HPV Vaccine Safety Review

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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:

I am informed by the UK MHRA that the paper 'Current Safety Concerns with Human Papillomavirus Vaccine: A Cluster Analysis of Reports in VigiBase' was recently evaluated via the European Medicines Agency (EMA) as part of the routine periodic safety update report for Gardasil/Gardasil 9. It was concluded that the publication does not raise any new safety concerns. Please provide evidence used in this review and advise where I can obtain a copy of the review report.

Yours faithfully,

Steve Hinks

PF-15, Europäische Arzneimittel-Agentur

Dear Sir/Madam,
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:
http://www.ema.europa.eu/ema/index.jsp?c...
For more information on ATD please refer to our guide on access to unpublished documents:
http://www.ema.europa.eu/ema/index.jsp?c...
Best regards,
The European Medicines Agency

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