165. 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 that a pharmaceutical company (details supplied) has submitted to the Health Products Regulatory Authority; the number of these reports the authority has submitted to the European Medicines Agency; if he will identify these reports by age, gender and year, chronologically; and if he will make a statement on the matter. [26772/15]

Summary

165. 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 that a pharmaceutical company (details supplied) has submitted to the Health Products Regulatory Authority; the number of these reports the authority has submitted to the European Medicines Agency; if he will identify these reports by age, gender and year, chronologically; and if he will make a statement on the matter. [26772/15]

This text is taken from the official record. PoliticalRepo does not editorialize.

Timeline

No timeline events have been ingested for this record yet.

Votes

No vote records are attached yet.

Versions

No version snapshots stored. Document URLs remain at the source.

Documents

1 official file

• Medicinal Products Licensing

  xml · EN · 2 July 2015

  ViewDownloadOpen at official source

Sponsors

No sponsors or actors listed by the source.

Related records

No cross-record relationships stored yet.