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
05/11/2020 Product Information Update- Viagra Connect (50 mg sildenafil) 3rd Party Publications
04/11/2020 Esbriet (pirfenidone) - Important Safety Information from Roche Products (Ireland) Ltd as approved by the HPRA 3rd Party Publications
30/10/2020 Product Information Update- Stilnoct (zolpidem tartrate) 3rd Party Publications
29/10/2020 Systemic and inhaled fluoroquinolones - Important safety information from Marketing Authorisation Holders as approved by the HPRA 3rd Party Publications
28/10/2020 Modafinil - Important Safety Information from Bluefish Pharmaceuticals as approved by HPRA (Date Corrected) 3rd Party Publications
20/10/2020 Product Information Update- Monover and Diafer (iron isomaltoside 1000/ ferric derisomaltose) 3rd Party Publications
15/10/2020 HPRA MIMS Article October 2020 3rd Party Publications
14/09/2020 HPRA IMF Article September 2020 3rd Party Publications
07/09/2020 Murexal 10mg/ml - Important Safety Information from Laboratoire Aguettant as approved by the HPRA 3rd Party Publications
17/08/2020 HPRA MIMS Articles July and August 2020 3rd Party Publications