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
28/07/2014 Arzerra (ofatumumab) - Important Safety Information from GlaxoSmithKline Pharmaceuticals as approved by the Health Products Regulatory Authority 3rd Party Publications
24/07/2014 Emergency Contraception – New information on levonorgestrel (Levonelle, Norlevo, Tyedra, Levonorgestrel Teva) and ulipristal (ellaOne) Advisory
23/07/2014 Vibativ (telavancin) - Important Safety Information from Clinigen Healthcare Ltd. as approved by the Health Products Regulatory Authority 3rd Party Publications
08/07/2014 Product Information Update- Caverject 5, 10 and 20 microgram (alprostadil) 3rd Party Publications
04/07/2014 Update regarding changes to the classification of nicotine replacement therapy (NRT) Advisory
01/07/2014 HPRA articles in MIMS Ireland - July 2014 3rd Party Publications
20/06/2014 TRANSDERMAL FENTANYL - Important Safety Information from Janssen Ireland, Pfizer Healthcare Ireland, Rowex Ltd., Takeda UK Ltd. as approved by the Irish Medicines Board 3rd Party Publications
17/06/2014 New drug driving offence in the UK - Implications for medicines authorised in Ireland Advisory
12/06/2014 Procoralan (ivabradine) - Important Safety Information from Servier Laboratories (Ireland) Ltd. as approved by the Irish Medicines Board 3rd Party Publications
03/06/2014 Rienso (Ferumoxytol) - Important Safety Information from Takeda Products Ireland Ltd. as approved by the Irish Medicines Board 3rd Party Publications