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
07/04/2011 Thyrogen (thyrotropin alfa) - Important Safety Information from Genzyme Therapeutics as approved by the Irish Medicines Board 07.04.2011 3rd Party Publications
07/04/2011 Tygacil (tigecycline) - Important Safety Information from Pfizer as approved by the Irish Medicines Board 3rd Party Publications
07/04/2011 Efient (prasugrel) - Important Safety Information from Daiichi Sankyo and Lilly as approved by the Irish Medicines Board 3rd Party Publications
06/04/2011 CHMP Pharmacovigilance Working Party Monthly report - March 2011 3rd Party Publications
05/04/2011 Fluoroquinolones – Risk of QT Prolongation/DHPCs 3rd Party Publications
21/03/2011 Zerit (stavudine) - Important Safety Information from Bristol-Myers Squibb Pharmaceuticals as approved by the Irish Medicines Board 3rd Party Publications
07/03/2011 Multaq (dronedarone) - Association with Severe Liver Injury 3rd Party Publications
24/02/2011 CHMP Pharmacovigilance Working Party Monthly report - February 2011 3rd Party Publications
23/02/2011 Lucentis (ranibizumab) - Important Safety Information as approved by the Irish Medicines Board 3rd Party Publications
14/02/2011 Modafinil (Provigil) - Important Safety Information from Cephalon as approved by the Irish Medicines Board 3rd Party Publications