Safety Notices

The purpose of these notices relating to the safety and/or quality of medicinal products is to update users and health care professionals of important changes to medicines, and to explain the reasons for those changes. The notices are classified under a number of 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
09/06/2020 Synulox Lactating Cow – Advisory Notice Update Advisory
02/06/2020 Recall of two batches of Pharmasin 200 mg/ml solution for injection for cattle, sheep, goats and pigs, VPA10782/015/001, labelled as Pharmasin 200 mg/ml Solution for injection for cattle and pigs, VM 30282/4028 to Veterinary Surgeon Level in Ireland Recall
28/01/2020 HPRA commences procedure to consider precautionary restrictions on the use of veterinary medicinal products containing the excipient diethanolamine Advisory
20/01/2020 Synulox Lactating Cow – Advisory notice Advisory
12/12/2019 European Medicines Agency advice on use of live attenuated PRRSV vaccines in pigs Advisory
03/12/2019 Recall of one batch of Cydectin 1% w/v Injectable Solution for Sheep, VPA10387/014/001 to Veterinary Surgeon / Licensed Merchant / Pharmacy Level Recall
21/10/2019 Suspension of marketing authorisation for Parofor 175 mg/ml solution for injection for pigs Advisory
28/08/2019 Santiola 50 mg/ml solution for injection for cattle and sheep - Change to the meat & offal withdrawal period Advisory
16/07/2019 Recall of one batch of Alfaxan Multidose 10mg/ml Solution for Injection for Dogs, Cats and Pet Rabbits, VPA10666/2/1 to Veterinary Surgeon level in Ireland Recall
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