Veterinary Medicines

CEVAC ND-IB-EDS K injekčná emulzia

Authorised
  • Newcastle disease virus, strain La Sota, Inactivated
  • Avian infectious bronchitis virus, type Massachusetts, strain M41, Inactivated
  • Eggdrop syndrome-1976 virus, strain B8/78, Inactivated
Download as PDF

Product identification

Medicine name:
CEVAC ND-IB-EDS K injekčná emulzia
Active substance:
  • Newcastle disease virus, strain La Sota, Inactivated
  • Avian infectious bronchitis virus, type Massachusetts, strain M41, Inactivated
  • Eggdrop syndrome-1976 virus, strain B8/78, Inactivated
Target species:
  • Chicken
Route of administration:
  • Subcutaneous use
  • Intramuscular use

Product details

Active substance and strength:
  • Newcastle disease virus, strain La Sota, Inactivated
    1.00
    Protective Dose
    /
    0.50
    millilitre(s)
  • Avian infectious bronchitis virus, type Massachusetts, strain M41, Inactivated
    6.00
    log2 haemagglutination inhibiting unit(s)
    /
    0.50
    millilitre(s)
  • Eggdrop syndrome-1976 virus, strain B8/78, Inactivated
    7.00
    log2 haemagglutination inhibiting unit(s)
    /
    0.50
    millilitre(s)
Pharmaceutical form:
  • Emulsion for injection
Withdrawal period by route of administration:
  • Subcutaneous use
    • Chicken
      • All relevant tissues
        0
        day
  • Intramuscular use
    • Chicken
      • All relevant tissues
        0
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QI01AA13
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Slovakia
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:
  • Ceva Animal Health Slovakia s.r.o.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Ceva-Phylaxia Zrt.
Responsible authority:
  • Institute For State Control Of Veterinary Biologicals And Medicaments
Authorisation number:
  • 97/050/03-S
Date of authorisation status change:

Documents

Combined File of all Documents

This document does not exist in this language (English). You can find it in another language below.
Slovak (PDF)
Published on: 21/12/2021
Download
How useful was this page?:
No votes yet
"Please do not include any personal data, such as your name or contact details. If you do, you consent to the processing of that data in accordance with EMA’s Privacy Statement concerning requests for information or access to documents. If you would like a reply from EMA, please Send a question to EMA instead."