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
09/11/2009 Rituximab (MabThera) - Important Safety Information from Roche as approved by the Irish Medicines Board 3rd Party Publications
30/10/2009 Cerezyme (Imiglucerase) - Important Safety Information from Genzyme as approved by the Irish Medicines Board 30.10.2009 3rd Party Publications
30/10/2009 Update on Monitoring Experience with Pandemic H1N1 Vaccines Advisory
21/10/2009 ACERYCAL (perindopril, amlodipine) - Important Safety Information from Les Laboratoires Servier 3rd Party Publications
19/10/2009 Intelence (etravirine) 100 mg tablets - Important Safety Information from Janssen-Cilag International NV as approved by the Irish Medicines Board 3rd Party Publications
14/10/2009 Important Safety Warning: Relenza inhalation powder must not be nebulised or administered by mechanical ventilation 14.10.2009 3rd Party Publications
14/10/2009 Important Safety Warning: Relenza inhalation powder must not be nebulised or administered by mechanical ventilation. Warning
05/10/2009 IMB Update on Use of Antiviral Medicines for Pandemic (H1N1) 2009 Influenza (1) 3rd Party Publications
28/09/2009 Fabrazyme (agalsidase beta) revised temporary treatment recommendations - Important Safety Information from Genzyme as approved by the Irish Medicines Board 3rd Party Publications
07/09/2009 Adverse reaction reporting to the IMB for 2008 - update 3rd Party Publications