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
24/05/2018 HPRA MIMS Article May 2018 Valproate (Epilim) - New contraindications, strengthened warnings and measures to prevent exposure during pregnancy 3rd Party Publications
17/05/2018 Xgeva (denosumab) - Important Safety Information from Amgen as approved by the HPRA (May 2018) 3rd Party Publications
08/05/2018 Summary of Direct Healthcare Professional Communications (DHPCs) issued in April 2018 Advisory
03/05/2018 Azithromycin - Important Safety Information from Pfizer Limited, Aspire Pharma Limited, Krka Pharma Dublin Ltd, Teva and Wockhardt UK Limited as approved by the HPRA 3rd Party Publications
18/04/2018 Valproate (Epilim) - Important Safety Information from Sanofi-Aventis Ireland Ltd. as approved by the HPRA 3rd Party Publications
20/03/2018 Xofigo (Radium-223-dichloride) - Important Safety Information from Bayer AG as approved by the HPRA (March 2018) 3rd Party Publications
13/03/2018 Zinbryta (daclizumab beta) - Important Safety Information from Biogen as approved by the HPRA (March 2018) 3rd Party Publications
20/02/2018 Esmya (ulipristal acetate) - Important Safety Information from Gedeon Richter Plc. as approved by the HPRA 3rd Party Publications
09/02/2018 Ocaliva (obeticholic acid) - Important Safety Information from Intercept as approved by the HPRA 3rd Party Publications
05/02/2018 Summary of Direct Healthcare Professional Communications (DHPCs) issued in January 2018 3rd Party Publications