned because of the risk to get a PML because of the treatment with one of the both drugs – although the treatment is pivotal for survival.
Thus, we kindly ask for a quick response!
Dr. Juergen Kirchner
Thank you for contacting the European Medicines Agency.
Please note that this mailbox is not monitored. If you wish to submit requests for information or access to documents, please use the webform by following the link below:
For more information on ATD please refer to our guide on access to unpublished documents:
The European Medicines Agency