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
17/02/2015 HPRA article in the Irish Medicines Formulary - Domperidone containing Medicines 3rd Party Publications
09/02/2015 Globulin component Macrophage Activating Factor (GcMAF) labelled as “First Immune” - Warning Warning
04/02/2015 Maxolon 5 mg/ml Solution for Injection (PA1142/011/001) and Maxolon 10mg tablets (PA1142/011/003)- Important Safety Information from Amdipharm Limited, as approved by the HPRA (January 2015 Update). 3rd Party Publications
03/02/2015 HPRA MIMS Article - February 2015 - Ivabradine 3rd Party Publications
12/01/2015 HPRA MIMS Article - January 2015 - Valproate-containing medicines: 3rd Party Publications
23/12/2014 Xofigo (radium-223 chloride) - Important Safety Information from Bayer Healthcare as approved by the HPRA. (Decemeber 2014 Update) 3rd Party Publications
16/12/2014 Cellcept (mycophenolate mofetil) and Myfortic (mycophenolic acid) - Important Safety Information from Roche Products (Ireland) Ltd. and Novartis Ireland Ltd. as approved by the Health Products Regulatory Authority 3rd Party Publications
12/12/2014 Procoralan (ivabradine hydrochloride) - Important Safety Information from Servier Laboratories (Ireland) Ltd. as approved by the Health Products Regulatory Authority 3rd Party Publications
10/12/2014 HPRA MIMS Article - Decemeber 2014 - Agomelatine (Valdoxan) 3rd Party Publications
10/12/2014 HPRA MIMS Article - Decemeber 2014 - Compendium 3rd Party Publications