Veterinary Medicines

HYOGEN EMULSION FOR INJECTION

Authorised
  • Mycoplasma hyopneumoniae, strain 2940, Inactivated
Download as PDF

Product identification

Medicine name:
HYOGEN EMULSION FOR INJECTION
Hyogen emulziós injekció sertések részére
Active substance:
  • Mycoplasma hyopneumoniae, strain 2940, Inactivated
Target species:
  • Pigs (for fattening)
Route of administration:
  • Intramuscular use

Product details

Active substance and strength:
  • Mycoplasma hyopneumoniae, strain 2940, Inactivated
    328.00
    enzyme-linked immunosorbent assay unit
    /
    2.00
    millilitre(s)
Pharmaceutical form:
  • Emulsion for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Pigs (for fattening)
      • All relevant tissues
        0
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QI09AB13
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Hungary
Package description:
  • Cardboard box of 5 bottles of 50 ml (5x25 doses)
  • Cardboard box of 1 bottle of 100 ml (1x50 doses)
  • Cardboard box of 5 bottles of 100 ml (5x50 doses)
  • Cardboard box of 1 bottle of 200 ml (1x100 doses)
  • Cardboard box of 5 bottles of 200 ml (5x100 doses)
  • Cardboard box of 200 ml in 1 bottle of 250 ml (1x100 doses)
  • Cardboard box of 5x200 ml in 5 bottles of 250 ml (5x100 doses)
  • Cardboard box of 1 bottle of 250 ml (1x125 doses)
  • Cardboard box of 5 bottles of 250 ml (1x125 doses)
  • Cardboard box of 1 bottle of 50 ml (1x25 doses)

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Full application - New active substance (Article 12(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Ceva-Phylaxia Zrt.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Ceva-Phylaxia Veterinary Biologicals Co. Ltd.
Responsible authority:
  • National Food Chain Safety Office
Authorisation number:
  • 3651/X/15 NÉBIH ÁTI
Date of authorisation status change:
Reference member state:
  • France
Procedure number:
  • FR/V/0278/001
Concerned member states:
  • Austria
  • Belgium
  • Bulgaria
  • Croatia
  • Cyprus
  • Czechia
  • Denmark
  • Estonia
  • Germany
  • Greece
  • Hungary
  • Ireland
  • Italy
  • Latvia
  • Lithuania
  • Netherlands
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Spain
  • Sweden
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

This document does not exist in this language (English). You can find it in another language below.
Hungarian (PDF)
Published on: 31/05/2022
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."