Product class: Authorized package
Medicinal product class: Veterinary medicine
Package code: 1750890
Name of medicinal product: Clynav
Active substances:
Salmon pancreas disease virus, DNA plasmid pUK-SPDV-poly2#1 encoding structural polyprotein
Estonian, English, Latin
ATC code: QI10AA02
Dosage form: solution for injection
Route of administration: intramuscular use
Strengh: 1annus 0.05ml
Amount in package: 250ml 1TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information:  
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). Onset of immunity occurs within 399 degree days (mean water temperature in °C multiplied by number of holding days) following vaccination. Duration of immunity: 1 year for reduction in impaired daily weight gain, and cardiac, pancreatic and skeletal muscle lesions and 9.5 months for reduction of mortality (demonstrated in a laboratory efficacy study in saltwater conditions using a cohabitation challenge model).
Safety features: No
Summary of product characteristics (SPC):
Package information leaflet (PIL): EST
Labelling:  
Withdrawal time: 0 kraadööpäeva
Species: atlandi lõhe
Last imported to Estonia: Never imported to Estonia
Marketing authorization holder: Elanco GmbH 
Marketing authorization number: EU/2/16/197 
Marketing authorization issued on: 27 June 2017 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: Centralised 
Entry/Changing date: 04 July 2022
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription