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
17/08/2022 Rubraca (rucaparib) - Important Safety Information from Clovis Oncology UK Ltd as approved by the HPRA (12.08.22) 3rd Party Publications
08/07/2022 Pharmacovigilance Risk Assessment Committee (PRAC) Meeting Highlights 3rd Party Publications
20/06/2022 Dexmedetomidine - Important Safety Information from Marketing Authorisation Holders of products containing dexmedetomidine as approved by the HPRA (16.06.22) 3rd Party Publications
14/06/2022 Defitelio (defibrotide) - Important Safety Information from Gentium S.r.l. as approved by the HPRA (13.06.2022) 3rd Party Publications
10/06/2022 Ocaliva (obeticholic acid) - Important Safety Information from Intercept Pharma Ltd as approved by the HPRA (09.06.2022) 3rd Party Publications
12/05/2022 Rucaparib (Rubraca): Important Safety Information from Clovis Oncology UK Ltd as approved by the HPRA (10.05.22) 3rd Party Publications
08/03/2022 Infliximab (Remicade, Flixabi, Inflectra, and Remsima): Important Safety Information from Marketing Authorisation Holders of products containing Infliximab as approved by the HPRA (07.03.2022) 3rd Party Publications
03/03/2022 HPRA IMF article March 2022 Ibuprofen containing medicines and potential risk of AGEP 3rd Party Publications
16/02/2022 Mavenclad (cladribine) - Important Safety Information from Merck Serono (Ireland) Limited as approved by the HPRA (14.02.22) 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