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
05/08/2020 BCG-medac (Bacillus Calmette Guérin for intravesical use) - Important Safety Information from medac GmbH as approved by the HPRA 3rd Party Publications
30/07/2020 Important Safety Information from Marketing Authorisation Holders of Leuprorelin-containing depot products as approved by the HPRA 3rd Party Publications
16/06/2020 HPRA MIMS Articles June 2020 3rd Party Publications
08/06/2020 Sinemet Plus (Carbidopa/Levodopa 25mg/100mg Tablets) and Sinemet (Carbidopa/Levodopa 12.5mg/50mg Tablets) – Caution in Use – Important Information for Healthcare Professionals from MSD Ireland 3rd Party Publications
04/06/2020 Important Safety Information from Marketing Authorisation Holders of products containing 5-Fluorouracil (i.v.), capecitabine and tegafur as approved by the HPRA 3rd Party Publications
26/05/2020 Flucytosine - Important Safety Information from Mylan IRE Healthcare as approved by the HPRA 3rd Party Publications
15/05/2020 Hydroxychloroquine (Plaquenil 200mg Film Coated Tablets) - Important Safety Information from Sanofi Ireland as approved by the HPRA 3rd Party Publications
13/05/2020 HPRA MIMS Articles May 2020 3rd Party Publications
16/04/2020 Cyproterone acetate - Important Safety Information from Bayer Ltd as approved by the HPRA 3rd Party Publications
07/04/2020 HPRA IMF Article March 2020 3rd Party Publications