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
20/02/2018 Esmya (ulipristal acetate) - Important Safety Information from Gedeon Richter Plc. as approved by the HPRA 3rd Party Publications
09/02/2018 Ocaliva (obeticholic acid) - Important Safety Information from Intercept as approved by the HPRA 3rd Party Publications
05/02/2018 Summary of Direct Healthcare Professional Communications (DHPCs) issued in January 2018 3rd Party Publications
23/01/2018 Mycophenolate mofetil (MMF)/mycophenolic acid (MPA) - Important Safety Information from Roche Products (Ireland) Limited, Novartis Ireland Limited, Teva, Accord Healthcare Limited, Clonmel Healthcare Ltd. and Rowex Ltd.as approved by the HPRA 3rd Party Publications
23/01/2018 Buccolam (midazolam) - Important Safety Information from Shire Services BVBA as approved by the HPRA (Jan 2018) 3rd Party Publications
17/01/2018 Summary of Direct Healthcare Professional Communications (DHPCs) - Issued in December 2017 3rd Party Publications
15/12/2017 FLOLAN (epoprostenol sodium) - Important Safety Information from GlaxoSmithKline Pharmaceuticals as approved by the HPRA 3rd Party Publications
13/12/2017 Xofigo (radium-223-dichloride) - Important Safety Information from Bayer AG as approved by the HPRA (December 2017) 3rd Party Publications
13/12/2017 Eligard (Leuprorelin acetate depot injection) - Important Safety Information from Astellas Pharma Co., Ltd. as approved by the HPRA 3rd Party Publications
12/12/2017 Gadolinium contrast agents - Important Safety Information from Bayer Ltd, Bracco Imaging S.p.A, GE Healthcare Ltd and Guerbet as approved by the HPRA 3rd Party Publications