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
22/07/2015 XGEVA (Denosumab) - Important Safety Information from AMGEN Ireland Limited as approved by the HPRA 3rd Party Publications
14/07/2015 SGLT2 inhibitors - Important Safety Information from Janssen-Cilag, AstraZeneca Ltd. and Boehringer Ingelheim Ltd. as approved by the HPRA 3rd Party Publications
13/07/2015 Ketoconazole HRA - Important Safety Information from HRA Pharma UK & Ireland Ltd. as apporved by the HPRA 3rd Party Publications
02/07/2015 Locabiotal (fusafungine) - Important Safety Information from Servier Laboratories (Ireland) Ltd as approved by the HPRA 3rd Party Publications
08/06/2015 HPRA article placed in MIMS - June 2015 - The importance of product information for medicines 3rd Party Publications
11/05/2015 Harvoni (sofosbuvir+ledipasvir) and Daklinza (daclatasvir) in combination with Sovaldi (sofosbuvir) - Important Safety Information from Gilead Sciences International and Bristol Myers Squibb (BMS) as approved by the HPRA 3rd Party Publications
11/05/2015 Product Information Update- Sublimaze 50 micrograms/ml (fentanyl citrate) 3rd Party Publications
05/05/2015 HPRA article placed in MIMS - May 2015 - Bisphosphonates 3rd Party Publications
30/04/2015 Imnovid (pomalidomide) - Important Safety Information from Celgene Ltd. as approved by the Health Products Regulatory Authority 3rd Party Publications
24/04/2015 Sustiva (efavirenz) - Important Safety Information from Bristol-Myers Squibb Pharmaceuticals as approved by the Health Products Regulatory Authority 3rd Party Publications