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
13/09/2013 Eliquis (apixaban), Pradaxa (dabigatran etexilate), Xarelto (rivaroxaban) - Important Safety Information from Bristol-Myers Squibb Pharmaceuticals/Pfizer EEIG, Boehringer Ingelheim, Bayer Pharma AG as approved by the Irish Medicines Board 3rd Party Publications
02/09/2013 Codeine*: restricted use as an analgesic in children and adolescents 3rd Party Publications
28/08/2013 Neupogen (filgrastim), Neulasta (pegfilgrastim) - Important Safety Information from Amgen as approved by the Irish Medicines Board 3rd Party Publications
26/08/2013 Plavix, DuoPlavin (clopidogrel) - Important Safety Information from Sanofi Ireland Ltd as approved by the Irish Medicines Board 3rd Party Publications
22/08/2013 Warning over Potentially Dangerous Chinese Medicines Advisory
16/08/2013 Vectibix (panitumumab) - Important Safety Information from Amgen Europe B.V. as approved by the Irish Medicines Board 3rd Party Publications
14/08/2013 IMF Publication - Changes to Arrangements for Drug Safety Newsletter Distribution 3rd Party Publications
24/07/2013 Pedea (ibuprofen solution 5mg/ml for injection) - Important Safety Information from Orphan Europe as approved by the Irish Medicines Board 3rd Party Publications
22/07/2013 Votrient (pazopanib) - Important Safety Information from GlaxoSmithKline as approved by the Irish Medicines Board 3rd Party Publications
18/07/2013 Diclofenac Important Safety Information from Novartis Ireland as approved by the Irish Medicines Board 3rd Party Publications