Clynav - opinion on variation to marketing authorisation

Opinion

EMA has issued an opinion on a change to this medicine's authorisation.

salmon pancreas disease vaccine (recombinant DNA plasmid)

Opinion

On 20 February 2020, 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 Clynav. The marketing authorisation holder for this veterinary medicinal product is Elanco GmbH.

Clynav is currently authorised as a solution for injection. The variation concerns extending the duration of immunity from 3 months after vaccination to 12 months after vaccination.

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.

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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.

CVMP post-authorisation summary of positive opinion for Clynav

AdoptedReference Number: EMA/CVMP/624348/2019

Key facts

• Name of medicine:
  Clynav
• EMA product number:
  EMEA/V/C/002390
• Active substance:
  pUK-SPDV-poly2#1 DNA plasmid coding for salmon pancreas disease virus proteins
• International non-proprietary name (INN) or common name:
  salmon pancreas disease vaccine (recombinant DNA plasmid)
• Species:
  Atlantic salmon
• Anatomical therapeutic chemical veterinary (ATCvet) code:
  QI10AX
• Marketing authorisation holder:
  Elanco GmbH
• Date of opinion:
  20/02/2020
• Status:
  Positive