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
10/02/2017 Pharmacovigilance Risk Assessment Committee (PRAC) Meeting Highlights 3rd Party Publications
10/02/2017 HPRA MIMS Article February 2017 Levetiracetam 100mg/ml Oral Solution - Global reports of medication errors resulting in the administration of higher than intended doses of levetiracetam 3rd Party Publications
25/01/2017 Flolan (epoprostenol) - Important Safety Information from GlaxoSmithKline as approved by the HPRA 3rd Party Publications
13/01/2017 HPRA MIMS Article January 2017 Otezla (apremilast) - Important advice regarding suicidal ideation and behaviour 3rd Party Publications
06/01/2017 Braltus (tiotropium) - Important Safety Information from Teva Pharmaceuticals Ireland as approved by the HPRA 3rd Party Publications
19/12/2016 HPRA MIMS Article November 2016 Fingolimod (Gilenya) - Risks related to immunosuppressive effects 3rd Party Publications
19/12/2016 Ammonaps (sodium phenylbutyrate) - Important Safety Information from Swedish Orphan Biovitrum International AB (Sobi), as approved by the HPRA 3rd Party Publications
25/11/2016 Keppra (levetiracetam) - Important Safety Information from UCB (Pharma) Ireland Limited as approved by the HPRA 3rd Party Publications
08/11/2016 Revlimid (lenalidomide) - Important Safety Information from Celgene Europe Limited as approved by the HPRA (Nov 2016) 3rd Party Publications
08/11/2016 Otezla (apremilast) - Important Safety Information from Celgene Europe Limited as approved by the HPRA 3rd Party Publications