Respiporc FLUpan H1N1

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Questions & Answers

On 16 March 2017 the Committee for Medicinal Products for Veterinary Use (CVMP) adopted a positive final opinion1, recommending the granting of a marketing authorisation for the veterinary medicinal product RESPIPORC FLUpan H1N1 suspension for injection for pigs, intended for active immunisation of pigs against swine influenza caused by pandemic subtype H1N1v further to a re-examination of the initial opinion adopted by CVMP on 8 December 2016. The applicant for this veterinary medicinal product is IDT Biologika GmbH.

RESPIPORC FLUpan H1N1 is an inactivated vaccine containing influenza virus A/Jena/VI5258/2009(H1N1)pdm09 (ATCvet code QI09AA03) as active substance. It stimulates an active immunity against pandemic porcine influenza A/Jena/VI5258/2009 (H1N1)pandemic09-like virus. It induces neutralising and haemagglutination-inhibiting antibodies against this subtype.

The benefits of RESPIPORC FLUpan H1N1 are its active immunisation of pigs from the age of 8 weeks onwards against pandemic H1N1 porcine influenza virus to reduce viral lung load and viral excretion. The most common side effects are transient increase in rectal temperature and transient swelling up at the site of injection.

Detailed conditions for the use of this product will be described in the summary of product characteristics (SPC) which will be published in the European public assessment report (EPAR) and will be available in all official European Union languages after the marketing authorisation has been granted by the European Commission.

The CVMP, on the basis of quality, safety and efficacy data submitted, considers that there is a favourable benefit-risk balance for RESPIPORC FLUpan H1N1 and therefore recommends the granting of the marketing authorisation.


1 Applicants may appeal any CVMP opinion, provided they notify the European Medicines Agency in writing of their intention to appeal within 15 days of receipt of the opinion.

Name Language First published Last updated
CVMP summary of positive opinion for RESPIPORC FLUpan H1N1 (English only) 2017-03-17  

Key facts

Product details for Respiporc FLUpan H1N1
NameRespiporc FLUpan H1N1
INN or common name

influenza A virus/Jena/VI5258/2009 (PanH1N1), inactivated

Active substance

influenza A virus/Jena/VI5258/2009 (PanH1N1), inactivated

Date opinion adopted16/03/2017
Company name

IDT Biologika GmbH

StatusPositive
Application typeInitial authorisation