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
07/01/2011 Thelin (sitaxentan) - Important Safety Information from Pfizer as approved by the Irish Medicines Board 3rd Party Publications
13/12/2010 Second DHPC on Ketoprofen - Important Safety Information from A.Menarini Pharmaceuticals as approved by the Irish Medicines Board 3rd Party Publications
13/12/2010 RoActemra (tocilizumab) - Important Safety Information from Roche as approved by the Irish Medicines Board 3rd Party Publications
09/12/2010 National Monitoring Update - HPV Vaccine (Gardasil)12/09/2010 3rd Party Publications
08/12/2010 Avastin (bevacizumab) - Important Safety Information from Roche as approved by the Irish Medicines Board 3rd Party Publications
08/12/2010 Sutent (sunitinib malate) - Important Safety Information from Pfizer as approved by the Irish Medicines Board 3rd Party Publications
06/12/2010 Oral Biphosphonates and Risk of Oesophageal Cancer 3rd Party Publications
26/11/2010 CHMP Pharmacovigilance Working Party Monthly report - November 2010 3rd Party Publications
24/11/2010 Warfarin Teva - Important Safety Information from Teva Pharmaceuticals Ireland as approved by the Irish Medicines Board 3rd Party Publications
12/11/2010 Alupent Syrup (orciprenaline sulphate) - Important Safety Information from Boehringer Ingelheim 3rd Party Publications