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
27/02/2023 Bendamustine Accord 25mg/ml concentrate for solution for infusion - Important Safety Information from Accord Healthcare Ireland Ltd as approved by the HPRA (21.02.2023) 3rd Party Publications
22/02/2023 Zolgensma (Onasemnogene aberparvovec) - Important Safety Information from Novartis UK Limited as approved by the HPRA (16.02.2023) 3rd Party Publications
22/02/2023 Medicinal Product Shortages - update - 22 February 2023 Advisory
17/02/2023 Safety Update: COVID-19 Vaccines — Overview of National Reporting Experience — 17 February 2023 Advisory
15/02/2023 ADAKVEO (Crizanlizumab) - Important Safety Information from Novartis Ireland Ltd as approved by the HPRA (14.02.23) 3rd Party Publications
15/02/2023 Medicinal Product Shortages - update - 15 February 2023 Advisory
08/02/2023 Medicinal Product Shortages - update - 8 February 2023 Advisory
01/02/2023 Medicinal Product Shortages - update - 1 February 2023 Advisory
30/01/2023 Levothyroxine containing products - Important Safety Information from Amdipharm Limited Ireland and Teva Pharmaceuticals Ireland as approved by the HPRA (20.01.23) 3rd Party Publications
27/01/2023 Caprelsa (vandetanib) - Important Safety Information from Sanofi-Aventis Ireland Limited as approved by the HPRA (10.01.23) 3rd Party Publications