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
26/02/2013 NeuroBloc (Botulinum Toxin Type B) Important Safety Information from Eisai Ltd as approved by the Irish Medicines Board 3rd Party Publications
25/02/2013 Warnings issued about unlicensed Chinese herbal medicines sold online Advisory
21/02/2013 Prolia (denosumab) Important Safety Information from Amgen Ireland Limited as approved by the Irish Medicines Board 3rd Party Publications
04/02/2013 Xagrid (anagrelide hydrochloride) - Important Safety Information from Shire as approved by the Irish Medicines Board 3rd Party Publications
31/01/2013 European Medicines Agency to review Diane -35 and its generics Advisory
28/01/2013 European Medicines Agency to review third and fourth generation combined oral contraceptives 3rd Party Publications
24/01/2013 Tredaptive (nicotinic acid/laropiprant) - Important Safety Information from Merck Sharp & Dohme as approved by the Irish Medicines Board 3rd Party Publications
18/01/2013 European Medicines Agency confirms recommendation to suspend Tredaptive, Pelzont and Trevaclyn 3rd Party Publications
17/01/2013 Tisseel Lyo, Tisseel Ready to use and Artiss Solutions for Sealant (Human Fibrinogen) - Important Safety Information from Baxter as approved by the Irish Medicines Board 3rd Party Publications
14/01/2013 Gilenya (fingolimod) - Important Safety Information from Novartis Ireland Ltd as approved by the Irish Medicines Board 3rd Party Publications