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
21/02/2005 Celebrex (celecoxib) - Important safety important from Pfizer as approved by the Irish Medicines Board 3rd Party Publications
21/02/2005 Bextra (valdecoxib) - Important safety information from Pfizer as approved by the Irish Medicines Board 3rd Party Publications
21/02/2005 Dynastat (parecoxib sodium) - Important safety information from Pfizer as approved by the Irish Medicines Board 3rd Party Publications
31/01/2005 DEPO-PROVERA (MEDROXYPROGESTERONE 3rd Party Publications
21/12/2004 Bextra (valdecoxib) film-coated tablets and Dynastat (parecoxib sodium) 3rd Party Publications
24/05/2004 Sonovue (sulphur hexafluoride) - Important Safety Information from Bracco as approved by the Irish Medicines Board 3rd Party Publications
16/04/2004 Risperdal (Risperidone) in elderly patients with dementia - Important Safety Information from Janssen-Cilag as approved by the Irish Medicines Board 3rd Party Publications
08/03/2004 Olanzapine - Important Safety Information from Eli Lilly as approved by the Irish Medicines Board 3rd Party Publications
04/02/2003 Enbrel (etanercept) - Important safety information from Wyeth as approved by the Irish Medicines Board 3rd Party Publications
31/01/2003 Rapamune (sirolimus) - Important safety information from Wyeth as approved by the Irish Medicines Board 3rd Party Publications