Bravecto (Fluralaner) – Conditions or restrictions regarding supply and use - QP53BX05
Updated on site: 08-Feb-2018
|Manufacturer:||Intervet International B.V|
A.MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Name and address of the manufacturer responsible for batch release
Intervet GesmbH Siemensstrasse 107 1210 Vienna AUSTRIA
Intervet UK Limited
Walton Manor, Walton,
Buckinghamshire, MK7 7AJ
B.CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
Veterinary medicinal product subject to prescription.
C.STATEMENT OF THE MRLs
D. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
Specific pharmacovigilance requirements:
The periodic safety update report (PSUR) cycle should be restarted for submission of 6 monthly reports (covering all authorised presentations of the product) for the next two years, followed by yearly reports for the subsequent two years and thereafter at 3 yearly intervals. The data lock point (DLP) for the next PSUR would be 31 August 2016.