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
09/09/2019 HPRA IMF Article September 2019 3rd Party Publications
05/09/2019 Lucentis (ranibizumab) - Important Safety Information from Novartis Ireland as approved by the HPRA 3rd Party Publications
05/09/2019 BLINCYTO (blinatumomab) - Important Safety Information from AMGEN Ireland Ltd as approved by the HPRA (September 2019) 3rd Party Publications
26/08/2019 Gilenya (fingolimod) - Important Safety Information from Novartis Ireland Ltd 3rd Party Publications
18/07/2019 Elmiron (pentosane polysulfate sodium) - Important Safety Information form bene-Arzneimittel GmbH as approved by the HPRA 3rd Party Publications
02/07/2019 Summary of Direct Healthcare Professional Communications (DHPCs) issued in June 2019 3rd Party Publications
28/06/2019 RoActemra (tocilizumab) - Important Safety Information from Roche Products (Ireland) Ltd as approved by HPRA 3rd Party Publications
28/06/2019 Febuxostat - Important Safety Information from Marketing Authorisation Holders of products containing febuxostat as approved by HPRA 3rd Party Publications
27/06/2019 Darzalex (daratumumab) - Important Safety Information from Janssen Ireland as approved by HPRA 3rd Party Publications
11/06/2019 Modafinil - Important Safety Information from Teva Pharmaceuticals Ireland, Clonmel Healthcare Ltd and Fannin Limited as approved by HPRA 3rd Party Publications