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
05/12/2014 Tecfidera (dimethyl fumarate): - Important Safety Information from Biogen Idec (Ireland) Ltd. as approved by the Health Products Regulatory Authority 3rd Party Publications
05/12/2014 Medicines containing valproate:- Important Safety Information from Sanofi-Aventis Ireland Ltd. T/A SANOFI as approved by the Health Products Regulatory Authority 3rd Party Publications
03/12/2014 Eligard (leuprorelin acetate depot injection) - Important Safety Information from Astellas Pharma Co. Ltd. as approved by the Health Products Regulatory Authority 3rd Party Publications
24/11/2014 Stelara (Ustekinumab) - Important Safety Information from Janssen Ireland as approved by the HPRA 3rd Party Publications
18/11/2014 TRIOMEL - Important Safety Information from Baxter Healthcare as approved by the HPRA Advisory
04/11/2014 SonoVue (sulphur hexafluoride) - Important Safety Information from Bracco International BV, as approved by the Health Products Regulatory Authority 3rd Party Publications
04/11/2014 Zovirax 30mg/g Eye Ointment - Advisory Notice Advisory
03/11/2014 HPRA MIMS Article - November 2014 - Fentanyl 3rd Party Publications
03/11/2014 HPRA MIMS Article - November 2014 - Diabetes Supplement 3rd Party Publications
31/10/2014 HPRA MIMS Article - October 2014 - Denosumab 3rd Party Publications