Safety Notices

From time to time notices relating to the safety, efficacy and quality of human medicinal products are published by the Health Products Regulatory Authority.

The issues covered by these notices include medicinal product safety information, updated efficacy information on the appropriate usage of medicines and quality defect information.

Notices are categorised in accordance with their importance at time of publication.

The four notice categories are outlined as follows:

  • Advisory  -  Routine safety information            
  • Warning  -  Urgent safety information
  • Recall  -  Urgent safety information relating to a product recall
  • Publications  -  General information provided by 3rd parties as approved by the HPRA, e.g. MIMS, Direct Healthcare Professional Letter or Product Information Update

The HPRA Drug Safety Newsletter is also published on a regular basis.

Date Title Type
17/02/2012 Domperidone - Risk of Cardiac Disorders (Products include Domerid/Motilium) 3rd Party Publications
31/01/2012 Apidra (insulin glulisine) - Important Safety Information from Sanofi-Aventis as approved by the Irish Medicines Board 3rd Party Publications
30/01/2012 Gilenya (Fingolimod) - Important Safety Information from Novartis as approved by the Irish Medicines Board 30.01.2013 3rd Party Publications
27/01/2012 CHMP Pharmacovigilance Working Party Monthly report - January 2012 3rd Party Publications
26/01/2012 CHMP Pharmacovigilance Working Party Monthly report - December 2011 3rd Party Publications
24/01/2012 Dianeal, Extraneal and Nutrineal - Important Safety Information from Baxter Healthcare Ltd as approved by the Irish Medicines Board 3rd Party Publications
18/01/2012 Velcade (bortezomib) - Important Safety Information from Janssen-Cilag Ltd as approved by the Irish Medicines Board 3rd Party Publications
04/01/2012 Precautionary notice for consumers on the health dangers of illegal medicines containing Sibutramine Advisory
23/12/2011 European Medicines Agency announces a review of aliskiren-containing medicines 3rd Party Publications
23/12/2011 Rasilez (aliskiren) - Important Safety Information from Novartis as approved by the Irish Medicines Board 3rd Party Publications