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
16/06/2017 Clexane Syringes, Clexane Forte Syringes (enoxaparin sodium) - Important Safety Information from Sanofi Ireland Ltd. as approved by the HPRA 3rd Party Publications
16/06/2017 Uptravi (selexipag) - Important Safety Information from Actelion Pharmaceuitcals UK Ltd as approved by the HPRA 3rd Party Publications
12/06/2017 Levact (bendamustine) - Important Safety Information from Mundipharma Pharmaceuticals Ltd. as approved by the HPRA 3rd Party Publications
12/06/2017 Pharmacovigilance Risk Assessment Committee (PRAC) Meeting Highlights 3rd Party Publications
07/06/2017 HPRA MIMS Article June 2017 - Reminder that fluconazole should not be used in pregnancy 3rd Party Publications
08/05/2017 HPRA MIMS Article May 2017 - Valproate-containing medicines – new EU review initiated 3rd Party Publications
24/04/2017 Cotellic (cobimetinib) - Important Safety Information from Roche Products (Ireland) Ltd. as approved by the HPRA 3rd Party Publications
05/04/2017 HPRA MIMS Article April 2017 - SGLT2 inhibitors and risk of lower limb amputation (mainly toe) 3rd Party Publications
22/03/2017 Herceptin (trastuzumab) - Important Safety Information from Roche Products (Ireland) Ltd. as approved by the HPRA 3rd Party Publications
21/03/2017 Recall of one lot of Epipen 300mcg to patient level in Ireland Recall