Bravecto (Fluralaner) – Conditions or restrictions regarding supply and use - QP53BX05

Updated on site: 21-Sep-2017

Medication name: Bravecto
ATC: QP53BX05
Substance: Fluralaner
Manufacturer: Intervet International B.V

A.MANUFACTURER RESPONSIBLE FOR BATCH RELEASE

Name and address of the manufacturer responsible for batch release

Chewable tablets:

Intervet GesmbH Siemensstrasse 107 1210 Vienna AUSTRIA

Spot-on solution:

Intervet UK Limited

Walton Manor, Walton,

Milton Keynes,

Buckinghamshire, MK7 7AJ

UNITED KINGDOM

B.CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE

Veterinary medicinal product subject to prescription.

C.STATEMENT OF THE MRLs

Not applicable.

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.

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