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
12/11/2013 Lariam (Mefloquine): Updated Product Information and Availability of Guidelines for Healthcare Professionals/Alert Cards for Patients 3rd Party Publications
06/11/2013 Jevtana (cabazitaxel) - Important Safety Information from Sanofi Ireland Ltd. as approved by the Irish Medicines Board 3rd Party Publications
30/10/2013 Erivedge (vismodegib) - Important Safety Information from Roche as approved by the Irish Medicines Board 3rd Party Publications
29/10/2013 Recall of Three batches of NovoMix 30 Penfill to Patient Level in Ireland Recall
17/10/2013 Valdoxan (agomelatine) Important Safety Information from Servier Laboratories (Ireland) Ltd. as approved by the Irish Medicines Board 3rd Party Publications
08/10/2013 Invega (paliperidone), Xeplion (paliperidone palmitate), Risperdal, Risperdal Consta (risperidone) - Important Safety Information from Janssen as approved by the Irish Medicines Board 3rd Party Publications
07/10/2013 Ventolin (salbutamol sulphate) - Important Safety Information from GlaxoSmithKline (Ireland) Ltd as approved by the Irish Medicines Board 3rd Party Publications
01/10/2013 Additional monitoring: Black triangle introduced as prompt to report suspected adverse reactions 3rd Party Publications
30/09/2013 Peginterferon alfa-2b, ViraferonPeg - Important Safety Information from Merck Sharp & Dohme (MSD) as approved by the Irish Medicines Board 3rd Party Publications
24/09/2013 Flupirtine containing medicines (not licensed in Ireland) -Important Safety Information from Irish Medicines Board 3rd Party Publications