Respiporc FLUpan H1N1

inactivated influenza A virus/humanstrain: A/Jena/VI5258/2009(H1N1)pdm09

Opinion

On 13 September 2018, the Committee for Medicinal Products for Veterinary Use (CVMP) adopted a positive opinion1, recommending the granting of a variation to the terms of the marketing authorisation for the veterinary medicinal product RESPIPORC FLUpan H1N1. The marketing authorisation holder for this veterinary medicinal product is IDT Biologika GmbH

RESPIPORC FLUpan H1N1 is currently authorised as suspension for injection for pigs. The variation concerns widening of the limits for a finished product specification parameter (potency upper limit) and demonstration of safety in target animals. The variation introduces changes to the Summary of Product Characteristic (SPC) and other product information.

Detailed conditions for the use of this product are described in the updated summary of product characteristics (SPC), for which an updated version reflecting the changes will be published in the revised European public assessment report (EPAR) and will be available in all official European Union languages after the variation to the marketing authorisation has been granted by the European Commission.


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.

Key facts

Name
Respiporc FLUpan H1N1
Agency product number
EMEA/V/C/003993
International non-proprietary name (INN) or common name
  • inactivated influenza A virus/humanstrain: A/Jena/VI5258/2009(H1N1)pdm09
Species
Pigs
Active substance
  • inactivated influenza A virus/humanstrain: A/Jena/VI5258/2009(H1N1)pdm09
Date opinion adopted
13/09/2018
Company name
IDT Biologika GmbH
Status
Positive
Application type
Post-authorisation

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