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
11/02/2014 Triomel (Refined Olive Oil and Refined Soybean Oil) - Important Safety Information from Baxter Healthcare Limited as approved by the Irish Medicines Board 3rd Party Publications
28/01/2014 Combined hormonal contraceptives (CHCs) - Important Safety Information from the Marketing Authorisation Holders as approved by the Irish Medicines Board 3rd Party Publications
22/01/2014 Zofran (ondansetron) - Important Safety Information from GlaxoSmithKline (Ireland) Limited as approved by the Irish Medicines Board 3rd Party Publications
21/01/2014 Abraxane (paclitaxel) - Important Safety Information from Celgene Europe Ltd. as approved by the Irish Medicines Board 3rd Party Publications
08/01/2014 Increlex (mecasermin) - Important Safety Information from Ipsen Pharmaceuticals Ltd. as approved by the Irish Medicines Board 3rd Party Publications
08/01/2014 Erbitux (Cetuximab) - Important Safety Information from Merck Serono Ltd. as approved by the Irish Medicines Board 3rd Party Publications
20/12/2013 Arzerra (ofatumumab) - Important Safety Information from GlaxoSmithKline (Ireland) Ltd. as approved by the Irish Medicines Board 3rd Party Publications
18/12/2013 Flixonase Allergy Relief (fluticasone propionate) - Important Safety Information from GlaxoSmithKline Consumer Healthcare (Ireland) Limited as approved by the Irish Medicines Board 3rd Party Publications
17/12/2013 Temodal (temozolomide) - Important Safety Information from Merck Sharp & Dohme as approved by the Irish Medicines Board 3rd Party Publications
17/12/2013 Xeloda (capecitabine) - Important Safety Information from Roche Products (Ireland) Ltd. as approved by the Irish Medicines Board 3rd Party Publications