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
25/05/2010 CHMP Pharmacovigilance Working Party Monthly report - April 2010 3rd Party Publications
10/05/2010 Fluoxetine and possible small risk of congenital cardiac defects 3rd Party Publications
10/05/2010 Fentanyl Transdermal Patches - Recommendations for Safe and Appropriate Use 3rd Party Publications
04/05/2010 Exelon / Prometax (rivastigmine) - Important Safety Information from Novartis as approved by the Irish Medicines Board 3rd Party Publications
04/05/2010 Avastin (bevacizumab) - Important Safety Information from Roche as approved by the Irish Medicines Board 04.05.2010 3rd Party Publications
26/04/2010 Fabrazyme (agalsidase beta) - Important Safety Information from Genzyme as approved by the Irish Medicines Board 3rd Party Publications
26/04/2010 Cerezyme (imiglucerase) - Important Safety Information from Genzyme as approved by the Irish Medicines Board 26.04.2010 3rd Party Publications
26/04/2010 Vectibix (panitumumab) - Important Safety Information from Amgen as approved by the Irish Medicines Board 26.04.2010 3rd Party Publications
23/04/2010 Guidance for Marketing Authorisation Holders on Direct Healthcare Professional Communication Drafting 3rd Party Publications
19/04/2010 Palifermin (Kepivance) - Important Safety Information from Biovitrum as approved by the Irish Medicines Board 3rd Party Publications