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
06/01/2016 Gilenya (fingolimod) - Important Safety Information from Novartis Ireland Ltd. as approved by the HPRA (January 2016) 3rd Party Publications
05/01/2016 Viekirax (ombitasvir, paritaprevir, ritonavir) with or without Exviera (dasubuvir) - Important Safety Information from AbbVie Ltd. as approved by the HPRA 3rd Party Publications
22/12/2015 HPRA MIMS Article December 2015 Adverse Reaction Reporting during 2014 3rd Party Publications
22/12/2015 HPRA MIMS Article November 2015 Donepezil and Reports of Rhabdomyolysis 3rd Party Publications
30/11/2015 Tecfidera (dimethyl fumarate) - Important Safety Information from Biogen Idec (Ireland) Ltd. as approved by the HPRA 3rd Party Publications
30/11/2015 Myfortic (sodium mycophenolate) - Important Safety Information from Novartis Ireland Ltd. as approved by the HPRA 3rd Party Publications
27/11/2015 Ikorel (nicoandil) - Important Safety Information from sanofi-aventis Ireland Ltd. T/A SANOFI as approved by the HPRA 3rd Party Publications
12/11/2015 InductOs (dibotermin alfa) - Important Safety Information from Medtronic BioPharma B.V. as approved by the HPRA (Nov 2015) 3rd Party Publications
12/11/2015 Thalidomide (Thalidomide Celgene) - Important Safety Information from Celgene Ltd. as approved by the HPRA 3rd Party Publications
11/11/2015 CellCept (mycophenolate mofetil) - Important Safety Information from Roche Products (Ireland) Ltd. 3rd Party Publications