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
02/11/2010 Roaccutane (isotretinoin) - Important Safety Information from Roche as approved by the Irish Medicines Board 3rd Party Publications
01/11/2010 CHMP Pharmacovigilance Working Party Monthly report - October 2010 3rd Party Publications
29/10/2010 Ebixa memantine hydrochloride oral solution - Important Safety Information from Lundbeck as approved by the Irish Medicines Board 3rd Party Publications
21/10/2010 Update on National Monitoring Experience with Gardasil 3rd Party Publications
13/10/2010 Tisseel Kit - Important Safety Information from Baxter as approved by the Irish Medicines Board 3rd Party Publications
06/10/2010 Adverse Reaction Reporting to the IMB for 2009 3rd Party Publications
30/09/2010 CHMP Pharmacovigilance Working Party Monthly report - September 2010 3rd Party Publications
28/09/2010 Rosiglitazone-containing products (Avandia, Avandamet, and Avaglim) - Important Safety Information from GlaxoSmithKline as approved by the Irish Medicines Board 3rd Party Publications
27/09/2010 RELISTOR (methylnaltrexone bromide) - Important Safety Information from Wyeth as approved by the Irish Medicines Board 3rd Party Publications
24/09/2010 Cerezyme (imiglucerase) - Important Safety Information from Genzyme as approved by the Irish Medicines Board 3rd Party Publications