Dáil Éireann Debate, Thursday - 25 September 2014
216. Deputy Michael Healy-Rae asked the Minister for Health if the information and advice that is available now was available in January 1998 or has the Department received any new guidelines-information since January 1998 with regard to the cancer drug Roaccutane; and the advice and guidelines that were in place in January 1998. [36365/14]
View answerRoaccutane (containing the active substance, isotretinoin) is authorised for treating severe forms of acne which have been resistant to other standard therapies in Ireland and across the EU. It should only be prescribed by or under the supervision of doctors with expertise in using the product and with a full understanding of the risks of therapy and the monitoring requirements. It has never been approved for use in the treatment of cancer in Ireland.
The currently available product information (i.e. Summary of Product Characteristics and package leaflet) for Roaccutane has been the subject of a number of changes since 1998. As with all medicines, any change to this information requires approval by the Health Products Regulatory Authority (or another EU Member State) on foot of a formal application to vary the authorisation and the submission of relevant supporting data. In practice, product information is frequently updated as new data become available through various sources of post-marketing experience, including further studies, literature reviews, evaluation of adverse reaction data etc. In this context there have been numerous updates and changes to the product information for Roaccutane from January 1998, until now.
If the Deputy seeks more detailed information on the changes to product information , it would be helpful if the specific concerns he would like addressed were specified.
