Safety Notices

From time to time notices relating to the safety and/or quality of medicinal products are published by the Health Products Regulatory Authority

These notices are classified under several priority related categories and may relate to human and veterinary medicines, or medical devices.   

The issues covered by these notices will range from quality defect information and medicinal product safety information through to updated information on the appropriate usage of medicines or devices.

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 safety information provided by the HPRA for publication via 3rd parties e.g. MIMS

The HPRA Drug Safety Newsletter is also published on a regular basis.

Date Title Type
10/08/2018 Esmya (ulipristal acetate) - Important Safety Information from Gedeon Richter Plc. as approved by the HPRA (August 2018) 3rd Party Publications
09/08/2018 Zinbryta (daclizumab beta) - Important Safety Information from Biogen as approved by the HPRA (August 2018) 3rd Party Publications
08/08/2018 Hydroxyethyl starch (HES) solutions for infusion - Important Safety Information from B. Braun Medical Ltd. as approved by the HPRA 3rd Party Publications
08/08/2018 Xofigo (radium-223-dichloride) - Important Safety Information from Bayer AG as approved by the HPRA (August 2018) 3rd Party Publications
02/08/2018 Summary of Direct Healthcare Professional Communications (DHPCs) issued in July 2018 Advisory
31/07/2018 Spinraza (nusinersen) - Important Safety Information from Biogen as approved by the HPRA 3rd Party Publications
17/07/2018 Keytruda (pembrolizumab) - Important Safety Information from Merck Sharp & Dohme B.V. as approved by the HPRA 3rd Party Publications
13/07/2018 Pharmacovigilance Risk Assessment Committee (PRAC) Meeting Highlights 3rd Party Publications
10/07/2018 Tecentriq (atezolizumab) - Important Safety Information Notice from Roche Products (Ireland) Ltd. as approved by the HPRA 3rd Party Publications
05/07/2018 Recall of a number of Valsartan-containing film coated tablet products - Important information for patients and healthcare professionals Recall