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
03/09/2021 Pharmacovigilance Risk Assessment Committee (PRAC) Meeting Highlights 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
12/07/2021 Xeljanz (tofacitinib) - Important Safety Information from Pfizer Healthcare Ireland as approved by the HPRA (July 2021) 3rd Party Publications
25/06/2021 DINOPROSTONE - Important Safety Information from Ferring Ireland Limited and Pfizer Healthcare Ireland of products containing Dinoprostone as approved by the HPRA 3rd Party Publications
22/06/2021 VAXZEVRIA - COVID-19 Vaccine AstraZeneca - Important Safety Information from AstraZeneca Pharmaceuticals (Ireland) DAC as approved by the HPRA 3rd Party Publications
11/06/2021 Venclyxto (venetoclax) film coated tablets - Important Safety Information from AbbVie Limited as approved by the HPRA 3rd Party Publications
08/06/2021 Product Information Update – Chloromycetin Redidrops Eye Drops (Chloramphenicol) 3rd Party Publications