Problem Or Issue:
Following an investigation, at the site of manufacture in another EU member state, of an issue around a lack of assurance in the Good Manufacturing Practice relating to one of the active substances included in Synulox LC, the HPRA, in December 2019 requested that batches of Synulox LC containing that ingredient be quarantined at wholesale level in Ireland. That quarantine has largely remained in place in the intervening period, subject to the availability of sufficient quantities of alternative lactating cow intramammary products.
Since the beginning of 2020, the HPRA has continued to actively monitor the supply of lactating cow intramammary products on the Irish market. From time to time, it has become apparent that the market demand for lactating cow intramammary products has exceeded the availability of sufficient quantities of suitable alternative products. In those instances, in the interests of animal welfare, the HPRA has permitted the interim supply of limited quantities of Synulox LC.
Actions To Be Taken:
In the event that suitable alternative lactating cow intramammary products are unavailable, veterinary practitioners may prescribe Synulox LC. Pharmacists and licensed merchants may dispense Synulox LC on foot of a veterinary prescription.
As is the position when an adverse event to a veterinary medicine is suspected, all such events should always be reported to the marketing authorisation holder (Zoetis, in this case) and/or to the HPRA.
The HPRA is continuing to monitor the availability of alternative intramammary lactating cow products and will update the situation based on developments.