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
30/04/2017 Product Information Update- Amoxil (Amoxicillin trihydrate) 3rd Party Publications
24/04/2017 Cotellic (cobimetinib) - Important Safety Information from Roche Products (Ireland) Ltd. as approved by the HPRA 3rd Party Publications
05/04/2017 HPRA MIMS Article April 2017 - SGLT2 inhibitors and risk of lower limb amputation (mainly toe) 3rd Party Publications
22/03/2017 Herceptin (trastuzumab) - Important Safety Information from Roche Products (Ireland) Ltd. as approved by the HPRA 3rd Party Publications
21/03/2017 Recall of one lot of Epipen 300mcg to patient level in Ireland Recall
15/03/2017 Product Information Update- Innohep 10,000 IU/ml (tinzaparin sodium) 3rd Party Publications
10/03/2017 HPRA MIMS Article March 2017 Lenalidomide (Revlimid) – Advice regarding viral reactivation 3rd Party Publications
23/02/2017 Recall of Batches of Viridal Duo Powder and Solvent for Solution for Injection to Patient Level in Ireland Recall
10/02/2017 HPRA MIMS Article February 2017 Levetiracetam 100mg/ml Oral Solution - Global reports of medication errors resulting in the administration of higher than intended doses of levetiracetam 3rd Party Publications
10/02/2017 Product Information Update- Buscopan Ampoules (Hyoscine butylbromide) 3rd Party Publications