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Ovilis Enzovax Lyophilisate and solvent for suspension for injection for sheep

Not authorised
  • Chlamydia abortus, strain 1B (thermosensitive), Live
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Product identification

Medicine name:
Ovilis Enzovax Lyophilisate and solvent for suspension for injection for sheep
Active substance:
  • Chlamydia abortus, strain 1B (thermosensitive), Live
Target species:
  • Sheep
Route of administration:
  • Subcutaneous use
  • Intramuscular use

Product details

Active substance and strength:
  • Chlamydia abortus, strain 1B (thermosensitive), Live
    100000.00
    fluorescent focus forming unit(s)
    /
    1.00
    Dose
Pharmaceutical form:
  • Lyophilisate and solvent for suspension for injection
Withdrawal period by route of administration:
  • Subcutaneous use
    • Sheep
      • Meat and offal
        7
        day
  • Intramuscular use
    • Sheep
      • Meat and offal
        7
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QI04AE01
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Surrendered
Authorised in:
  • Slovakia
Package description:
  • (ID3): 1 Box with 10 Box with (1 Bottle (Glass) with 1 Dose and 1 Bottle (Glass) with 2 millilitre(s)) (10 Dose, 20 millilitre(s))
  • (ID7): 1 Box with 100 Box with (1 Bottle (Glass) with 1 Dose and 1 Bottle (Glass) with 2 millilitre(s)) (100 Dose, 200 millilitre(s))
  • (ID6): 1 Box with 50 Box with (1 Bottle (Glass) with 1 Dose and 1 Bottle (Glass) with 2 millilitre(s)) (50 Dose, 100 millilitre(s))
  • (ID4): 1 Box with 20 Box with (1 Bottle (Glass) with 1 Dose and 1 Bottle (Glass) with 2 millilitre(s)) (20 Dose, 40 millilitre(s))

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Immunological veterinary medicinal product application (Article 13d of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Intervet International B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Intervet International B.V.
Responsible authority:
  • Institute For State Control Of Veterinary Biologicals And Medicaments
Authorisation number:
  • 97/023/MR/08-S
Date of authorisation status change:
Reference member state:
  • Germany
Procedure number:
  • DE/V/0246/001

Documents

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Slovak (PDF)
Published on: 2/03/2022
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