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
17/01/2018 Summary of Direct Healthcare Professional Communications (DHPCs) - Issued in December 2017 3rd Party Publications
15/12/2017 FLOLAN (epoprostenol sodium) - Important Safety Information from GlaxoSmithKline Pharmaceuticals as approved by the HPRA 3rd Party Publications
13/12/2017 Xofigo (radium-223-dichloride) - Important Safety Information from Bayer AG as approved by the HPRA (December 2017) 3rd Party Publications
13/12/2017 Eligard (Leuprorelin acetate depot injection) - Important Safety Information from Astellas Pharma Co., Ltd. as approved by the HPRA 3rd Party Publications
12/12/2017 Gadolinium contrast agents - Important Safety Information from Bayer Ltd, Bracco Imaging S.p.A, GE Healthcare Ltd and Guerbet as approved by the HPRA 3rd Party Publications
04/12/2017 Litak (Cladribine) - Important Safety Information from LIPOMED GmbH as approved by the HPRA 3rd Party Publications
01/12/2017 Direct Healthcare Professional Communications (DHPCs) - Issued in November 2017 3rd Party Publications
30/11/2017 Product Information Update- Solu-Medrone 40 mg (Methylprednisolone sodium succinate) 3rd Party Publications
29/11/2017 Buccolam (midazolam) - Important Safety Information communication from Shire Services BVBA as approved by the HPRA 3rd Party Publications
27/11/2017 Zinbryta (daclizumab) - Important Safety Information from Biogen Idec (Ireland) Limited as approved by the HPRA (November 2017) 3rd Party Publications