Safety Notices

From time to time notices relating to the safety and/or quality of medicinal products are published by the Health Products Regulatory Authority

These notices are classified under several priority related categories and may relate to human and veterinary medicines, or medical devices.   

The issues covered by these notices will range from quality defect information and medicinal product safety information through to updated information on the appropriate usage of medicines or devices.

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 safety information provided by the HPRA for publication via 3rd parties e.g. MIMS

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

Date Title Type
31/07/2006 Co-Amoxiclav and Hepatobiliary Reactions 3rd Party Publications
21/07/2006 Iris Syndrome (IFIS) and Tamsulosin - Important Safety Information from Astellas as approved by the Irish Medicines Board 3rd Party Publications
20/07/2006 Risk of serious hepatic (liver) toxicity with herbal medicinal products containing Cimicifugae Racemosae Rhizoma (Black Cohosh, root) Warning
07/07/2006 HBVAXPRO Hepatitis B vaccine - Important Safety Information from Sanofi Pasteur MSD as approved by the Irish Medicines Board 3rd Party Publications
30/06/2006 Clinical Trials in Ireland 3rd Party Publications
23/06/2006 Xigris (drotrecogin alfa) - Important safety information received from Eli Lilly as approved by the Irish Medicines Board 3rd Party Publications
19/06/2006 Lamictal (lamotrigine) - Important safety information from GlaxoSmithKline as approved by the Irish Medicines Board 3rd Party Publications
19/06/2006 Livial (tibolone) - Important safety information from Akzo Nobel as approved by the Irish Medicines Board 3rd Party Publications
15/06/2006 Safety Notice:Concerning two Chinese Herbal Products which may contain Undeclared Prescription Active Pharmaceutical Ingredients Advisory
07/06/2006 Remicade (infliximab) - Important safety information from Centocor and Schering Plough as approved by the Irish Medicines Board 3rd Party Publications