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
01/11/2012 CAELYX (pegylated liposomal doxorubicin) - Important Safety Information from Janssen Cilag International NV as approved by the Irish Medicines Board 3rd Party Publications
24/10/2012 TAMIFLU powder for oral suspension - Important Safety Information from Roche Products (Ireland) as approved by the Irish Medicines Board 3rd Party Publications
22/10/2012 Typhim Vi, Solution for Injection (Typhoid Polysaccharide Vaccine) - Important Safety Information from Sanofi Pasteur MSD as approved by the Irish Medicines Board 3rd Party Publications
11/10/2012 Valdoxan (agomelatine) - Important Safety Information from Servier Laboratories as approved by the Irish Medicines Board 3rd Party Publications
02/10/2012 Trimetazidine - Important Safety Information from Servier Laboratories as approved by the Irish Medicines Board 3rd Party Publications
04/09/2012 XGEVA (denosumab) - Important Safety Information from Amgen as approved by the Irish Medicines Board 3rd Party Publications
03/09/2012 CHMP Pharmacovigilance Working Party Monthly Report - July 2012 3rd Party Publications
20/08/2012 Miacalcic (calcitonin) Important Safety Information from Novartis as approved by the Irish Medicines Board 3rd Party Publications
09/08/2012 Zofran and generics (ondansetron) - Important Safety Information from GlaxoSmithKline as approved by the Irish Medicines Board 3rd Party Publications
24/07/2012 Volibris (ambrisentan) - Important Safety Information from GlaxoSmithKline as approved by the Irish Medicines Board 3rd Party Publications