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
02/02/2009 Levemir FlexPen & NovoRapid FlexPen - Important Safety Information from Novo Nordisk following approval by the Irish Medicines Board Advisory
23/01/2009 Sustiva (efavirenz)-Important Communication from Bristol-Myers Squibb on the discontinuation of 100mg hard capsules 3rd Party Publications
20/01/2009 CellCept (mycophenolate mofetil) Important Safety Information from Roche following approval by the Irish Medicines Board 3rd Party Publications
20/01/2009 CellCept (mycophenolate mofetil) Important Safety Information from Roche following approval by the Irish Medicines Board 20.01.2009 3rd Party Publications
19/01/2009 Zypadhera (olanzapine) Important Safety Information from Lilly following approval by the Irish Medicines Board 3rd Party Publications
06/01/2009 Torisel (temsirolimus) Important Safety Information from Wyeth following approval by the Irish Medicines Board 3rd Party Publications
05/01/2009 Champix – MIMS Publication 3rd Party Publications
08/12/2008 Acomplia - MIMS Publication 3rd Party Publications
08/12/2008 Acomplia (08 Dec) 3rd Party Publications
02/12/2008 Prograf & Advagraf (tacrolimus)-Important Safety Information from Astellas Pharma following approval by the Irish Medicines Board 3rd Party Publications