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
24/03/2020 Esmya 5mg Tablets (Ulipristal acetate) - Important Safety Information from Gedeon Richter UK Ltd as approved by the HPRA 3rd Party Publications
20/03/2020 HPRA MIMS Articles March 2020 3rd Party Publications
20/03/2020 HPRA MIMS Articles February 2020 3rd Party Publications
13/03/2020 Pharmacovigilance Risk Assessment Committee (PRAC) Meeting Highlights 3rd Party Publications
17/02/2020 XELJANZ (tofacitinib): Important Safety Information from Pfizer Healthcare Ireland as approved by the HPRA 3rd Party Publications
13/02/2020 HPRA MIMS Article January 2020 3rd Party Publications
13/02/2020 HPRA MIMS Articles December 2019 3rd Party Publications
30/01/2020 Picato (ingenol mebutate) - Important Safety Information from LEO Pharma as approved by the HPRA 3rd Party Publications
28/01/2020 LEMTRADA (alemtuzumab) - Important Safety Information from Sanofi-Aventis Ireland Limited as approved by the HPRA 3rd Party Publications
20/01/2020 Implanon NXT - etonogestrel 68 mg, implant for subdermal use - Important Safety Information from MSD Ireland as approved by the HPRA 3rd Party Publications