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
17/08/2009 Cerezyme (imiglucerase) - Important Safety Information from Genzyme as approved by the Irish Medicines Board 17.08.2009 3rd Party Publications
11/08/2009 EFIENT® (prasugrel) - Important Safety Information from Danchii-Sankyo and Lilly as approved by the Irish Medicines Board 3rd Party Publications
11/08/2009 Update on the Safety of Antipsychotic Medicines 3rd Party Publications
05/08/2009 Potential Interaction of Proton Pump Inhibitors with Clopidogrel-containing medicines (Plavix) - Important Safety Information from sanofi-aventis Ireland Ltd. as approved by the Irish Medicines Board 3rd Party Publications
28/07/2009 IMB Guidance on possible interaction between Clopidogrel and Proton Pump Inhibitors 3rd Party Publications
16/07/2009 Abelcet (amphotericin B-lipid complex) - Important Safety Information from Cephalon as approved by the Irish Medicines Board 3rd Party Publications
25/06/2009 Cerezyme (imiglucerase) and Fabrazyme (agalsidase beta) - Important safety information from Genzyme as approved by the Irish Medicines Board 3rd Party Publications
08/06/2009 CellCept (mycophenolate mofetil) - Important Safety Information from Roche as approved by the Irish Medicines Board 3rd Party Publications
05/06/2009 Exenatide (Byetta) – Risk of severe pancreatitis and warnings regarding use in renal impairment 3rd Party Publications
05/06/2009 Updated Information on Possible Interaction between Clopidogrel and Proton Pump Inhibitors Advisory