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
16/09/2014 Prolia (denosumab) - Important Safety Information from AMGEN Ireland Limited as approved by the Health Products Regulatory Authority 3rd Party Publications
09/09/2014 Simulect (Basiliximab) - Important Safety Information from Novartis Ireland as approved by the Health Products Regulatory Authority 3rd Party Publications
03/09/2014 Beta interferons: - Important Safety Information from Biogen Idec Ltd., Bayer Ltd., Novartis Ireland Limited and Merck Serono Ltd. as approved by the Health Products Regulatory Authority 3rd Party Publications
01/09/2014 HPRA MIMS Article September 2014 - New Important Advice to Mitigate the Risk of Serious Hypersensitivity Reactions with Rienso (Ferumoxytol) 3rd Party Publications
26/08/2014 Rienso (ferumoxytol) - Important Safety Information from Takeda Products Ireland Ltd. as approved by the Health Products Regulatory Authority 3rd Party Publications
14/08/2014 Important Information for healthcare professions and patients - Changes to tablet appearances, storage conditions, shelf-life and packs. 3rd Party Publications
13/08/2014 Ikorel (Nicorandil) - Important Safety Information from Sanofi-Aventis Ireland Limited T/A SANOFI as approved by the Health Products Regulatory Authority 3rd Party Publications
01/08/2014 Recommendation to restrict the combined use of medicines affecting the Renin – Angiotensin (RAS) system.(HPRA article in Irish Medicines Formulary - August 2014) 3rd Party Publications
30/07/2014 Precautionary Pharmacy Level Recall of Batches of Buccolam Solution in Ireland Recall
28/07/2014 Arzerra (ofatumumab) - Important Safety Information from GlaxoSmithKline Pharmaceuticals as approved by the Health Products Regulatory Authority 3rd Party Publications