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
29/08/2016 Pro-Epanutin (fosphenytoin sodium) - Important Safety Information from Pfizer Healthcare Ireland as approved by the HPRA 3rd Party Publications
24/08/2016 Zydelig (idelalisib) - Important Safety Information from Gilead Sciences Ltd as approved by the HPRA 3rd Party Publications
16/08/2016 HPRA IMF Article August 2016-Valproate containing medicines. New educational materials available for healthcare professionals and patients 3rd Party Publications
16/08/2016 Humalog (insulin lispro) - Important Safety Information from Eli Lilly and Co (Ireland) Limited as approved by the HPRA 3rd Party Publications
11/08/2016 HPRA MIMS Article August 2016 Miconazole and warfarin - reminder of the potential for interaction 3rd Party Publications
11/08/2016 HPRA MIMS Article July 2016 Risk of Pneumonia with Inhaled Corticosteroids for Chronic Obstructive Pulmonary Disease (COPD) 3rd Party Publications
20/07/2016 Noxafil (posaconazole) - Important Safety Information from Merck Sharp and Dohme Limited (MSD) as approved by the HPRA 3rd Party Publications
07/07/2016 Adempas (riociguat) - Important Safety Infomation from Bayer Pharma AG and MSD as approved by the HPRA 3rd Party Publications
21/06/2016 Thalidomide Celgene - Important Safety Information from Celgene Europe Limited as approved by the HPRA (June 2016) 3rd Party Publications
16/06/2016 HPRA MIMS Article June 2016 Withdrawal of Fusafungine containing Medicinal Products 3rd Party Publications