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
22/05/2014 Domperidone - Important Safety Information from McNeil Healthcare (Ireland) Ltd. as approved by the Irish Medicines Board 3rd Party Publications
09/05/2014 Herceptin (trastuzumab) - Important Safety Information from Roche Products (Ireland) Ltd. as approved by the Irish Medicines Board 3rd Party Publications
08/05/2014 Metoclopramide-Containing Medicines - Update on Outcome of Review and Revised Recommendations for Use 3rd Party Publications
02/05/2014 Fastum Gel (ketoprofen) - Important Safety Information from A. Menarini Pharmaceuticals Ireland Ltd. as approved by the Irish Medicines Board 3rd Party Publications
24/03/2014 Granocyte (Lenograstim) - Important Safety Information from Chugai Pharma UK Ltd. as approved by the Irish Medicines Board 3rd Party Publications
18/03/2014 Protelos (strontium ranelate) - Important Safety Information from Servier Laboratories (Ireland) Ltd. as approved by the Irish Medicines Board 3rd Party Publications
07/03/2014 Trazodone - Reminder on the Risk of Postural Hypotension and Somnolence in the Elderly Particularly in the Context of Polypharmacy 3rd Party Publications
27/02/2014 Recall of Seven Batches of Jext Adrenaline Autoinjectors in Ireland Recall
18/02/2014 Magicream Warning
12/02/2014 Rienso (ferumoxytol) - Important Safety Information from Takeda Development Centre Europe Ltd. as approved by the Irish Medicines Board 3rd Party Publications