Safety Notices

From time to time notices relating to the safety and/or quality of medicinal products are published by the Health Products Regulatory Authority

These notices are classified under several priority related categories and may relate to human and veterinary medicines, or medical devices.   

The issues covered by these notices will range from quality defect information and medicinal product safety information through to updated information on the appropriate usage of medicines or devices.

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 safety information provided by the HPRA for publication via 3rd parties e.g. MIMS

The HPRA Drug Safety Newsletter is also published on a regular basis.

Date Title Type
08/07/2008 Revlimid (lenalidomide)-Important Safety Information from Celgene as approved by the Irish Medicines Board 08.07.2008 3rd Party Publications
11/06/2008 Neupro (rotigotine)-Important Information from UCB (Pharma) on the recall of certain packs 3rd Party Publications
05/06/2008 Avandia (rosiglitazone) – Risk of Cardiovascular Adverse Reactions - MIMS Publication 3rd Party Publications
04/06/2008 EMEA recommends changes in the storage conditions for Neupro (rotigotine) Advisory
26/05/2008 Tysabri (natalizumab)-Important Safety Information from Elan/Biogen Idec concerning serious hepatic reactions with Tysabri 3rd Party Publications
19/05/2008 InductOs (dibotermin alfa)-Important Safety Information from Wyeth as approved by the Irish Medicines Board 3rd Party Publications
08/05/2008 Use of Cough/Cold Medicines in Children 3rd Party Publications
06/05/2008 Velcade (bortezomib)-Important Safety Information from Janssen-Cilag as approved by the Irish Medicines Board 3rd Party Publications
28/04/2008 Important Information Regarding Heparin Containing Products including Low Molecular Weight Heparins Warning
23/04/2008 Abacavir & Didanosine-Important Safety Information from GlaxoSmithKline and Bristol-Myers Squibb as approved by the Irish Medicines Board 3rd Party Publications