Safety Notices

From time to time notices relating to the safety and/or quality of medicinal products are published by the Health Products Regulatory Authority

These notices are classified under several priority related categories and may relate to human and veterinary medicines, or medical devices.   

The issues covered by these notices will range from quality defect information and medicinal product safety information through to updated information on the appropriate usage of medicines or devices.

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 safety information provided by the HPRA for publication via 3rd parties e.g. EMA

Date Title Type
24/06/2019 Change to information included in section 4.9 of the Summary of Product Characteristics for the product Tuberculin PPD Kit concerning advice on the reading of the tuberculin test after injection. Advisory
26/03/2019 Change of meat and offal withdrawal period for Closivet Pour on for cattle and Closamectin Pour on for cattle Advisory
04/02/2019 Changes to the marketing authorisation numbers of certain veterinary medicinal products Advisory
03/12/2018 Duotech Oral Suspension for Sheep, Parafend Plus Oral Suspension - Change to the meat withdrawal period Advisory
27/07/2018 HPRA commences procedure to consider precautionary restrictions on the use of veterinary medicinal products containing the excipient diethanolamine Advisory
04/07/2018 Removal of the indication for treatment of infections caused by E. coli in chickens and/or turkeys for veterinary medicinal products (VMPs) containing enrofloxacin that are administered via the drinking water. Advisory
26/04/2018 Advisory notice relating to eye injuries in humans and dogs when using Osurnia ear gel for dogs Advisory
05/04/2018 Update on pharmacovigilance activities concerning veterinary medicinal products in the European Union during 2017 Advisory
19/01/2018 Flukicides containing oxyclozanide. Changes to the withdrawal periods Advisory
19/01/2018 Gentamicin containing products presented as solutions for injection to be administered to cattle and pigs – changes to the withdrawal periods Advisory