Veterinary Medicines

Zylexis > 230 IFN/ml Liofilizat i rozpuszczalnik do sporządzania zawiesiny do wstrzykiwań

Authorised
  • Orf virus, strain D1701, Inactivated
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Product identification

Medicine name:
Zylexis > 230 IFN/ml Liofilizat i rozpuszczalnik do sporządzania zawiesiny do wstrzykiwań
Active substance:
  • Orf virus, strain D1701, Inactivated
Target species:
  • Cattle
  • Horse
  • Cat
  • Pig
  • Dog
Route of administration:
  • Intramuscular use
  • Subcutaneous use

Product details

Active substance and strength:
  • Orf virus, strain D1701, Inactivated
    10000000.00
    50% tissue culture infectious dose
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Lyophilisate for suspension for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Cattle
      • Meat and offal
        0
        day
    • Horse
      • Meat and offal
        0
        day
    • Pig
      • Meat and offal
        0
        day
  • Subcutaneous use
    • Cattle
      • Meat and offal
        0
        day
    • Horse
      • Meat and offal
        0
        day
    • Pig
      • Meat and offal
        0
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QL03AX
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Poland
Available in:
  • Poland
Package description:

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Full application (Article 12(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Zoetis Polska Sp. z o.o.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Zoetis Belgium SA
Responsible authority:
  • Office For Registration Of Medicinal Products Medical Devices And Biocidal Products
Authorisation number:
  • 1329
Date of authorisation status change:

Documents

Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Polish (PDF)
Published on: 4/02/2022
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Summary of Product Characteristics

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Polish (PDF)
Published on: 4/02/2022
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Labelling

This document does not exist in this language (English). You can find it in another language below.
Polish (PDF)
Published on: 4/02/2022
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