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
19/09/2011 New advice for healthcare professionals regarding non-prescription cough and cold medicines for young children Advisory
05/09/2011 Pioglitazone – New contra-indications and warnings following European review of bladder cancer risk 3rd Party Publications
26/08/2011 Urgent Information for Pharmacists: Nurofen Plus Tablets, PA 979/34/1 and PPA 1151/126/1 – All Batches : Precautionary Immediate Action Required Advisory
15/08/2011 Sprycel (dasatinib) - Important Safety Information from Bristol-Myers Squibb as approved by the Irish Medicines Board 3rd Party Publications
08/08/2011 Gardasil - Overview of National Monitoring Experience 3rd Party Publications
05/08/2011 CHMP Pharmacovigilance Working Party Monthly report - July 2011 3rd Party Publications
05/08/2011 MabThera (Rituximab) - Important Safety Information from Roche as approved by the Irish Medicines Board 3rd Party Publications
04/08/2011 Vimpat (lacosamide) - Important Safety Information from UCB Pharma Ltd as approved by the Irish Medicines Board 3rd Party Publications
03/08/2011 Actos (pioglitazone hydrochloride) and Competact (pioglitazone hydrochloride and metformin hydrochloride) - Important Safety Information from Takeda as approved by the Irish Medicines Board 3rd Party Publications
03/08/2011 Cardioxane (dexrazoxane) - Important Safety Information from Novartis as approved by the Irish Medicines Board 3rd Party Publications