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
12/10/2018 Sildenafil (Revatio and Viagra) - Important Safety Information from Pfizer as approved by the HPRA 3rd Party Publications
04/10/2018 Xarelto (rivaroxaban) - Important Safety Information from Bayer AG as approved by the HPRA (Oct 2018) 3rd Party Publications
20/09/2018 Insulin-containing product - Important Safety Information from Sanofi-aventis Ireland Ltd. T/A SANOFI, Eli Lilly and Company Limited and Novo Nordisk Ltd. as approved by the HPRA 3rd Party Publications
10/09/2018 Keppra (levetiracetam) - Important Safety Information from UCB (Pharma) Ireland Limited as approved by the HPRA (Sept 2018) 3rd Party Publications
06/09/2018 Hydroxyethyl starch (HES) solutions for infusion - Important Safety Information from Frasenius Kabi Limited as approved by the HPRA 3rd Party Publications
30/08/2018 HPRA IMF Article August 2018 3rd Party Publications
29/08/2018 Product Information Update- Azzalure (Clostridium botulinum toxin type a haemagglutinin complex) 3rd Party Publications
10/08/2018 Esmya (ulipristal acetate) - Important Safety Information from Gedeon Richter Plc. as approved by the HPRA (August 2018) 3rd Party Publications
09/08/2018 Zinbryta (daclizumab beta) - Important Safety Information from Biogen as approved by the HPRA (August 2018) 3rd Party Publications
08/08/2018 Hydroxyethyl starch (HES) solutions for infusion - Important Safety Information from B. Braun Medical Ltd. as approved by the HPRA 3rd Party Publications