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
07/07/2016 Adempas (riociguat) - Important Safety Infomation from Bayer Pharma AG and MSD as approved by the HPRA 3rd Party Publications
21/06/2016 Thalidomide Celgene - Important Safety Information from Celgene Europe Limited as approved by the HPRA (June 2016) 3rd Party Publications
16/06/2016 HPRA MIMS Article June 2016 Withdrawal of Fusafungine containing Medicinal Products 3rd Party Publications
25/05/2016 Implanon NXT - Important Safety Information from MSD Ireland as approved by the HPRA 3rd Party Publications
24/05/2016 HPRA MIMS Article May 2016 Fingolimod (Gilenya) : Risks related to its immunosuppressive effects 3rd Party Publications
23/05/2016 Product Information Update- Videx (Didanosine) and Zerit (Stavudine) capsules 3rd Party Publications
04/05/2016 Invokana (canagliflozin), Vokanamet (canagliflozin, metformin) - Important Safety Information from Janssen-Cilag Limited as approved by the HPRA 3rd Party Publications
26/04/2016 Fusafungine-containing medicinal products - Important Safety Information from Servier Laboratories (Ireland) Ltd. as approved by the HPRA 3rd Party Publications
26/04/2016 Imnovid (pomalidomide) - Important Safety Information from Celgene Europe Limited as approved by the HPRA (April 2016) 3rd Party Publications
20/04/2016 HPRA MIMS Article April 2016 : High Strength Insulin Preparations 3rd Party Publications