Safety Notices

From time to time notices relating to the safety and/or quality of medicinal products are published by the Health Products Regulatory Authority

These notices are classified under several priority related categories and may relate to human and veterinary medicines, or medical devices.   

The issues covered by these notices will range from quality defect information and medicinal product safety information through to updated information on the appropriate usage of medicines or devices.

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 safety information provided by the HPRA for publication via 3rd parties e.g. MIMS

The HPRA Drug Safety Newsletter is also published on a regular basis.

Date Title Type
12/11/2015 InductOs (dibotermin alfa) - Important Safety Information from Medtronic BioPharma B.V. as approved by the HPRA (Nov 2015) 3rd Party Publications
12/11/2015 Thalidomide (Thalidomide Celgene) - Important Safety Information from Celgene Ltd. as approved by the HPRA 3rd Party Publications
11/11/2015 CellCept (mycophenolate mofetil) - Important Safety Information from Roche Products (Ireland) Ltd. 3rd Party Publications
10/11/2015 Reminyl (galantamine hydrobromide) - Important Safety Information from Shire Pharmaceuticals Ireland Ltd. 3rd Party Publications
20/10/2015 Zelboraf (vemurafenib) - Important Safety Information from Roche Products (Ireland) Ltd. as approved by the HPRA 3rd Party Publications
15/10/2015 Xalkori (crizotinib) - Important Safety Information from Pfizer Healthcare Ireland as approved by the HPRA 3rd Party Publications
08/10/2015 HPRA MIMS Article October 2015 Proton Pump Inhibitors: very rare reports of SCLE 3rd Party Publications
08/10/2015 HPRA MIMS Article September 2015 Codeine:Restricted use in children and adolescents for cough and cold 3rd Party Publications
09/09/2015 Betmiga (mirabegron) - Important Safety Information from Astellas Pharma Co., Ltd. as approved by the HPRA 3rd Party Publications
18/08/2015 InductOs (dibotermin alfa) - Important Safety Information from Medtronic BioPharma B.V. as approved by the HPRA 3rd Party Publications