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
25/05/2016 Implanon NXT - Important Safety Information from MSD Ireland as approved by the HPRA 3rd Party Publications
24/05/2016 HPRA MIMS Article May 2016 Fingolimod (Gilenya) : Risks related to its immunosuppressive effects 3rd Party Publications
04/05/2016 Invokana (canagliflozin), Vokanamet (canagliflozin, metformin) - Important Safety Information from Janssen-Cilag Limited as approved by the HPRA 3rd Party Publications
26/04/2016 Fusafungine-containing medicinal products - Important Safety Information from Servier Laboratories (Ireland) Ltd. as approved by the HPRA 3rd Party Publications
26/04/2016 Imnovid (pomalidomide) - Important Safety Information from Celgene Europe Limited as approved by the HPRA (April 2016) 3rd Party Publications
20/04/2016 HPRA MIMS Article April 2016 : High Strength Insulin Preparations 3rd Party Publications
20/04/2016 HPRA MIMS Article March 2016 : Oral methotrexate and risk of unintentional overdose due to medication errors 3rd Party Publications
05/04/2016 BCR-ABL tyrosine inhibitors (imatinib, dasatinib, nilotinib, bosutinib, ponatinib) - Important Safety Information from Novartis, Pfizer, BMS and Ariad as approved by the HPRA 3rd Party Publications
24/03/2016 Zydelig (idelalisib) - Important Safety Information from Gilead Sciences Ltd. as approved by the HPRA 3rd Party Publications
21/03/2016 Zaltrap (aflibercept) - Important Safety Information from Sanofi-Aventis Limited T/A SANOFI as approved by the HPRA 3rd Party Publications