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
30/07/2010 CHMP Pharmacovigilance Working Party Monthly report - July 2010 3rd Party Publications
28/07/2010 Rosiglitazone–containing Medicines (Avandia/Avandamet) – Direct Healthcare Professional Communication issued by the Irish Medicines Board 3rd Party Publications
22/07/2010 European Medicines Agency issues interim update on ongoing benefit/risk review of rosiglitazone–containing medicines Advisory
20/07/2010 Invirase (saquinavir) - Important Safety Information from Roche Products (Ireland) Limited as approved by the Irish Medicines Board 3rd Party Publications
08/07/2010 PERFALGAN 10 mg/ml, solution for infusion - Important Safety Information from Bristol-Myers Squibb Pharmaceuticals as approved by the Irish Medicines Board 3rd Party Publications
05/07/2010 Sabril (vigabatrin) - Important Safety Information from sanofi-aventis as approved by the Irish Medicines Board 3rd Party Publications
05/07/2010 Clopidogrel and Proton Pump Inhibitors - Updated recommendations on interaction potential 3rd Party Publications
02/07/2010 CHMP Pharmacovigilance Working Party Monthly report - June 2010 3rd Party Publications
30/06/2010 Warfarin Teva - Important Safety Information from Teva Pharmaceuticals Ireland as approved by the Irish Medicines Board 30.06.2010 3rd Party Publications
08/06/2010 Yasmin - Update on risk of venous thromboembolism 3rd Party Publications