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
07/12/2011 Fourth DHPC on Ketoprofen - Important Safety Information from A.Menarini Pharmaceuticals as approved by the Irish Medicines Board 3rd Party Publications
01/12/2011 CHMP Parmacovigilance Working Party Monthly report - November 2011 3rd Party Publications
30/11/2011 Motilium (domperidone) - Important Safety Information from McNeil Healthcare (Ireland) Ltd as approved by the Irish Medicines Board 3rd Party Publications
29/11/2011 One-vial Taxotere (docetaxel) - Important Safety Information from Sanofi-Aventis as approved by the Irish Medicines Board 3rd Party Publications
25/11/2011 Vectibix - Important Safety Information from AMGEN (Ireland) Ltd as approved by the Irish Medicines Board 3rd Party Publications
04/11/2011 Pradaxa (dabigatran etexilate) - Important Safety Information from Boehringer Ingelheim as approved by the Irish Medicines Board 04.11.2011 3rd Party Publications
04/11/2011 Cipramil (citalopram) - Important Safety Information from Lundbeck (Ireland) Ltd as approved by the Irish Medicines Board 3rd Party Publications
04/11/2011 CHMP Pharmacovigilance Working Party Monthly report - October 2011 3rd Party Publications
01/11/2011 Multaq (dronedarone) - Restriction of use and new monitoring requirements 3rd Party Publications
25/10/2011 Xigris (drotrecogin alfa (activated)) to be withdrawn due to lack of efficacy 3rd Party Publications