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
18/03/2014 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
11/02/2014 Triomel (Refined Olive Oil and Refined Soybean Oil) - Important Safety Information from Baxter Healthcare Limited as approved by the Irish Medicines Board 3rd Party Publications
28/01/2014 Combined hormonal contraceptives (CHCs) - Important Safety Information from the Marketing Authorisation Holders as approved by the Irish Medicines Board 3rd Party Publications
22/01/2014 Zofran (ondansetron) - Important Safety Information from GlaxoSmithKline (Ireland) Limited as approved by the Irish Medicines Board 3rd Party Publications
21/01/2014 Abraxane (paclitaxel) - Important Safety Information from Celgene Europe Ltd. as approved by the Irish Medicines Board 3rd Party Publications
08/01/2014 Increlex (mecasermin) - Important Safety Information from Ipsen Pharmaceuticals Ltd. as approved by the Irish Medicines Board 3rd Party Publications