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
11/01/2013 Tredaptive (nicotinic acid/laropiprant) - Important Safety Information from Irish Medicines Board 3rd Party Publications
09/01/2013 Revlimid (lenalidomide) - Important Safety Information from Celgene as approved by the Irish Medicines Board 3rd Party Publications
08/01/2013 Tredaptive (nicotinic acid/laropiprant) - Important Safety Information from Merck Sharp & Dohme as approved by the Irish Medicines Board 08.01.2013 3rd Party Publications
08/01/2013 Pradaxa (dabigatran etexilate) - Important Safety Information from Boehringer Ingelheim as approved by the Irish Medicines Board 3rd Party Publications
07/01/2013 Paracetamol Overdose: New Guidance on Treatment with Intravenous Acetylcysteine 3rd Party Publications
04/01/2013 Angiox (bivalirudin) - Important Safety Information from The Medicines Company as approved by the Irish Medicines Board 3rd Party Publications
21/12/2012 European Medicines Agency (EMA) announces a review of Tredaptive, Pelzont and Trevaclyn 3rd Party Publications
20/12/2012 Pradaxa (dabigatran etexilate) - Update to Educational Materials 3rd Party Publications
06/12/2012 Fastum Gel (ketoprofen) - Important Safety Information from A. Menarini Pharmaceuticals Ireland Ltd as approved by the Irish Medicines Board 3rd Party Publications
30/11/2012 Tyverb© (lapatinib) - Important Safety Information from GlaxoSmithKline as approved by the Irish Medicines Board 3rd Party Publications