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
21/02/2019 Noradrenaline (Norepinephrine) - Important Safety Information from Laboratoire Aguettant as approved by the HPRA 3rd Party Publications
01/02/2019 Summary of Direct Healthcare Professional Communications (DHPCs) issued in January 2019 3rd Party Publications
31/01/2019 Lartruvo (olaratumab) - Important Safety Information from Eli Lilly & Company as approved by the HPRA 3rd Party Publications
22/01/2019 Sodium-Glucose-Co-Transporter 2 inhibitors (SGLT2i) - Important Safety Information from marketing authorisation holders of products containing SGLT2 inhibitors as approved by the HPRA 3rd Party Publications
18/01/2019 Medicinal products containing carbimazole or thiamazole - Important Safety Info from Amdipharm Limited and Essential-Healthcare Ltd as approved by the HPRA 3rd Party Publications
11/12/2018 Retinoids - Important Safety Information from Roche Products (Ireland) Ltd, Mylan Healthcare Ltd, Teva Pharmaceuticals Ireland, Galderma (UK) Ltd and Eisai Ltd as approved by the HPRA 3rd Party Publications
09/11/2018 Product Information Update- Tegretol product range (carbamazepine) 3rd Party Publications
31/10/2018 Product Information Update- Solu-Medrone (Methylprednisolone sodium succinate) 3rd Party Publications
24/10/2018 Systemic and inhaled fluoroquinolones - Important Safety Information from the Marketing Authorisation Holders of fluoroquinolones, as approved by the HPRA 3rd Party Publications
18/10/2018 Hydrochlorothiazide - Important Safety Information from Marketing Authorisation Holders of products containing hydrochlorothiazide as approved by the HPRA 3rd Party Publications