Respiporc FLUpan H1N1

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Questions & Answers

On 8 December 2016, the Committee for Medicinal Products for Veterinary Use (CVMP) adopted a negative opinion1, recommending the refusal of the granting of a marketing authorisation for the veterinary medicinal product Respiporc FLUpan H1N1 suspension for injection for pigs.

The applicant for this veterinary medicinal product is IDT Biologika GmbH.

The active substance of Respiporc FLUpan H1N1 is an inactivated influenza A virus/Jena/VI5258/2009 (H1N1)pdm09, and it is an immunological medicinal product (QI09AA03) developed for active immunisation of pigs against swine influenza caused by pandemic subtype H1N1.

The grounds for the negative opinion relate to efficacy and quality.

The CVMP, on the basis of quality, safety and efficacy data submitted, considers that the benefit-risk balance for Respiporc FLUpan H1N1 was not demonstrated to be favourable and therefore cannot recommend the granting of a marketing authorisation.


1Applicants 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 post-authorisation summary of negative opinion for Respiporc FLUpan H1N1 (English only) 2016-12-09  

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 adopted08/12/2016
Company name

IDT Biologika GmbH

StatusNegative
Application typeInitial authorisation