Veterinary Medicines

HYOGEN EMULSION FOR INJECTION

Authorised
  • Mycoplasma hyopneumoniae, strain 2940, Inactivated
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Product identification

Medicine name:
HYOGEN EMULSION FOR INJECTION
Mhyogen Vet. 5,5 ELISA enheder/ml injektionsvæske, emulsion
Active substance:
  • Mycoplasma hyopneumoniae, strain 2940, Inactivated
Target species:
  • Pig (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
    • Pig (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:
  • Denmark
Package description:
  • Cardboard box of 1 bottle of 50 ml (1x25 doses)
  • Cardboard box of 5 bottles of 250 ml (5x125 doses)
  • Cardboard box of 1 bottle of 250 ml (1x125 doses)
  • Cardboard box of 5x200 ml in 5 bottles of 250 ml (5x100 doses)
  • Cardboard box of 200 ml in 1 bottle of 250 ml (1x100 doses)
  • Cardboard box of 5 bottles of 200 ml (5x100 doses)
  • Cardboard box of 1 bottle of 200 ml (1x100 doses)
  • Cardboard box of 5 bottles of 100 ml (5x50 doses)
  • Cardboard box of 1 bottle of 100 ml (1x50 doses)
  • Cardboard box of 5 bottles of 50 ml (5x25 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 Zrt.
Responsible authority:
  • Danish Medicines Agency
Authorisation number:
  • 53768
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

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Danish (, INJEKTIONSVÆSKE, EMULSION 5,5 ELISA-ENHEDER-ML)
Published on: 4/05/2022
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