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
20/04/2016 HPRA MIMS Article March 2016 : Oral methotrexate and risk of unintentional overdose due to medication errors 3rd Party Publications
05/04/2016 BCR-ABL tyrosine inhibitors (imatinib, dasatinib, nilotinib, bosutinib, ponatinib) - Important Safety Information from Novartis, Pfizer, BMS and Ariad as approved by the HPRA 3rd Party Publications
24/03/2016 Zydelig (idelalisib) - Important Safety Information from Gilead Sciences Ltd. as approved by the HPRA 3rd Party Publications
21/03/2016 Zaltrap (aflibercept) - Important Safety Information from Sanofi-Aventis Limited T/A SANOFI as approved by the HPRA 3rd Party Publications
21/03/2016 SGLT2 inhibitors - Important Safety Information from Janssen-Cilag Limited, AstraZeneca Limited and Boehringer Ingelheim Limited as approved by the HPRA 3rd Party Publications
16/03/2016 Product Information Update- BCG-medac (BCG Bacillus Calmette Guérin bacteria) 3rd Party Publications
15/03/2016 Xofigo (radium-223 chloride) - Important Safety Information from Bayer Ltd. as approved by the HPRA 3rd Party Publications
15/03/2016 Tysabri (natalizumab) - Important Safety Information from Biogen Idec (Ireland) Ltd. as approved by the HPRA 3rd Party Publications
02/03/2016 Intrauterine contraceptives: Levonorgestrel Intrauterine Delivery Systems - Mirena and Jaydess - Important Safety Information from Bayer Ltd. as approved by the HPRA 3rd Party Publications
25/02/2016 Product Information Update- Orap (pimozide) 4mg Tablets 3rd Party Publications