Urgently required Data request for making an life-saving therapy decission
Dr Juergen Kirchner a fait une demande de Accès à l'information à Agence européenne des médicaments
This request has been closed to new correspondence. Contact us if you think it should be reopened.
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
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