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
08/08/2018 Xofigo (radium-223-dichloride) - Important Safety Information from Bayer AG as approved by the HPRA (August 2018) 3rd Party Publications
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
10/07/2018 Tecentriq (atezolizumab) - Important Safety Information Notice from Roche Products (Ireland) Ltd. as approved by the HPRA 3rd Party Publications
02/07/2018 Summary of Direct Healthcare Professional Communications (DHPCs) issued in June 2018 3rd Party Publications
25/06/2018 Darunavir/cobicistat - Important Safety Information from Janssen as approved by the HPRA 3rd Party Publications
06/06/2018 Vectibix (panitumumab) - Important Safety Information from Amgen as approved by the HPRA 3rd Party Publications
05/06/2018 Summary of Direct Healthcare Professional Communications (DHPCs) issued in May 2018 3rd Party Publications
28/05/2018 Granulocyte colony-stimulating factors (G-CSFs) (Filgrastim, Lenograstim, Lipegfilgrastim and Pegfilgrastim) - Important Safety Information from Amgen Europe B.V, Chugai Pharma UK, Teva, Apotex Europe B.V, and Accord Healthcare Ltd as approved by the HPRA 3rd Party Publications
25/05/2018 Tivicay (dolutegravir), Triumeq (dolutegravir, abacavir, lamivudine), Juluca (dolutegravir, rilpivirine) - Important Safety Information from Viiv Healthcare as approved by the HPRA 3rd Party Publications