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
14/01/2022 Pharmacovigilance Risk Assessment Committee (PRAC) Meeting Highlights 3rd Party Publications
10/11/2021 Beovu (brolucizumab) - Important Safety Information from Novartis Ireland Ltd as approved by the HPRA (09.11.21) 3rd Party Publications
29/10/2021 Forxiga (dapagliflozin) - Important Safety Information from AstraZeneca Pharmaceuticals (Ireland) DAC as approved by the HPRA (29.10.21) 3rd Party Publications
15/10/2021 VAXZEVRIA/COVID-19 Vaccine AstraZeneca - Important Safety Information from AstraZeneca (Ireland) DAC as approved by the HPRA (13.10.21) 3rd Party Publications
15/10/2021 COVID-19 Vaccine Janssen - Important Safety Information from Janssen Sciences Ireland UC as approved by the HPRA (13.10.21) 3rd Party Publications
04/10/2021 CHAMPIX (varenicline) - Important Safety Information from Pfizer Healthcare Ireland as approved by HPRA (30.09.21) 3rd Party Publications
18/08/2021 Deoxycholic acid (BELKYRA) - Important Safety Information from Allergan Ltd as approved by the HPRA 3rd Party Publications
19/07/2021 Covid-19 mRNA Vaccines Comirnaty and Spikevax - Important Safety Information from Biontech-Pfizer and Moderna Biotech Spain S.L. as approved by the HPRA 3rd Party Publications
19/07/2021 CHAMPIX (varenicline) - Important Safety Information from Pfizer Healthcare Ireland as approved by HPRA 3rd Party Publications
19/07/2021 Covid-19 Vaccine Janssen - Important Safety Information from Janssen Sciences Ireland UC as approved by the HPRA (19 July 2021) 3rd Party Publications