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
14/02/2011 Oruvail 2.5% w/w gel and Orugesic 2.5% w/w gel (ketoprofen) - Important Safety Information from Sanofi-Aventis as approved by the Irish Medicines Board 3rd Party Publications
11/02/2011 Revlimid (lenalidomide) - Important Safety Information from Celgene as approved by the Irish Medicines Board 11.02.2011 3rd Party Publications
09/02/2011 National Monitoring Update: HPV Vaccine [Gardasil] 02/09/2011 3rd Party Publications
07/02/2011 Champix (varenicline) 3rd Party Publications
07/02/2011 Keppra (levetiracetam) - Important Safety Information from UCB as approved by the Irish Medicines Board 3rd Party Publications
02/02/2011 CHMP Pharmacovigilance Working Party Monthly report - January 2011 3rd Party Publications
01/02/2011 Gadolinium containing contrast agents - Important Safety Information from the Irish Medicines Board 3rd Party Publications
31/01/2011 Daptomycin (cubicin) - Important safety information from Novartis as approved by the Irish Medicines Board 3rd Party Publications
27/01/2011 Multaq (dronedarone) - Important Safety Information from sanofi-aventis as approved by the Irish Medicines Board 27.01.2011 3rd Party Publications
26/01/2011 Nplate (romiplostim) - Important Safety Information from Amgen as approved by the Irish Medicines Board 3rd Party Publications