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
02/07/2012 CHMP Pharmacovigilance Working Party Monthly Report - May 2012 3rd Party Publications
02/07/2012 CHMP Pharmacovigilance Working Party Monthly Report - June 2012 3rd Party Publications
19/06/2012 Ti-Tre Tablets 20mcg (liothyronine) - Important Safety Information from Irish Medicines Board 3rd Party Publications
31/05/2012 Peyona (caffeine citrate) Important Safety Information from Chiesi as approved by the Irish Medicines Board 3rd Party Publications
23/05/2012 Anapen Range of treatments for Acute Allergic Reactions – Important Information for Users and Healthcare Professionals Advisory
21/05/2012 Adenuric (febuxostat) - Important Safety Information from Menarini as approved by the Irish Medicines Board 3rd Party Publications
17/05/2012 Protopic (tacrolimus) - Important Safety Information from Astellas Pharma Europe as approved by the Irish Medicines Board 3rd Party Publications
11/05/2012 Gilenya (fingolimod) - Important Safety Information from Novartis as approved by the Irish Medicines Board 3rd Party Publications
11/05/2012 Fastum Gel (ketoprofen) - Important Safety Information from Menarini as approved by the Irish Medicines Board 3rd Party Publications
01/05/2012 CHMP Pharmacovigilance Working Party Monthly Report - April 2012 3rd Party Publications