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
02/03/2010 Fabrazyme (agalsidase beta) - Important Safety Information from Genzyme as approved by the Irish Medicines Board 02.03.2010 3rd Party Publications
02/03/2010 Cerezyme (imiglucerase) - Important Safety Information from Genzyme as approved by the Irish Medicines Board 02.03.2010 3rd Party Publications
26/02/2010 Avoiding Medication Errors with Perindopril Arginine/Amlodipine (Acerycal) Combination Products 3rd Party Publications
22/02/2010 An update on the association of natalizumab (TYSABRI) with Progressive Multifocal Leukoencephalopathy (PML) - Important Safety Information from Elan and Biogen Idec (Ireland) Limited as approved by the Irish Medicines Board 3rd Party Publications
18/02/2010 Update on the National Monitoring Experience with Pandemic H1N1 Vaccines Advisory
16/02/2010 Protopic - Important Safety Information from Astellas Pharma Co. Ltd. as approved by the Irish Medicines Board 3rd Party Publications
07/02/2010 Bisphosphonates and Osteonecrosis of the jaw: update on risk minimisation including new recommendations on preventative dental measures 3rd Party Publications
04/02/2010 RAPAMUNE® (sirolimus) - Important Safety Information from Wyeth Pharmaceuticals Limited as approved by the Irish Medicines Board 3rd Party Publications
04/02/2010 Update on National Monitoring Experience with Pandemic H1N1 Vaccines Advisory
29/01/2010 Bisphosphonates and Osteonecrosis of the Jaw: Risk Minimisation and Recommended Preventative Dental Measures 3rd Party Publications