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
24/07/2024 Medicinal Product Shortages – update – 24 July 2024 Advisory
18/07/2024 17-hydroxyprogesterone caproate - Important Safety Information from European Medicines Agency's (EMA's) Pharmacovigilance Risk Assessment Committee (PRAC) as approved by the HPRA (17.07.24) 3rd Party Publications
18/07/2024 Abecma, Breyanzi, Carvykti, Kymriah, Tecartus and Yescarta (CD19- or BCMA-directed CAR T-cell therapies) - Important Safety Information from Marketing Authorisation Holders of these products as approved by the HPRA (18.07.24) 3rd Party Publications
18/07/2024 Medicinal Product Shortages - update - 18 July 2024 Advisory
12/07/2024 Pharmacovigilance Risk Assessment Committee (PRAC) Meeting Highlights 3rd Party Publications
10/07/2024 Medicinal Product Shortages - update - 10 July 2024 Advisory
09/07/2024 Atomoxetine Accord 10/18/25/40/60/80/100 mg - Hard Capsules, PA2315/019/001-007, Recall, All in-date batches Recall
03/07/2024 Medicinal Product Shortages - update - 03 July 2024 Advisory
28/06/2024 Recall notice for one batch of Palmeux 150 mg prolonged-release suspension for injection in prefilled syringe, PA1142/040/005 and one batch of Palmeux 75 mg prolonged-release suspension for injection in prefilled syringe, PA1142/040/003 Recall
26/06/2024 Medicinal Product Shortages - update - 26 June 2024 Advisory