Veterinary Medicines

ZYLEXIS, Lyofilizát a rozpouštědlo pro injekční suspenzi

Authorised
  • Orf virus, strain D1701, Inactivated
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Product identification

Medicine name:
ZYLEXIS, Lyofilizát a rozpouštědlo pro injekční suspenzi
Active substance:
  • Orf virus, strain D1701, Inactivated
Target species:
  • Dog
  • Cat
  • Horse
  • Cattle
  • Pig
Route of administration:
  • Subcutaneous use
  • Intramuscular use

Product details

Active substance and strength:
  • Orf virus, strain D1701, Inactivated
    1.00
    relative potency
    /
    1.00
    Dose
Pharmaceutical form:
  • Lyophilisate and solvent for suspension for injection
Withdrawal period by route of administration:
  • Subcutaneous use
    • Dog
    • Cat
  • Intramuscular use
    • Horse
      • Meat and offal
        0
        day
      • Milk
        0
        hour
    • Cattle
      • Meat and offal
        0
        day
      • Milk
        0
        hour
    • 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:
  • Czechia
Available in:
  • Czechia
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 Ceska Republika s.r.o.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Zoetis Belgium SA
Responsible authority:
  • Institute For State Control Of Veterinary Biologicals And Medicaments
Authorisation number:
  • 97/079/03-C
Date of authorisation status change:

Documents

Summary of Product Characteristics

This document does not exist in this language (English). You can find it in another language below.
Czech (PDF)
Published on: 10/07/2024
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Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Czech (PDF)
Published on: 10/07/2024
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Labelling

This document does not exist in this language (English). You can find it in another language below.
Czech (PDF)
Published on: 26/10/2022
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