Michael Healy-Rae (Kerry South, Independent)
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767. To ask the Minister for Health the number of persons involved in the initial clinical trials of roaccutane prior to its launch and market authorisation; if he will provide details of same; and if he will make a statement on the matter. [30606/15]

Kathleen Lynch (Cork North Central, Labour)
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Roaccutane® is the brand name for the medicinal substance isotretinoin which is authorised for use in the treatment of severe forms of acne. In the application for a marketing authorisation for Roaccutane®, received by the then Irish Medicines Board (now the Health Products Regulatory Authority) in 1982, 451 subjects entered clinical trials of isotretinoin (Roaccutane®) for the indications cystic and conglobate acne, and for severe acne resistant to systemic antimicrobial therapy. The number of patients that received isotretinoin was 423.