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
30/05/2019 XELJANZ (tofacitinib) - Important Safety Information from Pfizer Healthcare Ireland as approved by the HPRA 3rd Party Publications
29/05/2019 Product Information Update- Astilin 10mg and 25mg tablets (Amitriptyline hydrochloride) 3rd Party Publications
22/05/2019 Product Information Update- Sinemet (carbidopa/levodopa) 3rd Party Publications
22/05/2019 Tyverb (lapatinib) - Important Safety Information from Novartis Ireland Ltd. as approved by HPRA 3rd Party Publications
22/05/2019 Domperidone-containing products - Important Safety Information from Johnson & Johnson (Ireland) Ltd. as approved by HPRA 3rd Party Publications
14/05/2019 Lartruvo (olaratumab) - Important information from Eli Lilly and Company Ltd. as approved by the HPRA 3rd Party Publications
24/04/2019 Lemtrada (alemtuzumab) - Important Safety Information from Sanofi Genzyme as approved by the HPRA 3rd Party Publications
09/04/2019 Systemic and inhaled quinolone and fluoroquinolone antibiotics - Important Safety Information from the Marketing Authorisation Holders of fluoroquinolones as approved by the HPRA 3rd Party Publications
02/04/2019 Please find below the links to all Direct Healthcare Professional Communications (DHPCs) issued in March 2019 3rd Party Publications
02/04/2019 Benlysta (Belimumab) - Important Safety Information from GlaxoSmithKline Pharmaceuticals as approved by the HPRA 3rd Party Publications