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
12/03/2012 Onglyza (saxagliptin) - Important Safety Information from Bristol-Myers Squibb as approved by the Irish Medicines Board 3rd Party Publications
12/03/2012 New dosage instructions for children's liquid paracetamol medicines Advisory
09/03/2012 Benlysta (belimumab) - Important Safety Information from GlaxoSmithKline as approved by the Irish Medicines Board 3rd Party Publications
08/03/2012 Vernakalant (Brinavess) - Important Safety Information from MSD as approved by the Irish Medicines Board 3rd Party Publications
27/02/2012 Aliskiren-containing medicinal products - Important Safety Information from Novartis Ireland as approved by the Irish Medicines Board 3rd Party Publications
27/02/2012 CHMP Pharmacovigilance Working Party Monthly report - February 2012 3rd Party Publications
23/02/2012 Victrelis (boceprevir) - Important Safety information from MSD as approved by the Irish Medicines Board 3rd Party Publications
17/02/2012 European Medicines Agency finalises review of aliskiren-containing medicines 3rd Party Publications
17/02/2012 Pradaxa (dabigatran etexilate) - Recommendations for assessment of renal function and monitoring in the elderly 3rd Party Publications
17/02/2012 Domperidone - Risk of Cardiac Disorders (Products include Domerid/Motilium) 3rd Party Publications