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
24/05/2018 HPRA MIMS Article December 2017 New CPD e-learning module on reporting suspected adverse drug reactions 3rd Party Publications
24/05/2018 HPRA MIMS article January 2018 Quinine. Reminder of safety profile and potential drug drug interactions particularly where used for nocturanl cramps 3rd Party Publications
24/05/2018 HPRA MIMS Article February 2018 Educational Materials and Tools published on HPRA website 3rd Party Publications
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
04/05/2018 Product Information Update- Amoxil (amoxicillin) 3rd Party Publications
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
30/04/2018 Product Information Update- Ultra-Technekow FM radionuclide generator (Sodium pertechnetate ( 99mTc) injection) 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