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
25/02/2021 Stresnil 40 mg/ml Solution for Injection for Pigs and Sedanol 40 mg/ml Solution for Injection for Pigs - change in withdrawal period (meat and offal) and restriction of injection volume Advisory
15/01/2021 Alamycin LA 200 mg/ml Solution for Injection (VPA 22664/016/001) - change in withdrawal periods (milk, meat and offal) and change in dosing instructions for sheep and pigs Advisory
02/10/2020 Veterinary medicinal products containing tylosin base (as a single active substance) presented as solutions for injection for intramuscular use in pigs – change in the withdrawal period for animal slaughter Advisory
09/06/2020 Synulox Lactating Cow – Advisory Notice Update Advisory
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
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
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