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
28/05/2009 Fungizone® (Amphotericin B for injection) - Important Safety Information from Bristol-Myers Squibb Pharmaceuticals as approved by the Irish Medicines Board 3rd Party Publications
18/05/2009 Livial (tibolone) - Important Safety Information from Schering-Plough on updated prescribing information for Livial (tibolone) 3rd Party Publications
15/05/2009 Guidelines for Reporting Suspected Adverse Reactions to Antiviral Medicines an Influenza Pandemic Advisory
12/05/2009 Safety review of Clopidogrel – IMB interim advice on the concurrent use of Proton Pump Inhibitors in patients treated with Clopidogrel Advisory
07/05/2009 IMB warns consumers not to purchase anti-viral medication online Warning
04/05/2009 Tibolone and Breast Cancer – Result of LIBERATE trial – May 09, 2009 - MIMS Publication 3rd Party Publications
29/04/2009 Tazocin (Piperacillin/Tazobactam) - Important Safety Information from Wyeth following approval by the Irish Medicines Board 3rd Party Publications
23/04/2009 Medicines for the Management of Attention Deficit Hyperactivity Disorder (ADHD) (Part II) – Methylphenidate - Apr 09, 2009 - MIMS Publication 3rd Party Publications
23/04/2009 Topical Salicylate Products for oral use in children Advisory
07/04/2009 Update on the Heparin Over-Sulphated Chondroitin Sulphate (OSCS) issue Advisory