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
09/12/2013 Iclusig (ponatinib) - Important Safety Information from Ariad Pharma Ltd. as approved by the Irish Medicines Board 3rd Party Publications
09/12/2013 Restrictions to the Use of Short Acting Beta Agonists (SABAs) in Obstetric Indications 3rd Party Publications
05/12/2013 Fastum Gel (ketoprofen) - Important Safety Information from A. Menarini Pharmaceuticals Ireland Ltd. as approved by the Irish Medicines Board 3rd Party Publications
03/12/2013 Efient (prasugrel hydrochloride) - Important Safety Information from Eli Lilly and Company Ltd. as approved by the Irish Medicines Board 3rd Party Publications
03/12/2013 Pixuvri (pixantrone) - Important Safety Information from CTI Life Sciences Ltd. as approved by the Irish Medicines Board 3rd Party Publications
19/11/2013 Gilenya (fingolimod) - Important Safety Information from Novartis Ireland Limited as approved by the Irish Medicines Board 3rd Party Publications
15/11/2013 Intravenous (IV) Iron Products - Important Safety Information from Pharmacosmos UK Ltd./Vifor Pharma UK Ltd. as approved by the Irish Medicines Board 3rd Party Publications
12/11/2013 Infusion Solutions containing Hydroxyethyl Starch (HES) - Important Safety Information from B. Braun Medical Ltd/Fresenius Kabi Ltd. as approved by the Irish Medicines Board 3rd Party Publications
12/11/2013 MabThera (rituximab) - Important Safety Information from Roche Products (Ireland) Ltd. as approved by the Irish Medicines Board 3rd Party Publications
12/11/2013 Lariam (Mefloquine): Updated Product Information and Availability of Guidelines for Healthcare Professionals/Alert Cards for Patients 3rd Party Publications