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Medicinal Products

Product class: Authorized package
Medicinal product class: Veterinary medicine
Package code: 1510748
Name of medicinal product: Btvpur
Active substances:
Bluetongue virus vaccine
Estonian, English, Latin
ATC code: QI04AA02; QI02AA08
Dosage form: suspension for injection
Route of administration: subcutaneous use
Strengh:  
Amount in package: 100annus 1TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information:  
Indication: Active immunisation of sheep to prevent viraemia* and to reduce clinical signs caused by bluetongue virus serotypes 1, 2, 4 and/or 8 (combination of maximum 2 serotypes). Active immunisation of cattle to prevent viraemia* caused by bluetongue virus serotypes 1, 2, 4 and/or 8, and to reduce clinical signs caused by bluetongue virus serotypes 1, 4 and/or 8 (combination of maximum 2 serotypes). *below the level of detection by the validated RT-PCR method at 3.68 log10 RNA copies/ml, indicating no infectious virus transmission. Onset of immunity: 3 weeks (or 5 weeks in sheep for BTV2) after the primary vaccination course for BTV-1, BTV-2 (cattle), BTV-4 and BTV-8 serotypes. Duration of immunity: 1 year after primary vaccination course.
Safety features: No
Summary of product characteristics (SPC):
Package information leaflet (PIL): EST
Labelling:  
Withdrawal time: 0 päeva.
Species: veis, lammas
Last imported to Estonia: Never imported to Estonia
Marketing authorization holder: Boehringer Ingelheim Vetmedica GmbH 
Marketing authorization number: EU/2/10/113 
Marketing authorization issued on: December 17, 2010 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: Centralised 
Entry/Changing date: September 20, 2023
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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