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Medicinal Products

Product class: Medicinal product with marketing authorization
Medicinal product class: Veterinary medicine
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
Strength: 1annus 0.05ml
Legal status for supply*: Subject to medicinal prescription
Summary of product characteristics (SPC):
Package information leaflet (PIL): EST
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
Marketing authorization holder: Elanco GmbH 
Marketing authorization number: EU/2/16/197 
Marketing authorization issued on: June 27, 2017 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: Centralised 
Assessment report:   
Package code Name of medicinal product Dosage form Package Legal status Reimbursements Reference price Last imported PƤritolumaa Additional information
1750890  Clynav  solution for injection  1annus 0.05ml 250ml 1TK  Prescription           
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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