Safety Notices

From time to time notices relating to the safety, efficacy and quality of human medicinal products are published by the Health Products Regulatory Authority.

The issues covered by these notices include medicinal product safety information, updated efficacy information on the appropriate usage of medicines and quality defect information.

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 information provided by 3rd parties as approved by the HPRA, e.g. MIMS, Direct Healthcare Professional Letter or Product Information Update

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

Date Title Type
16/04/2020 Cyproterone acetate - Important Safety Information from Bayer Ltd as approved by the HPRA 3rd Party Publications
07/04/2020 HPRA IMF Article March 2020 3rd Party Publications
07/04/2020 HPRA MIMS Articles April 2020 3rd Party Publications
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
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