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
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
01/06/2006 Fleet (phosphosoda) - Important safety information from DeWitt as approved by the Irish Medicines Board 3rd Party Publications
31/05/2006 SAFETY REVIEW OF PROTOPIC (TACROLIMUS) 3rd Party Publications
22/05/2006 Revatio (sildenafil citrate) - Important Safety Information from Pfizer as approved by the Irish Medicines Board 3rd Party Publications