Nobivac L4

(asked on 24th October 2018) - View Source

Question to the Department for Environment, Food and Rural Affairs:

To ask the Secretary of State for Environment, Food and Rural Affairs, when he plans to respond to the European Medicines Agency's report on the Nobivac Leptospirosis 4 vaccine on breeding dogs with particular regard to the high mortality rate.


Answered by
David Rutley Portrait
David Rutley
Parliamentary Under-Secretary (Foreign, Commonwealth and Development Office)
This question was answered on 29th October 2018

The European Medicine’s Agency publishes the Veterinary Pharmacovigilance Public Bulletin. This document provides an update on pharmacovigilance issues relating to products authorised at an EU level. The March 2018 edition reports that the Committee for Medicinal Products for Veterinary Use (CVMP) has requested the marketing authorisation holder for Nobivac L4 Suspension for Injection for Dogs to provide a report focusing on all adverse events involving death or euthanasia. This report is still being assessed. At the current time, the CVMP considers that the benefits of use of this vaccine in preventing serious infection continue to outweigh the risks.

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