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
24/03/2021 Xeljanz (tofacitinib) - Important Safety Information from Pfizer Healthcare Ireland as approved by the HPRA 3rd Party Publications
24/03/2021 Zolgensma (onasemnogene abeparvovec) - Important Safety Information from Novartis Gene Therapies EU Ltd as approved by the HPRA 3rd Party Publications
12/02/2021 Solu-Medrone (methylprednisolone sodium succinate) 40mg powder and solvent for solution for injection - Important Safety Information from Pfizer Limited as approved by the HPRA 3rd Party Publications
03/02/2021 Esmya (ulipristal acetate) 5mg - Important Safety Information from Gedeon Richter UK Ltd as approved by the HPRA 3rd Party Publications
03/12/2020 Gliolan (5-aminolevulinic acid, 5-ALA) - Important Safety Information from medac GmbH as approved by the HPRA 3rd Party Publications
27/11/2020 LYNPARZA (Olaparib) - Important Safety Information from AstraZeneca Pharmaceuticals (Ireland) DAC as approved by the HPRA 3rd Party Publications
20/11/2020 HPRA MIMS Articles November 2020 3rd Party Publications
13/11/2020 Gilenya (fingolimod) - Important Safety Information from Novartis Ireland Ltd as approved by the HPRA 3rd Party Publications
12/11/2020 Tecfidera (dimethyl fumarate) - Important Safety Information from Biogen Idec Limited as approved by the HPRA 3rd Party Publications
06/11/2020 TRISENOX (arsenic trioxide) - Important Safety Information from Teva Pharmaceuticals as approved by the HPRA 3rd Party Publications