163. Deputy Michael Healy-Rae asked the Minister for Health the number of reports of serious, suspected adverse drug reactions associated with the use of Roaccutane within 15 days of first notification the Health Products Regulatory Authority has received; the number of these reports the authority has submitted to the European Medicines Agency and to the World Health Organization since its authorisation in 1983; if he will provide the details of these reports categorised by age, gender and year, chronologically; the legislative obligations for this; and if he will make a statement on the matter. [26770/15]

Summary

163. Deputy Michael Healy-Rae asked the Minister for Health the number of reports of serious, suspected adverse drug reactions associated with the use of Roaccutane within 15 days of first notification the Health Products Regulatory Authority has received; the number of these reports the authority has submitted to the European Medicines Agency and to the World Health Organization since its authorisation in 1983; if he will provide the details of these reports categorised by age, gender and year, chronologically; the legislative obligations for this; and if he will make a statement on the matter. [26770/15]

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