ClynavpUK-SPDV-poly2#1 DNA plasmid coding for salmon pancreas disease virus proteins

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This is a summary of the European public assessment report (EPAR) for Clynav. It explains how the Agency assessed this veterinary medicine to recommend its authorisation in the European Union (EU) and its conditions of use. It is not intended to provide practical advice on how to use Clynav.

For practical information about using Clynav, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.

What is Clynav and what is it used for?

Clynav is a veterinary vaccine used in Atlantic salmon to protect them against pancreas disease caused by salmonid alphavirus subtype 3 (SAV3). Pancreas disease in Atlantic salmon can lead to impaired daily weight gain, lesions of the heart, pancreas and skeletal muscle as well as death.

Clynav contains as active substance a DNA plasmid (a small piece of DNA) containing the genetic code for making salmon pancreas disease virus proteins.

For further information, see the package leaflet.

How is Clynav used?

Clynav is available as a solution for injection and can only be obtained with a prescription.

The vaccine is given to anaesthetised fish as a single injection into epaxial muscle (muscle of the upper half of the fish) in the area to the front and side of the dorsal fin. The time for protection to develop following vaccination depends on the water temperature: protection starts within 399 degree days, calculated as mean water temperature in °C multiplied by number of days, for example 40 days at a water temperature of 10 °C. Protection lasts approximately three months after vaccination at average water temperature of 12 ±2 °C.

How does Clynav work?

Clynav is a DNA vaccine. Vaccines work by ‘teaching’ the immune system (the body’s natural defences) how to defend itself against a disease. Clynav contains a DNA plasmid which, once injected into fish, will lead to the production of salmon pancreas disease virus (SPDV) proteins. The immune system recognises these virus proteins as ‘foreign’ and makes defences against them. In the future, if the fish are exposed to the virus, the immune system will be able to respond more quickly. This will help to protect against the disease.

What benefits of Clynav have been shown in studies?

Six laboratory studies were conducted in fresh water and sea water to show how effective the vaccine was in protecting salmon from disease caused by SPDV. A main laboratory model study looked at the signs of pancreas disease in fish given Clynav compared with a dummy saline injection. Following artificial infection by co-habitation with infected salmon 29 days and 3 months after vaccination, fish vaccinated with Clynav had improved weight gain, reduced heart, pancreas and skeletal muscle lesions and reduced risk of death compared to fish injected with the dummy saline injection.

What are the risks associated with Clynav?

The most common side effects with Clynav (which may affect more than 1 in 10 fish) are short lived changes in swimming behaviour for up to two days, altered pigmentation (colouration) for up to seven days and lack of appetite for up to nine days. Needle injuries at the site of injection are common following vaccination and can persist for at least 90 days.

For the full list of all side effects reported with Clynav, see the package leaflet.

What are the precautions for the person who gives the medicine or comes into contact with the animal?

Direct contact should be avoided and protective equipment (for example protective gloves) should be worn when handling the medicine.

In case of accidental needle stick or self-injection, medical advice should be sought immediately and the package leaflet or label shown to the doctor.

What is the withdrawal period in food-producing animals?

The withdrawal period is the time required after administration of a medicine before an animal can be slaughtered and the meat used for human consumption.

The withdrawal period for fish from Atlantic salmon treated with Clynav is ‘zero’ days, which means there is no mandatory waiting time.

Why is Clynav approved?

The Agency’s Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Clynav’s benefits are greater than its risks and recommended that it be approved for use in the EU.

Other information about Clynav

The European Commission granted a marketing authorisation valid throughout the EU for Clynav on 27/06/2017.

For more information about treatment with Clynav, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.

Name Language First published Last updated
Clynav : EPAR - Summary for the public BG = bălgarski 2017-07-20  
Clynav : EPAR - Summary for the public ES = español 2017-07-20  
Clynav : EPAR - Summary for the public CS = čeština 2017-07-20  
Clynav : EPAR - Summary for the public DA = dansk 2017-07-20  
Clynav : EPAR - Summary for the public DE = Deutsch 2017-07-20  
Clynav : EPAR - Summary for the public ET = eesti keel 2017-07-20  
Clynav : EPAR - Summary for the public EL = elliniká 2017-07-20  
Clynav : EPAR - Summary for the public EN = English 2017-07-20  
Clynav : EPAR - Summary for the public FR = français 2017-07-20  
Clynav : EPAR - Summary for the public IT = italiano 2017-07-20  
Clynav : EPAR - Summary for the public LV = latviešu valoda 2017-07-20  
Clynav : EPAR - Summary for the public LT = lietuvių kalba 2017-07-20  
Clynav : EPAR - Summary for the public HU = magyar 2017-07-20  
Clynav : EPAR - Summary for the public MT = Malti 2017-07-20  
Clynav : EPAR - Summary for the public NL = Nederlands 2017-07-20  
Clynav : EPAR - Summary for the public PL = polski 2017-07-20  
Clynav : EPAR - Summary for the public PT = português 2017-07-20  
Clynav : EPAR - Summary for the public RO = română 2017-07-20  
Clynav : EPAR - Summary for the public SK = slovenčina 2017-07-20  
Clynav : EPAR - Summary for the public SL = slovenščina 2017-07-20  
Clynav : EPAR - Summary for the public FI = suomi 2017-07-20  
Clynav : EPAR - Summary for the public SV = svenska 2017-07-20  
Clynav : EPAR - Summary for the public HR = Hrvatski 2017-07-20  

This EPAR was last updated on 20/07/2017 .

Authorisation details

Product details

Product details for Clynav
NameClynav
Agency product numberEMEA/V/C/002390
Active substancepUK-SPDV-poly2#1 DNA plasmid coding for salmon pancreas disease virus proteins
International non-proprietary name (INN) or common nameSalmon pancreas disease vaccine (recombinant DNA plasmid)
Species Atlantic salmon
Anatomical therapeutic chemical veterinary (ATCvet) codes QI10AX


Publication details

Publication details for Clynav
Marketing-authorisation holder

Elanco Europe Limited

Revision0
Date of issue of marketing authorisation valid throughout the European Union27/06/2017

Contact address:

Elanco Europe Limited
Lilly House
Priestley Road
Basingstoke
Hampshire RG24 9NL
United Kingdom

Product information

Product information

22/04/2016  Clynav -EMEA/V/C/002390

Name Language First published Last updated
Clynav : EPAR - Product Information HR = Hrvatski 2017-07-20  
Clynav : EPAR - Product Information HR = Hrvatski 2017-07-20  
Clynav : EPAR - Product Information HR = Hrvatski 2017-07-20  
Clynav : EPAR - Product Information HR = Hrvatski 2017-07-20  
Clynav : EPAR - Product Information HR = Hrvatski 2017-07-20  
Clynav : EPAR - Product Information HR = Hrvatski 2017-07-20  
Clynav : EPAR - Product Information HR = Hrvatski 2017-07-20  
Clynav : EPAR - Product Information HR = Hrvatski 2017-07-20  
Clynav : EPAR - Product Information HR = Hrvatski 2017-07-20  
Clynav : EPAR - Product Information HR = Hrvatski 2017-07-20  
Clynav : EPAR - Product Information HR = Hrvatski 2017-07-20  
Clynav : EPAR - Product Information HR = Hrvatski 2017-07-20  
Clynav : EPAR - Product Information HR = Hrvatski 2017-07-20  
Clynav : EPAR - Product Information HR = Hrvatski 2017-07-20  
Clynav : EPAR - Product Information HR = Hrvatski 2017-07-20  
Clynav : EPAR - Product Information HR = Hrvatski 2017-07-20  
Clynav : EPAR - Product Information HR = Hrvatski 2017-07-20  
Clynav : EPAR - Product Information HR = Hrvatski 2017-07-20  
Clynav : EPAR - Product Information HR = Hrvatski 2017-07-20  
Clynav : EPAR - Product Information HR = Hrvatski 2017-07-20  
Clynav : EPAR - Product Information HR = Hrvatski 2017-07-20  
Clynav : EPAR - Product Information HR = Hrvatski 2017-07-20  
Clynav : EPAR - Product Information HR = Hrvatski 2017-07-20  
Clynav : EPAR - Product Information HR = Hrvatski 2017-07-20  
Clynav : EPAR - Product Information HR = Hrvatski 2017-07-20  

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.


Name Language First published Last updated
Clynav : EPAR - All Authorised presentations HR = Hrvatski 2017-07-20  
Clynav : EPAR - All Authorised presentations HR = Hrvatski 2017-07-20  
Clynav : EPAR - All Authorised presentations HR = Hrvatski 2017-07-20  
Clynav : EPAR - All Authorised presentations HR = Hrvatski 2017-07-20  
Clynav : EPAR - All Authorised presentations HR = Hrvatski 2017-07-20  
Clynav : EPAR - All Authorised presentations HR = Hrvatski 2017-07-20  
Clynav : EPAR - All Authorised presentations HR = Hrvatski 2017-07-20  
Clynav : EPAR - All Authorised presentations HR = Hrvatski 2017-07-20  
Clynav : EPAR - All Authorised presentations HR = Hrvatski 2017-07-20  
Clynav : EPAR - All Authorised presentations HR = Hrvatski 2017-07-20  
Clynav : EPAR - All Authorised presentations HR = Hrvatski 2017-07-20  
Clynav : EPAR - All Authorised presentations HR = Hrvatski 2017-07-20  
Clynav : EPAR - All Authorised presentations HR = Hrvatski 2017-07-20  
Clynav : EPAR - All Authorised presentations HR = Hrvatski 2017-07-20  
Clynav : EPAR - All Authorised presentations HR = Hrvatski 2017-07-20  
Clynav : EPAR - All Authorised presentations HR = Hrvatski 2017-07-20  
Clynav : EPAR - All Authorised presentations HR = Hrvatski 2017-07-20  
Clynav : EPAR - All Authorised presentations HR = Hrvatski 2017-07-20  
Clynav : EPAR - All Authorised presentations HR = Hrvatski 2017-07-20  
Clynav : EPAR - All Authorised presentations HR = Hrvatski 2017-07-20  
Clynav : EPAR - All Authorised presentations HR = Hrvatski 2017-07-20  
Clynav : EPAR - All Authorised presentations HR = Hrvatski 2017-07-20  
Clynav : EPAR - All Authorised presentations HR = Hrvatski 2017-07-20  
Clynav : EPAR - All Authorised presentations HR = Hrvatski 2017-07-20  
Clynav : EPAR - All Authorised presentations HR = Hrvatski 2017-07-20  

Pharmacotherapeutic group

Solution for injection

Therapeutic indication

For the active immunisation of Atlantic salmon to reduce impaired daily weight gain, and reduce mortality, and cardiac, pancreatic and skeletal muscle lesions caused by pancreas disease following infection with salmonid alphavirus subtype 3 (SAV3).

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated

Initial marketing-authorisation documents

Name Language First published Last updated
Clynav : EPAR - Public assessment report HR = Hrvatski 2017-07-20  
CVMP summary of positive opinion for Clynav HR = Hrvatski 2016-04-22