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
04/12/2017 Litak (Cladribine) - Important Safety Information from LIPOMED GmbH as approved by the HPRA 3rd Party Publications
01/12/2017 Pharmacovigilance Risk Assessment Committee (PRAC) Meeting Highlights 3rd Party Publications
29/11/2017 Buccolam (midazolam) - Important Safety Information communication from Shire Services BVBA as approved by the HPRA 3rd Party Publications
27/11/2017 Zinbryta (daclizumab) - Important Safety Information from Biogen Idec (Ireland) Limited as approved by the HPRA (November 2017) 3rd Party Publications
09/11/2017 Gentamicin Injection and / or Infusion products - Caution-in-use notification Warning
07/11/2017 Gilenya (fingolimod) - Important Safety Information from Novartis Ireland Ltd as approved by the HPRA (November 2017) 3rd Party Publications
06/11/2017 HPRA MIMS Article November 2017 - Epoetins: New Warnings on Severe Cutaneous Adverse Reactions (SCARs) 3rd Party Publications
09/10/2017 HPRA MIMS Article October 2017 - Daclizumab (Zinbryta) and Risk of Severe Liver Injury: Initiation in Multiple Sclerosis Now Restricted, Promptly Review Patients Already on Treatment 3rd Party Publications
02/10/2017 Human Epoetins: Important Safety Information from the Marketing Authorization Holders (MAHs) of all epoetins as approved by the HPRA 3rd Party Publications
02/10/2017 Direct Healthcare Professional Communications (DHPCs) - Issued in September 2017 3rd Party Publications