529. Deputy Michael Healy-Rae asked the Minister for Health if he will provide the details of what dictates or requires the product information for Roaccutane to be reviewed and updated; the number of times this has been done since its authorisation in 1983; the way the Health Products Regulatory Authority and its European Union counterparts have worked with a pharmaceutical company (details supplied) to facilitate availability of appropriate product information in association with Roaccutane since 1983; if he will provide all data, documentation and details relating to this; and if he will make a statement on the matter. [28326/15]

Summary

529. Deputy Michael Healy-Rae asked the Minister for Health if he will provide the details of what dictates or requires the product information for Roaccutane to be reviewed and updated; the number of times this has been done since its authorisation in 1983; the way the Health Products Regulatory Authority and its European Union counterparts have worked with a pharmaceutical company (details supplied) to facilitate availability of appropriate product information in association with Roaccutane since 1983; if he will provide all data, documentation and details relating to this; and if he will make a statement on the matter. [28326/15]

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• Medicinal Products Availability

  xml · EN · 14 July 2015

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