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
11/05/2012 Gilenya (fingolimod) - Important Safety Information from Novartis as approved by the Irish Medicines Board 3rd Party Publications
11/05/2012 Fastum Gel (ketoprofen) - Important Safety Information from Menarini as approved by the Irish Medicines Board 3rd Party Publications
01/05/2012 CHMP Pharmacovigilance Working Party Monthly Report - April 2012 3rd Party Publications
20/04/2012 Protelos/Osseor (strontium ranelate) - Important safety information from Servier Laboratories (Ireland) as approved by the Irish Medicines Board 3rd Party Publications
20/04/2012 ViaSpan Solution for Organ Preservation - Important Safety Information from Bristol-Myers Squibb Pharmaceuticals as approved by the Irish Medicines Board 3rd Party Publications
03/04/2012 Saizen Solution for Injection (Somatropin) - Important Safety Information from Merck Serono as approved by the Irish Medicines Board 3rd Party Publications
03/04/2012 Tolvaptan (Samsca) - Important Safety Information from Otsuka as approved by the Irish Medicines Board 3rd Party Publications
03/04/2012 Somavert (pegvisomant) - Important Safety Information from Pfizer as approved by the Irish Medicines Board 3rd Party Publications
03/04/2012 CHMP Pharmacovigilance Working Party Monthly Report - March 2012 3rd Party Publications
29/03/2012 Perfalgan (intravenous paracetamol) - Important Safety Information from Bristol-Myers Squibb as approved by the Irish Medicines Board 3rd Party Publications