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
18/07/2013 DepoCyte (cytarabine liposome injection) - Important Safety Information from Pacira Ltd as approved by the Irish Medicines Board 3rd Party Publications
12/07/2013 Diclofenac Important Safety Information from Astellas as approved by the Irish Medicines Board 3rd Party Publications
08/07/2013 Lariam (mefloquine) Important Safety Information from Roche as approved by the Irish Medicines Board 3rd Party Publications
02/07/2013 Infusion Solutions containing Hydroxyethyl Starch (HES) - Important Safety Information from Irish Medicines Board 3rd Party Publications
01/07/2013 Dianette (Cyproterone Acetate 2mg/Ethinylestradiol 35mcg) - NEW RISK MINIMISATION MEASURES TO FURTHER MITIGATE THE KNOWN RISK OF THROMBOEMBOLISM 3rd Party Publications
26/06/2013 Revlimid (lenalidomide) Important Safety Information from Celgene as approved by theIrish Medicines Board 3rd Party Publications
25/06/2013 Durogesic DTrans Transdermal Patch (fentanyl) Important Safety Information from Janssen as approved by the Irish Medicines Board 3rd Party Publications
25/06/2013 Trobalt (retigabine) Important Safety Information from GlaxoSmithKline as approved by the Irish Medicines Board 3rd Party Publications
21/06/2013 Dianette (cyproterone acetate 2mg/ethinylestradiol 35 mcg) Important Safety Information from Bayer Ltd. as approved by the Irish Medicines Board 3rd Party Publications
21/06/2013 Sublimaze 50 micrograms/ml Solution for Injection Important Safety Information from Janssen as approved by the Irish Medicines Board 3rd Party Publications