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
27/01/2011 Multaq (dronedarone) - Important Safety Information from sanofi-aventis as approved by the Irish Medicines Board 27.01.2011 3rd Party Publications
26/01/2011 Nplate (romiplostim) - Important Safety Information from Amgen as approved by the Irish Medicines Board 3rd Party Publications
26/01/2011 Dianeal, Extraneal and Nutrineal - Important Safety Information from Baxter as approved by the Irish Medicines Board 3rd Party Publications
26/01/2011 Update - Dianeal, Extraneal and Nutrineal - Important Safety Information from Baxter as approved by the Irish Medicines Board 3rd Party Publications
25/01/2011 Magicream 25.01.2011 Warning
19/01/2011 Vistide (cidofovir) - Important Safety Information from Gilead as approved by the Irish Medicines Board 3rd Party Publications
10/01/2011 BCG Vaccine SSI and Severe Local Reactions 3rd Party Publications
10/01/2011 CHMP Pharmacovigilance Working Party Monthly report - December 2010 3rd Party Publications
07/01/2011 Thelin (sitaxentan) - Important Safety Information from Pfizer as approved by the Irish Medicines Board 3rd Party Publications
13/12/2010 Second DHPC on Ketoprofen - Important Safety Information from A.Menarini Pharmaceuticals as approved by the Irish Medicines Board 3rd Party Publications