Urgently required Data request for making an life-saving therapy decission
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
2. Natalizumab
AND clustered as follows:
a) By year (if possible cumulative for 2005 and earlier) AND
b) By the following regions:
• All
• 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!
Yours faithfully,
Dr. Juergen Kirchner
Dear Sir/Madam,
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Best regards,
The European Medicines Agency