Veterinary Medicines

PRIMUN BLUETONGUE S1-8 ONE SHOT

Authorised
  • Bluetongue virus, serotype 1, strain ALG2006/01 E1, Inactivated
  • Bluetongue virus, Serotype 8, strain BTV-8/BEL2006/02, Inactivated
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Product identification

Medicine name:
PRIMUN BLUETONGUE S1-8 ONE SHOT
Active substance:
  • Bluetongue virus, serotype 1, strain ALG2006/01 E1, Inactivated
  • Bluetongue virus, Serotype 8, strain BTV-8/BEL2006/02, Inactivated
Target species:
  • Sheep
Route of administration:
  • Subcutaneous use

Product details

Active substance and strength:
  • Bluetongue virus, serotype 1, strain ALG2006/01 E1, Inactivated
    1.28
    log10 serum neutralising unit(s)
    /
    1.00
    Dose
  • Bluetongue virus, Serotype 8, strain BTV-8/BEL2006/02, Inactivated
    1.40
    log10 serum neutralising unit(s)
    /
    1.00
    Dose
Pharmaceutical form:
  • Suspension for injection
Withdrawal period by route of administration:
  • Subcutaneous use
    • Sheep
      • All relevant tissues
        0
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QI04AA02
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription except for some pack sizes
Authorisation status:
  • Valid
Authorised in:
  • France
Package description:

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Full application - Known active substance (Article 12(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Laboratorios Calier S.A.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Laboratorios Calier S.A.
Responsible authority:
  • National Veterinary Medicines Agency
Authorisation number:
  • FR/V/1571453 2/2010
Date of authorisation status change:

Documents

Summary of Product Characteristics

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French (PDF)
Published on: 7/04/2022
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