EMEA Statement on the safety of Gardasil

Notice type: Advisory

Date: 24/01/2008


Product name or type:

Active Substance:
Human Papillomavirus Vaccine

Problem Or Issue:
The European Medicines Agency (EMEA) has issued a statement on the safety of Gardasil following reports of deaths in women who had previously received the vaccine, including two cases which occurred in the European Union (Austria and Germany). The EU cases were reported as part of the continuous monitoring of the safety of medicines. In both cases, the cause of death was not identified and a causal relationship between administration of Gardasil and the deaths of the women has not been established. On the basis of the currently available information, the EMEA’s Committee for Medicinal Products for Human Use is of the opinion that the benefits of Gardasil continue to outweigh its risks and that no changes to the product information are necessary.

Background Information Or Related Documents:
EMEA Statement on the safety of Gardasil Document

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