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
01/05/2013 Methylphenidate-Containing Medicines-Availability of web-based educational tools 3rd Party Publications
26/04/2013 European Medicines Agency (EMA) announces recommendation to restrict the use of Protelos/Osseor (strontium ranelate) 3rd Party Publications
19/04/2013 Warning issued about Zheng Tian Wan, a potentially toxic, unlicensed Chinese herbal medicine Advisory
19/04/2013 Thalidomide Celgene (thalidomide) Important Safety Information from Celgene as approved by the Irish Medicines Board 3rd Party Publications
15/04/2013 MabThera (rituximab) Important Safety Information from Roche Products (Ireland) Limited as approved by the Irish Medicines Board 3rd Party Publications
09/04/2013 Incivo (telaprevir) Important Safety Information from Janssen as approved by the Irish Medicines Board 3rd Party Publications
04/04/2013 Use of the IMB online ADR report forms and Drug Safety Newsletter (DSN) for CPD purposes 3rd Party Publications
27/03/2013 Mimpara (cinacalcet) Important Safety Information from Amgen Ireland Limited as approved by the Irish Medicines Board 3rd Party Publications
20/03/2013 Nulojix (belatacept) Important Safety Information from Bristol-Myers Squibb Pharmaceuticals as approved by the Irish Medicines Board 3rd Party Publications
05/03/2013 Vistide (Cidofovir) Important Safety Information from Gilead Sciences International Limited as approved by the Irish Medicines Board 3rd Party Publications