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Medicinal Products

Dáil Éireann Debate, Tuesday - 15 January 2019

Tuesday, 15 January 2019

Questions (722)

Michael Healy-Rae

Question:

722. Deputy Michael Healy-Rae asked the Minister for Health if he will address a matter (details supplied) regarding the HPV vaccine; and if he will make a statement on the matter. [1239/19]

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Written answers (Question to Health)

The Health Products Regulatory Authority (HPRA) is responsible for monitoring the safety and quality of all medicines and vaccines that are licensed in Ireland. While no medicine (including vaccines) is entirely without risk, the safety profile of Gardasil, as with all medicines, is carefully monitored and any new evidence concerning side-effects is taken into account. HPV is one of the most closely studied and monitored medicinal products around. The HPRA and the European Medicines Agency (EMA) continually monitor adverse events to vaccination. The vast majority of reports received by the HPRA have been consistent with the expected pattern of short term adverse side effects for the vaccine, as described in the product information. These are usually mild and temporary reactions to any kind of vaccination.

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